The good news concerning approval by the EU Commission for imports of corn for food and feed containing Syngenta’s Agrisure Viptera trait for above ground insect control in corn production was a reminder of how slow the process of government approval of biotech events has been recently.  The global market for corn will continue to be fractured until international approvals are harmonized.

Syngenta received deregulation from USDA for the Agrisure Viptera trait (Event MIR162) in April 2010.  It began the EU authorization procedure in July of 2010 with submission of an application to the German government.  On June 21 of this year the European Food Safety Authority concluded that corn with the Agrisure Viptera trait is as safe as its non-genetically modified counterparts.  EU Commission approval came on October 18.  The technology had previously been approved for cultivation in Argentina, Brazil, Canada and the U.S. and for import for food and feed use in Australia, Japan, South Korea, Mexico, Philippines, Russia, Taiwan and four other countries.  The U.S., Brazil and Argentina are expected to be the number 1, 2 and 3 exporters of corn in 2012/13.  Ukraine, India and South Africa, the number 4, 5, and 6 exporters, have not approved the trait.

The Agrisure Viptera trait also has received approval in all major export markets recommended by the National Corn Growers Association (NCGA) and the Biotechnology Industry Organization (BIO).  European approval was not expected at the time of commercial release of the new trait.  Japan will be the world’s largest importer of corn for 2012/13, followed by Mexico and South Korea.  The number 4, 5 and 6 importers are expected to be Egypt, the EU and Taiwan.  With the EU approval, Egypt is the only one of the top six importers that has not approved Agrisure Viptera. Columbia, Iran and Malaysia are close together in volume of corn imports as the number 7, 8 and 9 importers and none of them have approved the trait.

The country of greatest concern that has not approved Agrisure Viptera is China.  When Syngenta began the regulatory process in the U.S., China was not an importer of corn and was not on the NCGA and BIO list of importing countries needing approval before commercial release of the trait.  China imported 0.047 million metric tons (MMT) of corn in 2008/09, 1.3 MMT in 2009/10 and 1.0 MMT in 2010/11.  China imported 5.5 MMT in 2011/12 and is projected by the Foreign Agricultural Service (FAS) of USDA to import 2.0 MMT this year.

During the 2011 U.S. corn harvest season some elevators refused to accept corn with the Agrisure Viptera trait or required special arrangements for fear corn from the facilities would be rejected if exported to China.  Ethanol plants that exported distillers dried grains with solubles (DDGS) and corn gluten feed (CGF) had the same concern.  The approval by the EU removes one market impediment, but China remains.  China requires approval in the original country and one other before it starts the approval process, which guarantees fractured international corn, DDGS and CGF markets.

In late summer of 2011, Syngenta expected Chinese approval to come in the first quarter of 2012, two years after March 2010 when Syngenta applied for approval in China, roughly the same time needed for approval of other traits.  The approval still has not come.

The regulators in China requested additional information from Syngenta in June of this year.  Some analysts speculate that the change of leaders of the Communist Party and the government that is now taking place has caused the approval process to be put on hold.  That happens in almost all countries when government transitions occur.  FAS expects China to have a record large corn crop of 200 MMT this year and imports will not be of critical importance over the next few months.  If U.S. corn prices were to decline further in coming months, the Chinese government may decide to import corn to rebuild stocks and the approval process would take on more importance.  If this is not resolved by spring of next year and the new Chinese corn crop has early weather problems, the issue could become critical.

The U.S. Grains Council, a U.S. non-profit group that promotes the exports of corn, other feed grains and products, in a press release expressed enthusiasm about the decision by the EU.   It also had a note of caution by Cary Sifferath, Senior Regional Director, that the relief by the EU approval may be only temporary.  New crop biotech events are in the U.S. pipeline and have not been approved by the EU.  Some may be planted by U.S. farmers next spring and enter the market in the fall of 2013.  If the approval process remains slow, movement of DDGS and CGF could again be stalled.  This would hurt U.S. corn and ethanol producers and EU livestock and poultry producers who recognize the economic benefits in their feed rations.

Agrisure Viptera MIR162 has a critical production role to play as a new mode of action for pest control.  This new mode should help delay the development of resistance to the Bt traits which are currently used for corn borer control.  The availability of multiple resistances allows Syngenta to offer reduced refuge products and increase farmer compliance with refuge requirements.

Syngenta may already have one of the new products that Sifferath of the Grains Council noted in his comments about Agrisure Viptera.  Agrisure Duracade, 5307, expressing Bt protein Cry3.1Ab, may be on the market as soon as 2014.  The company has completed consultations with the Food and Drug Administration and was just granted registration by the Environmental Protection Agency.  It has a mode of action different from other corn rootworm Bt’s and provides Syngenta a second corn rootworm trait to market a complete in-house reduced refuge package for both corn borers and corn rootworms.  Full USDA deregulation is the next step.

Major trading nations in all industries appear to understand the need to provide harmonization of regulations to increase economic efficiencies and expand trade.  That approach should be applied to crop biotechnology.  Since commercialization in 1996, crop biotechnology has expanded from mainly herbicide tolerance to a much broader range of applications.  The safety record of biotech crops and the needs of crop producers and consumers should encourage regulators to find ways to begin international harmonization for the industry.  Each nation has its own unique scientific and political institutions and constituency concerns to respect, but all would benefit from more efficient regulatory policies on biotechnology.

Ross Korves is an Economic Policy Analyst with Truth About Trade and Technology