DuPont Pioneer biotech seed corn trait 1507 passed a critical milestone in the EU regulatory process when it was not rejected for cultivation by a qualified majority of EU member states. The final step before commercialization is formal approval by the EU Commission. That probably is not the end of the regulatory road.
DuPont Pioneer first filed for EU approval in 2001for TC1507 (co-developed with Dow Chemical and known in the U.S. as Herculex) a trait for corn borer resistance. At that time Monsanto’s MON810 for corn borer control was the only biotech corn trait approved in the EU. Thirteen years later it is still the only approved biotech trait. Last year Monsanto started withdrawing applications to grow additional biotech crops in the EU. Over those 13 years corn 1507 has been cleared six times by the European Food Safety Agency (EFSA) and prevailed in two court cases. It received approval for import into the EU for feed use in 2005 and for food use in 2006. It also has been approved for importing in all major corn importing countries, including Japan and China.
Its current travel through the EU regulatory process is unique. In September of last year, the General Court of the European Union ruled on a case brought by DuPont-Pioneer in 2007 that the Commission failed to act on a cultivation request. It never had been referred to the Council of Ministers for a ruling.
The EU Commission acting as “Guardian of the Treaties” that created the EU complied with the court ruling in early November by referring the case to the Council of Ministers of the member states to act within three months. They sent the case to the 28 members of the Council of Environment Ministers to decide on cultivation or not in the EU as a whole. A ‘yes’ or ‘no’ vote on the cultivation decision required a qualified majority for or against. In the council’s voting system, each of the 28 country has a different number of votes depending on their population size and other factors. The 19 countries opposed to cultivation did not have the required “qualified majority” to turn down the commission’s proposal to approve cultivation. They had 210 votes of the 260 required to block the measure.
Five countries voted for cultivation: Estonia, Finland, Spain, Sweden, and the United Kingdom. None of those was a surprise. The remaining four abstained: Belgium, Czech Republic, Germany and Portugal. Germany would normally have likely voted against cultivation, but the new coalition government had not formed an official position at the time of the vote. It is normal for European coalition governments to abstain on a public policy issue where there are differences of opinions within the coalition leadership and a firm position has not been developed. With Germany on the sidelines, the anti-cultivation group of countries did not have a qualified majority and the issue was kicked back to the EU Commission.
According to EU Health Commissioner Tonio Borg, the Commission is obliged by law to grant authorization since the Council did not have a qualified majority in favor or opposed to cultivation. Borg has not indicated a timeline for action, but the issue is complicated.
When the Commission sent the corn 1507 issue to the Council of Ministers last November, Commissioner Borg said the Commission also took parallel action to reactivate a debate on the so-called ‘cultivation proposal’ from the Commission four years ago, which has already been approved by the European Parliament, but has been stuck in the Council of Ministers. This ‘cultivation proposal’ would allow member states to restrict or prohibit cultivation of biotech crops on their territories on grounds other than those relating to risks to health, safety and the environment. If the Commission said ‘yes’ to cultivation, a member state could still refuse to allow cultivation in its own country. Eight countries have already adopted measures that restrict planting of biotech crops. It would not change the procedure for authorizing food and feed use. The Environment Ministers are now expected to discuss the ‘cultivation proposal’ in March.
When the ‘cultivation proposal’ was made four years ago it was immediately seen as a trade issue. Under the WTO Agreement on Sanitary and Phytosanitary (SPS) Measures, a country can refuse to allow a practice for issues related to health, safety and the environment, but not for other reasons. The EU proposal appears to be inconsistent with WTO commitments.
This has also raised question about the ongoing talks for the U.S.-EU Transatlantic Trade and Investment Partnership trade agreement. Biotech crops are one of many SPS issues needing to be resolved.
The five year appointment of the current EU Commission will expire later this year. The ‘cultivation proposal’ was part of the discussion in creating the current Commission and will be again for the new one. As an indication of political pressures, the European Parliament in a non-binding vote in January voted against the approval of corn 1507, 385 to 201 with 30 abstentions. If the Commission does approve corn 1507, groups like Greenpeace will sue the Commission.
Despite all the debate over cultivating another biotech corn, 49 biotech traits have been authorized by the EU for human food and animal feed including 27 for corn, eight for cotton, seven for soybeans and three for canola. According to the International Service for the Acquisition of Agri-biotech Applications, five EU countries planted a record 364,000 acres of biotech corn in 2013, up 15% from 2012. Spain was the principal adopter planting 94% of the total biotech corn acreage in the EU.
DuPont Pioneer is ready to move ahead with commercialization. The DuPont Pioneer Communications Manager in Europe said after the Council vote, “We are now confident that the European Commission, based on the seven positive safety opinions published by the EFSA, will adopt the decision for approval again as required under E.U. law. 1507 maize meets all EU regulatory requirements and should be approved for cultivation without further delay.” Thirteen years in the regulatory process should be long enough, but it probably is not.