One of the challenges of crafting a new free trade agreement with the EU in the Transatlantic Trade and Investment Partnership (TTIP) negotiations is overcoming existing relationships that are less than desirable. The future cannot be worked on until the present framework is operational. That is certainly true for approval of new biotech traits for major crops.
The current situation is doubly frustrating in that the situation was supposedly clarified less than a year ago. In September of 2013 the European Court of Justice (ECJ) ruled the EU Commission had to act more quickly at certain stages of the existing approval process for biotech traits for crops. They were specifically to submit approval applications for cultivation to the highest responsible body without delay when lower-level committees cannot reach a conclusion.
This applied to traits that previously were found safe by the European Food Safety Authority (EFSA). Neither technical-level officials from the 28 member countries nor ministers from those countries could reach a qualified majority to approve or reject the traits. The EJC ruled that ‘without delay’ meant ‘swiftly’. When the technical-level officials cannot approve or reject with a qualified majority, the EU Commission was to swiftly send the proposal to the EU Council and if they could not decide swiftly, the Commission had to act swiftly. The Court also ruled the Commission cannot slow down the process by sending the application back to the EFSA for further review, which the Commission did seven times for the case before the court. Only once before, in 2010, had the EU Commission acted when technical-level officials and minister failed to approve or reject a trait by a qualified majority.
The court also rejected the EU Commission’s argument that biotech crops were a constantly evolving area of research and a ‘pause’ in approvals was appropriate because a new cultivation proposal aimed at addressing the political deadlock had been made by the Commission. New scientific information is likely to become available in the future, but decisions had to be made based on the current information. The proposal allowed member countries of the EU to block cultivation of a biotech trait that had been approved by EFSA.
The procedures for approving biotech traits for imports of food and feed are slightly different and generally less politically sensitive. Both function the same way and delays for import approvals are also common. The American Soybean Association and 18 other interested groups sent letters to the U.S. Trade Representative (USTR) Michael Froman and the EU Commission about nine biotech events (soybeans, corn cotton, and canola) waiting for approval for import for food and feed use. All have received positive opinions by the EFSA and some as long as five years. Several of the products are already commercialized under stewardship programs and risk trade disruptions if not approved in September.
Timing is particularly important because the current EU Commission’s term expires this fall. The U.S. industry had hoped for approval at the Commission’s July meeting. If approvals are not granted in September, they will likely not be granted before the new Commission meets in January. By then, some new traits may be in the transportation pipeline and perhaps already disrupting trade.
In the letter to USTR Froman, the groups asked him to consider referring the matter to a WTO compliance panel if the EU Commission continues to refuse to act on the applications in September. We have done that before. In 2006, a WTO panel found that the EU’s biotech regulatory process was not meeting its own time lines for reviewing and acting on applications for imports and use. The panel concluded these failures represented an effective moratorium on new approvals. Despite consistent findings by the EFSA of no human, animal or environmental risk, the Commission has repeatedly delayed decisions on these products. These delays raise concerns that the EU has a new de facto moratorium.
A new WTO case based on findings of the 2006 panel, which the EU accepted, would be helpful. The time required for EU decisions on new biotech crops has only lengthened since the earlier case. In the TTIP talks, the U.S. agricultural industry has said it wants the EU Commission to speed up the approval process within the current regulatory framework – not to revamp it altogether. If the Commission is incapable or unwilling to shorten the timelines with the current regulations, then broader reforms are needed.
The EU negotiators on TTIP have already said that changes in existing EU laws related to all sanitary and phytosanitary (SPS) issue are not possible. The current EU regulatory processes on a wide range of commodities are not acceptable to U.S. agriculture. At least on biotech crops, the EU court said the EU Commission is not following the law and the WTO says the EU Commission has not meeting its obligations. Something has to change.
That something goes back to the EU Commission’s point of a few years ago that knowledge about biotechnology was changing so rapidly that decisions could not be made for approving biotech traits. But the changes are just the opposite of expected. Instead of being a new technology that has to be heavily regulated to protect humankind from all sorts of unintended consequences, it has become a conventional technology planted on 4 billion acres across the globe that has worked much as expected by the scientists involved. And it has not harmed people or wildlife.
The EU has a precautionary regulatory mindset for a technology that has a 20-year track record of safe, effective use. This is not a call for no government regulations. It is a call for regulations that focus on unanswered question and not on regulations that so gum-up the process that it does not work.