A report on Friday from USDA’s Foreign Agricultural Service (“EU Court Extends GMO Directive to New Plant Breeding Techniques,” by Jennifer Lappin) stated that, “On July 25, 2018, the Court of Justice of the European Union issued its judgment that organisms created through many newer genome editing techniques are to be regulated as genetically modified organisms (GMOs) in the EU. This decision subjects such organisms, and food and feed products containing these organisms, to expensive and lengthy approval processes as well as traceability, labelling, and monitoring obligations. In addition to affecting global agricultural trade, this judgment has significant consequences for EU innovation.”
The USDA update noted that, “Surprising many, the Court issued a judgment for ‘Case C-528/16 Confederation Paysanne and Others‘ taking a very restrictive view of how the EU’s main GMO legislation from 2001, ‘Directive 2001/18/EC,’ applies to organisms created by new plant breeding techniques such as CRISPR/Cas or Talen. Many scientists, breeders, and agri-food industry stakeholders had anticipated that the Court would categorize organisms derived from these newer mutagenic techniques as GMOs, but exempt them from the regulatory obligations in the Directive.
“Instead, the Court found that organisms produced with newer mutagenesis methods are subject to the regulatory obligations of the EU’s GMO Directive. As such, they will be subject to risk assessment and review requirements as they are applied to the cultivation and imports of transgenic varieties (incorporating foreign genes into the organism). For context, products approved for importation in 2017 under the GMO Directive took an average of six years to complete—five years for the risk assessment by the European Food Safety Authority and a year to garner Commission approval through the risk management process. Cultivation approvals, as well as new applications, for transgenic varietals have languished.”
Friday’s report stated that, “Under the EU’s GMO Directive 2001/18/EC, the EU focuses on the process of genetic alternation to determine what agricultural products are regulated. However, the EU’s GMO Directive exempts certain genetic modification techniques— notably for this case, ‘the mutagenesis exemption.’ In plant breeding, mutagenesis is a long-established technique that uses chemical, radiation, or other physical stimuli to induce mutations. Plant breeders then evaluate whether the genetic alternations have yielded beneficial properties. If so, these plants are selected for use in breeding programs. With the Directive’se xemption, plants developed through these common breeding techniques can enter the EU marketplace without additional GMO-related regulation. The EU’s GMO Directive does not have a legislative definition for mutagenesis. Although most new genome editing methods use mutagenesis in a more targeted manner than older techniques, the Court found that newer techniques are not covered by the ‘mutagenesis exemption.'”
The USDA update added, “The Commission has yet to react to the judgment. Follow on actions will likely have to wait until after the elections, as the European Commission and Parliament’s terms are coming to a close. The Commission’s election recess starts in October 2018, and the European Parliament’s recess usually starts by March with elections following in May of 2019.”
More information on the ruling is available here.
And Secretary of Agriculture Sonny Perdue responded to the ruling on Friday, noting in part that, “Government policies should encourage scientific innovation without creating unnecessary barriers or unjustifiably stigmatizing new technologies. Unfortunately, this week’s ECJ ruling is a setback in this regard in that it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms.”
