|
The European Union has adopted a regulation allowing streamlined approvals for gene-edited plants — a development that seed and biotech companies are lauding as a breakthrough on a continent known for its strict oversight of agricultural production.
The EU Parliament quickly rejected amendments that supporters said would have killed the deal, which was reached after years of discussions.
"The new EU rules mark a shift towards regulating plants on the basis of what they finally look like genetically and not how they were made," according to a press release issued after the approval by the Parliament's Committee on Environment, Public Health and Food Safety.
The regulation on New Genomic Techniques, or NGTs, divides gene-edited plants into two categories — NGT1 and NGT2. The former includes plants that differ from their parent plant “by no more than 20 genetic modifications." The latter would include everything else derived from NGTs, including seeds that are tolerant to herbicides or insecticides.
Getting legislation through the “trilogue” system involving the European Commission, the European Council and the Parliament is “a laborious process,” said Peter Beetham, president and chief operating officer of Cibus. The company develops and licenses “advanced plant traits that enable higher yields, lower input costs, and more sustainable farming,” according to its website.
“The outcome is really pretty clean,” he said. NGT1 is “basically … indistinguishable from what can occur in nature or in a plant breeding program.”
Under the regulation, NGT1 seeds would have to be labeled, but not foods grown with those seeds. NGT2 seeds would still require full labeling.
“Following intensive discussions and negotiations, the Council and the European Parliament negotiators agreed on a compromise text that assures transparency for conventional-like NGT1 seeds for farmers and growers through seed bag labelling while safeguarding practical feasibility and economic viability for subsequent operators,” according to a June 1 letter to members of the European Parliament from a host of organizations in the “agri-food value chain.”
Signers include COPA-COGECA, which represents farmers and co-ops, commodity groups, the biotech industry and the snacks industry.
“There's huge support across different industries, because those companies and associations see that the world around us is moving ahead, and of course, there's also the aspect of being able to compete with other industries around the world,” said Petra Jorasch, an adviser on plant breeding, innovation and research for European seed association Euroseeds.
Petra Jorasch (Euroseeds photo)Jorasch says companies have been waiting for the new regulatory regime. A startup in Sweden has developed a new potato with an improved starch that is “ready to go to the market,” she said. “They're just waiting for the implementation of the regulation, and then they will be going for commercial cultivation of this potato in Sweden, and maybe also in other countries.”
Cut through the clutter! We deliver the news you need to stay informed about farm, food and rural issues. Sign up for a FREE month of Agri-Pulse here.
Changes won’t happen overnight. Implementation of the regulation will take 12-24 months, though it could be shorter in countries with more robust agricultural production such as France, Germany and the Netherlands, Beetham said.
“Farmers won't see anything probably for three years,” he said. “So, somewhere between 2028 and 2030 is when farmers are going to see crops coming with gene-edited traits.”
Opponents including the organics industry in Europe criticized the regulation for not requiring “full supply chain traceability and consumer labelling,” according to IFOAM Organics Europe, an umbrella organization for organic food and farming. They also say the new rules “would provide seed companies even more legal leeway to patent plant properties of any origin” and primarily benefit large multinationals.
Jorasch notes that labeling is still required on seeds, even if they are in the NGT1 category.
“In addition, the regulation does foresee a database in which all plants that were verified as NGT1 are listed with an identification number,” she says. “If those plants are further developed into varieties that have to be registered for the EU market in order to be marketable the EU variety catalogue needs to include the identification number as well as the info that it is an NGT1 variety.”
Organic farmers “or other value chains that want to produce without NGTs” can use seeds of varieties that are non-NGT, she adds. “We currently have 65.000 varieties of vegetables, fruits and agricultural crops listed in the EU catalogue and available on the EU market, so [there is] enough choice also for non-NGT production.”
On the patent issue, Jorasch and Beetham both say the new reg would create opportunities for small and mid-sized companies.
Jorasch says the patent language in the regulation “preserves strong incentives for innovation while introducing targeted safeguards to ensure fair access and transparency.” Innovators get legal certainty and additional measures are included “such as a code of conduct, enhanced transparency obligations for patents, and commitments to fair and reasonable licensing practices.”
Beetham says because traits can be developed with much less expense, and in a shorter time than conventional plant breeding, the new regulatory process won’t just benefit large multinationals.
“Local seed companies, more regional seed companies that have smaller breeding programs will be able to participate in this,” he says.
Gene editing can shave years off the process of developing genetically modified varieties, Beetham says, and cost much less. Bayer, for example, says it takes 16 and a half years on average and $115 million to bring a genetically modified crop to market.
Beetham says gene editing can pare two-thirds of the time off the process and cost in the “hundreds of thousands” of dollars.
“It's about a third of the time,” Beetham says. Companies will still have to ensure the seed is distinct, uniform and stable (DUS). Then, “you’ve still got to do the testing, got to make sure that the trait is validated in the field, and that the seed companies have got it in their best genetics.”
Cibus has developed traits to reduce pod shatter in canola and winter oilseed rape, Beetham said.
“I think the early traits will be around disease resistance or agronomic traits like reducing pod shatter and making crops more amenable to using fertilizer, so nitrogen-use efficiencies and things like that,” he says.
He predicts that perhaps around 2030, traits giving crops better shelf life and enhanced nutrition will arrive.
“There's some really cool things around what gene editing will do,” he says.
