The European Union is pushing to advance legislation by the end of the year that would update the bloc’s framework for regulating genetically modified plants.
The changes could spur investments in new technologies and streamline exports for U.S. farmers and researchers, but three people familiar with the framework's development say discussions around sustainability requirements and intellectual property remain key sticking points.
A legislative effort to ease EU restrictions on genetically edited products using new genomic techniques – also known as precision breeding – is currently the subject of intense trilogue negotiations between the bloc’s legislative and policymaking bodies.
The proposal, which was originally drafted by the European Commission in July 2023, would introduce a three-tier regulatory system for GM plants.
Under the proposal, plants with fewer than 20 genetic modifications that could, in theory, occur naturally through conventional breeding techniques would be treated the same as conventionally bred plants and exempt from risk assessment requirements. These would be classified as NGT1 plants.
Plants that have more than 20 gene edits but still only contain genes from the same species – classified as NGT2 plants – would face an adapted risk assessment on a case-by-case basis.
All other genetically modified plants would remain subject to the existing restrictions and requirements established in 2001.
Two legislative bodies have now weighed in, with the European Parliament giving feedback on the proposal last year, and the Council of the European Union outlining its position in March. Discussions are now underway to reconcile the three positions on the legislation. Officials are pushing to reach a compromise before the end of the year when Denmark’s Council presidency ends, according to multiple sources.
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Proponents of simplifying EU regulations “see a definite urgency on the issue,” Alexander Hissting, the managing director of the Berlin-based Association of Food without Genetic Engineering, told Agri-Pulse.
Cyprus will assume the Council presidency next year, and there is no guarantee it will prioritize the issue. Previous Council presidents, like Hungary, avoided advancing the legislation over opposition to GE crops, Hissting said.
A smaller country like Cyprus may also lack the resources and capacity to drive the issue forward, Hissting said.
Three people familiar with the discussions say they are at a critical juncture, with countries divided over how to handle sustainability issues and intellectual property rights.
A meeting document sent to the attaches in the Council’s working party on agricultural innovation by the Danish presidency at the end of October obtained by Agri-Pulse shows that several sustainability and IP proposals were under consideration as part of trilogue discussions.
Some participants wanted NGT1 status to be conditional on gene edits meeting at least one sustainability criterion. Others preferred an approach which makes NGT1 conditional on plants not having any of the criteria outlined in an exclusion list, according to one of the people familiar with discussions.
Others wanted a lighter-touch approach which would not make NGT1 status conditional on any sustainability requirements, but would offer incentives for the inclusion of specific sustainability-boosting traits.
Betting on a settlement
Some are already betting on a legislative outcome from the talks and a smoother path to market for certain GE products. On Monday, Enza Zaden, a European vegetable breeding company, announced a partnership with North Carolina-based Pairwise, which provides precision plant breeding tools.
The agreement covers gene editing for both research and future commercialization opportunities in the event of an updated regulatory framework.
Dan Jenkins, Pairwise’s vice president of regulatory and government affairs, told Agri-Pulse the deal would not have been likely without the EU’s recent moves towards updating its regulatory framework.
“It certainly had a positive effect there,” Jenkins said.
Dan Jenkins (Pairwise photo)Jenkins is bullish that the EU’s regulatory overhaul will create significant opportunities for U.S. biotech companies that could spur investment, innovation and technological breakthroughs.“It opens up the potential for business partnership, collaboration and creating new things or taking existing things to market," he said.
EU investment in plant breeding has been sluggish for several decades. European Framework Programs have been the main investment tool since the 1980s. While the programs’ budgets have increased 42% over the last two decades, spending on plant breeding has lagged significantly, growing at just 9%, according to data from the European Technology Platform’s Plant for the Future initiative, a stakeholder forum for the plant industry.
More streamlined regulatory processes could spur new investment. It could also bring down the costs of commercialization. Companies currently face costs of up to $115 million a year to bring a GMO trait to market, according to an analysis by CropLife. A significant proportion of the expenses are going toward regulatory compliance, Sam Crowell, senior director of international programs and policy at the American Seed Trade Association, told Agri-Pulse.
“That legal certainty and that unified approach in Europe and that single market is so important,” Crowell said. He said the benefits of Europe’s NGT proposal could go well beyond research, and lead to additional export opportunities for seeds and final ag products.
Reducing the costs of gene editing, as well as an uptick in European interest in gene editing crops, could have particularly significant impacts on specialty crops, said Jeffrey Nawn, CEO and cofounder of North Hill Group, a consulting firm that specializes in agricultural and food regulation.
A tighter European regulatory environment, which keeps commercialization costs higher, has resulted in commodity crops getting most of the gene editing interest and investment, Nawn said. Large companies have focused efforts on widely planted crops to ensure adequate returns on investment. With lower overheads, smaller specialty crops could get more attention.
But Nawn and Crowell also argue that looser restrictions on gene-edited commodities in Europe could boost yields and productivity in more established row crops and accelerate adoption of technologies in the U.S.
For bulk commodities that are commingled before export, growers must ensure their seeds comply with the regulatory regimes of all of their trading partners. Accordingly, when a major importer of U.S. food and ag products maintains a stringent regulatory regime on genetically edited products, Nawn said, “innovations get left on the shelf, and they don't make it to the field, and they don't benefit farmers or consumers.”
Europe is not alone in revisiting its regulatory framework for precision breeding, Nawn pointed out. Other countries in Asia and Central and South America are doing the same. The more countries streamline approvals and remove bureaucratic barriers to trading GE products, Nawn said, the bigger the catalyst for adoption.
But he noted that significant barriers still remain because of restrictions on precision breeding in important export U.S. destinations – including Mexico and South Korea.
“It's really important that our key trading partners put in place frameworks – gene editing frameworks – that allow for market access” and established streamlined and efficient regulatory procedures, like that under consideration in Europe, Nawn said. Jenkins adds China to that list.
The issue is particularly pressing, Nawn argued, because there will likely be a sharp influx of genome-edited crops that will be ready for the market in the next few years.
Jeffrey Nawn (LinkedIn photo)“A likely scenario is that there will be hundreds of different crops produced by hundreds of different companies,” Nawn said. “The strain that that will put on regulatory systems is going to be significant, particularly if the governments don't resource their regulatory assessment correctly, and if the technical requirements are too onerous.”
Implementation will be key
Even if the EU finds a legislative compromise before the end of the year and updates its regulatory framework, many of the opportunities for U.S. agriculture will depend on its implementation. If the commission imposes onerous reporting and eligibility requirements on companies as part of the implantation process, it could blunt the impacts.
“The fear for most of us that work in [regulation] is that Europe is going to put in place requirements that are not as streamlined as some of the other countries that are rapidly adopting gene-editing technology,” Nawn said.
Alice O’Donovan, secretary general of the European Liaison Committee for the Agricultural and Agri-food Trade, also recommended U.S. industry maintains “cautious optimism” around Europe’s NGT legislation.
“There's a long way to go,” she cautioned.
“It's not a case of, say, this thing comes to pass and then suddenly you can start shipping everything,” O’Donovan warned. The implementation process could take months, she argued. “It's going to be a journey.”
Jenkins also said the bloc needs to make sure that its approach of regulating plants based on the number of gene edits doesn’t hamper future technological breakthroughs.
Gene-edited crops are edited again and again to meet ever-evolving productivity and climate challenges, Jenkins said. The regulatory framework, Jenkins argued, should be robust enough to allow for future technology to build on the innovations of the past without coming up against the ceiling of 20 gene edits.
The EU should include “some sort of mechanism in their regulations that allows for them to consider whether or not they could improve that approach in the future,” Jenkins said. “But I think as a starting point, it's actually pretty good.”
