To regulate or not to regulate: Current legal status for gene-edited crops

Posted 4th May 2018 by Jane Williams

Gene editing is the latest and sexiest DNA editing tool in the continuum of plant breeding innovations. With genetically modified organism (GMO) technology, scientists introduce “foreign” genes, i.e. genes from a different organism, into crops. With gene editing, scientists create additional genetic variation by making precise changes to the existing crop’s genome. It offers great opportunities, but also creates regulatory challenges.

The key challenge is that gene-edited crops could become indistinguishable from naturally occurring crop variants because the same changes in the crop genome could also arise by random mutation. Governments all over the world struggle with this paradox and the regulatory status of gene-edited organisms. Are they regulated? Should they be regulated? And if so, how?

The main regulatory trigger for subjecting organisms to regulatory oversight is safety. To follow the fierce debate about the legal status of gene-edited crops, we have to dig deep into those concerns that form the basis for regulatory oversight in different countries.

US and Canada regard gene editing as equivalent to traditional breeding

The US Department of Agriculture regulates solely based on the presence (or absence) of DNA derived from plant pests, not on the basis of the trait or product qualities. So, it did not signify a change of heart, when USDA announced on March 28, 2018, that it will not regulate gene-edited plants. Gene-editing researchers hailed the announcement as it affirms that gene-edited crops are not riskier than any other new plant varieties.

The agency basically acknowledged gene editing as a much faster form of traditional breeding. So, as long as the genetic changes could have been bred in a plant — say a simple deletion, base pair swap, or insertion from a reproductively compatible relative — it won’t be regulated. However, most plant genome editing experiments use Agrobacterium-mediated transformation to deliver genome editing nucleases into plant cells. If gene-edited plants contain 35S promoters, T-DNA or similar they will still require regulation. Also, if you use gene-editing technology to introduce genes from distant species, you still have to jump through all the regulatory hoops.

Canada regulates the introduction of “novel traits” into crops. Its biotechnology regulatory framework dates from 1993 and is not triggered by the use of a certain technology, but by the novelty of the final plant product. Therefore, it is not expected to require any amendment to accommodate case-by-case decisions on products derived from gene editing.

Latin America incorporates gene editing in its current biosafety governance

Most countries in Latin America established governances on biotechnology that rely heavily on principles and concepts established in the Cartagena Protocol on Biosafety (CPB). The CPB is an international agreement that aims to ensure the safe handling, transport and use of GMOs (called LMOs – living modified organisms – in CPB). LMOs are defined as “any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology”. Argentina, the world’s third-largest producer of GM crops, is NOT among the 170 countries that ratified the CPB. Yet, it defines GMOs in provision no. 701-2011 exactly as the CPB.

In 2015, Argentina extended its regulatory framework and published the world’s first regulation for new breeding technologies including genome-editing. In resolution No. 173/2015a, the Secretariat of Agriculture, Livestock and Fisheries outlines the procedure for a case-by-case assessment to determine whether a crop will be regulated as GMO or not. In a nutshell, gene-edited crops will not be subject to GMO regulation if no transgene is inserted.

Chile and Brazil followed Argentina’s lead. Chile signed a normative resolution in 2017. Brazil published a resolution in January 2018. Both regulate gene-edited product case-by-case and exempt them from regulation when there is no insertion of transgenes.

There is optimism that other South American countries will adopt similar regulations. The Colombian government recently announced that it would not regulate gene-edited cacao developed by researchers at the University of California, Berkley with money from Mars Inc., one of the world’s biggest chocolate producers.

The European struggle

The European Union GMO regulatory framework dates back almost three decades. It was set up in 1990 just after the development of recombinant DNA technology (directive 90/220/EEC was replaced by the current directive 2001/18/EC in 2001). At that time, experience with recombinant DNA technology for crops was limited. The US and Canada embraced the new technology, but Europe rejected it. The authorities took an overcautious approach that resulted in one of the most severe sets of GMO regulations in the world. Strict safety assessments, cumbersome bureaucracy and activism against GM organisms have almost chocked research and release of GM crops in Europe. Almost no significant quantities of GM crops are cultivated on the continent.

Scientists, breeders and seed producers are afraid that gene-edited crops will be placed under the same onerous GM regulations, which would make the technology too expensive and too slow for competitive agricultural biotech. The question at stake is: do gene-edited crops fall under EU Directive 2001/18/EC? The EU Commission has been ducking and diving to avoid taking action on the issue. But, this year a European Court of Justice (ECJ) might clarify the legal limbo for European researchers.

At stake is a loophole in the EU’s GMO directive that exempts chemical mutagenesis and ionizing radiation, which cause random mutations in an organism’s genome, from GM regulation. In 2016, an alliance of nine French non-governmental organizations (NGOs) opposed to GMOs filed a case with the highest court in France to challenge the “mutagenesis exemption” by both conventional mutagenesis techniques, and ‘new mutagenesis techniques’, like gene-editing. Arguably, molecular gene-editing techniques create similar products as conventional mutagenesis, but with greater precision. As a result, the French court posed four questions about EU law to the ECJ.

On January 18, 2018, European Union (EU) Advocate General Michal Bobek took a first stab at how new mutagenesis techniques might be regulated. His complex preliminary opinion is both confusingly clear and clearly confusing. Bobek advises that “organisms obtained by mutagenesis” should not be seen as genetically modified, unless they contained recombinant nucleic acid molecules or other GM organisms. Therefore, Bobek does not see any grounds to update legislation, which could mean that gene-edited crops would not fall under laws restricting the use of GMOs the EU. However, the opinion only refers to ‘mutagenesis’ without explicitly mentioning gene-editing; and the term ‘recombinant nucleic acids’ is still open to interpretation. The opinion is only advisory and non-binding, but the ECJ often adopts the Advocate General’s legal analysis in its court decisions. Now, European researchers eagerly await the ECJ’s decision that is expected later this year.

Conclusion

Both North and South American countries paved the way for development of gene-edited crops by removing regulatory uncertainty. Time will tell whether the European Commission also grasps the opportunity to re-consider its over-cautious approach to biotech crops. The EU’s GMO directive has effectively regulated GM crops to death in Europe. Most big biotech companies have moved their R&D to the US and the cost of current regulatory approvals restricts them to the largest agribusinesses. Regulating gene-edited crops as GMOs will do nothing to support sustainable agriculture. It would simply make it too expensive for European academics, small companies and humanitarian projects to develop such products.

Especially in Europe, we need to learn from the GMO debate. Public concerns are important and the European Commission is well advised to listen to them. However, it is equally important not to let loud voices block the development of rational, evidence-based and non-discriminatory regulatory framework that provides legal certainty.

Dr. Sarah Schmidt is a Project Coordinator, working within the Eom Group at the Heinrich Heine-University, Düsseldorf.

Sarah Schmidt will be chairing the Plant Genome Engineering track at the 6th Plant Genomics & Gene Editing Congress: Europe. To find out more, take a look at the agenda. 

Tags: cas-9, CRISPR, EU, european union, gene editing, plant genomics, regulations