Improved plant and animal strains bred with the use of genome editing do not fall within the scope of EU legislation on genetically modified organisms (GMOs) and should be regulated according to the specific agricultural trait or product, rather than the technology by which they are produced, according to a report by the European Academies' Science Advisory Council (EASAC), a body representing all the EU’s national academics.
EASAC’s recommendations are intended to provide a road map for policy makers as genome editing techniques become cheaper and more advanced. “A European Commission decision on the status of these products is urgent in view of the accelerating pace of research and development and of the regulatory initiatives being undertaken by individual member states,” the report says.
Germ line (heritable) genome editing of human embryos that are intended for use in establishing a pregnancy should not be allowed, but the report backs the use of the technique in basic research, saying, “It should proceed subject to appropriate legal and ethical rules and standardised practices.”
The report suggests the Commission should, nonetheless, take note of what is being discussed and proposed outside the EU, pointing to the report by the US National Academy of Sciences published in February, which recommended the door should not be closed on the use of germ line genome editing for treating serious disease or disabilities.
The EASAC report comes at a time when scientists are making spectacular progress in genome editing and policy makers in several member states are starting to lay the regulatory ground.
For example, a gene edited canola strain has been assessed as being non-GMO in Germany. The Swedish Board of Agriculture also confirmed that some plants in which the genome had been edited using CRISPR–Cas9 do not fall under the EU GMO definition.
Genome edited plants have received a green light from the US Government too, including CRISPR–Cas9-edited mushrooms, in which the activity of a particular enzyme is reduced, extending the shelf life, and a strain of corn engineered to generate a certain kind of starch.
The first phase I CRISPR–Cas9 clinical trial has started in China, enrolling patients suffering from lung cancer.
Against this backdrop, the report says it would “seem reasonable to conclude that there is a case for considering genome editing in livestock breeding.”
Examples of the potential benefits include making chickens resistant to infectious diseases and modifying them to produce only female offspring, avoiding the culling of male chicks, which are not required for egg production.
Bees, one of the most important insects for crop production, could be modified to be less susceptible to mites, fungi or other pathogens. The Belgian Blue, a breed of cattle, has suffered problems related to “significant inbreeding” with which gene editing may help.
EU paralysed on GMOs
The EU regulation of genome editing in plants and animals will be subject to a forthcoming decision of Directorate General for Health and Food Safety, DG Sante, on what is a GMO.
For now, the area of science is in a state of legal limbo. Current EU legislative frameworks governing the genetic modification of plants and animals are controversial. Even where there is an overarching EU policy framework, there is little certainty for researchers and breeders, because individual member states vary in their implementation or can exercise an opt-out.
In some member states there is considerable uncertainty about whether existing bans on genetic engineering in embryos and germ line cells for clinical applications also prohibit basic research.
The regulation of genetic engineering techniques in Europe is a “legacy of contention and polarisation”, the report says. This echoes a report by the UK House of Commons Science and Technology Committee on genome editing published last year, which said, “The regulation of genetic science is an area in which the EU has so far not come close to satisfactorily demonstrating an evidence-based approach to policy making.”
Despite continued uncertainty over the rules, some European countries are streaking ahead on gene-editing. Basic research in human embryos of up to 14 days, under licence, is now approved in the UK and Sweden.
To avoid adding to the legal morass, the report calls for more social sciences research. Genome editing raises fears of a slippery slope that leads to a society of genetic haves and have-nots. “There may be a risk of increasing inequality and tension between those who have access to the benefits of genome editing applications and those who do not,” the report says.
While concerns have been raised about the possibility of genome editing being practised outside regulated laboratory settings the report is relaxed about DIY ‘biohackers’ playing around with genome editing tools.
The equipment and reagents are readily available but, “There is no evidence that genome editing is much used yet by DIY biologists,” the report says. “There is no reason to expect the DIY community to cause more harm when using genome editing than anyone else, and DIY biologists must similarly conform to established biosafety legislation.”