Here’s a quick quiz for you. Which of the following would you regard as genetic modification?
A: Adding a gene from another organism
B: Inducing mutations with radiation or toxic chemicals
C: Making a single precise change to an organism’s genome
For me, the answer is D: All of the above. For the European Commission, though, the answer is “A – yes, B – no, and C – well, we can’t make up our minds.”
This position has never made any sense and now, with the CRISPR gene-editing revolution, it appears even more ludicrous.
The fact is, we have been genetically modifying plants and animals for at least 10,000 years. The Scentimental rose in your garden, the Majestic potato on your plate and the flandoodle dog by your feet – all have hundreds of genetic changes compared with their wild ancestors, some of them huge.
This makes things tricky for those who want to draw a firm line between “conventional” breeding and modern biotechnology. The EU decided to define genetically modified organisms as “organisms in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.
What is “natural”?
The thing is, gene editing works by exploiting natural recombination. It can be used to introduce new genes, but the simplest form merely involves cutting DNA at a specific site. When the cell repairs the damage, it often adds or deletes a few DNA letters. Exactly the same kind of mutations occur naturally when a cell repairs DNA breaks caused by, say, cosmic radiation.
Our ancestors had to wait for beneficial mutations to happen by chance before they could select for them. Modern breeders aren’t so patient. They zap plants with radiation or DNA-damaging chemicals, and then screen thousands of cells to find one with the desired change. The EU has specifically ruled that mutagenesis as this is known (option B above) does not count as genetic modification, along with a host of other far-from-natural tricks. A genetically mutated organism, apparently, is definitely not a GMO.
The EU, however, has yet to decide whether simple gene editing (option C above) counts as genetic modification. Rationally, it makes no sense to subject gene-edited organisms to far greater scrutiny than the products of mutagenesis when the end result can be identical. If anything, mutagenesis is riskier because it is far less precise.
A working party was set up in 2007 to look at how gene-edited organisms should be regulated. Nearly 10 years on, we are still waiting for a decision. The European Commission was due to make an announcement in March, but it failed to and there is now no timetable for a decision.
Why? The suspicion must be that officials fear a storm of protest should they rule that the simplest form of gene-editing is not genetic modification. This would allow gene-edited plants and animals to be introduced without safety testing, rather than having to undergo the strict and very expensive testing process required of GMOs.
Corn in the US
This is what is happening in the US. It has no specific rules on genetically modified crops. Instead, the US Department of Agriculture (USDA) has been regulating them on a technicality, using laws that govern potential plant pests. The USDA has already said it cannot regulate several gene-edited organisms, most recently a high-yielding waxy corn and a non-browning mushroom. The developers are still legally obliged to ensure these products are safe to eat, but the US Food and Drug Agency does not insist on seeing the data before they go on sale.
This hands-off approach has been welcomed by those who think gene-edited plants and animals could bring a lot of benefits. For instance, gene-editing has been used to create hornless cattle, by introducing a mutation that some breeds already possess. This could eliminate the common practice of de-horning cows.
We need to move to a system that focuses not on how new strains of plants and animals are created but whether they have been changed in a way that could harm people or damage the environment
But allowing new strains of plants and animals to be introduced without any safety testing seems just as undesirable as imposing onerous regulations that only rich corporations can afford to comply with. This is not just a concern about gene-editing: some companies are trying to avoid the EU’s strict laws on GMOs by using, say, mutagenesis to create crops with GM-like traits. And a few conventionally bred plants have turned out to be poisonous, like the famous Lenape potato.
There’s widespread agreement on the solution: we need to move to a system that focuses not on how new strains of plants and animals are created but whether they have been changed in a way that could harm people or damage the environment. In the case of animals, their welfare should also be considered.
This trait-based approach is already taken by Canada. The bad news is that there is no appetite for changing the rules in Europe. “It’s not going to happen in my lifetime,” says Huw Jones, a plant geneticist at Aberystwyth University in Wales.
That makes the commission’s decision all the more important. Is it going to slam shut the floodgates by making the logically indefensible decision that gene-edited organisms are GMOs when the products of mutagenesis are not? Or is it going to fling open the floodgates by deciding they are not? Don’t hold your breath for an answer.