A European Court ruling widely interpreted to mean that all gene-edited organisms are GMOs (Genetically Modified Organisms) may not be as prescriptive as many first assumed.
Many small regulatory elements, including miRNAs, miRNA binding sites, and cis-acting elements, comprise only 5~24 nucleotides and play important roles in regulating gene expression, transcription and translation, and protein structure, and thus are promising targets for gene function studies and crop improvement.
A protein hijacked from a bacterial pathogen helps to facilitate more precise genome editing in plants. A new genome editing system enhances the efficiency of an error-free DNA repair pathway, which could help improve agronomic traits in multiple crops.
Few technologies have made as big a splash in recent years as CRISPR/Cas9, and rightfully so. CRISPR/Cas9, or clustered regularly interspaced palindromic repeats (CRISPR) and associated genes, is a bacterial gene editing toolbox that allows researchers to edit genomic sequences much more precisely and efficiently than previously possible, opening up doors to new ways of doing research. As with many new biotechnologies, the application of CRISPR in biology began with genetic model organisms such as Arabidopsis thaliana. In recent research authors review the prospects for expanding the use of CRISPR for research beyond genetic model plant species.
Field trials show that poplar trees can be genetically modified to reduce negative impacts on air quality while leaving their growth potential virtually unchanged
Researchers have developed a set of tools that make it faster and easier to modify large segments of DNA. The new tools are for use in a technique called recombineering.
New research has found that the European Union’s opposition to modern crop breeding is at odds with the majority of other countries around the world and could jeopardise international trade.
At July’s New Breeding Technologies workshop held in Gothenburg, Sweden, Dr. Staffan Eklöf, Swedish Board of Agriculture, gave us an insight into their analysis of European Union (EU) regulations, which led to their interpretation that some gene-edited plants are not regulated as genetically modified organisms. We speak to him here on the blog to share the story with you.
Could you begin with a brief explanation of your job, and the role of the Competent Authority for GM Plants / Swedish Board of Agriculture?
I am an administrative officer at the Swedish Board of Agriculture (SBA). The SBA is the Swedish Competent authority for most GM plants and ensures that EU regulations and national laws regarding these plants are followed. This includes issuing permits.
You reached a key decision on the regulation of some types of CRISPR-Cas9 gene-edited plants. Before we get to that, could you start by explaining what led your team to start working on this issue?
It started when we received questions from two universities about whether they needed to apply for permission to undertake field trials with some plant lines modified using CRISPR/Cas9. The underlying question was whether these plants are included in the gene technology directive or not. According to the Swedish service obligation for authorities, the SBA had to deliver an answer, and thus had to interpret the directive on this point.
Could you give a brief overview of Sweden’s analysis of the current EU regulations that led to your interpretation that some CRISPR-Cas9 gene-edited plants are not covered by this legislation?
The following simplification describes our interpretation pretty well; if there is foreign DNA in the plants in question, they are regulated. If not, they are not regulated.
Our interpretation touches on issues such as what is a mutation and what is a hybrid nucleic acid. The first issue is currently under analysis in the European Court of Justice. Other ongoing initiatives in the EU may also change the interpretations we made in the future, as the directive is common for all member states in the EU.
CRISPR-Cas9 is a powerful tool that can result in plants with no trace of transgenic material, so it is impossible to tell whether a particular mutation is natural. How did this influence your interpretation?
We based our interpretation on the legal text. The fact that one cannot tell if a plant without foreign DNA is the progeny of a plant that carried foreign DNA or the result of natural mutation strengthened the position that foreign DNA in previous generations should not be an issue. It is the plant in question that should be the matter for analysis.
Does your interpretation apply to all plants generated using CRISPR-Cas9, or a subset of them?
It applies to a subset of these gene-edited plants. CRISPR/Cas9 is a tool that can be used in many different ways. Plants carrying foreign DNA are still regulated, according to our interpretation.
What does your interpretation mean for researchers working on CRISPR-Cas9, or farmers who would like to grow gene-edited crops in Sweden?
It is important to note that, with this interpretation, we don’t remove the responsibility of Swedish users to assess whether or not their specific plants are included in the EU directive. We can only tell them how we interpret the directive and what we request from the users in Sweden. Eventually I think there will be EU-wide guidelines on this matter. I should add that our interpretation is also limited to the types of CRISPR-modified plants described in the letters from the two universities.
We are currently waiting for the EU to declare whether CRISPR-Cas9 gene-edited plants will be regulated in Europe. Have policymakers in other European countries been in contact with you regarding Sweden’s decision process?
Yes, there is a clear interest; for example, Finland handled a very similar case. Other European colleagues have also shown an interest.
What message would you like plant scientists to take away from this interview? If you could help them to better understand one aspect of policymaking, what would it be?
Our interpretation is just an interpretation and as such, it is limited and can change as a result of what happens; for example, what does not require permission today may do tomorrow. Bear this in mind when planning your research and if you are unsure, it is better to ask. Moreover, even if the SBA (or your country’s equivalent) can’t request any information about the cultivation of plants that are not regulated, it is good to keep us informed.
I think it is vital that legislation meets reality for any subject. It is therefore good that pioneers drive us to deal with difficult questions.
This week’s blog was written by Dr Craig Cormick, the Creative Director of ThinkOutsideThe. He is one of Australia’s leading science communicators, with over 30 years’ experience working with agencies such as CSIRO, Questacon and Federal Government Departments.
So what do you think CRISPR cabbage might taste like? CRISPR-crispy? Altered in some way?
Participants at the recent Society for Experimental Biology/Global Plant Council New Breeding Technologies workshop in Gothenburg, Sweden, had a chance to find out, because in Sweden CRISPR-produced plants are not captured by the country’s GMO regulations and can be produced.
Professor Stefan Jansson, one of the workshop organizers, has grown the CRISPR cabbage (discussed in his blog for GPC!) and not only had it included on the menu of the workshop dinner, but also had samples for participants to take away. Some delegates were keen to pick up the samples while others were unsure how their own country’s regulatory rules would apply to them
— Wayne Parrott (@ProfParrott) July 7, 2017
The uncertainty some delegates felt about the legality of taking a CRISPR cabbage sample home was a good demonstration of the diversity of regulations that apply – or may apply – to new breeding technologies, such as CRISPR and gene editing – and there was considerable discussion at the workshop on how European Union regulations and court rulings may play out, affecting both the development and export/import of plants and foods produced by the new technologies.
A lack of certainty has meant many researchers are unable to determine whether their work will need to be subjected to costly and time-consuming regulations or not.
The need for new breeding technologies was made clear at the workshop, which was attended by 70 people from 17 countries, with presentations on the need to double our current food production to feed the world in 2050 and reduce crop losses caused by problems such as viruses, which deplete crops by 10–15%.
The two-day workshop, held in early July, looked at a breadth of issues, including community attitudes, gene editing success stories, and tools and resources. But discussions kept coming back to regulation.
Regulations of gene technologies were largely developed 20 years ago or so, for different technologies than now exist, and as a result are not clear enough for researchers to determine whether different gene editing technologies they are working on may be governed by them or not.
The diversity of regulations is also going to be an issue, for some countries may allow different gene editing technologies, but others may not allow products developed using them to be imported.
That led to the group beginning to develop a statement that captured the feeling of the workshop, which, when complete, it is hoped will be adopted by relevant agencies around the world to develop their own particular positions on gene editing technologies. It would be a huge benefit to have a coherent and common line in an environment of mixed regulations in mixed jurisdictions.
And as to the initial question of what CRISPR cabbage tastes like – just like any cabbage you might buy at your local supermarket or farmers market, of course – since it is really no different.
— GARNet (@GARNetweets) July 7, 2017