My Lords, I am very grateful for this interesting debate on this first section. I will start with, I hope, a note of humility: I understand that I am in the presence of people who have proved, in the introductions by the noble Lords, Lord Winston and Lord Krebs, and others, that I sit at the foothills of knowledge compared with them. The noble Baroness, Lady Bennett, quoted Descartes—I think he said, “All I know is that I know nothing”. I hope I know a bit more than that, although my learning curve has been very steep. I am grateful to officials at Defra and others who have helped me through this process.
I am aware that the term “precision breeding” has been controversial in some quarters, although well received in others. I thank noble Lords for this opportunity to explain why we have adopted it. The noble Lord, Lord Winston, suggested “directed bred” as an alternative term to “precision bred”, whereas, on this point, the
noble Baroness, Lady Bennett, suggested “genome editing” to replace “precision breeding”. Concerns have been raised about using the term “precision bred” to describe these organisms, because they can result in off-target changes to the organism’s DNA. Although off-target changes can occur using precision breeding technologies, the advice we have received from our Advisory Committee on Releases to the Environment—ACRE—in relation to precision-bred plants is that off-target changes are significantly rarer than those produced during the course of conventional methods of plant breeding. This is also the view of the European Food Safety Authority, which advises the EU Commission.
On animals, ACRE concluded in its advice published in September last year that there is good evidence to suggest that the use of techniques such as CRISPR-Cas9 in animals does not result in a greater number of off-target changes than the background rate for natural mutations—the noble Lord, Lord Krebs, referred to this. Indeed, many recent gene-editing studies on animals have reported no incidences of off-target changes when using CRISPR-Cas9. Therefore, although off-target changes may occur using these technologies, the scientific advice is that they are more precise than traditional breeding, both in terms of making targeted changes to the DNA of a plant or animal and in terms of the number of off-target changes they cause.
In her amendment, the noble Baroness, Lady Bennett, used the term “genome editing” instead of “precision breeding”. The class of plants and animals we intend the term to cover will include some gene-edited organisms. However, it will not cover all gene-edited organisms; it will not include plants and animals that contain genetic features produced by modern biotechnology that could not have occurred naturally or by traditional processes. For example, plants or animals developed using gene-editing techniques to contain engineered gene drives would not be included in this new class of organism; they will still be regulated as GMOs. In addition, there are techniques of modern biotechnology other than gene editing that could produce plants and animals in this new class—for example, cisgenesis. It is important to note that the EU is also considering cisgenic, as well as gene-edited, plants in its plans for regulatory reform.
We considered using the term “gene edited” in the Bill but, for the reasons I have explained, we concluded that this would be more misleading and confusing. The purpose of the Bill is to more closely align the regulation of this class of animals and plants with those produced by traditional breeding, recognising that the genetic changes they contain will have arisen in a more targeted and precise manner.
The noble Lord, Lord Winston, makes a very good point about the very important need to engage the public more on this case. The Government have tried very hard to do this, and the Food Standards Agency and wider organisations are doing some very good work. There is a big social science job to do to get the message out about what we are talking about—and, perhaps as importantly, what we are not—and the wider benefits, which we will come to in this and other clauses, about how we can improve the life of us here on this planet, protect animal health and make us
more resistant to such factors as climate change. These are factors that we need to hold in our minds as we rightly debate this important Bill, line by line.
Amendment 10 would, in effect, remove the requirement that every feature of an organism’s genome must have been capable of resulting from traditional processes or natural transformation in order for the organism to qualify as precision bred. I understand that the noble Lord’s intention in tabling this amendment was to explore the meanings of the concepts of “traditional processes” and “natural transformation” that are used in this Bill. I hope to address his concerns around the terminology that we have used in this Bill and why it is appropriate. I will begin by defining what we mean by “traditional processes” and “natural transformation”.
For the purposes of this Bill, traditional processes refer to a number of methods listed in Clause 1(7). The noble Baroness, Lady Hayman, also referred to these. They are well known conventional breeding methods, some of which have been utilised for over 10,000 years, and therefore have a long history of safe use. The methods outlined in Clause 1(7) were not chosen to represent an exhaustive list of traditional breeding processes. Instead, they were chosen because they represent the full range of genetic changes known to occur naturally between sexually compatible plants and animals.
Scientific advice is that genetic changes that could have been achieved through traditional processes, as outlined, do not pose a greater risk as a result of being introduced by modern biotechnology. This is why we have included
“could have resulted from traditional processes”
as a criterion for obtaining “precision bred” status.
“Natural transformation” refers to the process by which DNA from a sexually incompatible organism may be inserted into an organism. In plants and animals, this is almost always the result of infection with a bacterium or virus. Often, the fragments of genetic material left behind after infection no longer serve a purpose or function. The material is non-functional and does not affect the physical characteristics, also referred to as the phenotype, of the plant or animal.
The effect of Clause 1(2)(c)(ii) and Clause 1(6) taken together is to ensure that, for the purposes of this Bill, DNA from a sexually incompatible species which is similar to that which occurs through natural transformation is allowed in a precision-bred organism. This is so long as it does not affect the physical characteristics of the precision-bred organism. This is supported by scientific advice that genetic features produced through modern biotechnology but which could have arisen in nature do not pose a risk as a result of the method of production.
DNA from a sexually incompatible species is critical in the intermediate stages of development of many precision-bred plants and animals. They enable the subsequent precise genetic changes to be made to these organisms. For example, CRISPR-Cas9 often involves insertion of the Cas9 editing machinery to enable the intended precise genetic edits. The Cas9 gene would need to be removed for the resulting plant or animal to be classed as precision bred. Clause 1(6)
comes into play where, in some cases, small non-functional fragments of DNA from the Cas9 gene may be left behind. This would be allowed, provided the genetic changes created could have been introduced through natural transformation.
Taken together, the terms “traditional processes” and “natural transformation” ensure that precision-bred organisms are able to contain, in principle, changes that could develop in nature. It is this characteristic that makes precision-bred organisms and GMOs fundamentally different, and we believe that regulating them as such is a proportionate response to the growing body of scientific evidence supporting the safe use of precision-bred organisms.
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The probing Amendment 13 would remove the definition of “stable” in relation to genetic features introduced using modern biotechnology. This Bill stipulates criteria that a plant or animal must adhere to in order to be considered precision-bred. As noble Lords will no doubt know from previous debates, these criteria are that they must have a genetic feature made using modern biotechnology, that every feature of the organism’s genome could have arisen naturally or through traditional processes and that any feature made using modern biotechnology must be stable.
There are several reasons why we have stipulated a stable genetic change and subsequently defined what this means. Concerns have been raised that the use of genetic technology would inherently destabilise the genome at the site of the genetic change. While scientific evidence and advice generally does not bear out this assertion, the inclusion of a clause stipulating that the genetic change must be stable and a definition of what this means provides reassurance that such effects will not be tolerated. It also provides additional clarity to users on what kinds of genetic changes are acceptable in a precision-bred organism.
In direct answer to the probing amendment of the noble Lord, Lord Winston, stable genetic features are set out in the subsection that this amendment would remove; the genetic feature that is being introduced must be capable of remaining in the genome over the course of multiple generations, whether by sexual or asexual reproduction. This is not to say that the genetic feature itself must be immune to further mutations in the course of further traditional breeding, which would be impossible both to achieve and to enforce.
Put another way, the genetic feature being introduced must not be done so as to be deliberately or unintentionally transient. As the noble Lord knows, there are a number of ways this could occur, including through looping out any inserted DNA. I hope that this clears up any confusion in this regard.
I note the noble Lord’s intent with Amendment 14. I am happy to go into detail, or to talk to and reassure the noble Lord prior to Report, because I think we can agree on this.
On my noble friend’s point about cloning—a number of noble Lords mentioned Dolly the sheep—it needs saying here and now that cloning is not within the terms of the Bill. It is a different activity altogether, which is outside the remit of this legislation.
I also thank the noble Baroness, Lady Bennett, for her Amendment 11, which as proposed would exclude any plant or animal from the definition of a precision-bred organism if the insertion of exogenous genetic material was used during any step of its development, whether or not that exogenous genetic material is subsequently removed.
It is important that we regulate based on the best available scientific advice. The advice is clear: if an organism contains genetic changes that could have occurred naturally or by traditional breeding methods, it does not present a greater risk than its traditionally bred counterparts, irrespective of the techniques used to develop it.
It follows that regulations should be based on the nature of the genetic changes present in organisms intended to be released or marketed, rather than on the techniques used to develop them. While exogenous DNA might have been used in the process of developing the precision-bred plant or animal, functional fragments of this DNA must have been removed before the organism can be classed as precision bred.
As I have explained, the use of exogenous DNA represents important intermediate stages in the development of precision-bred plants and animals. It is true that some non-functional fragments of exogenous DNA may be left behind in the production of a precision-bred plant or animal. However, this is similar to the genetic changes that can occur naturally and be introduced through a process called natural transformation.
Subsections (2)(c)(ii) and (6) in Clause 1 allow a precision-bred organism to contain exogenous DNA, so long as this DNA is similar to that which could have resulted from natural transformation and is non-functional. The intention is that this would allow exogenous DNA to be present in a precision-bred organism only if it would not affect the organism’s physical characteristics.
Examples of natural transformation include the natural presence of fragments of exogenous DNA in the genome of most cultivated sweet potatoes, which have been eaten for decades without any adverse effects on human, environmental or animal health. Therefore, many plants and animals under development would not be capable of being classed as precision bred if this amendment stood.
Innovation through technology such as precision breeding can help to create new markets, support sustainable economies and help British business to compete globally. If we were to accept this amendment, countries elsewhere in the world with proportionate regulations would be able to benefit from the huge potential of this technology as it develops, whereas we would remain impeded by our current legislation.
I hope that my words have provided some reassurance for noble Lords and that they will not press their amendments.