Baroness Bennett of Manor Castle:

Moved by Baroness Bennett of Manor Castle

12: Clause 3, page 3, line 30, at end insert—“(iv) the details of the gene editing event, and the record of the whole genome sequence of the qualifying organism, are recorded in a publicly available register established by regulations,”

My Lords, in moving Amendment 12, I will speak also to Amendment 13 in my name. This is an adaptation and development of the work done by the noble Lord, Lord Winston, in Committee—he is not currently in his place; I hope he will be back in a second—when he put forward the idea of a register. This is my attempt to write that register into the Bill, to establish full transparency and traceability around gene editing.

The drafting is my own, although I thank the Table Office for its help. I will not claim that this is the perfect way to set this in the legislation, but in this legislation it absolutely should be, for the sake of transparency and traceability. We are giving commercial companies the right to mess around with the basis of life on earth. Showing their working and allowing the knowledge to be available to others is a small price to pay.

The noble Lord, Lord Krebs, and I had a detailed debate in Committee about whether it is possible to identify gene-edited organisms; some aspects of that debate remain in dispute, but we heard on Friday’s call that, should the nature of the gene-editing event be recorded, as Amendment 12 calls for, there is absolutely no doubt that any gene-edited organism can be identified.

This amendment goes further in calling for the record of the whole-genome sequence of the qualifying organism to be recorded. For the House’s information, I think it is worth going a little further into that, and into an explanation of why the regulations should be covered by the affirmative procedure.

Whole-genome sequencing can accurately identify the full spectrum of unintended mutations at both off-target and on-target editing sites, including the inadvertent insertion of foreign DNA. Given what we heard from the Minister in the last group, I am not sure how we can be sure than an organism is legal if we do not have this. Multiple-reference genomes derived from the whole-genome sequencing of major crop plants are available already in the public domain. That has yielded important information about the unintended effects of gene editing on the genome. For example, in a study on gene-edited rice using CRISPR-Cas, whole-genome sequencing was used to investigate unintended mutations arising from several aspects of the gene-editing procedure. The procedure, which taken as a whole includes tissue culture and Agrobacterium-mediated cell transformation, resulted in several times more unintended mutations than were found in rice propagated through natural pollination. If you do not do the whole-genome sequencing, you simply cannot know that to be the case.

We are sometimes told that this is too complicated, difficult and expensive. We have been talking about how fast this field is moving, and one recent innovation is what is known as long-read DNA sequencing. Unlike many things in this area, its meaning is pretty clear-cut from its self-description. It provides a continuous sequence that reads up to 1.5 million DNA base units and would provide unequivocal understanding of the placement of long stretches of repeat sequences, which some of the older methods that break up the DNA strand do not do so easily. Several companies offer a long-read genome sequencing service, making this technology readily available.

I did not write this into the Bill, and it is another reason why I put in the affirmative procedure, but this register could also include requirements for molecular compositional profiling methods: gene expression-profiling transcriptomics, protein-profiling proteomics and small biochemical molecule-profiling metabolomics—let us call them “omics”. These are now used by thousands of research groups around the world to gain a more comprehensive and deeper insight, not just into the genome but into how an organism functions. It is crucial to understanding the health and disease implications of the genome to see how that genome plays out in the proteins in the cells.

A 2016 research paper published in the extremely prestigious journal Nature used a multi-omics approach to demonstrate that a glyphosate-tolerant GM maize was not substantially equivalent to its non-GM relative. The large-scale protein and metabolite alterations that were detected were unintended consequences of the GM transformation process, with potential downstream health consequences for the consumer in terms of the introduction of toxins and allergens.

I see that the noble Lord, Lord Winston, is here and I refer Members of your Lordships’ House to his speech in this area and our discussion in Committee. To know what is going on is scientifically and practically essential. That is why I have tabled these amendments. I do not intend to move to a vote, but this is a matter that the Government should commit to. It is interesting that in our discussion on Friday with all the experts one of them said to me, “Yes, there is a public register. At least that’s how it’s going to work”. I do not know whether the Minister can explain this, but my understanding is that there is nothing in the legislation that provides for a public register. If I am wrong, I am happy to be corrected. However, these people are proponents of the Bill and this procedure, and they believe that there will be a public register. If that is what the experts are trusting in and want to be able to use—it is a public resource—and if it is not already there, the Government certainly should introduce it. I beg to move.

I thank the noble Baroness, Lady Bennett, for introducing the amendment because it gives me a chance to say two things quickly. One, which she alluded to, is our discussion in Committee about detectability by analytical methods. I asked Wendy Harwood from the John Innes Centre to give me an exact form of words about that, which I shall repeat with her permission. It confirms, in a way, what the noble Baroness has just been saying. Wendy Harwood said:

“If you had details of the exact edit made, then you could detect” the PBO by polymerase chain reaction,

“followed by sequencing of the PCR product. If you were just presented with a plant, and no audit trail and asked whether it was genome edited, you could not determine whether it was or not.”

One therefore needs an audit trail in order to be able to tell. She continued:

“If exactly the same change had been made by precision breeding as had been made by traditional breeding, and you tested by looking for that precise change, then you would not be able to tell which was which. Again an audit trail would be required. You might however have a case where both PB and traditional breeding had made changes to the same gene, giving the same trait, but these changes were not identical at the DNA level, in this case you could tell the difference.”

That emphasises that if one is serious about knowing which products on the shelves are produced by PB, there needs to be an audit trail.

On whether whole-genome sequencing is of value, one angle is that so much mutation in the genome is going on all the time that it is hard to know what one’s reference material would be. The Royal Society produced in its evidence to the Defra consultation a calculation that in a hectare of wheat there would be at least one mutation for every base pair in the wheat genome. There are 10 billion base pairs in a wheat genome. In a one-hectare field of wheat, there would be a mutation somewhere in every one of those base pairs. So the difficulty with using whole-genome sequencing is what one makes of the information one gets. There will be huge variation and one does not quite know what the value of the information is.

I think we have agreement that some parts of the genome are functionally relevant and have a particular functional significance. We perhaps have points of disagreement about how relatively protected some of those may be from natural mutations. There are lots of mutations that happen naturally in areas that may be beneficial to the plant but only in certain parts of the genome and with certain sorts of functional effects. The parts of the genome that are particularly crucial to the function of the organism are the structural, basic ones, where there are far fewer natural effects. If you read the complete list of the genome, you are going to look at certain bits to see which changes are significant, which ones may be deleterious and which ones are less significant. Does the noble Lord agree?

Obviously, I agree that the different parts of the genome serve different functions. As the noble Baroness said in Committee, when we were students, we learned about junk DNA. However, it is not junk DNA; it can play an important part in regulating the expression of other genes. I take the point.

I love the idea of the noble Lord’s field of wheat waving gently in the breeze and the sunlight, but does he not agree that certain genes in those wheat seeds are rather well conserved and, in fact, do not change? Indeed, certain genes are protected from mutation. Therefore, there is nothing to prevent us looking at analysis to see the frequency of certain mutations within the genome; perhaps we need to be doing that. The data there could be very useful in all sorts of ways.

My Lords, this group of amendments deals with technical scientific issues and moving whole or parts of clauses from the negative procedure to the affirmative. Your Lordships will know that I am not a scientist so I shall, I hope, avoid digging a hole for myself or getting caught in the crossfire.

Amendment 12, in the name of the noble Baroness, Lady Bennett of Manor Castle, would require the details of genome sequencing to be recorded in a publicly available register. If the processes outlined in this Bill are to be carried forward successfully, it will be necessary for farmers, producers and the public especially to have confidence in the process. Ensuring that there is transparency and visibility through a publicly available register can only help this process. The DPRRC was strongly in favour of such a register in its report of 2 December.

Amendment 13, also from the noble Baroness, Lady Bennett, seeks to make the whole regulation in Clause 3 affirmative. Currently, the Bill is silent on whether Clause 3 is affirmative or negative. I suspect that, as it currently stands, Clause 4(6) applies to the whole of the section headed “Release”.

I am grateful to the Minister for his amendments in this group. At Second Reading and in Committee, concerns were raised at the number of negative procedures in the Bill. The Minister has tabled government Amendments 14 and 15 to Clause 4, which would qualify the section on marketing and keep subsection (1)(b) as negative while the rest of this clause will be moved to the affirmative procedure. This is welcome and gives the opportunity for debate on the notification requirements if necessary. Perhaps the Minister can clarify in his response whether Clauses 3 and 4 are covered by his Amendments 14 and 15. If not, can he say what process is applied for Clause 3? I am sorry; I may have misunderstood what this is all about.

Amendment 16, to Clause 6(4), moves regulations on the precision bred confirmation from negative to affirmative. We welcome the Minister’s movement on this point. This is a sensible way forward and, again, gives the opportunity for further debate.

Government Amendments 24 and 25 are somewhat confusing. Amendment 24 indicates that the regulations under Clause 18(1) are to be affirmative, and Amendment 25 deletes “this section” and inserts “subsection (6)”. I think this means that Clause 18(1) is affirmative while the rest of the clause is negative, as Clause 18(7) has not been amended. I would be grateful for the Minister’s clarification. It is important for when we come to debate these things later to know whether it is affirmative or negative. Although these are technical amendments, they are very important and provide transparency in the Bill, which is to be welcomed.

My Lords, the noble Baroness, Lady Bennett, has tabled two amendments. Amendment 12 concerns the publicly available register. Clearly, transparency and information for the public will be important if we are to carry people with us, so we need to look at how we develop registers and information to reassure people and to give them the information that they need to have confidence in the legislation.

In Committee, my noble friend Lord Winston and the noble Baroness, Lady Parminter, drew attention to the parallel piece of legislation, the Human Fertilisation and Embryology Act, in which there is a requirement for the surrender of ongoing records containing the information about the impacts, both the positive and the adverse outcomes, on individuals used under the terms of that Act. The noble Lord, Lord Krebs, read out an opinion which emphasised the importance of an audit trail, so there is a general feeling in this House that information and a public register are important.

Amendment 13 is also in the name of the noble Baroness, Lady Bennett. I thank the Delegated Powers and Regulatory Reform Committee for its report on the Bill, which was very helpful. I reassure the Minister, who knows that we support the Bill, that what concerns us is that so much is left to an unknown number of SIs over an unspecified timescale. If the regulations in Clause 3 are under the affirmative procedure, Parliament will rightly have a formal role in improving the finer details of the release and marketing notices, crucially ensuring that we have proper political consensus on this. As the noble Baroness, Lady Bakewell, said, the Government have moved a number of clauses from the negative to the affirmative procedure. I will not go into all the detail, as she covered everything that I was going to ask about on this, since some of it is not crystal clear. We know that the Government can see that there is merit in moving from the negative to affirmative. Can the Minister clarify why not this clause as well if that is not the case, as this is important?

My Lords, I thank the noble Baroness, Lady Bennett, for her Amendment 12, which would require details of the specific gene editing event and the whole-genome sequence of a qualifying precision-bred organism to be made publicly available for its release into the environment. The noble Baroness’s Amendment 13 to Clause 3 would require that regulations made under this clause to establish a public register containing this information are subject to the affirmative procedure.

It is not our intention to require breeders to include sequence data as part of their release or marketing notices. I have discussed this previously following an amendment tabled by the noble Lord, Lord Winston, in Committee. We have since had a very useful meeting with the noble Lord and our scientific advisors, ACRE, to explore why whole- genome sequencing information has limited value in most cases, and the noble Lord has not retabled his amendment on Report.

This type of information has limited value because there is a significant degree of genetic variation between individual plants and animals within a species, which is more or less the point that the noble Lord, Lord Krebs, was making. This amount of background noise means that the value in requiring whole-genome sequences is limited in terms of addressing regulatory questions; for example, questions about the precision-bred status of a plant or animal. Additionally, the release notice that researchers are required to submit to Defra will be in line with the requirements of the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022, which were agreed by the affirmative procedure.

Our intention is that information provided in release notices will be published on the precision breeding register and will include the relevant and necessary information about the precision-bred organism in it. We also intend to require developers to confirm that the organisms that they intend to release in research trials meet the criteria in the Bill. The technical details of this notice will be prescribed by regulations, prepared with input from the advisory committee appointed to advise the Secretary of State on the regulatory status of these organisms and, in accordance with the amendments to Clause 4 that I have tabled, our intention is that such regulations will be scrutinised using the affirmative procedure before they are made.

I hope that this reassures noble Lords and that the noble Baroness, Lady Bennett, is persuaded to withdraw this amendment and not move her additional amendment to Clause 3, which would specify the parliamentary procedure for the delegated power that her substantive amendment would insert.

I always pay particular attention to points raised on secondary legislation by the noble Baroness, Lady Bakewell. As a member of the Secondary Legislation Scrutiny Committee, she is very good at holding me to account on these. I did not quite understand her point about Clause 3 because there are no regulations in Clause 3 and therefore no requirement for it to be affirmative or negative.

We remain of the belief that the matters to be set out in the regulations under the powers in Clauses 4(3) and 6(2) are administrative in nature. However, the Government acknowledge that these provisions are of significant public interest. We have heard this previously in the House and the Delegated Powers and Regulatory Reform Committee has raised this as well. We have considered these matters closely and have decided to change the procedure from negative to affirmative for both powers. These changes will increase the scrutiny when these powers are used to prescribe the information which must be provided to the Secretary of State by a person who wishes to release or market a precision-bred organism. I hope that noble Lords feel that I was serious in Committee when I said that I had listened to them. I hope that they feel that this improves the Bill. Regulations under Clause 4(1)(b) would be administrative in nature, not of significant public interest, and will remain subject to the negative procedure. I hope that this reassures noble Lords.

Amendments 24 and 25 will increase the level of scrutiny when powers are used to prescribe information that must be included in the precision breeding register. The Government acknowledge that these provisions are of significant public interest. We accept noble Lords’ concerns about the level of scrutiny for such provisions. Therefore, we will change the parliamentary procedure from negative to affirmative for the power in Clause 18(1). Regulations under Clause 18(6) regarding the keeping of the register, which is an administrative matter and, again, not of significant public interest, will remain under the negative procedure.

My Lords, I thank the Minister for what he has just said, but can he answer this question about whole-genome sequencing?

When we first started genome sequencing, it was laborious, expensive, time-consuming, and so on. It is now a pretty rapid process and can be done without huge expense. Does the Minister not agree that one of the reasons for doing this is not just marketing—because of course there are different issues there, which is how we are addressing this—but the advantage of getting more knowledge about what we are doing? The advantage there would be seeing where things are moving within the organisms that we are trying to edit. That is important as a research tool because, ultimately, we are doing something that—admittedly—we do not fully understand, and this would greatly increase knowledge. Does he feel that this is a relevant point?

It is entirely a relevant point, and was much on our minds when we debated some months ago a research measure in secondary legislation to allow the development of plant precision editing but not for it to be taken forward to market. The noble Lord is absolutely right that this is fast-moving and that we therefore need to be clear about how we regulate: that we are regulating a research process and a process to take products to market. Ministers will have to be clear about the intention of the organisation taking that forward. I hope, through the changes that we made, that there will be greater parliamentary scrutiny, that people with real knowledge, particularly in this place, will be able to scrutinise that, and that the Secretary of State of the day will have the best available information about what is being taken forward and why—whether it is just for research. The point made by the noble Lord about the value of research of products that will never go to market, that it is just to understand a particular aspect of genomic sequencing, is crucial.

My Lords, I thank the Minister for his answer, and everyone who contributed to this debate. Once again, the noble Lord, Lord Winston, gave us the expert nailing of the issues. I thank particularly the noble Baronesses, Lady Bakewell of Hardington Mandeville and Lady Hayman of Ullock, for stressing the importance of transparency, both for scientific and public confidence reasons.

The Minister went over some of the same ground that the noble Lord, Lord Krebs, and I circulated back and forth on in terms of saying “Oh, there are lots of mutations” is not a reason not to do whole-genome sequencing. What we see are the mutations that are of greater importance in particular areas of the genome, et cetera, so the claim that “Oh, there are lots of mutations, so it doesn’t matter” does not scientifically stack up.

We are in a situation of regulations. The Minister said that the regulations will specify that the release notices contain “relevant and necessary” information. I think it is already clear that the detail of what “relevant and necessary” actually means is going to be crucial. We all know the problem with regulation and the way in which we are given it on a take it or leave it basis. Again, I feel great reluctance: I feel that we really should have whole-genome sequencing, and indeed broader omics testing. But I see no option at the present moment but to withdraw the amendment, with great reluctance.

Amendment 12 withdrawn.

Amendment 13 not moved.

Clause 4: Release of precision bred organism: notification requirements