Genetic Technology (Precision Breeding) Bill
(Limited Text - Ministerial Extracts only)
Read Full debateWednesday 25th January 2023
(1 year, 10 months ago)
Lords ChamberGenetic Technology (Precision Breeding) Act 2023 View all Genetic Technology (Precision Breeding) Act 2023 Debates Read Hansard Text Watch Debate Amendment Paper: HL Bill 83-I Marshalled list for Report - (23 Jan 2023)
17:22 - Division on Amendment 11 - Ayes: 192 / Noes: 206 - Amendment 11 disagreed.
18:14 - Division on Amendment 21 - Ayes: 173 / Noes: 193 - Amendment 21 disagreed.
19:20 - Division on Amendment 22 - Ayes: 161 / Noes: 176 - Amendment 22 disagreed.
Lord Curry of Kirkharle (CB)
My Lords, I will briefly respond to the noble Lord, Lord Winston, on that point. It is a fair question, which we do need to respond to: what happens if we narrow the gene pool and expose animals to genetic risk? There has been evidence in the past that by narrowing the gene pool in dairy cows, we have had lameness problems; there has been an issue in other species. That is because we have not properly understood; indeed, random breeding, as the noble Lord, Lord Trees, has said, has resulted in that kind of action. Through better understanding of the genes, and through ensuring that we retain as wide a gene pool as possible from which to choose, but being selective and more careful and intelligent about the use of those genes, we should avoid that consequence.
The Minister of State, Department for Environment, Food and Rural Affairs (Lord Benyon) (Con)
My Lords, I start by reminding noble Lords of my entry in the register. This has been a fascinating opener for this afternoon’s proceedings. I know that this is an area of great importance to this House. I want to take account of the concerns raised in the debate and more clearly show our intention on this issue. Perhaps I should start by saying that, having been in, then out and now back in Defra over about a decade or more—and not being a scientist—I absolutely do take the point made by the noble Lord, Lord Krebs. I try never to use the words that the noble Lord, Lord Winston, attributed to me, which was that I was following the science. The science is imprecise, and what we have to do as policy- makers is take a view, listen to reputable people who advise us and organisations both here and around the world, and hope we get it right.
I shall say just two things at this stage of the proceedings on what my involvement in the Bill is not about. First, to tackle what the noble Baroness, Lady Bennett of Manor Castle, said—that this is somehow to satisfy the demands of the global agricultural corporations—no, it is not that. As far as I know, we have had no lobbying from any of those organisations, and this is about something else which I shall come to. Secondly, it is not about taking back control. For me, it is about looking at crops that I see frying in heatwaves that we never had when I was younger. It is about talking to farmers who have Belgian Blue cattle that can give birth to calves only by Caesarean section because they have been bred through traditional breeding methods in a way that makes natural calving impossible. It is about correcting some of those aberrations that have existed, as well pointed out by the noble Lord, Lord Trees. We can tie ourselves down with negativity about this, but the opportunities for this legislation, what it offers for animal welfare and for tackling issues such as climate change, are immense.
On the amendment to remove animals from the Bill completely, as was highlighted in Committee and in today’s debate, I say that it is vital that animals remain part of the Bill. We focused on farmed animals in debate because there is already research in the UK and abroad showing the exciting potential of precision breeding to help tackle some of the most pressing challenges to our food system, the environment and animal welfare. These challenges are significant, and while these technologies are not a silver bullet, they can work alongside other approaches to help us to improve animal health and welfare, enhance the sustainability of farming, and strengthen food security and resilience. It is vital that we create an enabling regulatory environment to translate the research that we have already highlighted in debates into practical, tangible benefits.
It is equally vital that these technologies are used responsibly. That is why we have included specific measures in the Bill to safeguard animal welfare. These go beyond what is required for traditional breeding and under current GMO requirements. We therefore do not see this legislation as a route to lowering welfare standards. Instead, we see it as a real opportunity to improve animal welfare and our food system.
The debate about outliers was fascinating. As a policymaker, I quite like challenging Defra scientists and those who advise us by pushing an outlying piece of science, something that may not even be peer-reviewed. It is one of my criticisms of the scientific lobby that, to get peer-reviewed papers, you have to be in the centre. In this case, I have looked at the broad range of views in the scientific community. I entirely endorse the sentiments put forward by the noble Lord, Lord Krebs. However, I understand concerns raised in the debate about the use of precision-breeding technologies in certain groups of animals, such as companion animals, and I recognise and agree with noble Lords on the importance of building confidence in the regulatory system.
There is a case for prioritising where there is the greatest research interest and where there are greatest potential benefits for animal welfare in our food system. That is why I want to make a commitment on the Floor of this House that we will adopt a phased approach to commencing the measures in the Bill in relation to animals. In other words, we will commence the measures in the Bill for only a select group of animal species in the first instance before commencing them in relation to other species. For example, in the first phase it is likely to be animals typically used in agriculture or aquaculture.
As indicated during Committee, we intend to use the commencement powers within the Bill to achieve that. These powers allow us to bring the provisions in the Bill into force in relation to a specific list of species or group of animals; for example, we can apply the provisions to cattle by stating the species name as Bos taurus—domestic cows. That means that until the relevant commencement regulations applicable to them are made, some species or groups of animals, such as companion animals, will not be affected by changes in the Bill. Likewise, GMO rules would continue to apply to them if they are produced using precision-breeding technology. Taking this approach allows us to limit the practical effect of the Bill for a time, while retaining the flexibility and durability needed to capture the potential benefits in other species in the future.
The Duke of Montrose (Con)
It is encouraging to think that the Minister would pick one genus of defined animal such as Bos taurus, but how long would it remain the only race being investigated? Moreover, they are only about half of the cattle beasts; there are also all the beasts descended from Bos indicus that occupy tropical areas.
Lord Benyon (Con)
I understand the point that my noble friend is making. I cited Bos taurus as perhaps the greatest priority in our minds, but I have also mentioned the benefits that would accrue if we could tackle conditions such as PRRS in pigs. He is right that there are other genuses across farm animal species that we must consider.
As I said, we also intend to produce guidance on the animal marketing authorisation process outlined in the Bill. That will include guidance on the evidence that regulations will require to be submitted alongside the animal welfare declaration by the breeder and, if necessary, more specific guidance relevant to particular species. Through that consideration of evidence and clear guidance, we will ensure that the regulatory system works effectively for different species of animals. I hope that the Government’s intended approach, our commitment to phase the introduction of animals under this legislation and the words that I have said from this Dispatch Box are clear and reassuring for noble Lords. I ask noble Lords to consider not pressing their amendments.
Baroness Bennett of Manor Castle (GP)
My Lords, I thank the Minister for his answer. I thank everyone who has participated in, as he said, this fascinating, detailed and high-quality debate.
I will start with the small bombshell that the Minister that just dropped. We appear to have had a new outline for the way in which the Bill is to be implemented presented to us at the final stage of Report on the Floor of the House—and, as the noble Duke, the Duke of Montrose, pointed out, with some very unclear elements where we suddenly appear to be covering half the cattle but not the other half. I question whether this is the way in which we should be making legislation.
I want to raise a point on something the Minister said which has not been raised before: why is aquaculture here? As the noble Lord, Lord Winston, said, the reality of land animals is that at least you can keep control of them and muster them fairly well. If we include aquaculture in the early stages, we have to realise that once you release something into the sea, as we know from farmed salmon, there will of course be escapes. We have not had a chance to debate all the things the Minister just said.
I want to go back to first principles. I return to the immensely powerful and important speech by the noble Lord, Lord Winston. As he said, he has 40 years’ experience of working with genes. He is your Lordships’ House’s absolute expert. The noble Lord said that we are embarking on a massive experiment with potential global repercussions, but we do not understand what we are doing. Before I go further, I want to put those words to the Minister. My understanding is that the precautionary principle is part of government policy. How does this Bill fit with that principle?
Lord Benyon (Con)
Let me address some of the points that the noble Baroness has made. The Government have always said that our priority for the rollout of this technology will be plants, then animals. I have added to that the reassurance, in frequent meetings that I have held with noble Lords before today, that we can phase that part of it as well. So I do not consider that to be a bombshell.
ACRE, the body that advises the Government on releases into the environment, has recommended that precision-bred organisms pose no greater risk than their traditionally-bred counterparts. Its advice is supported by the Royal Society, the Royal Society of Biology and the Roslin Institute. As for food and feed, consumer safety will be ensured through a case-by-case assessment by the FSA to ensure that products are safe for consumption.
So I hope the noble Baroness feels that his is not a bombshell, that clear processes are involved and that we have been, in every way, precautionary about how we do this. I put it to her that surely it is being precautionary to tackle some of the problems we face. The greatest challenge ever for humanity is to adapt to climate change and to produce food in a way that a modern society, a civilised society, wants—to make sure we address issues such as animal welfare. That is the opportunity of this Bill.
Baroness Bennett of Manor Castle (GP)
I thank the Minister for his answer. I will pick up that point about animal welfare, and indeed pick up the points made by the noble Lord, Lord Krebs, about pigs in the US that have been gene-engineered—or, rather, gene-disrupted— to make them resistant to porcine reproductive and respiratory syndrome.
This is a case of knocking out one gene in these pigs. We know that any given strain of a virus mutates at a rapid rate—we only need to look at Covid-19. Where we have pigs held in the kind of crowded, dangerous conditions in which we know pigs are held in the US, the virus will mutate very quickly. We have been through this many times. We had it with resistance to pesticides: we got rid of a single disease with one gene and then, of course, it goes. This is the way that biology works, as the noble Lord, Lord Winston, said. We hold those pigs in the kind of crowded, dangerous conditions where PRRS is a concern. Let us remember that this genetic change is only against that one disease. When swine flu arrives, there is nothing in those pigs that will protect them against it, or prevent it becoming a zoonosis and crossing the species barrier into humans. Yet we continue those farming practices.
I pick up the point from the Minister and the noble Lord, Lord Taylor of Holbeach, who said that this is the only way we will feed the world and the only way to get more production. That is what we were saying in the 20th century. The discussion on Friday that I referred is only a preprint, but it reflects the direction of the new biology. The noble Lord, Lord Krebs, said that there is a centre of gravity, but we also know there are tipping points. The new biology acknowledges that a wheat plant and every other complex organism is a holobiont; it operates as a complex of what we think of as the plant, bacteria and fungi that work together. The preprint showed that when a wheat crop is dealing with drought, the epigenetic changes—the kind of changes that the noble Lord, Lord Winston, was talking about, where the plant adapts to circumstances and has its genes expressed in different ways—were happening overwhelmingly in the bacteria and fungi. It is not the genetics of the wheat plant at all. I do not accept that this is the way to feed the world, without tackling the issues of poverty, inequality, food waste and feeding perfectly good food to animals. We need good management of soils and crop diversity—that is how we feed the world.
I feel a sense of despair at this point; I have no alternative but to withdraw my amendment with great reluctance. I really hope that your Lordships’ House has listened, particularly to the speech by the noble Lord, Lord Winston, and that the Government listen to this as we go forward from here.
Lord Benyon
Member’s explanatory statement
This amendment would limit the test in Clause 1(2)(c) to features of a precision bred organism’s genome that result from the application of modern biotechnology and would require them to be capable of resulting just from traditional processes (whether or not in conjunction with selection techniques).
Lord Benyon (Con)
My Lords, I will begin by speaking to the amendments tabled by the noble Lord, Lord Krebs, whom I thank for his amendments and his ongoing support for the Bill. I will come on to the government amendments in due course.
The noble Lord’s amendment highlights some of the challenges in maximising the potential of plant and animal genomes using traditional breeding methods. The crucial issue is whether the types of genetic features under discussion could, in principle, occur in the genome of the organism by traditional processes. In other places in the Bill, where we intended to refer to outcomes that
“could reasonably be expected to result”
from a process, rather than outcomes that could in principle so result, we have expressly said so. This means that it is unnecessary to add further descriptions to the word “could” in Clause 1. Consequently, the existing wording—“could” have resulted from traditional breeding —already achieves the Government’s intended ambition, without the need for further descriptors in the definition. I believe that it achieves the outcome that the noble Lord wants it to.
Baroness Bennett of Manor Castle (GP)
My Lords, having spoken a great deal on the last group, I will be extremely brief now. What we have is the Government still trying to define what the Bill is about at this incredibly late stage. We have been through Committee, Report and the other stages in the other place and here, and here we are still trying to find the wording. Neither the science nor the law is stable enough for this to become an Act and we have just seen a very useful demonstration in this short debate of how this is very likely to be a field day for lawyers, so the lawyers in your Lordships’ House can get ready.
Lord Benyon (Con)
My Lords, I thank both noble Lords for their contributions to this debate. I particularly thank the noble Lord, Lord Krebs, for his continuing help in trying to get this right. I hope the eyes of not too many noble Lords glazed over. I had to get on the record, about what is undoubtedly a very technical piece of legislation, what we were seeking to do by the changes that we were putting in.
The noble Lord makes a very good point about “modern biotechnology” as a term. I am at great pains not to throw in new definitions that could one day come back to bite us, but “modern technology” is widely recognised to cover a specific set of technologies for regulatory purposes. In particular, it is used in the UN’s Cartagena Protocol on Biosafety. The definition of modern biotechnology can be updated—to be probably even more modern technology—subject to the affirmative procedure under powers in the Bill if required.
I hope that the government amendments, which aim to clarify which kinds of genetic features are permissible in a precision-bred organism and the techniques by which they may be introduced, will provide assurance to the noble Lord not to press his amendments. I hope that noble Lords are confident in accepting these government amendments.
Lord Benyon
(d) its genome does not contain any feature that results from the application of any artificial modification technique other than modern biotechnology.”Member’s explanatory statement
This amendment would introduce a new requirement to ensure that the genome of a precision bred organism could not contain features that result from artificial modification techniques that are not modern biotechnology within the meaning of the Bill.
Lord Benyon
“(7A) An “artificial modification technique” means any technique by which genes or other genetic material can be artificially modified within the meaning of Part 6 of the Environmental Protection Act 1990 (as it has effect from time to time).”Member’s explanatory statement
This amendment would define artificial modification techniques in line with Part 6 of the Environmental Protection Act 1990 (which deals with genetically modified organisms).
Baroness Hayman of Ullock (Lab)
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?
Lord Benyon (Con)
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.
Lord Winston (Lab)
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?
Lord Benyon (Con)
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.
Lord Benyon
Member's explanatory statement
This amendment is consequential on the Minister’s next amendment to Clause 4.
Lord Benyon
Member's explanatory statement
This amendment would provide for regulations under Clause 6(2) to be subject to the affirmative procedure.
Lord Benyon
“(9A) Regulations under subsection (5) are subject to the affirmative procedure.”Member's explanatory statement
This amendment would provide for regulations under Clause 11(5) to be subject to the affirmative procedure.
Lord Benyon (Con)
My Lords, I thank the noble Baroness, Lady Jones of Whitchurch, for her amendments, to which the noble Baroness, Lady Bakewell of Hardington Mandeville, and—in the case of the first of the amendments—the noble Lord, Lord Cameron of Dillington, have added their names.
The amendments require the animal welfare advisory body, when assessing precision-bred animal marketing authorisation applications, to also consider and report on the notifier’s history of compliance with relevant provisions of the Human Fertilisation and Embryology Act 1990, the Animal Welfare Act 2006 and other legislation it deems relevant. However, the purpose of the animal welfare declaration process is not to vet notifiers themselves, but to assess their applications for marketing authorisations. The role of the welfare advisory body is to use its scientific expertise to evaluate the notifier’s animal welfare declaration. It would not be an appropriate body to assess compliance history.
We expect notifiers, as with any other keepers of animals, to ensure they are in full compliance with all applicable animal welfare laws. The Animal Welfare Act, as mentioned in the noble Baroness’s amendment, will continue to apply to all vertebrate animals subject to precision breeding. Under the Act, it is already an offence either to cause any captive animal unnecessary suffering or to fail to provide for the welfare needs of the animal. Persons found to have committed certain serious offences under the Animal Welfare Act may be disqualified from keeping animals. Such persons would therefore be unable to keep animals that have been precision-bred.
Similarly, other animal welfare legislation provides for appropriate sanctions for non-compliance. For example, notifiers may also be licence holders for research under the Animals (Scientific Procedures) Act, known as ASPA. It is in the interest of such notifiers to ensure that any research involving animals carried out in the UK complies with the requirements of the ASPA licences relating to that research; these licences may be revoked or suspended if their conditions are not complied with.
Furthermore, the Bill provides powers under Clause 15 for regulations to enable the Secretary of State to suspend or revoke a precision-bred animal marketing authorisation if new information about the health or welfare of the animal or, crucially, its qualifying progeny comes to light, or if the notifier fails to comply with a legal requirement to report information about a relevant animal’s health and welfare under Clause 14. Regulations will describe the procedures to be followed when a marketing authorisation is suspended or revoked, and the consequences of such suspension or revocation.
Amendment 21 reflects ones put forward during previous stages, in this House and the other place. We intend to explore these matters further as we develop the technical details underpinning the animal welfare declaration process. The Government agree that safeguarding animal welfare is crucial, and I acknowledge the high level of interest in this topic. That is why, as I mentioned previously, we have commissioned an external research project to gather the evidence required to develop the health and welfare assessment that underpins the declaration process. This will enable us to set out, in regulations and guidance, the information that a notifier must provide to support their declaration that the health and welfare of a precision-bred vertebrate animal is not expected to be adversely affected.
Furthermore, Clause 13 already ensures that the Secretary of State will need to be satisfied with the animal welfare declaration before issuing a marketing authorisation. That is why we do not consider the amendment to be necessary. In addition, as I mentioned before, the power in Clause 25 allows us to set out in regulations what constitutes an adverse effect on health or welfare. This includes any parameters needed for assessing that and could include consideration of any known health and welfare issues in selectively bred animals.
Finally, the welfare declaration and the welfare advisory body’s assessment will be based on the principle that relevant precision-bred animals will need to be kept in conditions which satisfy existing requirements in the Animal Welfare Act 2006 and, where relevant, the Welfare of Farmed Animals (England) Regulations 2007. I fully understand the noble Baroness’s concerns. None the less, existing animal welfare legislation is in place and the Bill is intended to work alongside that to enable responsible innovation.
I will now address Amendments 17, 18 and 26 in my name. It is essential that the animal welfare protections under this Bill command strong public and stakeholder confidence. To that end, we have listened carefully to the points raised by the Opposition and stakeholders about the need for strong animal welfare protections. We understand that noble Lords feel that there should be more opportunity for parliamentary oversight of these vital elements of the legislation. Consequently, we are tabling these amendments so that regulations made under the powers in Clauses 11(5) and 22(3) will need to be debated and actively approved by both Houses of Parliament through the affirmative resolution procedure before they come into effect.
Amendment 17 relates to Clause 11(5). The amendment provides an increased opportunity for parliamentary scrutiny when powers are used to lay out the form and content of the animal welfare declaration and accompanying documents, and the information that must accompany the declaration.
Regulations under Clause 11(9) regarding provisions for an application for a precision-bred marketing authorisation to be made by a person other than the notifier are a technical and administrative matter and not of significant public interest. They will therefore remain subject to negative procedure.
Amendment 26 relates to Clause 22(3). This amendment will provide Parliament with an increased opportunity to scrutinise and debate the body which is to be designated as the animal welfare advisory body, while retaining the flexibility the Bill provides on how the advisory body can be established. We expect there to be strong public interest in the requirements set out in the animal welfare declarations, and we want to come to Parliament with a robust set of proposals informed by expert advice. Indeed, that is why we have already commissioned in Scotland’s Rural College to run an independent research project to set criteria for the animal welfare assessment and the evidence that will be required to accompany it.
The research will involve experts from the Animal Welfare Committee and a wide range of organisations with expertise in animal welfare, genetics and industry practice. This is a growing, innovative sector, and the regulatory system that oversees it is likely to need to evolve over time. Establishing the regulations in secondary legislation subject to the affirmative procedure will allow the Government to ensure that the regulatory system continues to achieve its goals in the long run, while maintaining proportionate parliamentary oversight of its design and future development. I hope noble Lords will be content to accept these amendments.
Baroness Jones of Whitchurch (Lab)
My Lords, I should first declare an interest through my involvement at Rothamsted, as in the register. I have tabled Amendments 19, 20 and 21 in this group. They all focus on the welfare advisory body in protecting animal welfare. I am grateful to the noble Baroness, Lady Bakewell, and the noble Lord, Lord Cameron, for their support.
Amendments 19 and 20 would require the welfare advisory body to look beyond the information provided by applicants to ensure that they have a consistent record of meeting animal welfare standards, as set out in previous legislation. Amendment 21 would require the welfare advisory body or the Secretary of State to consider wider health and welfare issues before granting a marketing authorisation. These factors, set out in the new clause, include the direct and indirect effects on the health of the animal or its offspring, whether there might be pain or suffering arising from increased yields or faster growth, and whether the precision-bred traits may result in the animal being kept in worse conditions. These amendments reflect the widespread concern raised in Committee about the consequences for animal welfare of extending precision-breeding techniques from plants to animals, and they also express the concerns of many animal welfare organisations, including the RSPCA and Compassion in World Farming, as well as the report from the Nuffield Council on Bioethics.
As we discussed before, British farming and traditional breeding techniques have not always had a great record on considering animal welfare. Without going back over all the arguments raised in Committee, I will say that there remains a fundamental concern that the genetic editing of animals will be used for the wrong purpose. Once we understand that there could be benefits from improved disease resistance in animals, we need better guarantees that this will not result in animals being kept in more crowded, stressful conditions, which in turn could result in the spread of new and emerging pathogens. Similarly, we need better guarantees that precision-breeding techniques will not be used to speed up selective breeding for fast growth, high yields and large litters, when they have historically caused a great deal of suffering to farm animals, despite the animal welfare legislation already in place.
All these concerns are raised against the backdrop that so much of the detail in this Bill is left to secondary legislation, so we do not know how its provisions will work in practice. I hope the Minister will understand why we are trying to spell out in more detail the specific animal welfare protections in this Bill. I shall make a further point: this is specifically about animal welfare. It is not a criticism of the whole Bill. It is about the specifics and our widespread concern about wanting to get animal welfare protections right.
Baroness Hayman of Ullock (Lab)
My Lords, I welcome the government amendments that move the regulations to the affirmative procedure; they are extremely welcome.
I thank my noble friend Lady Jones of Whitchurch for her thorough introduction to her Amendments 19 to 21. I am sure noble Lords will remember that in Committee I tabled a number of amendments relating to the welfare advisory body, so we are very pleased to see my noble friend Lady Jones tabling similar amendments today. I spoke at length on this issue in Committee, my noble friend has introduced her concerns and we have heard from across the House, so I shall be brief.
Amendment 19 makes it clear that, in addition to considering information submitted by the notifier, the welfare advisory body should satisfy itself that the notifier has a record of acting in a manner that is consistent with research and animal welfare requirements across other Acts of Parliament. That really should be part of the body’s role. We do not want any confusion or different decision-making across different bodies.
I may have this recollection wrong, but I thought that in an earlier meeting a flow chart was mentioned showing how different animal welfare bodies, in Defra and the Home Office, would interact. I had been hoping to receive a copy of that to get some clarification about precedence and how this was all going to work together. It may have gone into my spam folder and I may have missed it, but if the Minister could check on that, that would be very helpful.
Currently, the Bill states that the welfare advisory body has to determine whether in the animal welfare declaration the notifier has paid regard to the risks to an animal. One of my concerns has always been that it is the notifier who is driving the process and is in the driving seat, rather than the welfare advisory body, which is why we were all very concerned about more checks and balances. We know the Bill says that the notifier has to take reasonable steps to assess those risks, but we do not believe that is a strong enough protection for animals in the Bill.
My noble friend’s amendment would mean that the welfare advisory body had to assess the impact on animals where a precision-bred trait was developed, with the aim, as she said, of achieving fast growth, high yields or other increases in productivity. As we have heard, we have seen that too often in traditional breeding methods, so we need to bring in these protections. We have heard many examples of traditional selective breeding producing animals that were highly efficient but this was often at the expense of animal welfare, and we need to ensure that that is not an unfortunate consequence of the Bill. The RSPCA and Compassion in World Farming have raised serious concerns about the lack of safeguards in the Bill to prevent that happening. In addition, the Nuffield Council on Bioethics has drawn our attention to the fact that many of the effects of selective breeding have been unintended.
We agree with our noble friend that it is reasonable that welfare impacts should be assessed here. Without the amendment, it is not clear exactly how that would be part of that process with the advisory body, particularly in relation to other bodies that already exist. So we strongly support my noble friend and believe that her amendments should be in the Bill.
Lord Benyon (Con)
My Lords, I am grateful for another useful debate. I assure the noble Baroness that we sent her a copy of my flow chart, so it must have ended up in her spam folder. I hope none of my other correspondence to her will be rejected into the ether. It sets out in five clear steps the process of taking something through to authorisation.
I say to the noble Lord, Lord Cameron, that I am not one of those people who repel all boarders when it comes to amendments; we have actually moved considerably on the scrutiny of the Bill, and we want to ensure that there is as much agreement as possible. I concede that we might have a problem on Amendment 19, but I will come on to that.
I repeat that the welfare declaration and the welfare advisory body’s assessment will be based on the principle that precision-bred relevant animals will need to be kept in conditions that satisfy existing requirements in the Animal Welfare Act 2006 and, where relevant, the Welfare of Farmed Animals (England) Regulations 2007. So existing animal welfare legislation is in place, and the Bill is intended to work alongside it to enable responsible innovation.
An accusation was made, although I cannot remember who by, that this was an enabling Bill and was somehow a forest of Henry VIII clauses. I reject that. It is not a skeleton Bill. We have set out our substantive policy proposals in the Bill and have included appropriate delegated powers to supplement those provisions. Delegated powers serve a valuable purpose and it is always important to assess them in context. Simply counting up the number of powers in a given Bill is not necessarily always meaningful, but I hope we have shifted the balance in terms of those that are affirmative and those that are negative.
There has been talk of belt and braces. I think you can overdo caution in these circumstances, and you can clog up the system. I really feel it would be difficult to accept Amendment 19 as it would pre-empt the Scottish royal college research project. The Bill already outlines a regulatory framework to safeguard animal welfare that goes beyond existing requirements in traditional breeding.
I hope that my words, and the government amendments to increase the degree of parliamentary scrutiny on the animal welfare provisions in the Bill, provide noble Lords with sufficient reassurance not to press their amendments.
Lord Benyon
Member's explanatory statement
This amendment is consequential on the Minister’s previous amendment to Clause 11.
Lord Cameron of Dillington (CB)
My Lords, I repeat, again, that I am a very strong supporter of this Bill and everything it stands for. However, again, as I have said at every stage and indeed a moment ago on the previous grouping, the one weakness of the Bill is around animal welfare. Anyone reading the Hansard of the passage of this Bill through the Commons will note that it was the greatest concern of MPs too, but they failed to make even a dent in the Government’s protective carapace on this issue.
In Committee, many noble Lords from all sides of the House—myself included—put down amendments to try to minimise the possibility of any genetic change being proposed or implemented that could result in the future suffering or discomfort of, or distress to, animals or their progeny involved in the process. However, none of these amendments was put to the vote. We now have a well-thought-out amendment—or two—which precisely covers the worries that we all had and attempts to avoid them. The Government should think seriously before they reject them.
Lord Benyon (Con)
I thank noble Lords for their engagement on this important issue. I am grateful for the meetings that I have had with noble Lords from across the House on this and for them taking the time to share their thoughts with me and with the House on this occasion. I have found it constructive and enlightening.
We recognise that there is a need to safeguard animal welfare in the new regulatory regime; we are all united on this. That is why we are taking a step-by-step approach with regulatory changes for plants first, followed by animals. The measures in this Bill in relation to precision-bred animals will come into force, as I said before, only when safeguards for animal welfare are in place. This will include a monitoring and reporting system for the precision-bred animals once they are placed on the market.
The Bill will give us the ability to place a time-limited and proportionate duty on breeders and developers to monitor for significant health and welfare outcomes in animals that could be linked to their new traits and to report such outcomes to Defra. This monitoring and reporting system will be informed by research that we intend to carry out—which I have already spoken about—to help us identify the specific outcomes that must be reported, as well as appropriate timeframes and numbers of generations that must be monitored for each species or type of animal.
We believe that the powers in the Bill are sufficient to enable us to put this monitoring system in place. Clause 14 sets out that regulations may require the notifier, or any other person specified, to provide information to the Secretary of State about the welfare of the relevant animal and its qualifying progeny. The regulations may set requirements on the information that must be collected, and they allow the Secretary of State to apply reporting requirements in a bespoke manner. This flexibility is essential to ensure that any obligations placed on businesses are proportionate to risk—this is the key point that I hope I may be successful in getting across.
Lord Benyon
“(6A) Regulations under subsection (1) are subject to the affirmative procedure.”Member’s explanatory statement
This amendment would provide for regulations under Clause 18(1) to be subject to the affirmative procedure.
Lord Benyon
Member’s explanatory statement
This amendment would provide for regulations under Clause 22(3) to be subject to the affirmative procedure.
Baroness Hayman of Ullock (Lab)
My Lords, I thank the noble Baroness, Lady Bennett of Manor Castle, for her thorough introduction to her amendment. I completely understand why she is bringing it forward. There are areas of the Bill around implementation, oversight and the step-by-step process that we have discussed time and time again that people are still concerned about. The requirement of the amendment for a report to be published that identifies any gaps in scientific evidence is an interesting one. It will be good to hear the Minister’s thoughts on this.
Lord Benyon (Con)
My Lords, I thank the noble Baroness, Lady Bennett, for this amendment. I am keen to have a much wider conversation with people. My learning curve has been incredibly steep as I have gone through this—the noble Baroness, Lady Hayman, is nodding as well. It is an area of science which is not understood by an awful lot of people. While I have sought to bring in as many safeguards as possible, there is a continuing job to do for all sorts of parties, not just the Government, to explain the benefits of this technology and the safeguards that the Government are introducing. However, I do not think that a priority setting partnership should be established in or under this Bill.
The Bill places science at its core. ACRE advised that precision-bred organisms pose no greater risk than traditionally-bred counterparts. As I said earlier, its advice is supported by the Royal Society, the Royal Society of Biology, the Roslin Institute and a wealth of peer-reviewed literature. The Royal Society stated that
“these are no more likely to pose a risk to human health or the environment than non-editing derived mutations, which occur spontaneously in each new generation”.
In earlier debates, I have sought to make it clear that if we inserted regulatory measures or language into the Bill that somehow elevated this technology beyond where it is, we risk misleading the public and we have to be really careful about that.
ACRE’s expertise in precision-breeding technologies is considerable, having first advised on them in 2013. We used this as a basis for our intervention in a pivotal European Court of Justice case in 2018 and for our consultation on genetic technologies in 2021.
The Secretary of State will be required to make decisions based on the advice of expert committees. As part of its current role as adviser on genetically modified organisms, ACRE will also advise the Secretary of State on whether an organism is precision bred. A comprehensive understanding of the underlying science is essential for this process and ACRE members have a wealth of experience in the regulation of genetic technologies. Moreover, this Bill will sit alongside existing legislation that deals with human, animal, and environmental health.
I understand the noble Baroness’s reservations. However, where we have identified evidence is incomplete, we have taken steps to address this. The regulations under the Bill will not come forward until the relevant measures are in place, and Parliament will have the opportunity to further scrutinise them.