Genetic Technology (Precision Breeding) Bill - Report – in the House of Lords at 6:00 pm on 25 January 2023.
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.
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.
In his response in Committee, the Minister talked about getting the right balance of information between the welfare advisory body and the notifier requesting the marketing authorisation, but we do not believe that what is set out in the Bill is the right balance. It does not allow the welfare advisory body to make the wider checks on the past record of the notifier that our amendment would allow, and the Minister had just said that he does not think that it is the role of the welfare advisory body to do that vetting. We argue very much that it is its role.
The Minister also argued that it is important to balance innovation with animal welfare. He argued this in Committee. He said that setting out parameters in more detail in the Bill could limit the implementation of more detailed measures that will follow—but this is precisely our concern. Moving from genetic plants to genetic animals is a huge ethical and environmental step, and it is right that the protections are spelled out in the Bill, where Parliament can have some control.
In Committee, the Minister referred to Clause 11, which requires applicants to make a declaration that they do not expect the health or welfare of an animal to be adversely affected. Well, in the words of a well- known quote, “They would say that, wouldn’t they?” The Minister also referred to Clause 14, which provides for further information to be required on animal health and welfare, but the clause states only that regulations may be made. There is no guarantee that they will be produced or what the additional information will be. The Minister also said that the Bill is intended to work alongside existing animal welfare legislation, but as it stands it does not empower the welfare advisory committee to cross-reference the notifier’s compliance with those regulations. In fact, the whole emphasis of Clause 12 is for the welfare advisory committee simply to scrutinise the information provided by the notifier rather than make any wider checks.
The Minister also sought to reassure us that the Government have an ambitious reform agenda for animal welfare, but I remind him that we are still awaiting legislation on many of the reforms promised in the manifesto.
So we believe that these amendments are proportionate and necessary. As the Bill stands, there is too much left to chance. There is nothing to ensure that the welfare advisory committee will be proactive and inquiring. In fact, the Minister, in his call for balance, does not want it to be too proactive in case it holds things up. There is far too much left to future regulation that may or may not happen. All these amendments do is ensure that the welfare advisory committee looks at the background of applicants to check that they are complying with existing animal welfare legislation and give the committee greater powers to investigate the impact of precision-bred techniques on the consequent pain, suffering and lasting harm to animals and the conditions in which they are kept.
We believe these additional protections will have broad public support, as well as being in the interests of the animals involved. We welcome the fact that the Minister has set up this external body to give further advice. That does not go against the amendments that we have tabled. It may be that there are further regulations that need to come after this Bill goes through. That is fine, but it does not militate against our amendments at this time. I therefore give notice that, depending on the Minister’s response, I may be minded to test the opinion of the House.
My Lords, I thank the Minister for tabling Amendments 17, 18 and 26. The Government have responded well to the concerns expressed in Committee about the number of negative procedures on some critical issues. Amendments 17 and 18 relate to Clause 11, “Application for precision bred animal marketing authorisation”, which is a key element of the Bill. Regulations under subsection (5) are moved to affirmative, and only subsection (9), which deals with regulations for precision-bred animal marketing authorisations for a relevant animal, are negative and reserved to the Secretary of State. While it would have been preferable for all that clause to be affirmative, we are pleased with this movement, as the change allows more debate on these issues in future.
I turn now to Amendments 19 and 20 in the name of the noble Baroness, Lady Jones of Whitchurch, to which I have added my name—she introduced them fully, as always. The Government have been trying for a long time to introduce gene editing of plants and animals. Changing the name of this process to “precision engineering” has somewhat helped their case. At the heart of previous and current objections which have been raised over time against precision engineering is animal welfare.
Whenever a man, woman or child is to undergo a surgical or medical procedure, numerous forms have to be completed, and a consent form signed; in the case of a child, a parent or guardian signs. Animals undergoing genetic change have no such individual guardian, and they certainly cannot speak for themselves. It is therefore necessary for those of us in this Chamber to ensure that safeguards and trust are in place which will be robust. This trust is placed in the welfare advisory body. The noble Lord, Lord Winston, referred to ethics in his comments on the first group of amendments, and the issue runs all through the Bill. The process is that the notifier applies to the Secretary of State for an authorisation in relation to an animal, and the Secretary of State then refers the application to the welfare advisory body, which in turn provides a report for the Secretary of State. Amendment 19 requires the welfare advisory body to ensure that the notifier has a record which provides the necessary reassurance that animal welfare will not be compromised in any way. Precision engineering can take place, but not at the expense of the animal’s suffering. Amendment 20 is consequential on Amendment 19.
The noble Baroness, Lady Jones of Whitchurch, has also spoken to her Amendment 21, which proposes a new clause. This lists some additional factors which the welfare advisory body or the Secretary of State must consider before granting a marketing authorisation. The Minister has said that he does not feel that this is necessary, but such is the interest in the Bill and the consequences which flow from it that we believe a belt-and-braces approach is necessary.
We on these Benches do not wish to interrupt the passage of the Bill, but we support all efforts to ensure that animal safety and welfare are protected. This is not the stage of the Bill at which to relate cases of experimentation on animals which have gone horribly wrong and ended with considerable suffering to the animals concerned. Animal welfare is our prime concern, and I look forward to the Minister’s response, but if the noble Baroness, Lady Jones, is not satisfied with it and decides to divide the House, we will support her.
My Lords, for the purposes of Report, I declare my interests: I am still involved in a family farming enterprise growing crops and rearing livestock, I chair the board of the UK Centre of Ecology & Hydrology, and I am president of the Royal Association of British Dairy Farmers.
As the House knows, I am a very strong supporter of the Bill and everything it stands for. It is only to strengthen the Bill that I have added my name to Amendment 19 tabled by the noble Baronesses, Lady Jones and Lady Bakewell, because here again we touch on the same weakness in the Bill that I referred to at earlier stages—notably, the oversight of the ongoing welfare of animals and their ensuing progeny affected by these processes. As I said at Second Reading:
“To my mind, however, there is too much responsibility, certainly in the latter stages of the proposed development process, for the notifiers themselves to keep the welfare advisory body informed. It appears that the notifiers are in the driving seat.”—[Official Report, 21/11/22; col. 1218.]
These notifiers will be the ones who have probably invested millions of pounds, and almost certainly years of man-hours and academic endeavour in the process, and will therefore be very strongly motivated to ensure that the results give them some sort of positive return. I am not saying that they will necessarily falsify the evidence, although that may not be beyond the realm of possibility, but they will surely be sorely tempted to slant the results—if only for the sake of their commitment to what they see as the greater good. For instance, one person’s definition of bovine, ovine or avian distress might be another person’s idea of, say, satisfactory close family living. Therefore, it is essential that the welfare advisory body has the duty to audit and check up on these notifiers.
I know that the Government—any Government—have a priority to repel all boarders when it comes to amendments to their legislation, but I cannot see how or why they would want to tell the public that their new welfare advisory body would not have an obligation to check up on and satisfy itself that the notifier is conforming to the codes of practice set out in existing legislation. I am sure that the Government will tell us that this is not necessary—in fact, they have already done so—that there are other bodies involved, and that the notifiers already have an obligation. However, unless the welfare advisory body has a specific duty to check on and audit the notifier, it is quite possible that such persons or bodies could slip through the Met. Oh! That is not necessarily a Freudian slip—I mean “the net”, of course, but after last week’s revelations about rogue policemen I expect you can see how my mind is working. The welfare advisory body needs a specific duty spelled out in the legislation to ensure that there are no rogue notifiers.
I hope that the Government will see fit to accept this amendment, or undertake to discuss a positively worded government replacement amendment to be introduced at Third Reading, either for Amendment 19, to which I put my name, or Amendment 21, or indeed Amendment 22 in the next grouping. There has to be some give here on their part to persuade me, and I would like to think to persuade the House, that a vote on this matter of animal welfare is not necessary.
My Lords, during the proceedings on the Bill—I spoke at Second Reading—it has been clear that some people, both inside and outside the House, do not want anything to do with genetics in terms of food production, and think that its application is anathema. I understand that and I do not blame them in the least, although I do not agree with it, but I have been looking at Amendment 21 in the name of the noble Baroness, Lady Jones of Whitchurch, and I ask her whether she thinks that the provision in proposed new subsection (3)(b) might well give an opportunity for one of those people. Its wording is about progeny being
“likely to experience … lasting harm” resulting from “faster growth” If you take that to its logical conclusion and encourage faster growth in an animal used in the meat trade, it is fairly clear that the animal will become suitable for slaughter at an earlier stage than if it had not had the influence of genetics. If you create faster growth by the application of genetics that ends up with the animal having a shorter life, is that not lasting harm? Some people could argue that, and I ask the noble Baroness if she would like to comment on that question.
I am not sure if this is the right moment to speak, but, in answer to the noble Lord’s specific question, the amendment is saying only that the welfare advisory body should take that into account. If there were other overriding reasons why we would want to have faster growth, for example, then that would be a balanced decision that it would make. However, if the faster growth were indeed leading to more pain, we hope it would take that into account. That is what the animal welfare role ought to be about. In Committee we heard lots of examples of new breeding techniques causing considerable pain, but I hope we are moving away from that now and can have a more generous attitude towards both conventional breeding and, potentially, the genetic breeding of animals where it does not have that effect. So it is all about the balance, and this is just one factor that the welfare advisory body will take into account.
My Lords, I declare my interests as a tenant farmer and as chairman of the Rock review into England’s agricultural tenancies.
The Government’s procedural amendments will increase parliamentary oversight of the design and future development of the animal welfare provisions. The Government recognise that there is a need to safeguard animal welfare, and that is why we need a step-by-step approach by bringing legislation into effect for precision-bred plants first and then for animals. Research in farmed animals is already leading to the development of animals that have increased resistance to some devastating diseases that, as farmers, we all see, and it thereby enhances the health and welfare of animals.
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.
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.
Amendment 17 agreed.