My Lords, I am grateful for what has been a fascinating debate. I am conscious that there is in this Room a fellow of the Academy of Medical Sciences, who is also a fellow of the Royal College of Physicians, and the Royal College of Obstetricians and Gynaecologists, and others who are fellows of the Royal Society and winners of the Frink Medal—and that is just two of them—and that my attempt at a biology A-level sits me down at the other end of the spectrum. I will endeavour to answer the points that were raised.
The noble Lord, Lord Winston, made an important contribution to this debate. First, I say to him that the references to CRISPR Cas-9 are not relevant to this legislation. I know that he knows this, but he makes an analogy to that. Important though it is, it is specifically outside this legislation.
Independent scientific advice from ACRE, the Advisory Committee on Releases to the Environment, is that precision-bred organisms pose no greater risk to the environment and health than traditionally bred organisms. That advice is supported by the Royal Society, the Royal Society of Biology and the Roslin Institute. Professor Lovell-Badge from the Crick Institute reminded us that:
“Generally, on the risk of a random mutation versus a genome-edited one, you are actually better off with a genome-edited one because you know what you are doing.”—[Official Report, Commons, Genetic Technology (Precision Breeding) Bill Committee, 28/6/22; col. 37.]
This was supported by Professor Houston, director of innovation at Benchmark Genetics, who told us that it is now getting very good data from research experiments showing that off-target effects are very rare. In summary, our advice has been that there is no increased risk to health and the environment.
My commitment today is absolutely to study the papers that the noble Lord mentioned and to assure the Committee, including the noble Lord, Lord Cameron,
who made a very important intervention, that we would be happy to meet. I repeat that invitation; some noble Lords have already met me, the Bill team and others who are advising us to make sure that we are addressing their concerns and that we reflect that in any changes that we want to see to make sure that this works.
In my response to the amendments in group 8 I will cover our thinking on the provisions for release into the environment and the marketing of precision-bred animals, including animal marketing authorisations. I will start with the amendments on the interplay between this Bill and the Animals (Scientific Procedures) Act 1986, commonly known as ASPA.
I reassure noble Lords that ASPA will apply during the first stages of developing a breeding line using precision-breeding techniques in animals. ASPA rightly places rigorous requirements on the use of animals in scientific procedures, including precision breeding. ASPA requires that animals may be used in science only where there are no alternatives, where the number of animals used is the minimum needed to achieve the scientific benefit, and where the potential harm to animals is limited to that needed to achieve that benefit. I know that they are the values and priorities that the noble Lord, Lord Winston, will have operated under through many decades of research.
We will of course continue to work closely with the Home Office, which regulates these matters, as we develop guidance on this issue. As I said on Monday, we have also commissioned Scotland’s Rural College to carry out research which will provide further information on how breeding lines are developed using precision breeding, including the stages which would be covered by ASPA and this legislation. This research is due to complete next summer and will be important in helping us produce guidance outlining when and how these two pieces of legislation will apply in the process of placing a precision-bred animal on the market. I reiterate what I said on Monday: our priority is to develop these new technologies in plants first and then, as we get the structure, framework and architecture right, we can proceed with animals.
In relation to Amendments 23 and 72A, I reiterate that ASPA licences will be needed for scientific procedures for precision breeding in animals, as defined in ASPA. Under ASPA, three licences are required: a personal licence for each person carrying out procedures on animals, a project licence for the programme of work, and an establishment licence for the place at which the work is carried out. I hope that addresses the concerns about broom cupboards—we want to make sure that this is taking place in registered, agreed, regulated premises.
Furthermore, the Bill will not make changes to the way precision-bred animals are regulated under the existing Genetically Modified Organisms (Contained Use) Regulations. This means, among other things, that facilities where precision breeding takes place must be registered with the Health and Safety Executive and comply with the requirements to apply appropriate containment and control measures. Both of these regimes work effectively to ensure precision breeding is conducted in a known premises or laboratory, under suitably regulated conditions.
I turn now to Amendments 20 and 22. Clause 3 applies to the release of plants and animals which will be primarily for research purposes. The ASPA regime already works effectively to protect animals used in science and research, so although I understand the intention, I do not think it would be appropriate to insert this further requirement here. Furthermore, developers will already be required to submit a release notice to Defra confirming that the “founder” organism they intend to release for research trials meets the criteria set out in the Bill. They will have generated genomic data in order to confirm that this is the case. However, requiring the information set out in the amendment, including epigenetic data, would be disproportionate.
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I turn to Amendments 34, 35, 36, 38, 50 and 87, particularly on the points raised by the noble Baroness, Lady Parminter. These amendments are in relation to the welfare advisory body. I appreciate the concerns and reassure noble Lords that the powers in these clauses already allow the welfare advisory body to carry out proper assessment and report the results to the Secretary of State. Clause 12 sets out that the advisory body’s report must consider whether the notifier has taken reasonable steps to identify the animal’s precision-bred traits, and the risks to the health or welfare of the animal or its qualifying progeny that could reasonably be expected to result from those traits. The Bill enables the advisory body to request further information from the notifier.
Moreover, if the welfare advisory body considers that the notifier has not made an appropriate assessment, this would be reflected in its report to the Secretary of State, who can reject the application. We consider that this provides the right balance, ensuring that the Secretary of State has the necessary information to assess a marketing application without long delays and unnecessary duplication.
I will now speak to the form and function of the welfare advisory body. Clause 22 will ensure that we can designate the most suitable body to this vital role. As noble Lords will know, we intend to bring the provisions of the Bill concerning precision-bred animals into force once the regulatory system to safeguard animal welfare is established. The power in Clause 22(3) provides the flexibility to use whatever committee or other public body is most suited to the role when the time comes, or to create a new one if needed. I repeat: a new one may be created if needed. This gives future Governments the ability to reflect this area of fast-moving technological change.
Clause 22(4) establishes that the welfare advisory body will be a public body and therefore subject to the rules, principles and scrutiny which apply to public bodies generally. That addresses some of the comments of the noble Baroness, Lady Jones; I will come on to some of her other concerns in a minute. The members of the welfare advisory body will have sufficient scientific experience on the health and welfare of animals to be able to assess whether the notifier has correctly identified the precision-bred traits and the health and welfare risks.
The amendment suggests placing an additional function on the welfare advisory body in the Bill. I think that goes substantially beyond its core role of providing
independent scientific advice on individual animal welfare declarations, and would require it to take on a role in policy and regulation which properly belongs to the Secretary of State. The amendment would, in effect, give the welfare advisory body the power to require the Secretary of State to set aside regulations that the Secretary of State had already made and had been scrutinised by Parliament.
The Bill’s powers will enable the Secretary of State to appoint an existing committee to this new role or, as I say, to create a new one if needed. Defra already has access to independent expertise on animal welfare, principally through the Animal Welfare Committee. We have been engaging with that committee and other expert bodies as the Bill has developed. The Animal Welfare Committee is also represented on the Scotland’s Rural College project steering group.
The noble Baroness, Lady Jones, asked about the sentience committee. As the Government explained when we took what is now the Animal Welfare (Sentience) Act through—it received Royal Assent in April—it required us to get actively working to establish the animal sentience committee. I am pleased to say that the chair, Michael Seals, has already been appointed. He is well known to Defra and has proved himself to be a very good adviser. We expect it to be some years before precision-bred animals are brought to market, so de facto the animal sentience committee will be established for more than 12 months prior to the first precision-bred animals coming on to the market, which addresses points in other parts of our debates today.
I turn now to Amendments 37, 39, 40, 54 and 55, which noble Lords have tabled in relation to the technical details on which the animal welfare declaration should be based. The Bill is intended to work alongside the existing animal welfare legislation to enable responsible innovation and protect animal welfare. Let me reassure noble Lords that the Government share the public’s high regard for animal welfare. We have set out our ambitious reform agenda in the action plan for animal welfare. As part of our plans for future farming, we launched the animal health and welfare pathway this year and will push forward to support continued improvement in farm animal health and welfare.
I will address the points made by the noble Baroness, Lady Hayman. While this Bill is not the place to address the conditions in which animals are kept, I remind noble Lords that animals in England are already protected by the Animal Welfare Act 2006, as well as by more specific requirements for farmed animals in the Welfare of Farmed Animals (England) Regulations 2007. Alongside these regulations, there are also statutory welfare codes for the main kept species. I raise this, more perhaps in response to some points made by the noble Baroness, Lady Bennett, and others when we were talking about this on Monday, to address the fear that this might be some sort of Trojan horse to allow overstocking or densities of animals. Issues such as stocking densities of farmed livestock are, as I say, regulated in legislation and in regulation. These include detailed requirements for the use of enriched cages for laying hens, farrowing crates for pigs, and pens for calves. The Bill is very much intended to go alongside existing animal health and welfare legislation. Keepers
of precision-bred animals will be subject to the same legislative requirements concerning protecting and promoting good welfare as those of traditionally bred animals.
Moving forward with this legislation, we recognise that it is important to balance innovation with ensuring the introduction of appropriate safeguards to protect the welfare of precision-bred animals and their qualifying progeny. To set out the parameters in more detail in the Bill would limit the scope of this development and could prevent the implementation of the most appropriate, detailed measures, as developed through collaborative work with technical experts. Further, the power in Clause 25 allows us to set out in regulations what constitutes an adverse effect on health or welfare, including any parameters needed for assessing this. This could include consideration of any known health and welfare issues in selectively bred animals.
As mentioned before, the research we have commissioned from Scotland’s Rural College will help us to develop the criteria for assessment and evidence that must support the notifier’s application, which the welfare advisory body will then assess and report on to the Secretary of State. These details will be set out in secondary legislation and guidance. I confirm that the welfare declaration process will require notifiers to submit health and welfare information in response to prescribed questions and metrics. I believe that our framework is already capable of adequately addressing concerns about any health and welfare risks to a precision-bred animal and its qualifying progeny from any precision-bred traits. Adding a requirement to provide a wider evaluation of the quality of life for future generations of a relevant animal will lead to considerable uncertainty as to the overall basis on which a notifier’s animal welfare declaration will be assessed. I hope that this addresses the point that the noble Lord, Lord Cameron, raised.
Clause 14 will provide for the ability to make regulations requiring the notifier or any other person to monitor for significant adverse health and welfare outcomes in precision-bred animals which are authorised for marketing under the Bill, and their qualifying progeny, and report such outcomes to the Secretary of State. This addresses the ongoing requirement which the noble Lord rightly raised for the monitoring of these animals in future. This requirement is intended to pick up on the health and welfare problems that might arise after a marketing authorisation has been granted and the animals are being commercially produced. It is linked to the powers under Clause 15, enabling the Secretary of State to make regulations covering the suspension or revocation of a precision-bred animal’s marketing authorisation, in cases where new information shows that the health or welfare of the animal or its qualifying progeny is adversely affected by precision-bred traits.
The marketing authorisation will consider the whole life of the animal, and its qualifying progeny, in assessing whether any health and welfare risks arise from any precision-bred traits. I reassure noble Lords that I am confident that the most effective and proportionate means of keeping the requirements relating to animal welfare up to date is to set them out in regulations to be approved by Parliament rather than requiring amendments to primary legislation.
I turn to Amendments 24, 44 and 45, which seek to ensure that the Bill provides sufficient transparency. Clause 18(1)(j) already allows for these regulations to prescribe additional matters relating to this legislation to be published on the register of precision-bred organisms. I hope that that addresses the point that the noble Baroness, Lady Parminter, and the noble Lord, Lord Rooker, raised. I can therefore assure noble Lords that including the specific details set out in this amendment is not necessary, and I hope that this gives them enough information for the amendment not to be pressed.
On Amendment 24, I recognise that the noble Baroness is seeking to ensure that the Bill provides sufficient reporting requirements on the health and welfare of precision-bred animals and their progeny. During the stage before marketing, we expect that researchers or breeders will be collecting data for the animal welfare assessment that must be passed before precision-bred animals can be marketed. We also expect that any research involving precision breeding in animals in England will be covered by the ASPA regime, which is already effective and robust. Therefore, we do not consider it necessary to apply additional requirements. However, I reassure the noble Baroness that the type of information suggested will need to be collected before the animal can be marketed.
Before an authorisation can be granted to market a precision-bred relevant animal, Clause 11 requires a declaration that the notifier does not expect the health or welfare of the relevant animal or its qualifying progeny to be adversely affected by any precision-bred trait. Clause 11 also sets out that the application will have to be accompanied by an assessment of risks to the health and welfare of the relevant animal and its qualifying progeny that could reasonably be expected to result from a precision-bred trait, and an explanation of the steps required to identify these risks. We are trying to create a more proportionate regulatory system to enable research to take place, and much of the information will be collected as part of the marketing authorisation process.
With regard to Amendment 45, I reassure the noble Baroness that, in the interest of transparency and public reassurance, the Government are committed to maintaining a comprehensive, accurate and up-to-date register, because this information concerns a wide range of matters that she and the noble Baroness, Lady Bennett, rightly say that the public are very interested in. The register will be accessible by electronic means in real time on GOV.UK. Any interested parties are able to access the GMO register and can view all the applications for, and consents to release, GMOs, as well as notifications concerning release of qualifying higher plants. The precision-breeding register will follow the same regime.
I hope that my words have provided the assurance required for these amendments not to be pressed.