Examination of Witness

Genetic Technology (Precision Breeding) Bill – in a Public Bill Committee at on 30 June 2022.

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Penny Hawkins gave evidence.

Photo of Graham Stringer Graham Stringer Labour, Blackley and Broughton 2:00, 30 June 2022

The Committee is now sitting in public and the proceedings are being broadcast. We will now hear oral evidence from Penny Hawkins, head of the animals in science department at the Royal Society for the Prevention of Cruelty to Animals, who is now before us on Zoom—welcome. Would you like to introduce yourself? We will then move straight to questions.

Penny Hawkins:

Good afternoon. I am Dr Penny Hawkins. I am a biologist by training. I am head of the RSPCA animals in science department, which seeks to implement replacement, reduction and refinement with respect to animal experiments, and to ensure the robust ethical review of animal use.

Photo of Graham Stringer Graham Stringer Labour, Blackley and Broughton

Thank you. We will be finishing at 2.20 pm, so Members should keep their questions brief, and answers should be as precise and brief as possible.

Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs

Q174 Welcome, Penny, to this afternoon’s session. Can you briefly outline what protections are in place for the welfare of animals, more specifically farmed animals, which were the source of concern this morning? Can you elaborate on whether you are reassured that all precision-bred lines for animals will be developed under the Animals (Scientific Procedures) Act 1986 controls assessing the ethics of the approach? In addition, what else would you like to see? Where do you think the Bill does well and where do you perhaps think there are more challenges?

Penny Hawkins:

Right, there were quite a few components to that question, so if I start to go off topic, do please bring me back. I will start by saying that my area of expertise is the Animals (Scientific Procedures) Act 1986, so while I am aware that there are various pieces of legislation and codes of practice that regulate how farmed animals are kept and what it is permissible to do to them—of course, the Animal Welfare Act 2006 comes into play if farm animals are cruelly treated—what I really know about is the 1986 Act.

That was a major concern for the RSPCA, because when you look at the draft Bill, there is actually no mention at all of the Animals (Scientific Procedures) Act, which I will call ASPA for short from now on. The drafting team kindly gave us some of their time, so I now understand that every new line—every new precision-bred line that is created and that will then go on to fall under this Bill—will still require licensing under the ASPA for the foreseeable future.

That is absolutely essential, because within the ASPA, you have a framework for minimising the harms to animals, for reducing or avoiding wastage, and for ensuring that gene edited animals are properly characterised or phenotyped, so you understand the physical impact on the animal. There are also proper requirements for welfare assessment and, very importantly, a harm-benefit analysis and ethical review of every line, as you mentioned. In cases of special ethical animal welfare or societal concern, there is the provision to ask the Animals in Science Committee to review the project licence application, which is also critical.

The key reason why the harm-benefit analysis is essential is that at the moment, as drafted—and as previous people who have appeared before the Committee have explained—there is nothing in there about permissible purposes, less permissible purposes or purposes that should be really carefully scrutinised. So I think the ASPA is and will remain an essential safeguard to ensure that there is proper risk minimisation for animals, ethical review, and an element of social licence to use these techniques. People have to remember that the public need to consent to this, and at the moment, there are deep-seated public concerns that have not been properly explored.

Photo of Daniel Zeichner Daniel Zeichner Shadow Minister (Environment, Food and Rural Affairs)

Good afternoon and thank you, particularly for your written evidence and for the points that you have just made about ASPA. I want to follow on from that slightly, in relation to laboratory animals. I do not think we have really talked about that at all so far in the evidence sessions and I wonder whether you could say a little about it. Could you also comment on the overall framework of protection and, in particular, where the Animal Sentience Committee might fit in with regard to some of this? We are slightly concerned that it seems that the Bill could be on the statute books before the Animal Sentience Committee is even establishedQ .

Penny Hawkins:

Indeed. I think some very useful lessons can be learnt from the way in which genetically altered laboratory animals are regulated, but I emphasise that, within a laboratory setting, genetically altered laboratory animals include those in which genes have been inserted from other species. We are very clear that within this Bill we are talking just about gene editing and not about deliberate transgenesis, although there have been some discussions about potential accidental additions of exogenous material.

When genetically altered animals are created under the ASPA, a licence is required for their creation, because, obviously, regulated scientific procedures are required in order to generate these animals—procedures that relate to, for example, administering substances to animals so that they produce large numbers of eggs, or super-ovulation, removing those eggs from animals, preparing other animals to receive the gene edited pregnancies, and so on. All those require licensing, and then, when the line of genetically altered animals has been created, they have to be, as I mentioned, phenotyped. That is a battery of behavioural and biochemical tests to look at what the eventual genetic alteration was and to look at the whole animal that this creates—the phenotype.

There is a system of licensing under which the impact on the animal is categorised as mild, moderate or severe. If a researcher or research team can demonstrate that the gene edit they have done is stable for at least two generations, and if they have phenotyping data and animal welfare assessment data to demonstrate that the animal is not going to suffer as a result of being gene edited—the impact would have to be what is referred to as below threshold; not even mild suffering—then, in those circumstances, they can apply for the breeding of that particular line to be released from the controls of ASPA. That would mean that those animals would still be bred in a laboratory under all the codes of practice that normally apply to laboratory animals, but a licence would not be required in order to breed the animals, because there is no risk to their welfare because of the gene edit.

Those are the safeguards in place for laboratory animals. The issue with farmed animals is that, obviously, if they are released from ASPA and their breeding is then controlled or regulated by this PB legislation, they will not be held in a laboratory setting, with all the controls that that entails; they will join the national herd or flock. That is a very different environment, and it can be far from clear how the genes will express themselves once they are in that environment.

Also, this Bill presumably applies to other animals: companion animals, wild animals and sporting animals. At the moment, for example, projects are under way to look at gene editing grey squirrels to result in fewer females being born or male infertility. Presumably, their breeding will also be covered by the Bill. And when they are released, they really will be released into the wild. Again, that is an extremely different environment. So the safeguards that laboratory animals have will be severely reduced or absent for other types of animal.

Photo of Daniel Zeichner Daniel Zeichner Shadow Minister (Environment, Food and Rural Affairs)

Q What would be needed in the Bill to safeguard against the issues that you have just raised?

Penny Hawkins:

Well, I was listening to the representations this morning and I can only echo what everybody was saying about the welfare advisory body. At present it is there to report to the Secretary of State on whether the notifier has had regard to the risks to the health and welfare of the animal and their progeny. There does appear to be some provision in clause 15 on the suspension and revocation of marketing authorisation. That provides for the Secretary of State to receive information on the health and welfare of the progeny of those animals, but that is dependent on clause 14 on reporting obligations, which states only that:

“Regulations may make provision for requiring the notifier…to provide the Secretary of State with…information” about their progeny

“during periods…prescribed by the regulations”.

All those elements that relate to long-term surveillance really need to be tightened up, and they need to be “musts” instead of “mays”. Many of those are subject to the affirmative procedure, which I know is normal for statutory instruments, but that again does not reassure people who are concerned about the long-term welfare effects that an adequate mechanism is in place for picking these up.

Similarly, it is not at all clear what qualifications the inspectors who are going to be active under the Bill need to have, so it would be good to see some reassurance as to how they are going to be qualified and to see it explicitly said that they will have the right to access and inspect animals.

Photo of Deidre Brock Deidre Brock Shadow SNP Spokesperson (Wales), Shadow SNP Spokesperson (Environment, Food and Rural Affairs), Shadow SNP Spokesperson (COP26)

Thank you for coming along to speak to us this afternoon. The RSPCA has raised concerns about the safety of gene editing, stating:Q

“There is no history of safe and reliable use”.

What else could that cover? What are your concerns? Can you expand on that, please?

Penny Hawkins:

Just to clarify, when we talk about safety we are talking about the safety of animals. There are two kinds of concerns about gene editing: one from the consumer point of view and one from an animal welfare point of view, and we are talking about the animal welfare point of view. I listened particularly to Professor Henderson when he spoke to you, and I noted that he said there will have to be a two to three-year process of gathering and analysing scientific evidence around both on-farm and off-farm welfare

“before the secondary legislation can be enacted.”––[Official Report, Genetic Technology (Precision Breeding) Public Bill Committee, 28 June 2022; c. 17-18, Q24.]

He said that the process for that was laid out in the Bill, but I have looked at the Bill really carefully and I cannot see any such process either in the Bill or the explanatory notes.

This morning Professor Henderson said that more thinking needed to be done regarding animal welfare advisory bodies and advice on the Bill. Coming from the DEFRA chief scientific adviser, I do not think that that is very reassuring. All of the concerns that I expressed previously about the longitudinal reporting and monitoring of health and welfare also apply here. I am particularly thinking about clause 9, which explains what happens from the bureaucratic aspect if an animal is no longer deemed to be precision bred. Presumably if an animal is no longer deemed to be precision bred, it will either be because they have not been characterised or phenotyped properly or because the genome is no longer stable.

As you heard from the Royal Society of Biology, genes can have effects in multiple tissues, so in these cases there must be a much clearer mechanism for identifying and tracing these animals, and that is also lacking in the Bill. From an animal safety and welfare perspective, there really are some issues that need to be addressed.

Photo of Deidre Brock Deidre Brock Shadow SNP Spokesperson (Wales), Shadow SNP Spokesperson (Environment, Food and Rural Affairs), Shadow SNP Spokesperson (COP26)

Q You mentioned ASPA. What are your thoughts on the potential conflicts between this legislation and the Animal Welfare (Sentience) Act 2022?

Penny Hawkins:

That is an extremely important question. Reading the sentience Act, I do not think it will necessarily preclude gene editing per se. What it requires is an examination of whether or to what extent the Government are having or have had all due regard to the ways in which the policy might have an adverse effect on the welfare of animals as sentient beings. At the moment it is simply not possible to say that on the basis of the information in the draft statute.

Clause 12 talks about the welfare advisory body reporting to the Secretary of State on whether the notifier has had regard to the risks to the health or welfare of the animal or their progeny and has taken “reasonable steps” to identify or address them. But we do not know how the welfare advisory body will be constituted or resourced, how independent it will be, what kind of expertise it will have access to, whether it will just confine its assessment to looking at those particular traits that have been identified by the notifier or whether it will think about wider issues relating to the process of gene editing, as Professor Campbell said, looking at purposes or at the global impact of gene editing those animals. So it is not possible to say from the way the statute is drafted at the moment whether all due regard has been paid. We just have to hope that the secondary legislation will address this, but at the moment we just don’t know.

Photo of Deidre Brock Deidre Brock Shadow SNP Spokesperson (Wales), Shadow SNP Spokesperson (Environment, Food and Rural Affairs), Shadow SNP Spokesperson (COP26)

Q I have seen criticism that the Bill is too focused on enabling the commercial opportunities inherent within gene editing, rather than focusing sufficiently on animal welfare, for example. Would you agree with that, looking at the Bill as it is drafted at the moment?

Penny Hawkins:

Yes, because even the animal welfare applications are ultimately for human benefit. If you think about the gene edited polled cattle, which are the poster child for the animal welfare applications, clearly polling cattle is extremely painful and distressing for them. A world in which that did not have to happen would certainly be a better world for the cattle, but it is actually possible to keep horned cattle together. It can be done, but it is very expensive. Many farmers would not be able to afford it and many consumers would be unwilling, or probably unable, to pay the prices that would be involved. So, yes, there is a welfare benefit, but it is ultimately an economic benefit.

Photo of Kerry McCarthy Kerry McCarthy Shadow Minister (Climate Change and Net Zero)

Could I just press a little more about the Animal Sentience Committee side of things? We are now in the position where there is the welfare advisory body under this legislation, the Animal Sentience Committee and all the licensing regimes under the Animals (Scientific Procedures) Act 1986. Do you think it would be better if this was all merged into one organisation? We also heard about the codes that apply in terms of farm animal welfare, some of which is legislative and some of which is guidance. Is it not all a bit messyQ ?

Penny Hawkins:

No, I do not think it is messy. The Animal Welfare Centre of Excellence, which will bring all these committees together, will ensure co-ordination. The purpose of the Animal Welfare (Sentience) Act 2022 is to look at policy across all policy areas and see whether due regard has been paid to the effects on the welfare of animals as sentient beings. The welfare advisory body is something that the Animal Sentience Committee would look at when it was making that assessment. I still think it is really important to have this overarching body that will look at policy right across the board. To me, they are all separate entities that complement one another.

Photo of Kerry McCarthy Kerry McCarthy Shadow Minister (Climate Change and Net Zero)

Q Do you not worry that things would get lost in the mix, and that something might be seen as the responsibility of one body and then be overlooked by another?

Penny Hawkins:

No, I do not believe they would. I think there is a suitable framework in place to ensure co-ordination that I think will work.

Photo of Graham Stringer Graham Stringer Labour, Blackley and Broughton

Can I thank Dr Hawkins for her time and for the evidence she has given to the Committee, which I am sure we will find very valuable? Thank you very much.

Penny Hawkins:

Thank you for the opportunity.