Clause 11 - Application for precision bred animal marketing authorisation

Part of Genetic Technology (Precision Breeding) Bill – in a Public Bill Committee at 2:30 pm on 5th July 2022.

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Photo of Jo Churchill Jo Churchill The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs 2:30 pm, 5th July 2022

I thank the hon. Gentleman, because animal welfare is close to all our hearts. It is something that this Government—indeed, any Government—need to be cognisant of, and I am proud that we have a strong record of supporting and improving it. With the animal health and welfare pathway, we have laid out where we intend to go further.

I will take the eight amendments in turn. The hon. Gentleman will not be surprised to hear that I do not feel that amendment 13 is necessary. The purpose of this part of the Bill is to create the regulatory framework for the approval of marketing authorisations for precision bred animals. I assure all Members that we propose to work closely with the industry, expert groups, scientific advisers, non-governmental organisations and all other stakeholders on the development of that technical detail. I think the hon. Gentleman would agree that it is important that all those voices are heard, and that we work on that technical detail with everyone.

For the animal welfare declaration, that will include setting out metrics and the evidence that is necessary to accompany it. As part of that work, we will commission—indeed, we are commissioning—further evidence through independent research, and we will draw on our animal welfare advisory board. Once the technical details are designed, they will be set out in secondary legislation and guidance will be provided. They will benefit from co-design with those expertise and stakeholders. That is important to ensure we get this right.

We want to enable, rather than hamper, innovation while ensuring that animal welfare requirements are fully regarded and adhered to. We believe the amendment to clause 11 is not needed because it would cover only administrative and technical details. I hope the hon. Gentleman feels reassured that, in order to get to the right conclusion, we are trying to do this openly and transparently with all those who need to have their voices heard.

In essence, the clause signals to science and innovators, who are at the forefront, that the Government support the adoption of beneficial modern technologies and that they should have confidence moving forward. However, we recognise that as well as enabling innovation to keep pace with new and beneficial technologies, we must continue to uphold the high standards of animal welfare.

Clause 11explains the application process for precision bred animal marketing authorisations, which will be required, in addition to the precision-bred confirmation, which we have already debated when we considered clauses 6 to 9. It is a crucial part of the Bill, as it sets out a new framework for the new system, to ensure that the health and welfare impacts on animals from precision breeding are assessed by a body of operationally independent subject experts—the welfare advisory body—before animals can be marketed.

We do not expect to implement these measures quickly. The technical and administrative details of this new system will be carefully developed with stakeholder input. As a result, we intend that the provisions of this Bill relating to the marketing of relevant animals will be brought into force after those relating to precision-bred plants.

Clause 11 further explains that the application to obtain a precision bred animal marketing authorisation is made to the Secretary of State, and it must be accompanied by an animal welfare declaration. This will be a declaration, with supporting evidence, stating 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. That is why it is important to be broad in that discussion, because I take on board the points of the hon. Member for Cambridge. The Secretary of State must refer the welfare declaration and all the required accompanying information to the welfare advisory body, unless he has decided not to issue a precision-bred confirmation in relation to the animal.

Clause 11 also sets out the framework for information required in the application for a precision bred marketing authorisation. These administrative requirements will be set out in secondary legislation later. The clause also allows for regulation using the negative procedure to set out when a person other than the notifier can apply for a precision bred marketing authorisation for a precision bred animal. To give the hon. Gentleman an example, if some research was seen to be good research but the company became insolvent or something, the clause would then allow for somebody else to become the notified person.

I turn to the group of amendments—4, 5, 6, 7, 35 and 36—that go to the heart of clause 12 and the perceived potential impacts. I will take those amendments as a group.

Amendment 4 proposes that the welfare advisory body complete its own assessment of the risks of the likely impact of any precision bred trait referred to in the application on the health and welfare of the relevant animal and the qualifying progeny.

In amendments 5, 6, 7, 35 and 36, there are proposals for further detail on the information that must be considered by the welfare advisory body when producing its report for the Secretary of State. The suggestions included relate to the technical details on certain traits of the animals that the advisory body would be required to consider.

Clause 12(2)(b) already sets out that the advisory body’s body must consider

“whether the notifier has taken reasonable steps to identify those traits”— that is, their precision-bred traits—

“and risks”— that is, the related risks—

“and has made an appropriate assessment of those risks”.

The Bill enables the advisory body to request further information from the notifier within a reasonable timeframe if the advisory body does not feel that it has had sufficient information, or that it has not been included with the application.

Moreover, if the welfare advisory body considers that the notifier has not had sufficient regard for the risk or has not made an appropriate assessment, that would then be reflected in its report to the Secretary of State, who can decide to reject the application. The safeguards are there. We consider that this is the most suitable approach, ensuring that the Secretary of State has the right information on which an application for a marketing authorisation can be assessed without incurring lengthy delays to the assessment process and the unnecessary duplication of effort, which is particularly relevant for smaller organisations.

Furthermore, the members of the welfare advisory body will have sufficient scientific expertise on health and welfare to be able to understand and assess whether the notifier has correctly identified the precision bred traits and the health and welfare risks.

The welfare declaration process requires notifiers to submit health and welfare information in response to prescribed questions and metrics—those I referred to earlier. Notifiers will not be able simply to decide for themselves what welfare evidence they want to submit.

As I noted earlier, all vertebrate animals are already protected by extensive animal health and welfare legislation. Indeed, animals may be kept for farming purposes only if it is expected that they can be kept without any detrimental effect on their health and welfare. The Bill works alongside that existing legislation to enable responsible innovation. There will be no relaxation of current animal welfare standards; indeed, a rigorous framework will be put around them.

I think that we all understand that breeders will want to ensure that animals produced using that technology have high health and welfare from the outset. We will ensure that that happens through checks and balances in the legislation. I acknowledge the concerns about the potential for precision bred animals to be affected, including those that can sometimes arise from traditional breeding—the hon. Member for Cambridge gave some examples. I contend, however, that precision breeding is a way of developing new traits, and is therefore not, in and of itself, a negative process.

I understand the hon. Gentleman’s concerns, and I assure him and others that the powers in the Bill set out a framework to safeguard animal welfare in precision bred animals. As I have said—it is important that I repeat it—we want to work closely with a range of experts and others to further develop the technical details of the criteria and metrics for the animal welfare declaration, and the evidence that will be required to accompany it. We will set out those details in secondary legislation and guidance.

The amendments are not needed because clause 12 already requires the advisory body to report to the Secretary of State on whether the notifier, when making their animal welfare declaration, has had regard to health and welfare risks to the animal or its progeny that could reasonably be expected to result from its precision bred traits. The advisory body’s report must consider whether the notifier has taken reasonable steps to identify the animal’s precision bred traits and any related risks, and has made an appropriate assessment of those risks.

In line with previous responses, we intend to engage further with stakeholders, including scientific experts, animal welfare organisations and the industry, to ensure that the technical details required for all relevant animals are appropriate. We want the Bill to be durable, and that is exactly the type of detail that we would want to include in the secondary legislation and guidance. I urge the hon. Gentleman to withdraw his amendments, because I anticipate that more information will be readily available as we proceed.

Amendment 8 proposes to alleviate concerns about the risk to animal welfare associated with precision breeding. We agree that safeguarding animal welfare is vital, and I know that the intentions behind the amendment are honourable. The suggestions represent issues that must be explored further as we develop technical details of the system for safeguarding welfare in precision bred animals. We do not consider, however, that proposed new paragraphs 13(1)(za) and (zb) are necessary, because clause 13 will ensure that the Secretary of State needs to be satisfied with the declaration before issuing a precision bred animal marketing authorisation.

The declaration and supporting evidence, which is built by consultation with others, must state that the notifier does not expect the health and welfare of the relevant animal or its qualifying progeny to be adversely affected. The welfare declaration and all required accompanying information must be referred to a functionally independent welfare advisory body, which will report its conclusions to the Secretary of State. Those steps provide for a rigorous but proportionate basis for the Secretary of State’s decision to be made before marketing authorisations are issued.

Furthermore, the power in clause 25 allows us to set out in regulations what constitutes an adverse effect on health and welfare, including any parameters that are needed to assess it. That will be based on the principle that precision bred animals can be kept in conditions that satisfy the existing requirements on the keeping of animals. Those requirements are set out in 2006 Act and the Welfare of Farmed Animals (England) Regulations 2007, to which we have referred frequently today.

We do not consider it appropriate to include the proposed new paragraph (zc), which relates to any precision trait that could not reasonably have been achieved by means that do not involve modification of the genome of the animal through precision breeding. For example, that would in effect remove the potential to develop the welfare benefits of disease resistance that could be achieved through precision breeding.