Genetic Technology (Precision Breeding) Bill (Sixth sitting)

Daniel Zeichner Excerpts

Committee stage
Tuesday 5th July 2022 Public Bill Committees

[Daniel Zeichner (Cambridge) (Lab)]

I beg to move amendment 11, in clause 6, page 5, line 31, leave out “negative” and insert “affirmative”.

[The Chair]

With this it will be convenient to discuss the following:

Clause stand part.

Clause 7 stand part.

Clause 8 stand part.

Amendment 31, in clause 9, page 6 line 33, at end insert—

“(iii) safeguarding the health and welfare of those animals that are no longer deemed to be precision bred;”.

This amendment would require regulations conferring power on the Secretary of State to revoke a precision bred confirmation relating to an organism to include provision to safeguard the health and welfare of any animals which would as a consequence of such a revocation no longer be deemed precision bred.

Amendment 12, in clause 9, page 7, line 9, leave out “negative” and insert “affirmative”.

Clause 9 stand part.

[Daniel Zeichner]

It is a pleasure to have you in the Chair again, Ms McVey, as we continue this interesting discussion. You were part of the evidence sessions.

We come to a series of clauses about precision bred confirmation, and we have a number of amendments that largely relate to how Parliament scrutinises the secondary legislation. As we argued this morning, we think that far too much is being pushed off into secondary legislation. Even within that, too much of the secondary legislation is subject to the negative procedure, so it will go through without any scrutiny. I will not repeat the broad points about why we think that is not the way to do it, as they are familiar to most people.

Clause 6 concerns the applications for precision bred confirmation. The Government will be given powers to make secondary legislation that prescribes the form and content of a marketing notice and the information that is to accompany one. It is really important that the advisory committee, the welfare body and the Secretary of State have all the information they need to come to an informed decision on both the release and the marketing of precision bred organisms. Frankly, I am not comfortable —and I do not think many others will be—giving the Government a blank cheque to determine what information must be provided. I understand that it needs further consideration and thought, but it seems to us to be too significant an issue not to merit proper scrutiny in this House. Amendment 11 simply tweaks it to make the clause subject to the affirmative, rather than the negative, procedure.

Clause 9 allows for the revocation of a precision bred confirmation. Again, that is a very important matter, and I have a series of questions, which I touched on in the discussion before lunch, about how these decisions are arrived at. What triggers them? What is the information? What is the process? As one begins to think it through, one can see that there is really not a lot of detail in the Bill as it stands. It is not clear to me, and I hope the Minister can go through in detail some examples of how all this might work.

If the Government are no longer satisfied that a precision bred organism is indeed precision bred—perhaps it has become apparent through some complaint or some new science that it does utilise genetic modification technologies, which require a higher level of regulation, or perhaps some adverse impacts have come to light—we appreciate that they would need to be able to revoke an authorisation, and we support that, but I cannot quite see in the real world how that situation arises. It would be really helpful for me and, I am sure, others if the Minister could walk us through an actual example. In what circumstances would that happen? Does the Minister anticipate that there will be challenges, and that the Government might lose and therefore have to step back? In that case, it is right to have a procedure for dealing with this. It would be useful to know quite what the thinking was behind it. We need proper scrutiny of some of these powers, and amendment 12 would make the clause subject to the affirmative procedure to ensure proper scrutiny takes place.

When a precision bred confirmation is revoked, even though we cannot entirely envisage how it will work, it is important that the Secretary of State has a process to safeguard the health and welfare of those animals—we are talking about animals in this case—that are no longer deemed to be precision bred. We took advice from Compassion in World Farming on this, which gave evidence in the evidence sessions. It says that where that is the case, it will be because the organism has either been mischaracterised or the genome is no longer stable, which, in their view, may create health and welfare risks. Again, I would welcome the Minister’s comments on whether that is that situation is envisaged. That raises the question of what to do with the creatures that have been created through this process and how to bring the breeding of the line back under the appropriate regulations.

What I am saying about this amendment goes right back to the beginning, when we were nervous about embarking on the animal route without knowing more detail. As one begins to look at the detail in the Bill for dealing with some of these issues, without knowing the wider thinking, wider background and wider regulatory framework, it is quite hard to comment on the potential unintended consequences and how they might be dealt with. The reason that this matters to all of us is that animal welfare matters. I hardly need remind the Minister of her Government’s 2019 manifesto commitment, which I helpfully have before me:

“High standards of animal welfare are one of the hallmarks of a civilised society. We have a long tradition of protecting animals in this country, often many years before others follow. Under a Conservative Government, that will continue”

—well, quite. We fully endorse that. In the spirit of that commitment, I hope that the Government will welcome amendment 31, which would require the regulations that make provision for the procedure to be followed if the Secretary of State proposes to revoke a precision bred confirmation to include provisions to safeguard the health and welfare of any animals that are no longer deemed to be precision bred.

[The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs (Jo Churchill)]

It is a pleasure to serve under your chairmanship, Ms McVey. Amendment 11 would provide for further parliamentary scrutiny on the marketing notice. The amendment is not necessary, as this power cannot be used to deliver a substantive change in policy; it is merely to prescribe details that are technical and administrative in nature, such as the form of the marketing notice or the information that must accompany that notice. I worry that what the hon. Member for Cambridge is seeking is because these regulations are as yet not in place. We have gone over the fact that we will look to work with experts and stakeholders and so on in order to ensure that we have the right guidelines so that we can move forward.

The criteria for defining a precision bred organism is set out in the Bill. We will continue to seek expert, independent advice on the technical details before any regulations are brought before Parliament. It is appropriate for the technical detail which demonstrates how the given organism meets these criteria to be specified in regulations and for such regulations to follow the negative procedure, as there may be an appropriate time for them to be added to.

In amendment 31, the hon. Gentleman proposes placing a duty on the Secretary of State when revoking a precision bred animal confirmation to safeguard the health and welfare of animals. All vertebrate animals are already protected by extensive animal health and welfare legislation, including the Animal Welfare Act 2006, which makes it an offence either to cause any captive animal unnecessary suffering or to fail to provide for the welfare needs of the animal. The Welfare of Farmed Animals (England) Regulations 2007 include specific requirements to protect animals when bred or kept, prohibiting breeding procedures that

“cause, or are likely to cause, suffering or injury”.

The regulations further state that:

“Animals may only be kept for farming purposes if it can reasonably be expected, on the basis of their genotype or phenotype, that they can be kept without any detrimental effect on their health or welfare.”

The protections provided by these regulations would apply to an animal where a precision bred confirmation relating to that animal had been revoked. Those welfare requirements cover all animals. With those protections already in place, we see no need for anything further and I urge the hon. Member to withdraw the amendment.

On amendment 12, I stand by what I have said before on the use of parliamentary time. The key proposition that a precision bred confirmation should be capable of being revoked is set out in the Bill.

Clause 9 sets out a pathway by which a precision bred confirmation may be revoked. It is a criminal offence to market genetically modified organisms without prior consent, and we believe that companies will continue to be incredibly careful to avoid mistakes. However, to provide a belt-and-braces measure, in the unlikely event that a GMO goes through the procedures under this Bill and is marketed as a precision bred organism, the clause establishes a transparent process for dealing with such an eventuality. That is important for consumer confidence and transparency.

Clause 9(4) addresses conferring additional functions on the Advisory Committee on Releases to the Environment. The ability to seek scientific advice on any relevant new information that comes to light will be an important component part of this process. The clause states that we will need the help of outside experts to ensure that we move forward appropriately.

[Daniel Zeichner]

I am afraid that I am still not entirely convinced, for a number of reasons, going back to some of the points I made just before we broke for lunch. There seems to be a closed, narrow group of people making these decisions. What ACRE—this group of eminent people—is being asked to do is to make a judgment on whether something that has been submitted to them is a PBO.

Following our discussions on the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 a few months ago, ACRE released guidance on how the process would be approached. The guidance is quite technical, to put it mildly, and it is thoughtful and nuanced, and has quite a lot of caveats. Obviously, the guidance is not before us today, but it is relevant, because it is what ACRE will consider—there are no additional terms of reference being introduced in these clauses. There will not be a simple, clear-cut process and that probably explains why the Government have introduced this method for revoking confirmations, because more science and more evidence can come to light.

My worry is that it feels like a discussion between a very small group of people. If we are trying to address the question of public confidence, which is key, it does not seem to give the degree of reassurance that people seek. If one were being kind and generous to the Government, as obviously I would be, one way to provide that reassurance might be to bring forward secondary legislation so that it is discussed, rather than just being passed without discussion, as we know many statutory instruments are all the time. We think it is worth looking more closely at the procedure and making the secondary legislation subject to the affirmative, rather than the negative, procedure.

Although the Minister did respond to my invitation to give us an example, I am still not really very clear quite how it would happen. What happens to the animals—we are talking about animals here rather than plants—in those circumstances? I appreciate that there are existing protections, but the question is whether any additional protections are needed given the new set of procedures available, and how that should be handled. That seems to be worthy of further interrogation.

--- Later in debate ---

Meaning of “relevant animal”

[Daniel Zeichner]

I beg to move amendment 33, in clause 10, page 7, line 12, leave out—

“means an animal which is a vertebrate”

and insert—

“has the meaning given by section 5 of the Animal Welfare (Sentience) Act 2022”.

This amendment would make the definition of animal from the Animal Welfare (Sentience) Act 2022 the relevant definition, rather than that from the Animal Welfare Act 2006.

[The Chair]

With this it will be convenient to discuss amendment 34, in clause 10, page 7, line 13, leave out subsections (2), (3) and (4).

This amendment, which is consequential on Amendment 33, would remove the provision to extend the definition of “animal” to include (further) invertebrates, which would instead be provided by section 5 of the Animal Welfare (Sentience) Act 2022.

[Daniel Zeichner]

The amendments in this group are relatively straightforward, the Committee will be glad to hear. We are interested in looking at the relationship between the Bill and the Animal Welfare (Sentience) Act 2022, which some of us were involved in, discussing it in this very room only a few months ago. To our joint delight, it received Royal Assent in April.

The Act defines “animal” as

“any vertebrate other than homo sapiens…any cephalopod mollusc, and…any decapod crustacean”.

Members may remember the debate about the definition, which was based on a Government amendment, if I recall, after a report commissioned by them to review the scientific evidence for the sentience of cephalopod molluscs and decapod crustaceans. The London School of Economics published that review in November last year, after which the Government made their amendment to the animal sentience Bill to reflect the most up-to-date understanding. Despite that, however, clause 10 of this Bill defines animals only as vertebrates.

There are all kinds of exciting jokes that one can make about vertebrates and all the rest of it, but I shall resist that today. We also note that the clause does not exclude homo sapiens explicitly. Basically, our issue is about trying to align the definitions with the most recent piece of legislation to have gone through the House.

The clause also makes provision for the Bill’s definition to be extended to include invertebrates if the Animal Welfare Act 2006 is extended to include them. It therefore seems to pose rather a strange system involving two different definitions of “animal” in law: one from the 2006 legislation and the other from the very recent legislation. We still seem to be waiting to get our definitions in line.

As an aside, given that the Government’s aim of the Animal Welfare (Sentience) Act was to recognise the sentience of animals in law, we are slightly surprised that the Animal Welfare Act has not been extended to reflect the Government’s latest stance. Regardless of that, it seems that the Bill should use the most up to date definition, that is why we have tabled amendment 33, and we think that amendment 34 is consequential on that, to replace the definition of animal in the Bill to the one from the 2022 Act. It is possible that it was mistake—that happens—or an accidental oversight, which we think could be rectified if the Government were to accept the amendment. If not, it would be useful to hear the Government’s explanation, and I invite the Minister to give it.

[Jo Churchill]

The hon. Gentleman proposes that we change the substance of the definition of relevant animal from that in 2006 Act to the more recent definition in the 2022 Act. Although we do not feel that the amendment is necessary, I am really grateful for the opportunity to put down on record our reasons for that.

Clause 10 defines relevant animal as a vertebrate for the purpose of welfare protection measures in clauses 11 to 15. That is line with the definition of animal in the 2006 Act—the core legislation that establishes the practical rules for individuals and businesses that handle, keep and care for animals in this country. For that reason, it is the right definition to apply.

It is worth noting that the definition of animal in the 2022 Act sets out what type of animals the animal sentience committee can consider when carrying out its work, but it does automatically not extend the definition of animal in the 2006 Act. We totally accept that it will be more than likely appropriate to broaden that definition so it is important to note that in clause 10 we allow a provision for regulations to be made to extend the definition of relevant animal, if the definition of animal in the Animal Welfare Act 2006 is extended to include invertebrates of any description. Any amending regulations that extend that definition would be subject to the affirmative procedure in the House, and therefore subject to debate and approval by both Houses before being made.

I assure the hon. Gentleman that the Government, like the Opposition, were very pleased that the sentience Bill received Royal Assent, but the next step is to carefully consider the implications of extending the 2006 Act to include cephalopod molluscs and decapod crustaceans because that will include implications for how they are caught and handled, treated and transported. The Government are working constructively with industry and stakeholders on this issue; I assure the hon. Gentleman of that.

I understand the point made by the hon. Gentleman but the appropriate definition of animal is that which sits in the 2006 Act, although I agree that the extension of that definition is in process. It is not correct, however, to say that the definition in the 2022 Act would sit appropriately in this legislation for the reasons I have cited.

[Daniel Zeichner]

I am grateful for the explanation, although I am not entirely sure that I am convinced by it. It seems to me to be a slightly curious way of proceeding. At the end of it, I am not entirely sure whether it means that cephalopods and decapods are protected under the Bill or not—possibly not, as it stands. I understand why the new regulations have practical implications, particularly for the fishing sector, and why they need to be thought through carefully. I can see why there might be complications, although that is more to do with the animal sentience Act than it is to do with the Bill.

We will come back in a moment to the question of the relationship between the animal sentience Act and the Bill. It is an interesting one, because it goes to the heart of the concern that we on the Labour Benches have: that the various structures that are in place to make decisions, give expert advice, and so on may no longer be quite right. During the evidence session, we heard the suggestion that there may well be people within Departments who are already thinking along those lines and looking at ways in which those structures may be updated. That, of course, creates some difficulties for us, because we are looking at the legislation as it stands today. I do not want to sound like a broken record, but that is the problem with trying to second-guess the thinking of the Government when they are so vague on some of these animal welfare issues.

There is considerable interest in the whole question about cephalopods and decapods, and we think it would be more consistent to have a unified approach. On that basis, I am afraid we will test the opinion of the Committee by pressing amendment 33 to a vote, although we will not feel the need to move amendment 34.

Question put, That the amendment be made.

--- Later in debate ---

[Jo Churchill]

As discussed, clause 10 defines a relevant animal as a vertebrate for the purposes of the welfare protection measures in clauses 11 to 15. That is in line with the definition of an animal in the Animal Welfare Act 2006, which is the core legislation that establishes the practical rules for individuals and businesses that keep, handle, or care for animals in this country. I commend the clause to the Committee.

[Daniel Zeichner]

I will be brief, given that we have just discussed the amendments. I stand by the comments we have already made, but I am grateful that regulations made under subsection (2) of the clause will be subject to the affirmative procedure. We will doubtless be back here on another day, discussing this issue again.

Question put and agreed to.

Clause 10 accordingly ordered to stand part of the Bill.

Clause 11

Application for precision bred animal marketing authorisation

[Daniel Zeichner]

I beg to move amendment 13, in clause 11, page 8, line 25, leave out “negative” and insert “affirmative”.

[The Chair]

With this it will be convenient to discuss the following:

Clause stand part.

Amendment 4, in clause 12, page 8, line 28, at end insert—

“(1A) The welfare advisory body must carry out an assessment of the likely impact of any precision bred trait referred to in the application on the health and welfare of the relevant animal and its qualifying progeny.

(1B) In carrying out an assessment under subsection (2) the welfare advisory body must consider—

(a) scientific expertise on the health and welfare of animals with similar traits (whether or not resulting from the application of modern biotechnology) to those of the animal in respect of which an application for a precision bred animal marketing authorisation has been made;

(b) the animal welfare declaration provided by the notifier under subsection (3) of section 11 and the assessment, explanation and information provided under subsection (4) of section 11; and

(c) any other matter it considers appropriate.”

Amendment 5, in clause 12, page 8, line 28, at end insert—

“(1A) Where the purpose of a precision bred trait referred to in the application includes achieving fast growth, high yields or any other increase in productivity, the welfare advisory body must in preparing a report under subsection (2)—

(a) consider whether animals or their progeny with similar traits resulting from selective breeding or traditional processes have experienced pain, suffering or lasting harm arising from or connected with fast growth, high yields or any other increase in productivity, and

(b) assess whether the relevant animal and its qualifying progeny are also likely to experience pain, suffering or lasting harm arising from or connected with fast growth, high yields or any other increase in productivity.”

Amendment 6, in clause 12, page 8, line 28, at end insert—

“(1A) In preparing a report under subsection (2) the welfare advisory body must consider whether the precision bred traits may facilitate the keeping of the relevant animal or its qualifying progeny in conditions that may have an adverse effect on animal welfare.”

Amendment 7, in clause 12, page 8, line 30, at end insert—

“(za) the likely impact of the precision bred traits on the health and welfare of the relevant animal and its qualifying progeny,

(zb) whether the relevant animal and its qualifying progeny are likely to experience pain, suffering or lasting harm arising from or connected with fast growth, high yields or any other increase in productivity,

(zc) whether the precision bred traits may facilitate the keeping of the relevant animal or its qualifying progeny in conditions that are likely to have an adverse effect on animal welfare,”.

Amendment 35, in clause 12, page 8, line 40, at end insert—

“(d) whether the health or welfare of the parents, grandparents or great grandparents of the qualifying progeny of the relevant animal may reasonably be expected to be adversely affected by the precision bred trait.”

This amendment would require the welfare advisory body to report on the likely effects of a precision bred trait on breeding stock.

Amendment 36, in clause 12, page 8, line 40, at end insert—

“(2A) In its report under subsection (2) the welfare advisory body must take into account direct and indirect effects and intended and unintended effects of the precision bred trait on the health and welfare of—

(a) the relevant animal and its qualifying progeny, and

(b) the parents, grandparents or great grandparents of the qualifying progeny.”

This amendment would require the welfare advisory body to take into account direct and indirect, and both intended and unintended, effects of the precision bred trait on the animal and its qualifying progeny and on breeding stock.

Clause 12 stand part.

Amendment 8, in clause 13, page 9, line 20, at end insert—

“(za) that the precision bred traits will not have an adverse effect on the health or welfare of the relevant animal or its qualifying progeny,

(zb) that the precision bred traits will not facilitate the keeping of the relevant animal or its qualifying progeny in conditions that are likely to have an adverse effect on animal welfare,

(zc) that any precision bred trait could not reasonably have been achieved by means that do not involve modification of the genome of the animal,”.

This amendment would prevent the Secretary of State issuing a precision bred animal marketing authorisation unless satisfied on the health or welfare effects listed and that the precision bred trait could not reasonably have been achieved by means that do not involve modification of the genome of the animal.

Clause 13 stand part.

[Daniel Zeichner]

We have quite a complicated set of amendments and clauses before us, so I will try to take them in turn—[Interruption.]

[The Chair]

Order. Can we keep the noise down?

[Daniel Zeichner]

The measures all refer to the animal legislation, which, as we said at the beginning, we are not convinced was sufficiently developed. Nevertheless, we have some detail here so it is worth looking closely at what is proposed. Unfortunately, a lot is, again, left to secondary legislation under the negative procedure; given the likely interest in this topic, which I have mentioned often today, that gives us cause for concern.

--- Later in debate ---

[Daniel Zeichner]

We have had an excellent discussion of the issues and, as always, I find myself in agreement with much of what my hon. Friend the Member for Bristol East has said, not least because she has agreed with me.

There was a lot in the Minister’s opening remarks, and I will go away and study them closely. Part of the problem is that a lot of the what the Minister said is not in the Bill, and this has been a problem throughout. She said that clauses 11 and 12 were crucial because they set up the new regulatory framework, but that that was not expected to be done quickly, because time would be spent on it. That is good and welcome, but, frankly, in the awful situation where another Minister potentially was in place, there is nothing in the Bill to ensure that that original assurance would hold good. As far as I can see, that framework could be established rather quickly if we pass the Bill as it is written.

When we discuss matters when considering secondary legislation, it may be that many of the things that we have raised will be covered, but there are no guarantees, which is why we have tabled the amendments. That is the problem, and why it is our responsibility to lay down some thoughts as to what the framework should be. Perhaps we will help to set some of thinking going forward, and if that is the case, even though I do not anticipate that the amendments will be agreed to, they may help to contribute to setting out the type of framework that we would like.

I very much agree with my hon. Friend the Member for Bristol East that the proposed framework still looks rather weak. The Minister spoke of the advisory body being able to request further information, and that is good and proper, but I think it may need to be able to do more than that. If we have the opportunity to discuss the matter further, I suspect this type of question will come up: what are the actual powers available to the body? I do not think I have yet heard anybody talk about the composition of the animal welfare body, but that it is quite important, because it could be quite a narrow group of experts. There is nothing wrong with that but, as I have said before, people drawn from the same set of people almost inevitably tend to end up thinking the same kind of things. I think the public would quite like some other voices involved in the decisions.

I agree that, ultimately, matters must go to the Secretary of State for decision, so that there is a chain of accountability, but we all know that in reality the earlier processes are quite significant. We will come to our suggestions about how matters should be considered when we discuss the new clauses. People have suggested that the other models should be followed, such as that of the Human Fertilisation and Embryology Authority. My understanding is that at times the latter has had a wider membership and remit than originally set. Such a possibility would give people confidence about the work of the animal welfare body as we go into a brave new world, because it is just that: we have fantastic opportunities.

The Minister said that some of our comments suggested that we see the Bill as a negative; we do not. We see it as offering huge opportunities, if done in the right way and with the right safeguards, so that people have confidence that any application is made for the right purpose. We are not that far apart, but it is quite hard to work out from the Bill how everything will look a few years down the line. The worry is that if the Bill is approved unamended, there will nothing to stop matters proceeding rather quickly without the appropriate safeguards. The Opposition would be irresponsible were we not to make that point and to challenge, and that is what we will continue to do.

We have quite a complicated set of clauses and amendments ahead of us, and perhaps we will take them one by one, if that is all right with you, Ms McVey.

[The Chair]

Absolutely. To confirm, would you like to withdraw this amendment or to press it to a vote?

[Daniel Zeichner]

I am happy to beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 11 ordered to stand part of the Bill.

Clause 12

Report by welfare advisory body

--- Later in debate ---

[Jo Churchill]

Clause 14 sets out the reporting obligations that will apply once a precision bred animal marketing authorisation has been issued. Although the provisions in the Bill are intended to prevent adverse welfare outcomes in precision bred animals, we consider it prudent to have a monitoring function in place during the early stages of the marketing of precision bred animals in England. The Bill will provide for the ability to place a time-limited and proportionate duty on breeders and developers to monitor animals and their offspring for any significant adverse health and welfare outcomes that can be linked to the new trait, and to report any such outcome to DEFRA.

The clause sets out that regulations may make provision to require the notifier, or any other specified person, to provide information to the Secretary of State about the welfare of the relevant animal and its qualifying progeny. If the relevant animal is supplied to another person, the notifier may be required to take steps to collect health and welfare information, or enable it to be collected from the other person. Regulations may set requirements on the information that must be collected, including, for example, specific time periods for reporting, and technical requirements for the types of information to be provided.

[Daniel Zeichner]

We are now getting to the Bill’s more administrative details, about which we have fewer concerns.

Clause 14 concerns the reporting obligations for precision bred animal marketing authorisations. Clause 15 concerns the suspension and revocation of precision bred animal marketing authorisations. In many ways, what I am about to say is similar to what I have said before about those things. I am glad that reporting obligations are included in the Bill, especially those that relate to animal welfare and to potential unintended consequences. It is right that those processes be monitored and reported on.

The suspension and revocation of authorisations concerning animals appears to be an area where greater scrutiny of secondary legislation would be beneficial. The clause confers powers on the Government to introduce secondary legislation, with provisions to suspend or revoke precision bred animal marketing authorisations where the Secretary of State receives information regarding the health and welfare of the animal concerned, and where they believe the health or welfare of an animal is likely to be adversely affected. It also contains provisions for those decisions to be publicly announced and shared. That raises the question of who is doing the monitoring and how, and it would be helpful if the Minister said a little more about that.

At the risk of being endlessly repetitive, it would be better for the secondary legislation to be subject to the affirmative procedure, rather than the negative. That is the force of amendment 14. As we have said frequently, the House should be able to scrutinise the Government’s proposals, especially as they have been decidedly vague so far. These things do matter, because they concern the potential pain and suffering of sentient beings.

[Jo Churchill]

I thank the hon. Member for tabling the amendment. Clause 15 allows for provision to be made in regulation for the circumstances in which a precision bred animal marketing authorisation may be revoked or suspended, and to set out the procedure to follow in such cases. The affirmative procedure would not be a meaningful use of parliamentary time. The power to make regulations for the circumstances in which an authorisation may be revoked or suspended is, in effect, a power to specify more details of those circumstances, but the circumstances are already set out in the Bill and cannot be changed. Given the content of the regulations made under clause 15, the negative procedure is a better fit.

We, like the Opposition, are committed to animal welfare and want the Bill’s provisions to be backed by proportionate and workable measures to safeguard animal welfare. Clause 15 enables the Secretary of State to make regulations, using the negative procedure, to suspend or revoke a precision bred animal marketing authorisation in certain circumstances. The requirement to provide a welfare declaration before an animal welfare marketing authorisation is granted will ensure the proper evaluation of known risks. The clause provides further reassurance that Government will have the power to act should there be adverse effects.

[Daniel Zeichner]

I hear the Minister and in some ways I am comforted, but clause 15(3) states:

“Regulations under this section may confer a function on the welfare advisory body.”

What on earth does “may confer a function” mean? That seems extraordinarily wide, and it is not unreasonable that something so wide should come back to this place for a discussion.

[Jo Churchill]

It is important that the Animal Welfare Committee has the space to look at such things. The clause covers scenarios in which new information shows that animal welfare may be affected contrary to the assessment conducted when the authorisation was issued. In such cases, the welfare declaration no longer holds, so it may be appropriate that the Secretary of State revokes an authorisation in the interests of animal welfare. If the Secretary of State receives new information on animal health or welfare, he may consider it appropriate to suspend the marketing authorisation while information is properly considered. If the Secretary of State has not received the health and welfare information that he needs because the developer has failed to report it under clause 14, it may be appropriate that he suspend the authorisation pending investigation, or revoke it if there are concerns. In both scenarios, we set out to protect animal welfare as strongly as we can.

Clause 15 also sets out that the regulations may allow bespoke reporting requirements in particular cases. That flexibility is essential to ensure that any obligations placed on businesses are minimised proportionately to risk. Good practice indicates that breeders and developers will already carry out health and welfare monitoring as part of their breeding programmes. We want to work with stakeholders to ensure that that element of the new measures works in practice and is proportionate before it is introduced.

Question put and agreed to.

Clause 14 accordingly ordered to stand part of the Bill.

Clause 15 ordered to stand part of the Bill.

Clause 16

Reviews and appeals relating to Part 2

[Daniel Zeichner]

I beg to move amendment 15, in clause 16, page 11, line 30, leave out “negative” and insert “affirmative”.

[The Chair]

With this it will be convenient to discuss clause stand part.

[Daniel Zeichner]

The clause is about reviews and appeals relating to part 2. We heard about the relative power in the industry from some of the witnesses. There are some very big organisations, and hopefully some smaller enterprises coming forward that are able to operate in the sector. We want a system that is fair to all. We want to make sure that the appeals system does not disproportionately benefit, possibly unintentionally, those who have the most resource to make the system work for them.

The clause begins to lay out what an appeals system under the Bill might look like, but once again the fine detail is left to secondary legislation. We want to be able to see and scrutinise any delegated powers in the area, and that is what amendment 15, which is similar to a number of the other amendments, would do. It is an important clause, and I am interested to hear what the Minister has to say about it.

[Jo Churchill]

As the hon. Member laid out, the amendment seeks further parliamentary scrutiny of the reviews and appeals conferred by part 2. He will not be surprised to hear that I do not feel the amendment is necessary. What it proposes would not, in our view, be a meaningful use of time. I want to assure hon. Members that the power does not signal a change in policy, as all key substantive requirements of the review and appeal processes are set out in the Bill. Therefore, it is appropriate for the regulations to be subject to the negative procedure.

We are committed to bringing in appropriate safeguards to ensure that decisions affecting a person’s ability to market a precision bred organism are correct, and to provide for an appropriate and efficient mechanism to challenge decisions. To achieve that, the clause requires regulations to provide for a mechanism for reviews and appeals. That mechanism can be used if the appellant considers that certain decisions made by the Secretary of State were based on an error of fact, wrong in law or unreasonable.

The clause covers decisions not to issue a precision bred confirmation or a precision bred animal marketing authorisation, to revoke a precision bred confirmation, or to revoke or suspend a precision bred animal marketing authorisation. It aims to deal with such issues in a sensible fashion. Having a review mechanism allows the Secretary of State to review the decision and to uphold or reverse it in a quick and cost-effective manner, without the need for legal proceedings. A subsequent right to appeal to the first-tier tribunal ensures that, where the appellant is not satisfied with the outcome of the review, said person can ask an independent tribunal to adjudicate.

[Daniel Zeichner]

I hear what the Minister says. I am still nervous about this. It is striking that a lot in the Bill is on the appeal and challenge processes, but without the earlier detail—which would make it easier to envisage how things work—to explain how we might get to that point in the process. I worry that that will benefit those with the resources to use the system effectively to make their case in a way that others might not. That is sufficient to say that we would want to see this again, rather than just let it go through under the negative procedure. We will therefore proceed to a vote on this one.

Question put, That the amendment be made.

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Restrictions on importation and acquisition of precision bred organisms in England

[Daniel Zeichner]

I beg to move amendment 19, in clause 17, page 11, line 34, leave out “may” and insert “must”.

[The Chair]

With this it will be convenient to discuss the following:

Amendment 16, in clause 17, page 12, line 22, leave out “negative” and insert “affirmative”.

Clause stand part.

[Daniel Zeichner]

This part of the Bill deals with risk assessments and the restriction of importation and acquisition of precision bred organisms in England. I am interested to hear what the Minister has to say. Given our debate on the very concept of the category and the fact that there are other, similar categories, some interesting questions are raised about who will determine it and how it will work with the other categories established in other jurisdictions. In itself, that is an interesting question.

For the purpose of the amendments, we note that the clause states that regulations “may” make provision to require a person to carry out environmental risk assessments. This is for veterans of the Environment Bill discussions, who will know that we had many “may” or “must” amendments, and long discussion as to whether that was reasonable. The clause, quite reasonably, gives the Government discretion on whether regulations happen at all, sooner or later. I understand why Government might want that discretion, but it poses the question why the provision is here and, if it is important, why it is not being implemented quickly. I will seek the Minister’s guidance on thinking behind it.

We can see why that matters, so one of our amendments is to turn “may” into “must”, and the other—guess what—is on the issue of the negative or the affirmative procedure. We think that is important too. It raises all the questions of what we think is reasonable for people here to do and for people elsewhere to do, and the relationship between them, while not putting our own people at a disadvantage. It is familiar ground in some ways for the wider arguments. We want to see it settled more precisely in the Bill and to have the opportunity to consider it again when the Government feel the time is right to bring a provision forward. I will listen closely to the Minister’s observations.

[Deidre Brock (Edinburgh North and Leith) (SNP)]

I seek clarification from the Minister on a point arising from the clause. It is about whether the passing of the Bill will open the UK to gene edited organisms from other countries that have adopted such practices to a greater extent than has been the case up to now or, indeed, to the extent that there has been a case up to now. I am interested to hear the Minister.

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[Jo Churchill]

Through scientific research.

In amendment 16, the hon. Member for Cambridge proposes to provide for further parliamentary scrutiny of the provisions on environmental risk assessments that may be required before importing a precision bred organisation into England, or acquiring a precision bred organism that is in England. The amendment is not needed because, in the case of clause 17, the affirmative procedure would not be meaningful. I want to reassure all hon. Members that this power does not signal a change in policy, but we think it appropriate to set out the relevant obligations in regulations. The corresponding provision in the Environmental Protection Act 1990 allows for the details of risk assessment to be set out in regulations, together with the exemption provisions. The regulations will be concerned primarily with the details of the nature of the risk assessment to be carried out, which makes them appropriate to be subject to the negative procedure. I urge the hon. Gentleman not to press his amendments.

On whether clause 17 should stand part of the Bill, I remind the Committee of the evidence we heard last week that precision bred plants and animals do not present a greater risk to human health or the environment than their conventional counterparts. As such, the Government do not intend to introduce additional risk assessment requirements for organisms of this type that are imported or acquired when they are released into the environment. Our approach is to maintain the proportionate science-based approach to regulation that has enable the UK’s research community to carry out world-leading science under contained-use conditions, such as in laboratories. I think we all agree that we are exceptionally lucky to have such individuals across the UK. The powers in the clause will enable the Government to make regulations to maintain the risk assessment requirements that currently apply to precision bred organisms imported or acquired for contained use under the genetically modified organism legislation, from which they will be removed.

[Daniel Zeichner]

How interesting. Once again, it seems to me that the Minister’s explanation says a lot more than is in the Bill. The hon. Member for Edinburgh North and Leith raised a good point. As I read the clause, it does not seem to me to say what the Minister has just explained.

[Deidre Brock]

Having looked at the clause again, I am struggling to see where it specifies that it applies only to the importation of organisms that will be used in scientific research, or are the products of scientific research, and purely that and not for commercial use.

[Daniel Zeichner]

Absolutely. I suspect that the answer will probably come later in secondary legislation, which will clarify the matter. That is the ongoing problem that we have, because it is very hard to discern the answers from the Bill. There seems to be a logical problem in saying that the current situation will continue when we are introducing the notion of a precision bred organism. We can hardly be carrying forward the current framework when we are introducing something new. I understand the intention, as explained by the Minister, but it seems a long way from how the Bill is drafted. I still think that creates a logical problem in terms of who defines a precision bred organism from another jurisdiction, given that those other jurisdictions do not recognise the term and use a different one.

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Precision breeding register

[Daniel Zeichner]

I beg to move amendment 17, in Clause 18, page 13, line 16, leave out “negative” and insert “affirmative”

[The Chair]

With this it will be convenient to consider clause stand part.

[Daniel Zeichner]

As I made clear on Second Reading, it is absolutely clear that consumers want information about what they are eating and where it has come from. Excellent research by the Food Standards Agency has found that most consumers think it is appropriate to regulate gene edited foods differently from genetically modified foods, but that they want transparent labelling, reassurance about the thoroughness of regulation and safety assessments, and consideration of animal welfare impacts. I suspect that we will talk more about that as we proceed with our consideration of the Bill. We have already discussed the animal welfare impacts, but clause 18 includes some important points on this front.

The clause will establish a publicly available register of precision bred organisms, which we welcome, and lays out the sort of information that the register might include, ranging from release notices to information provided by the welfare advisory body. However, the clause also states that the Secretary of State can disapply those requirements in the interests of commercial confidentiality, requiring only disclosure of the name of the notifier and a general description of the organism. Something tells me that quite of lot of applications will cite commercial confidentiality. Given the importance of transparent information to consumers, and the lack of any explicit labelling requirements in the Bill as it stands, the very least we need is a strong and publicly accessible register.

The importance of nutritional and allergen information was raised several times in our evidence sessions. Despite the Government giving a reassurance on nutritional labelling, these promises are not made in the Bill, so far as we can see, so the register is the only public source of information that is absolutely guaranteed within it. If a plant or animal has been gene edited so that its nutritional content differs from its natural content—we have talked repeatedly about tomatoes with high levels of vitamin D, for example—consumers might need to know about that. My constituent with a vitamin D allergy will need to know if she can no longer buy certain tomatoes. I pursued that with one or two witnesses in evidence, and we will come back to it.

Given that the register might be the only mechanism by which people can find that out, it is important that we consider more closely what it will contain and, in particular, how the commercial confidentiality provisions will work. If every application is subject to commercial confidentiality, the register really will not achieve the purpose that the Government have set out. However, as I tried to pursue with one or two witnesses, when we look at the impact assessment, we see that the purpose of the register is not so much to inform the public as to check whether more registrations are coming forward—in other words, to see whether the deregulatory intent behind the Bill has had an effect. We have not discussed that until now, but it seems rather different from what most of us understand the purpose of the register to be. There are issues with the register that we think will need to be revisited when it is introduced in secondary legislation. I suspect that the Minister will not agree and that the Committee will have to vote on this, but I will listen to her comments with interest.

[Jo Churchill]

I will not disappoint the hon. Gentleman, because I do not agree. The amendment is not needed, because in the context of clause 18 it would not be meaningful. This power does not warrant a change in policy, as all key substantive requirements in respect of the register are set out in the Bill, so it is appropriate for the regulations to be subject to the negative procedure.

However, I hope that the hon. Gentleman will find a little more light when I speak on clause stand part. In line with our commitment to transparency, clause 18 imposes a duty on the Secretary of State to maintain a new public register, which the hon. Gentleman welcomed in his comments. The register will include information on precision bred organisms that have been notified for release into the environment for research and development, as well as for marketing purposes. As we have discussed during the course of the day, those will have passed other frameworks in order to get to that point.

The register will contain information provided in notifications as well as further information, such as reports from the advisory committee and the welfare advisory body, enforcement notices and other information relating to precision bred organisms set out in this clause and prescribed in regulations. The register will provide transparency and assure the public that the Government have oversight of plants and animals developed using such techniques. The register will be kept electronically in a free and accessible form on gov.uk.

The hon. Gentleman made a specific point about food, which we have touched on—Professor May’s evidence was good. The hon. Gentleman will have noticed that the FSA has sent further information overnight. The product in the example that he gave would be subject to the FSA’s procedure before the it arrived on the market, so it could be labelled to outline the health benefits for 2.5 billion people across the globe, while alerting constituents such as his, who might wish to steer away from it. On the basis that we are offering transparency, I urge the hon. Gentleman to withdraw his amendment, and I commend the clause to the Committee.

[Daniel Zeichner]

Once again, I hear the Minister’s point, and again, the additional information from the Food Standards Agency, which I suspect we will look at more closely as we proceed, is helpful. It occasionally feels as if I am in a very large room with the lights off, holding a very small torch, and every now and then, I turn it on and can gradually discern part of the structure emerging. I have a feeling that the Minister has had the lights on the whole time. That is the problem: we are beginning, bit by bit, to get a sense of how the measures might work, but if we are trying to persuade the wider world about how the system will work, it would be better to turn the lights on at the beginning.

I still think there is some difficulty. Yes, we welcome the register, but I notice that the Minister did not address commercial confidentiality. I appreciate that that is not simple, but there is a danger that the register ends up being very limited indeed, and that would be disappointing. I would much rather have the opportunity to look at the matter again later as the secondary legislation comes through, because it is too important to go through without further consideration. On that basis, I will divide the Committee on the amendment.

Question put, That the amendment be made.

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[Daniel Zeichner]

It is interesting to note that suddenly we have a wealth of detail, but it is not entirely clear how that fits with some of previous bodies we have discussed. Is the regulator part of some new organisation that sits next to ACRE? Is it part of the welfare body, or is it something separate, again? We have some difficulty understanding exactly how all this fits together. It is quite interesting to look at the impact assessment of the number of applications that the Department anticipates. The spectrum outlined starts at zero over the next few years, which rather makes this a pointless exercise, frankly. We hope that the applications are not at that end of the spectrum. We believe that they will range from a medium position up to an upper band of, I believe, 18. I anticipate that with the animal aspects coming forward, possibly one would expect to see more applications. I believe that it is more oriented towards animal welfare aspects than to crop protection, but who knows? That is the truth.

It is quite hard to comment on the clauses, other than to say that the monitoring regime is welcome, and that the inspection regime is welcome. It is still a bit of a puzzle to see how it all fits together. We have no amendments tabled and no objection to the clauses, but we would like a better account of how the system fits together, not least because if we did have that, it would be much easier to explain to the public why they should have confidence in it. It is quite hard to explain that as the system emerges through this rather curious process.

Question put and agreed to.

Clause 19 accordingly ordered to stand part of the Bill.

Clauses 20 and 21 ordered to stand part of the Bill.

Clause 22

Advisory bodies

[Daniel Zeichner]

I beg to move amendment 18, in clause 22, page 15, line 26, leave out “negative” and insert “affirmative”.

[The Chair]

With this it will be convenient to discuss the following:

Clause stand part.

Clause 23 stand part.

Clause 24 stand part.

Amendment 20, in clause 25, page 16, line 19, leave out “may” and insert “must”.

Amendment 9, in clause 25, page 16, line 24, at end insert—

“(1A) In making regulations under this section the Secretary of State must consider (among other things) the possible direct or indirect adverse impact of precision breeding traits on the—

(a) respiratory system,

(b) cardiovascular system,

(c) immune system,

(d) bone strength,

(e) mobility, and

(f) ability to exhibit normal behaviour patterns

of precision bred animals and their qualifying progeny.”

Clause 25 stand part.

--- Later in debate ---

[Daniel Zeichner]

Amendment 18 is another that seeks to replace the negative procedure with the affirmative procedure. Much has been said about the advisory bodies in the Bill—that is the point we are reaching in the clauses. We understand—because it is outlined in clause 22(1), which contains a reference to the Environmental Protection Act 1990—that ACRE will be the advisory committee that considers whether precision bred organisms are indeed precision bred. We are familiar with ACRE, a senior member of which gave oral evidence.

As I hinted in my previous comments, however, the welfare advisory body that considers the impacts on animal welfare is much less clearly defined. The Bill allows for that body to be an existing committee or a new one. Much of the administrative set up of the Committee, and details on how it will operate, are—guess what?—being left to secondary legislation.

Had the Bill not been drafted in such haste, and had the Government determined those details, we would not have felt the need to table so many new clauses. This is a framework Bill. It is a far-from-satisfactory piece of legislation that, as I have just explained, makes it quite hard to work out how the whole system will function. In the light of the role that the welfare advisory body will play in making important considerations about the welfare, pain and health of animals that we now all agree are sentient beings, the provisions in clause 22 should be laid under the affirmative procedure, not the negative procedure. We have tabled amendment 18 to that effect.

I mentioned that I would come to the definition of “adverse effects”, which are referenced in clause 25 but are not laid out in full. That clause states simply that “regulations may prescribe” what is considered an adverse effect on the health or welfare of an animal. As this matter underpins the Bill, and given the ability of the welfare body to consider applications, I believe that that necessary requirement should be a “must” rather than a “may”. We have tabled amendment 20 to that effect.

Amendment 9 was tabled to give examples of what the Bill should consider when it comes to adverse welfare effects, such as the impact of precision breeding traits on the respiratory system, on the immune system and on the ability to exhibit normal behaviour patterns. There is a fairly familiar pattern in what we are seeking to achieve through our amendments, and I suspect that I know what the Minister’s answer will be.

[Jo Churchill]

I thank the hon. Gentleman for tabling amendment 18, but he will not be surprised to hear that I do not feel that it is necessary. In the case of the measures in clause 22, the affirmative procedure would be inappropriate. The identity of the welfare body will be of interest to Parliament. The appointment itself is a straightforward administrative matter, and it is therefore appropriate for the regulations to be subject to the negative procedure. I urge the hon. Gentleman to withdraw the amendment.

[Daniel Zeichner]

Almost inevitably, I disagree. The measures are of considerable significance and public interest, so I will press the amendment to a vote.

Question put, That the amendment be made.