I accept the point the noble Baroness makes, and of course, there are others who fervently want measures brought in as quickly as possible that deal with animal disease, animal welfare and those sorts of things.
As the noble Lord, Lord Krebs, quite rightly upbraided me earlier for boring the House, I will try to be as quick as I can, but there is a lot in this section, and I want to be open with the Committee in my comments.
I will respond first to Amendment 16, which would require the Secretary of State to consult, first, representatives of a number of interested groups and then European partners including but not limited to the EU and its member states. This is to agree on a definition of precision breeding and, if a definition is agreed, to amend the definition of a precision-bred organism in the Bill accordingly, using a Henry VIII power. The amendment could be used to change the key concepts that form the basis on which this legislation has been drafted and debated in both Houses of Parliament.
This summer, the EU conducted a consultation in which 80% of participants agreed that the existing provisions of the EU GMO legislation are not adequate for plants produced by certain new genomic techniques, which largely aligns with our view of precision breeding. As I have previously mentioned, the definition of a precision-bred organism in the Bill aims to cover all plants and animals produced by modern biotechnology that could have occurred through traditional processes or natural transformation. This approach to carving out precision-bred plants and animals from GMO legislation is in line with scientific evidence and advice, because it focuses on the end product rather than the technology used to produce it.
Furthermore, we have continuously engaged with national and international stakeholders and regulators to develop a definition that reflects the key principle of this legislation. Our approach is based on the science. With regulations on precision-bred plants and animals changing around the world, we believe the measures in this Bill will facilitate greater trade.
On the topic of trade, I am grateful for the opportunity to discuss how differences in regulation and public perception in other countries will impact on our trade
with them. Noble Lords have referred to genetically modified organisms in the amendment we are dealing with, and I want to be clear that there is a scientific distinction between GMOs and precision-bred organisms. Many countries recognise this and have changed, or are in the process of changing, their regulations to reflect it. As the international regulatory landscape evolves, our approach could help facilitate greater trade with countries that have already adopted a similar approach to the regulation of precision-bred organisms, with trading partners such as the USA, Canada, Japan and Argentina.
Currently, there are only a few precision-bred products on the market globally, and none of those are traded internationally. Many of them are still in the early development stage, allowing time to monitor and understand the international regulatory framework as it develops. Britain is an exporter of quality products, and one of the reasons for introducing this new, proportionate regulatory approach is to enable the development of more nutritious, higher-quality products that have been grown more sustainably.
Turning to Amendment 77 and the remarks made by the noble Baroness, Lady Bakewell, I would like to outline developments that are likely to change the requirements for companies exporting precision-bred products specifically into the EU; we have been following these developments with interest.
As our legislation on genetically modified organisms mirrors the EU’s, it is not surprising that we have the same drivers for change. The timing of the EU’s reform plans means that we are unlikely to be able to consider any new EU legislation while we are drafting our regulations under this Bill. However, we will continue to monitor developments closely and work with the EU, and other countries we trade with, to enable innovation and trade. I hope I have reassured noble Lords on this.
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I want to address the point on Scotland made by the noble Baroness. The United Kingdom Internal Market Act 2020 would not prevent the Scottish or Welsh Parliaments and Governments regulating the use of precision-bred ingredients in the production of food in their territories. We are working closely with the devolved Governments; we want to make sure that we are carrying them with us, and we want to try to persuade them to take similar action. Of course, in Scotland, there is the continuity Bill, which seeks to maintain the same regulatory structures as exist in the EU. Now that the EU is moving, no doubt Scotland is looking at it with interest. I know that certain elements of Scotland’s coalition might not be so happy about that but it is a conversation that we will continue to have with them; we want to make sure that we continue to allow seamless trade across these islands.
I thank noble Lords for raising in Amendment 78 the issue of enabling small and medium-sized businesses to access precision breeding technologies. Plant and animal breeders and research scientists have told us about the beneficial characteristics locked away in the DNA of plants and animals, which could help us meet some of the major challenges facing us. We have used
traditional breeding methods to mine this potential for thousands of years, and now have technologies that can achieve this far more efficiently. It is crucial for businesses of all sizes to access these precision-breeding technologies.
Where countries have taken the same approach to regulating precision-bred products as we intend to do, there is evidence of a democratisation of companies involved compared with those developing GM products. This is a crucial point. Argentina introduced its regulations for precision-bred plants back in 2015; this was followed in 2019 by regulations covering animals. The impacts of these legislative changes have been well studied, and the results published in peer-reviewed papers. They showed that, between 2016 and 2019, 91% of precision-bred organisms used in research and development trials in Argentina were produced by small and medium-sized businesses, compared with less than 10% when GMO legislation applied. This suggests that current GMO regulations disproportionately affect small and medium-sized businesses, which is a likely consequence of their inability to overcome the high regulatory costs. Even then, only a relatively small number of large multinationals are involved in using GM to produce a limited range of traits in major crop species.
This is consistent with what we have heard from our stakeholders—that a proportionate, science-led approach to regulating precision-bred products will encourage innovation in different-sized businesses and a diversification in the traits being investigated. I refer noble Lords to the evidence given by Sam Brooke of the British Society of Plant Breeders at Committee stage in the other place.
There is time for industry to develop these arrangements where they are needed. Many of the products are still in the early development stage and commercial production is several years away. In addition, secondary legislation for which an impact assessment is required by our existing rules, and which is not covered in detail by the impact assessment produced for the Bill, will be assessed separately, as appropriate, before it comes into force. This will include assessing the impacts of the authorisation system that the Food Standards Agency is designing for food and feed derived from precision-bred plants and animals, to be put into place by the Secretary of State under Part 3 of the Bill.
I turn to Amendment 75, which would add a provision in the Bill to require the Secretary of State to review and report to Parliament on whether the primary legislation and its implementation achieves the objectives. There are already provisions for reviewing secondary legislation in UK law, such as the regulations that would be used to implement the Bill. The Small Business, Enterprise and Employment Act 2015 contains a statutory duty for UK Ministers to include in new secondary legislation a review provision that has a regulatory effect on businesses, unless to do so would not be appropriate, and subject to limited exceptions. The purpose of these provisions of the 2015 Act is to strengthen existing arrangements for ensuring that any new regulations affecting businesses are subject to periodic review. Within five years of the secondary legislation becoming effective, the relevant Minister is
obligated to review the legislation and publish a report outlining the conclusions. This provision ensures that the objectives of the legislation have been achieved and regulations remain appropriate and proportionate.
If deemed necessary, regulations can be amended or repealed using existing powers in primary legislation. I assure noble Lords that the Government will monitor and review the impact of the statutory instruments made under the Bill as part of their standard policy-making procedures, and ensure that the provisions are adhered to in line with existing requirements.
I note the points raised by the noble Baroness, Lady Jones, in Amendment 88, and thank her for this propping amendment on whether further changes to the Environmental Protection Act 1990 and the associated Genetically Modified Organisms (Deliberate Release) Regulations 2002 will be required to facilitate the release and marketing of precision-bred plants and animals.
Clause 41 is perhaps one of the most important clauses in the Bill. It ensures that precision-bred organisms will no longer be treated as GMOs under the Environmental Protection Act 1990, in England, but will instead come under the more suitable new regulatory regime set out in and under the Bill. As a result, no further amendments should be needed to the Environmental Protection Act 1990 as a result of the Bill.
However, the noble Baroness is right regarding the Genetically Modified Organisms (Deliberate Release) Regulations 2002, which complement Part 6 of the Environmental Protection Act 1990 to regulate the deliberate release and marketing of genetically modified organisms. They will require consequential amendments to remove precision-bred organisms from their scope, so far as they apply in England, therefore allowing the release and marketing of precision-bred plants and animals in England to be regulated under a new regime set out in and under the Bill.
Finally—I can hear noble Lords’ tummies rumbling—I will respond to Amendment 89 from the noble Baroness, Lady Hayman of Ullock. I am grateful to her for the opportunity to lay out the Government’s intended step-by-step approach to implementing the new regulatory framework for precision-bred organisms after the Bill receives Royal Assent.
As we have stated, we intend to take steps to facilitate field trials and the commercial use of precision-breeding technologies in relation to plants first, followed by animals later. Our first step was the SI earlier this year to make field trials of qualifying higher plants easier in England. This has already proved to be successful: three research projects have been notified under these regulations, with positive feedback from the research community.
Following Royal Assent to the Bill, as well as commencing its substantive provisions, we will need to lay secondary legislation to put in place the technical details of the necessary regulatory framework required for the Bill to work in practice. As we have stated, we intend to start with the research and marketing of precision-bred plants first.
The secondary legislation will need to follow the standard parliamentary procedures. It is expected that the statutory instruments laying down the technical details of the regulatory framework for precision-bred plants, as well as the substantive provisions of the Bill so far as they relate to precision-bred plants, will be brought into force within the next couple of years.
We will not introduce changes to the regulation of precision-bred animals until the framework to safeguard animal welfare in the Bill is developed and in place. I hear the points of the noble Lord, Lord Cameron, and think that there is an element of urgency here, because the Bill’s provisions will help us tackle issues such as our ability to adapt to climate change. I do not agree with noble Lords who constantly say that we are rushing this and that now is not the time, as this can be done many years from now, but we want to move at a pace that noble Lords are comfortable with, and we want to show the wider public that we are regulating in the right way, mindful of concerns in stakeholder groups.
As I made clear in previous debates, this is just the beginning, and we want to make sure that we get it right. Before we create new regulations and guidance for precision-bred animals, we will utilise the outputs of the Scottish colleges research project and work with stakeholders to design the technical requirements for the animal welfare safeguards.
The Bill also allows us to take a step-by-step approach with the commencement of the relevant substantive provisions in relation to certain animal groups or species before others. The timing of this approach will be determined by the period it takes to complete the regulatory process and develop the animal welfare safeguards. These will then need to be reflected in secondary legislation under the Bill’s powers setting out the technical details of this process. Additionally, on the basis of promising research on precision-bred crops in the UK—which has already begun—we predict it will be several years before domestically produced precision-bred crops will be on the market for farmers and consumers. Therefore, although there are no dates for these steps in the Bill, there is a clear policy approach for these regulatory changes and for precision-bred products to come to market. I hope my words have provided noble Lords with some reassurance not to press their amendments.