Motion to Approve
My Lords, I will speak also to the Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019, with which this instrument has been grouped.
Plant protection products, commonly called pesticides, are currently regulated by means of EU Regulation (EC) 1107/2009 of the European Parliament and the Council, concerning the placing of plant protection products on the market, and the associated Regulation (EC) 396/2005 of the European Parliament and the Council on maximum residue levels of pesticides in or on food and feed of plant and animal origin. These two regimes, on plant protection products and maximum residue level regulatory regimes, are closely related to each other and both rely on centralised EU processes and mechanisms.
These statutory instruments make technical adjustments. There will be minimal modification of the current EU regime and these represent no changes of policy; nor will they have any significant impact on businesses or the public. Although the regime relies on EU processes to take and implement decisions which need to be corrected, much of the business of the regime already operates at a national level. Decisions at EU level are taken on the basis of evaluations and assessments undertaken by member states, such as by our own Health and Safety Executive. In future, these evaluations will inform a national decision, rather than informing UK input into an EU decision. This means that much of the infrastructure and expertise that we need is already in place within the UK. This will provide a good degree of continuity when we implement the UK-wide regime.
On the plant protection product regime, the main corrections made by this instrument include the following adjustments. All decision-making functions and powers are repatriated from the EU to national level, including approval of active substances and a number of other related functions. We will be able to continue to draw on the considerable scientific and technical expertise of the Health and Safety Executive, which will continue to operate as our expert national regulator on behalf of the UK Government and the devolved Administrations. The Chemicals Regulation Division, or CRD, of the HSE already has around 150 staff working on pesticides—a considerable resource. This means we are well placed to operate a national regime that maintains the highest standards.
A mechanism is established to give effect to national decisions by listing approved active substances on a new statutory register, in the form of a publicly available online database. This replaces the EU mechanism whereby these decisions are given effect by a constant flow of EU tertiary legislation. Other EU tertiary legislative powers will be repatriated to national level to convert them into a power to make regulations by statutory instrument, therefore keeping them on a statutory footing, with just minor exceptions where it is more appropriate to undertake very minor or frequent functions administratively.
EU processes set out in the regulations are replaced with new national processes. The functions are retained where they remain relevant in the national context, for instance: consideration of specific technical issues specified in the regulations; public consultation on active substance applications; provision for consultation with independent specialists where appropriate; and final decision-making. National arrangements for independent scientific advice and assurance are in place. We already have existing independent advisory committees of experts and academics—the Expert Committee on Pesticides and the Expert Committee on Pesticide Residues in Food—which are busy preparing to be ready to meet our changed advice needs after exit day. The EU regime’s power to establish a rolling active substance renewals programme will be replaced with a power to establish a national renewals programme. In the meantime, we will be able to take renewals decisions as necessary.
Some elements of the current regime which rely on EU membership will no longer be able to operate; for example, the mutual recognition provisions for fast-tracking product approvals between member states in the same zone are no longer relevant. However, the UK will be able to take account of relevant assessments by other countries’ regulators in our own national assessments.
Similarly, parallel trade permits rely on the sharing of information between member states and will no longer be relevant. Current parallel trade permits at the point of exit will remain valid for a period of two years after exit or until the extant expiry date—whichever is sooner. Transitional measures have been put in place ensuring that changeover to the national regime is smooth; for example, ensuring that all current approvals and authorisations remain valid after the point of exit, and making provision for handling applications which are in train at the point of exit.
The second instrument makes corrections to the pesticides maximum residue levels regime, and many of the corrections repeat the changes I have just set out for the first instrument. All decision-making functions and powers are repatriated from the EU to national level; for example, the setting of maximum residue levels. A mechanism is established to give effect to national maximum residue level decisions by listing them on a new statutory register in the form of a publicly available online database. EU processes set out in the regulations are replaced with new national processes. The functions are retained where they remain relevant in a national context, such as evaluation functions specified in the regulations. As I said, national arrangements for independent scientific advice and assurance are in place with two highly respected expert committees.
The requirement for reviews of EU maximum residue levels to ensure that they are set at appropriate levels has been replaced with a provision for reviews at national level. The power to establish an EU residue monitoring programme has been replaced with an equivalent national power to put in place a national monitoring programme. The current EU programme looks three years ahead, so the UK’s obligations under this programme for the next three years are retained. This will ensure that the same standards of protection are maintained after exit. Again, transitional measures have been put in place, ensuring that changeover to the national regime is smooth; for example, all maximum residue levels in place at the point of exit will be carried over.
There has been a constant flow of EU tertiary regulations on plant protection products and maximum residue levels—typically several each month—giving effect to decisions on active substances and maximum residue levels. Within this regulation on maximum residue levels, which was laid before Christmas, two minor transitional provisions relating to Regulation (EC) 396/2005, which converts EU maximum residue levels into our new statutory register, have become redundant, due to amendments made to that regulation by the EU in January.
We have today laid the miscellaneous EU exit environment amendments and revocations in draft, which, among other amendments, will revoke these two transitional provisions. Both SIs will be made together once the draft instrument laid today has passed the sifting process. This will ensure that our regulations are linked correctly to retained EU law as it is on exit day. The miscellaneous amendments will deal with the fact that there had been a change in the EU in January. Again, I shall ensure that noble Lords are kept in the picture on that, but I wanted to make that clear, as I heard about it only today and did not want any ambiguity or feeling that there had been any secrecy in these matters.
I hope I have expressed sufficiently that the Government take these matters extremely seriously, and that continued levels of protection for human health and the environment, as well as making matters straightforward for businesses to put products on the market, are a given and essential. Without these corrections, the plant protection product and maximum residue level regimes would be inoperable and would not provide a functioning regulatory regime; for example, we would be unable to take action in response to new evidence on environmental or health risks, or to adjust maximum residue levels, approve new active substances or even renew approval of current ones.
These instruments will establish a UK-wide plant protection products and maximum residue level regime and ensure that a stable regulatory framework is in place. I am pleased to report that again we have worked very closely with the devolved Administrations to develop the instruments and they have consented to them being made on a UK-wide basis. These statutory instruments will put in place, when the UK leaves, an independent, UK-wide regime enabling us, most importantly, to protect human health and the environment. I beg to move.
My Lords, these two statutory instruments are probably the most important ones we have had from Defra to date. The products are widely used in agriculture and industry and in people’s gardens and homes. As the Minister has rightly acknowledged, they can do serious damage to human health and the environment. It is important that these SIs give people the confidence that, if we are to leave the European Union, the protection is going to be as good, if not better, than what we have at the moment. Reading the statutory instruments, I am not entirely reassured. I have three questions which I will come to in a moment. I hope that the Minister will be able to answer these and to give me more satisfaction, given the importance to the general public of this issue.
These SIs show very clearly what we are losing if we leave the European Union. At present, we have a fully formed, established regime which works and protects human health. If we end up with no deal that will be lost. Equally, there will be significant additional costs to businesses if they operate across the European market both in the UK and on the continent. The impact assessment does not include those costs because it looks only at the costs for the UK regime, but there will be significant costs for most of the companies, such as Bayer and Syngenta, which work right across the continent. I found out what the fees are at the moment in a footnote somewhere. Each individual application costs in the region of £150,000 per product, irrespective of the cost of administering the application. Companies will be expected to find not insignificant sums of money if they have to follow the regime in the UK and also stay within the European regime if they wish to sell the products across Europe.
What concerns me not quite the most but nearly is that the Government’s proposed regime is somewhat sketchy. In the Explanatory Memorandum, they say:
“The EU regime sets out decision making processes in considerable detail”.
The EU has done; I only wish that the British Government had done the same in setting out the proposals before us tonight. There is quite a lot to be taken on trust. They talk about setting up a statutory register, but there are no details. They talk about a process for taking independent scientific advice, but again there are no details. They talk about proposals for a renewal and that is where I get particularly worried. Paragraph 7.7(E) of the EM says:
“We will … establish the national renewals programme in a way which maintains effective protection but enables the UK to ensure it has a manageable and proportionate workload for one country alone”.
That is quite open-ended and does not guarantee the protections that we have at present.
It is baffling that neither the EM nor the impact assessment sets out how many applications the Government would expect to see per year if we have a no-deal situation. I scoured them in detail and could not find any, and yet it sets out, quite clearly, that the EU has 50 additional regulations a year, so how many applications are the Government expecting to process?
Although there is an impact assessment which says that these options will present “additional costs” to both government and business, there is absolutely no indication of what those costs to the Government will be. Equally, there are no costs identified for businesses and whether they will go up, as opposed to the regime that they are presently having to work to. I ask the Minister: what are the costs to the Government of administering this new regulatory process, and for the decision-making and taking the advice? It is absolutely critical that we get a figure. If another impact assessment has this phrase, this House is being treated poorly. As I said, there is no indication in the impact assessment of the costs to our Government of administering this regulatory process. It says on page 5:
“These additional costs need to be weighed against any savings from no longer being part of the EU”.
That is a really poor comment when we do not have a clear indication of the costs the Government will face in terms of staff, access to scientific advice and the IT database.
What worries me most about the statutory instruments before us is what they do not say about the overall government approach to taking decisions on these pesticides. I know this is an issue that the noble Baroness, Lady Young of Old Scone, has referred to in the past, but the impact assessment says that they will take decisions based on the evidence. It does not go on to confirm that the process which is in place—the precautionary principle—will be upheld and maintained by the Government. The Minister has said previously there will be a commitment in the environment Bill and that it should talk about the precautionary principle in there, but all this statutory instrument talks about is taking an approach on risk based on the evidence. We know that, in the past, there have been issues about how much evidence is needed, and that can be used to delay making decisions.
The very last page of the impact assessment says that there might be marginally different opinions between ourselves and other EU decision-makers when presented with the same evidence and criteria as another group because they will, obviously, be making specific judgments. That leads me to this point which, again, we have touched on in relation to other statutory instruments: the power to make decisions will be in the hands of the Secretary of State. We may all have confidence in the current Secretary of State, but in the past we have had Secretaries of State looking at issues such as neonicotinoids, which is a classic example of a pesticide that might need looking at again in the future. There is no guarantee that a degree of political judgment may not be taken by the Secretary of State, and therefore there is a question for the Government: is the advice given by those scientific bodies binding on the Government? I think that is difficult for them to say, but then there has to be a question mark about who holds the Government to account for the decisions they make and how that is achieved. If, for example, the Secretary of State makes a decision on a pesticide in the future which is not in agreement with the advice being given to them by the scientific experts, who holds them to account? There is a governance gap, unless I am missing something.
There are some significant issues around costs, on whether the precautionary principle will be upheld, and on how we will hold the Secretary of State to account on an issue which is of such importance to human health and the environment.
My Lords, I have a fairly fundamental objection to this set of regulations. I am sure that most of the detail is absolutely correct and necessary and I cannot say that I have read every sentence of these two regulations, but I have long held, going back to my days as the Minister in Defra, that the current regime for the regulation of pesticides, both at British and European level, has been inadequate for a number of reasons, some of which have already been touched on by the noble Baroness, Lady Parminter. I am rather afraid that the “solution” of leaving the European Union is going to aggravate that position.
Most of the issues I have approached the department on in recent years have related to human health, but it is a much wider issue than that. I believe that the totality of the approach to pesticide regulation does not take into account the widespread effects of misuse of pesticides, the lack of enforcement on the way pesticides are used and the relative ease with which new pesticides and modified pesticides come on to the market. In some cases, the EU regulation has actually been held back by previous British interventions. Like the noble Baroness, Lady Parminter, I commend the current Secretary of State on neonicotinoids, but in general it is the Brits who have held back and there has been a lot of pressure—corporate pressure, one has to say—on the totality of the system. This could reinforce that tendency.
I understand, and I have been in some contact with the department about, the need to introduce provisions on chemicals broadly—on REACH provisions. These regulations tend to mirror, in a sense, the broader regulation structure of REACH. In the main, I think it is very sensible to maintain the success of the REACH provisions, but pesticides are different. They are different because they have a serious and often unacknowledged human health impact. More particularly, I want to emphasise tonight the effect they have on the environment in general: the effect of pesticides on the air, the water and the soil.
Soil has been degraded as a result of the overuse of pesticides. Pesticides in the air have affected both human and particularly insect life: this week we have seen very serious effects in the form of the worldwide reduction in insect life, some of which has been caused by pesticides here and elsewhere, and on the water system. One of the successes, to some extent, of the water framework directive has been to reduce that effect; nevertheless, there is still a very serious problem in our water supply, as the effect of pesticides comes through the soil, into the water and has an effect on insect life and on whatever you call those creatures that crawl on the bottom of our rivers—I am sure that my noble friend Lady Young can name them all, but I cannot—and therefore on our diversity. A lot of those are affected by the misuse or overuse of pesticides.
It is true that successive Governments have attempted to rationalise and pinpoint the use of pesticides more effectively in terms of agricultural use. However, unlike the industrial chemicals that will be covered by the transposition of arrangements on REACH, the use of pesticides—this particular form of chemical—is a matter not so much of industrial use but of agricultural use: its effect on the environment, on land management, on soil management and on air quality. I therefore find it somewhat surprising that we are to retain the HSE rather than an environmental body to oversee this. I know that the HSE has access to significant scientific information, and the transfer of a separate pesticide arrangement into the HSE probably was an improvement, but would I argue that if we are going to move to a new regime post Brexit, the appropriate body is actually the Environment Agency, because it has responsibility for agricultural practice and land use; for air, water and soil.
That is where, together with human health, pesticides have an impact. I am therefore disturbed that the whole rationale for these arrangements is to assign that role to the HSE and not to the Environment Agency and devolved environment agencies. I ask the Minister to think about that; it is not necessary, but we are moving into a new era, and the responsibility ought to be with an environmental body rather than with one which deals with the industrial use of other chemicals.
My Lords, I refer to my interests as set out in the register. I thank the Minister for his introduction and for his courtesy in meeting us before this debate. I also thank the two noble Lords who have raised a number of important issues about these SIs, all of which I agree with. They both made very powerful points.
These SIs go to the heart of our concerns about the transposition process. This goes right back to our earlier discussions on the amendments to the European Union (Withdrawal) Act 2018. The use of pesticides is of huge public interest—a point made by the noble Baroness—and they present significant environmental and public health challenges. It is an issue where the use of the precautionary principle is vital—supported of course by strong scientific evidence and detailed scrutiny of the potential impact of the new products.
At the moment, we have in the EU a thorough process of evaluation of products. The responsibilities for risk assessments are shared out across member states. There are clear decision-making roles for the European Food Safety Authority, the rapporteur member state, individual member states and the European Commission. All this is supported and backed up by access to the best scientific advice. While no process is perfect, there is considerable assurance that within the EU a detailed assessment of the risks has been carried out and cross-checked.
These proposals are intended to replace all of this with an assessment by the Health and Safety Executive and a decision in the hands of one person, the “competent authority” as described in the text—otherwise known as the Secretary of State. Under these proposals, full power to make, amend or revoke guidance, principles and regulations for the UK rests with the Secretary of State and the devolved Ministers. There is a major loss of scrutiny, checks and balances, and audit powers.
This really is not good enough. It does not represent an accurate transposition of the current EU provisions into UK law. It also reopens our argument about the need for an independent environment watchdog to oversee the application of these new rules. This is a point other noble Lords have made—my noble friend Lady Young made it very eloquently in the earlier debate. That watchdog clearly needs to be in place from day one. I know that the Minister has said he cannot be precise about the timetable for this, but it would be helpful if he could reassure us again that the watchdog will be in place from 1 April, and that there will be no delay.
There is another big issue about what we will lose when we transpose to the UK. How can it be acceptable that the only reporting mechanism on national decisions for new active substances will be to publish the information online, when the previous EU regime required a report to be made to the EU Commissioner and a proper process of scrutiny and approval?
It also raises once again the fact that, by leaving the EU, we are cutting ourselves off from access to a huge resource of scientific data and analysis. Should we not be taking urgent steps to agree with the EU that we will continue to share this data for mutual benefit? For example, we will no longer have access to the advice of the European Food Safety Authority and will therefore have to pay considerable sums of money to try to replicate its advice. Would it not make sense to negotiate a mutual recognition agreement with the EU so that decisions taken in the EU and the UK continue to be mutually honoured? Can the Minister say whether discussions are taking place to create a shared register of approved pesticides and a mutual recognition scheme across the EU and UK, and what the timescale is for the outcome for those discussions?
I now address the arrangements set out in the SI for a transitional period. This is crucial if we are to leave on 29 March without a deal. It seems clear that none of the structures proposed in the SI will be in place by that date. We will need an interim decision- making process for new products coming on stream. The references to transitional arrangements in the SI are relatively brief but, as I read it, they account only for current product authorisations to remain valid and, in some cases, to be extended. They also allow for parallel trade permits to be in place for up to two years and for the use of seeds authorised by other member states for three years. They do not make clear what happens on, say, 30 March when a pesticide manufacturer wants to seek approval for a new product.
The Explanatory Memorandum makes it clear that the EU currently produces in the order of 50 new regulations a year, so we can expect new UK regulations needing to be processed within weeks of Brexit day. Can the Minister explain the process that will be in place to process these new applications on day one? Is it not also the case that the level of scrutiny will be pared back in the longer term? Paragraph 7.25 of the plant protection Explanatory Memorandum states that the renewal programme will,
“need to be proportionate for one country alone to deliver”.
It also says that,
“current approvals may be extended using existing powers”.
This inevitably means that we will not be applying the latest scientific advice because we will be letting these products exist on the market for longer and longer periods. It also creates a loophole under which extensions on approvals could become indefinite. This is not the rigorous system we were promised in the withdrawal Bill debates.
I now turn to the detail of the proposals and their implication for business. Again, the noble Baroness, Lady Parminter, touched on some of these issues. The SI makes clear that an impact assessment has not been produced. Instead, we have a document that assesses the impact but is not an impact assessment. I think it is the same thing. That document sets out the arguments for a new stand-alone UK pesticides regulatory regime. It suggests that the new regime will be beneficial to business. But given that the vast majority of pesticide manufacturers will be multinational companies, why is it any benefit to business to have to go through a separate evaluation and approval process unique to the UK? Instead of cutting red tape, this just adds to it. Indeed, is there not a danger that some companies will choose to miss out the UK altogether because of the added bureaucracy and concentrate on marketing to EU countries where applications are uniform?
We do not really know what business thinks about the proposal because there was no consultation. As the EM spells out, businesses and other stakeholders were summoned to a contingency planning workshop and told to make themselves ready for a no-deal exit. Does the Minister really think this was adequate consultation given the scale of regulatory change proposed? Does he agree that there should be a requirement set out in the SI to consult stakeholders formally in the future for the making, amending or revoking of guidance and principles?
The impact assessment then sets out the cost to government of setting out a separate regulatory function. This includes making the ultimate decisions on active substances, liaising with other regimes, reporting to the WTO, managing boundaries with the EU and managing relationships with stakeholders. There will be an extra cost to Defra.
Then there are the additional functions for the Health and Safety Executive as the regulator, the Environment Agency for environmental monitoring and Natural England for policy and scientific advice. This is estimated to cost in the region of an extra £10 million. The noble Baroness said that she could not find a figure for it, so it would be helpful if the Minister could clarify what the extra cost will be. Can he also say what assessment has been made of the other options available, rather than just assuming that this will be the way forward? Can he say, too, how quickly these organisations will be able to staff up for these new responsibilities, and whether the additional funds that have been earmarked have already been made available to allow these additional appointments to be made?
Perhaps I may also ask the Minister for more specific information on the additional scientific advice that will be necessary. Each time we deal with an SI, it brings new responsibilities on to the shoulders of our UK scientific community. I am sure that it is well able to deal with the intellectual challenge that this entails, but what assessment has been made of the overall capacity of the scientists? Has a proper appraisal been made of the additional number of people who will be required and the time it will take to ensure that they have the additional skills? What additional funds have been earmarked for the extra responsibilities set out in this SI and the many others that we will be dealing with in the weeks ahead? If such a document exists, I would be grateful if the Minister could make it available to us.
We are also concerned that these two sets of regulations place no requirement for the Secretary of State to seek independent scientific advice. They enable the advice to be sought but do not make it compulsory. There is much use of the word “may” rather than “must” in terms of seeking advice. Again, that really is not acceptable. The SI should spell out the specific independent role that the scientists should be required to play; otherwise, there is a real danger that, when budgets are cut in the future, the lack of scientific capacity will be used to short-circuit this requirement and put even more power in the hands of the Secretary of State. This is particularly vital given that there are plans within the document to extend the times for which pesticides are authorised before they are reviewed, meaning that the scientific advice applied might not even be the most up to date available. We need to be assured that it is required and on the face of the statute.
Given that the Secretary of State has so much individual power in determining the future authorisation of pesticides, does the Minister not accept that a formal role for scientific advice should be sought and published, and that it should be on the face of the SI? Would that not go some way towards giving comfort to consumers and environmentalists? As my noble friend and the noble Baroness have said, they would no doubt be concerned if they knew the extent to which the powers had been watered down in these proposals. I look forward to the Minister’s response.
My Lords, I am most grateful to all noble Lords for their contributions. I do not think that I will be in a position to satisfy the noble Lord, Lord Whitty, in that, in the whole process of bringing these matters back, the HSE is deemed to be the relevant body in this country. However, I obviously note his observations about the UK and the EU, and the concern that he raised about both EU and UK regulation. As far as this SI is concerned, I take his general point, but I am dealing with the fact that the HSE is our regulator.
I want to open with the precautionary principle—a matter raised by the noble Baronesses, Lady Parminter and Lady Jones of Whitchurch. I suspect that, as with a lot of the issues relating to these statutory instruments, one needs a dossier to understand how everything is pitched. However, I reassure noble Lords that the precautionary principle is expressly a part of the plant protection product regime. It is specifically referred to in Article 1 of EU Regulation 1107/2009 as the underpinning basis of the provisions of the regime in protecting health and the environment. This statutory reference will be retained in UK law after leaving the EU. The precautionary principle is not mentioned in this particular instrument simply because it is not being amended, so nothing in our instrument affects it. I am most grateful for the opportunity to give that reassurance.
A number of points were made on the issue of decision-making, which the noble Baroness, Lady Parminter, raised. We will be taking our own independent decisions under the UK-wide regime but the instruments carry across all the statutory requirements on standards of protection unchanged. All the considerable body of EU technical guidance which has been officially noted under the EU regulations, and which sets the standards to be met in informing decisions, is carried across by these instruments and will remain the basis for the national regime.
I am parking the point that the noble Lord, Lord Whitty, made. On the capacity of the regulator, it is important that I should emphasise that the national regulator, the HSE, is recognised across the world as having considerable expertise, and it has a very strong scientific standing. It currently covers a substantial share of the workload under the EU regime and is by some way the best-performing national EU regulator in terms of meeting timescales. For that reason, many international companies have chosen to make their applications under the EU regime via the HSE, due to its excellent record. The HSE’s considerable capacity will be redeployed to deliver the national regime. Much of the scientific work under the current regime already takes place at national level, so there will be a good degree of continuity.
I can confirm to the noble Baronesses, Lady Parminter and Lady Jones of Whitchurch, that extra public funding will be required from government for the national legislative framework for pesticides, plus the related policy and regulatory capability to operate a UK-wide regime. While budgets for future years have not yet been finalised, this will vary depending on the exit scenario. However, additional costs will be broadly in the order of £5 million per year, with slightly more in the set-up phase over the first couple of years. The costs relate primarily to additional staff in Defra and the HSE to manage the additional responsibilities that will fall at national level but also—I hope this will please the noble Lord, Lord Whitty—to a lesser extent the Environment Agency.
In developing our national renewals programme, we will need to look at issues such as how best to collaborate internationally. Again, I emphasise that obviously so much of these matters may be—we hope it will be—the subject of negotiations and the deal that is achieved, which we also fervently want. But on all these matters, both in the European and UK prisms, collaboration is always best.
The noble Baroness, Lady Jones of Whitchurch, raised a point about independent scientific expertise. Independent advice and assurance are invaluable; in my experience of dealing with these matters, and certainly when we came to the neonicotinoids issue, we relied on the best scientific assessment available. While I have been at Defra, that has been the mantra for all these matters. Perhaps one of the current Ministers is a scientist by background but certainly I am not, so scientific evidence and independent scientific experience is vital.
I emphasise that our existing independent advice arrangements primarily draw on the expertise of the UK Expert Committee on Pesticides. The ECP is chaired by Professor William Cushley of the University of Glasgow and has a broad range of important expertise. Its membership includes academics with expertise in ecotoxicology, toxicology, the fate of pesticides in the environment, and pesticide residues in food. In other words, these are experts who are most vital to providing us with the right advice.
Working with the committee, we are also preparing to meet any changed advice needs after leaving. I should say to the noble Baroness, Lady Jones of Whitchurch, that we have undertaken extensive work with the committee, looking at its workload, particularly in the event of no deal—although we hope that there will be a deal—including an assessment of the impact of the additional functions that it will take on from the EU. I understand that, for instance, there are about seven active new substances a year: that is the sort of figure I am hearing, and I think that would be digestible. We established that the committee has the appropriate expertise to take on the required additional functions, but any responsible Government would obviously want to continue to monitor those matters. That is what we have established so far.
The noble Baroness, Lady Jones of Whitchurch, raised mutual recognition. Clearly, in negotiations that we hope will be taking place that is an area in which I hope there will be productive results. I reassure noble Lords that the functions set out in the EU regime, including those of the European Food Safety Authority, remain relevant in the national context and are being repatriated to the national regime. These will be carried out mostly by the HSE, which will, for example, produce reasoned opinions on maximum residue levels and undertake public consultations on active substances, alongside the independent advice that will be provided by the ECP.
I stress that other UK bodies with scientific expertise will also play a role in ensuring that the system is robust and sound. Input goes wider than just the HSE. For example, the Food Standards Agency will continue to take an overview of food safety that will encompass pesticides residues in food. FERA will continue to undertake the UK’s comprehensive residues-testing programme on behalf of HSE, which currently monitors much more than is required by the current EU monitoring regime. In replacing the EU active substance decision-making processes with national processes, we have made it explicit that the decision-maker must take account of environmental monitoring information submitted by the Environment Agency and its devolved equivalent bodies.
The noble Lord, Lord Whitty, referred to the existing regime. These regulations do not change any existing policy. The approach in the withdrawal Act is to bring policy across into retained EU law unchanged. Any future changes to respond to concerns raised would be for a future Parliament to deal with. On the role of the EA in pesticides management, the HSE is the current competent body, as I mentioned before, and we need to build on its expertise. We need to develop its role and resource and we are also investing in additional capacity for staffing the EA to support the pesticides policy. That is very important.
The noble Baroness, Lady Parminter, raised the issue of future divergence. We are committed to maintaining high levels of protection for people and the environment in our decision-making. In particular—I know that in considering the previous statutory instrument we had a debate about the interim arrangements for the OEP, but I emphasise this again—the OEP’s role in terms of the regulator or Minister would trigger if there had been non-compliance with the law. I will include discussions on this matter when I write about interim governance arrangements as well, but that is terribly important.
I mention to the noble Lord, Lord Whitty, declaring my farming interests, the advances we have seen in recent years, the investment in agritech and the fact that many of us involved in farming are actively engaged in integrated pest management. I am responsible for pollinators in Defra and assure the noble Lord that I am very proud of the two beehives we have at the department’s headquarters. Bees’ Needs Weeks and the pollinator work are bearing fruit. Pollinators are much more stable than they were before, but there is much more to do, and we need to look at how we develop pesticides or alternatives that are much more friendly to the environment and much more selective. It is important to stress that.
As for burdens on business, obviously we seek to minimise the impact of having a separate national regime. For example, the information required will be the same and the documentation will be in the same format as the status quo. We do not want to place any undue burden. Indeed, the fees for applications are small compared to the cost of developing a pesticide and bringing it to the market—which is, all too often, hundreds of millions of pounds. I should also say that the instrument makes no changes to fees.
Again, it is hugely important that the national renewals programme ensures that we have all our arrangements properly in place, with safety always in mind and to maintain effective protection to ensure that we have a properly focused work programme. I have taken considerable note of what the noble Baroness, Lady Parminter, said on the matter.
I referred to capacity and resources in terms of what we need to do and extra investment to have in place. I will look at any other points made during the debate, but on the point raised by the noble Baroness, Lady Jones of Whitchurch, about new applications from day one, the HSE will be able from day one to assess applications for new active substances in order to take decisions. If it has been involved in assessment before we leave, it will have the information to move this forward quickly. For new applications, it will be able to start the process. We know that some pesticide manufacturers are already discussing with the HSE which applications they would wish to make.
I so endorse what was said: that this area is of the utmost importance not only to public health but to the environment. If the environment is in a bad state, it does not help public health, so the whole thing is a circular matter.
I hope that I have reassured your Lordships that under this Government, and, I must say, I think, any future Government—I am sure that this applies to the noble Baroness opposite, when she has the privilege of serving in government, and I hope that happens at some point; it is a great privilege—the regulation of pesticides will be of the utmost importance not only for public confidence but because of the pressures on this country and this planet from not looking after the environment. Yes, there is the report today about insects and what we do in this country, whether through Defra, countryside stewardship, environmental land management or payment for public goods for public benefit. All of us contributing to this debate share all that territory, and we must roll it all out. I am well aware of Defra’s considerable workload. No one is more anxious than I am to put these fine words into action. On this occasion, it is important for us to bring these regulations into our national arrangements; indeed, we must do so.