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.
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:
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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.
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.
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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,
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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.
“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?
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.
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?