Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019
(Limited Text - Ministerial Extracts only)
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Lord Gardiner of Kimble
That the draft Regulations laid before the House on 13 December 2018 be approved.
The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Gardiner of Kimble) (Con)
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.
Baroness Parminter (LD)
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?
Lord Gardiner of Kimble
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.