Draft Plant Protection Products (Miscellaneous amendments) (EU Exit) Regulations 2019
Draft Pesticides (Maximum Residue Levels) (Amendment Etc.) Regulations 2019
(Limited Text - Ministerial Extracts only)
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The Minister for Agriculture, Fisheries and Food (George Eustice)
I beg to move,
That the Committee has considered the draft Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019.
The Chair
With this it will be convenient to consider the draft Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019.
George Eustice
These are two of a number of affirmative statutory instruments to be considered as the UK leaves the European Union, as provided for by the European Union (Withdrawal) Act 2018. They ensure that pesticide regulations remain operable after 29 March when we leave the European Union.
Plant protection products, commonly called pesticides, are currently regulated by means of EU regulation 1107/2009 concerning the placing of plant protection products on the market, and associated regulation 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin. Those two regulatory regimes are closely related and currently rely on centralised EU processes and mechanisms, although much of the business of the regimes is already conducted at national level. Decisions at EU level are taken on the basis of evaluations and assessments undertaken by member states, such as those undertaken by our Health and Safety Executive.
In future, those evaluations will inform a national decision rather than informing UK input to an EU decision. That means that much of the infrastructure and expertise we need is already in place in the UK, which will provide a good degree of continuity when we implement the UK-wide regime. The Chemicals Regulation Directorate, which sits within the HSE, already has around 150 staff working on pesticides, which is a considerable resource. We are known as probably the most advanced and developed country in Europe in terms of technical expertise.
Under the current system, a chemicals company that seeks an authorisation for a new active substance will go to a member state to have its technical information and scientific data evaluated. Those technical evaluations are currently conducted in the UK by the Chemicals Regulation Directorate. UK authorities already do around 30% of all the assessments of new products that take place in the European Union—we are known to be very efficient at doing that work and chemicals companies often choose to come to the UK.
The CRD then produces a draft assessment report, which contains a technical evaluation, looking at issues such as eco-toxicity, human health impacts, the fate of the chemicals in the environment and their efficacy. That draft assessment report is then submitted to the European Food Safety Authority which, in some cases but not all, runs a simple peer review process using a committee of experts. Following that process, EFSA reaches a final conclusion and makes a recommendation to the Commission. That recommendation is ultimately approved as a decision by one of the European Union’s standing committees—in this case the Standing Committee on Plants, Animals, Food and Feed.
In future, we will still run all that information. Instead of having an EU peer review process, we will use the UK Expert Committee on Pesticides, and rather than the EU running a public consultation, there will be a requirement on the HSE to run the public consultation.
The regulations are designed to achieve a number of things. First, all decision-making functions and powers are repatriated from the EU to national level in the way that I have explained. That includes approval of all active substances and a number of related functions, such as the precise nature and format of the documents required and some of the renewals processes that are currently provided for in EU law.
Secondly, 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 current EU mechanism for giving effect to decisions through a large volume of tertiary legislation that establishes the register.
Thirdly, other EU tertiary legislative powers will be repatriated. These are the powers to set out the principles and decisions and the thresholds and end points that should inform decisions. The powers will be exercised in future through statutory instruments rather than through tertiary legislation from the EU. A few very minor things, such as the precise format of dossiers and of assessment reports, can be dealt with administratively.
As I have explained, 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. Examples are 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 advisory committees of experts and academics—the Expert Committee on Pesticides and the Expert Committee on Pesticide Residues in Food. They are preparing to meet the challenge of any additional advice that they will need to give. They are already looking at the forward pipeline of potential renewals and new product applications that they would need to consider, and reviewing whether they have the right skills balance in their existing committee structures and seeking to recruit additional ones where they deem that necessary.
Sandy Martin (Ipswich) (Lab)
Under the current regime, the EU produces in the order of 50 additional regulations per year. Once the powers have been repatriated to this country, will there be very close alignment of this country with the new regulations being produced in the EU? If not, how will we be able to maintain our ability to trade with the EU given our need to demonstrate that our pesticide standards are at least as good as the EU’s?
George Eustice
It is obviously open to us as an independent country to choose independently to adopt processes and have things similar to those in the EU if we want to. There is nothing to prevent us from doing that, but I believe that, when it comes to pesticides, it is very important to base our decisions on the correct scientific and technical interpretation of the risk to the environment and to health. We have instances where European countries have sometimes done the calculations wrong and authorised products that they should not have authorised. We would not want to follow them if they had made errors in their analysis. The important thing is that, as I have said, the CRD has the best scientific experts on pesticides in the EU definitely and possibly in the world. It is very important that we rely on that to protect the rigour of the process and do not simply slavishly follow decisions that come from elsewhere.
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 to ensure that we are able to take renewal decisions as necessary from day one of exit.
Some elements of the current regime that 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 will no longer be relevant. However, as I said earlier, the UK will be able to take account of relevant assessments by other countries’ regulators in our own national assessments. Similarly, parallel trade permits for products 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 transitional period of two years after exit or until the extant expiry day—whichever comes sooner. Transitional measures have been put in place, ensuring that changeover to the national regime is smooth. For example, we have measures to ensure that all current approvals and authorisations remain valid after the point of exit and measures to make provision for the handling of applications in train at the point of exit.
We are also taking forward a separate instrument, as I mentioned at the start, that was laid on 12 February. The Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019 make some further minor changes relating to plant protection products and maximum residue levels. Those regulations are being made under the negative procedure. It is essentially a wash-up revocation and miscellaneous amendments SI to deal with changes that have come late in the day from the European Union. As Members will understand, there is a constant torrent of regulation in this space, so it is important that we make any necessary updates at the end of the process.
Those separate regulations also reinstate the original wording of article 46 of regulation 1107/2009 in place of the replacement article 46, which was to be substituted by regulation 5(24) of the draft Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019, which we are debating. That reinstatement is because the correction of article 46 made by the original drafting inadvertently altered the grace periods permitted under the article as it operates currently. In the new regulation, we have reverted to the original text.
The main changes in the Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019 are very similar to those in the first instrument. First, the regulations repatriate all decision-making functions and powers, such as the setting of maximum residue levels, from the EU to the national level. Secondly, a mechanism is established to give effect to national maximum residue limit 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 the valuation functions specified in the regulations. National arrangements for independent scientific advice and assurance are in place with our two highly respected expert committees. The requirement for reviews of EU maximum residue levels to ensure that they are set appropriately has been replaced by a provision for reviews at the national level. That has been necessary to ensure that it is practical and realistic for the UK to deliver acting alone. More realistic timelines to undertake reviews in a national context have therefore been set. They better match the real time that this work takes in practice in the EU at the moment.
The power to establish an EU residue monitoring programme has been replaced by 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 the programme for the next three years are retained. That will ensure that the same standards of protection are maintained after exit. Transitional measures have been put in place to ensure that changeover to the national regime is smooth. For example, all MRLs in place at the point of exit will be carried over.
I make one final point clear to the Committee. There is a constant flow of EU tertiary regulations, typically with several each month giving effect to decisions on active substances and maximum residue levels. Two minor transitional provisions in the regulation on maximum residue levels, which were laid before Christmas and relate to regulation 396/2005, and which convert EU MRLs into our new statutory register, have already become redundant due to amendments made to that regulation by the EU in January. As I mentioned earlier, last week we introduced the draft Environment (Miscellaneous Amendments and Revocations) (EU Exit) Regulations 2019. Among other amendments, it will revoke the two transitional provisions that have been overtaken by events in the EU. Both SIs will be made together once the draft instrument laid last week has passed through the necessary parliamentary processes, which will ensure that our regulations link correctly to retained EU law as it is on exit day.
I want to make one final point. I appreciate that the SIs are very lengthy—they are longer than many of the other exit SIs. Hon. Members will note that there are large schedules at the back of the regulations that contain a long list of revocations of EU regulations that we no longer need, since those pieces of tertiary legislation were essentially the vehicle that delivered a message that will be recorded on our statutory register in the future. The vehicle itself is no longer needed and is redundant, which is why there are so many revocations at the back of these statutory instruments.
I hope I have explained the process to hon. Members and reassure them that we have a very high degree of technical expertise. Although we operate under an EU regime, in practice most of the technical work is done by our national authorities, which are well equipped to continue to do this task after we leave the European Union.
George Eustice
I want to draw on some of the points made by the shadow Minister, the hon. Member for Stroud. I will return to the comments of my right hon. Friend the Member for Scarborough and Whitby at the end.
The first thing to note is that the current regulation that governs active substances is Regulation (EC) 1107/2009. Our own HSE was largely instrumental in the drafting of it. I have to point out to the hon. Member for Stroud that the then Labour Government voted against that infrastructure despite the fact that we had been involved in drafting it on the basis that they did not agree with the hazard-based principle. Nevertheless, we as a Government are bringing across the existing regime, with all its imperfections, including the hazard-based principle. We are bringing it over exactly as it is and placing it on the UK statute book.
To address the point raised by my right hon. Friend the Member for Scarborough and Whitby, who is obviously anxious to do things better, yes there are indeed opportunities to do things better and to refine the system, but that is a discussion for another day. We are absolutely crystal clear that the EU (Withdrawal) Act is about bringing across the existing regulatory structure. It seeks to make no policy changes whatever, and the regulations make no changes whatever.
To draw on the point about HSE resources, probably only the eight largest member states of the European Union have any meaningful capacity to do such work on pesticides. The UK is renowned in Europe for being the leader in terms of the scale and scope of our expertise. As the hon. Member for Stroud says, we have 150 experts on pesticides in the chemical regulations directorate. We have identified that there will be an additional workload. Scoping work has suggested that the directorate will probably need another 40 members of staff. The directorate has commenced that work, and we have identified that we will probably need to give it an additional £5 million a year to do it. The hon. Gentleman should recognise that the directorate already does the bulk of the work. It is simply fiction to think that the European Union does it. The European Union has an oversight role and owns the regulations, but the actual work—the technical evaluation—is already done by our own Health and Safety Executive.
George Eustice
It is very much the case that I would be open to saying that, as part of any future partnership, we should still have wider European technical working groups, so that the European Union can continue to benefit from British expertise but, at the moment, we are obviously not at the point of being able to advance discussions at that level of detail—as things stand, we are struggling to get a withdrawal agreement agreed by both sides at all.
Sandy Martin
Is there not a danger, Minister, that the people with the expertise will find that there is a more ready market for their expertise in the rest of the European Union, and that they will take their expertise back to the European Union rather than remaining in this country?
George Eustice
I do not think so because we will still need to comply with the regulations in the UK. The opportunities offered by Brexit to all DEFRA agencies add up to an exciting time. Rather than slavishly following EU law as we have had to do for decades, we have the opportunity to think through from first principles what good policy looks like, and to shape it independently.
Let me give hon. Members a sense of the scale of the renewal programme. Each year, usually around seven new active substances come on to the market, so the workload involved in assessing those is relatively modest, but dozens of active substances need to be reviewed every year. As the shadow Minister pointed out, currently under EU law the maximum residue limits are supposed to be reviewed within a 12-month period, which never happens. The European Union routinely breaks its own rules and typically takes up to three years to do that job.
We have to ask ourselves an important question. Is it better to rush things through in a hurry to hit some 12-month deadline, and to do things in a rather slipshod fashion, or is it better to take the time it takes to do the job thoroughly so that we have an absolutely proper understanding of any changes in the science on MRLs, and ensure that we have available all the necessary data on which to base a decision, and then be realistic about that timescale? The position we have taken, having discussed that with the HSE, is, “If you are going to do the job, do it properly; and if you are going to do it properly, be realistic about the time it takes to gather the raw data.” The HSE believes that a three-year window makes more sense than 12 months, and that in practice the EU works to that deadline anyway regardless of its own rules. We think it is better to have rules that we can abide by and that make sense than to have rules, as the EU does, that are routinely broken.
On peer review of the scientific advice, as I pointed out, we have the Expert Committee on Pesticides. Just as the EU currently puts together a peer review panel to look at the technical assessments done by the CRD, we envisage that the Expert Committee on Pesticides and the Expert Committee on Pesticide Residues in Food will be able to carry out a peer review process on the work done by our CRD officials.
The hon. Gentleman also raised the issue of accountability. It is important to recognise that, under the current system, there really is no political accountability. As I said, the blizzard of tertiary regulations that come from the European Union go to a standing committee, where things are decided. After that, there is no parliamentary process in the European Parliament. As far as our Parliament is concerned, those regulations do not even warrant an explanatory memorandum to tell hon. Members what has been done. This is the simplest of all delegated Acts, of which there is zero political scrutiny at present.
In the future, there will be a maintained register, a national consultation run by the HSE and a peer review process run by the ECP, with its minutes published in the same way they are now for product authorisations. We will have a very open and transparent process that people with technical expertise will be able to probe and challenge, and people who seek to understand why a particular product is on the statutory register will readily be able to find the information they require.
In conclusion, I believe we have the expertise in place to run both regimes effectively. We have also taken on a scoping exercise to recruit additional staff and provide additional resources to the CRD. We have the expertise. The statutory instruments will ensure that we have an operable set of regulations that change nothing and bring across the EU regime. I commend the regulations to the Committee.
Question put and agreed to.
Resolved,
That the Committee has considered the draft Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019.
Draft Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019
Resolved,
That the Committee had considered the draft Pesticides (Maximum Residue Levels) (Amendment etc.) (EU Exit) Regulations 2019.—(George Eustice.)