Environment and Climate Change Committee
Tuesday 23rd June 2026
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10:00
Speaker 1
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Speaker 1
May I extend a very warm welcome to you all, and thank you for finding the time to be the Honourable Baroness Hayman. The Veterinary Medicines Directorate and the Environment Agency with us during London Climate Action Week, which I know is a very busy time for us all. We start, may I remind everyone that the session will be webcast live on Parliament TV and a transcript will be taken and made public witnesses will have an opportunity to review the transcript and make very minor amendments if necessary. Members are reminded that any relevant interests must be declared the first time they speak, and this, of course, applies equally to our witnesses.
And I take the opportunity here to say that I am a director of Peers for the planet. So before we start, I ask each of our witnesses to briefly introduce themselves, starting with Minister Baroness Hayman. Yes. Good morning, and.
And I take the opportunity here to say that I am a director of Peers for the planet. So before we start, I ask each of our witnesses to briefly introduce themselves, starting with Minister Baroness Hayman. Yes. Good morning, and.
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Speaker 1
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Speaker 1
Excellent. Thank you very much indeed again for being with us today. Um, so the first question is a very straightforward one because we really want to understand the level of concern about these chemicals. Um, what is your understanding of the robustness of the scientific evidence that the chemicals in pet parasite products are accumulating in the environment and whether they are now present in quantities that are of concern. And Doctor Bradburn, may I ask you to address that first?
10:03
Speaker 3
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Speaker 3
Certainly. Thank you. Um, so the Environment Agency has been monitoring the two prime chemicals that I think we'll be discussing today. Fipronil and imidacloprid since before 2014. In 2014, we instigated a new liquid chromatography mass spectroscopy method for measuring them. And so generally speaking, I'll refer from 2014 onwards, which is when we have comparable data. So we have picked them up in sites across the country. Um in water, both in surface waters, estuarine systems and in groundwater.
Uh, for some of the chemicals, we pick them up in a particularly high proportion of sites. So for fipronil, we are picking them up in surface waters in over 90% of the sites that we monitor. Um, for imidacloprid, it's slightly lower between, but still between 70 and 50% in surface waters. The figures in Groundwaters are down in the teens and 20%. We. Measure these in a semi-quantitative way. This is one of the chemicals that we scan for when we do a wide chemical scan for our water samples.
So that scan takes into account about 1600 different chemicals. So rather than take a lot of effort to very precise quantifications for each of those chemicals, we take a broad approach which tells us whether they are present in the environment and gives a rough idea of the sorts of concentrations. So bearing that in mind, um, the levels that we see in the environment, I think it's safe to say when we pick these things up in the environment, they will be at levels, which when you look at the evidence that has been scanned for impacts, would suggest that they are at concentrations that could have an impact on invertebrates in the environment.
So when we say we've picked it up, it's at a level where we would assume that there could be some impact on the environment. What I'd just like to make clear, however, is that we don't have any strong evidence of cause and effect on invertebrate populations in the environment. That is where our evidence does not allow us to do that scientific experiment, because there are so many things that will impact invertebrate populations in our river systems and where we are picking up these chemicals. You will have seen in previous evidence that they are more common downstream of wastewater treatment and urban areas.
There are very, very many chemicals that are also impacting the environment in those systems. So yes, these chemicals are present in the environment and yes, they are present at levels where we would expect to see some sort of ecological impact. But I cannot say that there is a cause and effect of their presence in the environment.
Uh, for some of the chemicals, we pick them up in a particularly high proportion of sites. So for fipronil, we are picking them up in surface waters in over 90% of the sites that we monitor. Um, for imidacloprid, it's slightly lower between, but still between 70 and 50% in surface waters. The figures in Groundwaters are down in the teens and 20%. We. Measure these in a semi-quantitative way. This is one of the chemicals that we scan for when we do a wide chemical scan for our water samples.
So that scan takes into account about 1600 different chemicals. So rather than take a lot of effort to very precise quantifications for each of those chemicals, we take a broad approach which tells us whether they are present in the environment and gives a rough idea of the sorts of concentrations. So bearing that in mind, um, the levels that we see in the environment, I think it's safe to say when we pick these things up in the environment, they will be at levels, which when you look at the evidence that has been scanned for impacts, would suggest that they are at concentrations that could have an impact on invertebrates in the environment.
So when we say we've picked it up, it's at a level where we would assume that there could be some impact on the environment. What I'd just like to make clear, however, is that we don't have any strong evidence of cause and effect on invertebrate populations in the environment. That is where our evidence does not allow us to do that scientific experiment, because there are so many things that will impact invertebrate populations in our river systems and where we are picking up these chemicals. You will have seen in previous evidence that they are more common downstream of wastewater treatment and urban areas.
There are very, very many chemicals that are also impacting the environment in those systems. So yes, these chemicals are present in the environment and yes, they are present at levels where we would expect to see some sort of ecological impact. But I cannot say that there is a cause and effect of their presence in the environment.
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Speaker 3
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Speaker 3
Yes. So several years ago, the chemicals started to be removed from agricultural use. I can find you some dates, although dates when they stop being used or bans take place, have buffers around them to allow use up, etc.. Uh, but they have been successfully removed from uses where they are widely applied in the environment. So as you say, agricultural uses. Um, and so now they are restricted to a very few uses, such as flea treatments on companion animals.
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Speaker 4
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Speaker 4
Um thank you. Just in answer to the question about how seriously we're taking this, um, when we were made aware through the Bug Life report many years ago that there was concern about the levels of fipronil and imidacloprid detected, we absolutely faced into that. We know that there's no medicine that is risk free. That's the nature of medicines that are authorised. Um, however, we have looked at what we need, what questions we need to ask, and to fill those evidence gaps.
And that's exactly what we did at the VMD many years ago, was to instigate the research and development that was necessary to answer some of those questions. Additionally, I set up the pharmaceuticals and the environment group, bringing together a number of stakeholders across government, across devolved administrations, across expertise to bring this conversation to the fore so that we can really address, um, much of the problem statement, but in a way that we understand that there are many things that we don't yet know, and how can we get further forward to understand what those answers may be?That can then indicate any regulatory activity that we should take as a result.
So we take it very seriously.
And that's exactly what we did at the VMD many years ago, was to instigate the research and development that was necessary to answer some of those questions. Additionally, I set up the pharmaceuticals and the environment group, bringing together a number of stakeholders across government, across devolved administrations, across expertise to bring this conversation to the fore so that we can really address, um, much of the problem statement, but in a way that we understand that there are many things that we don't yet know, and how can we get further forward to understand what those answers may be?That can then indicate any regulatory activity that we should take as a result.
So we take it very seriously.
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Speaker 5
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Speaker 5
I mean, I think that, um, as commissioning the research, um, the Rosemary Perkins research was, um, sort of key to advancing our understanding of this issue and also the, um. The formation of the pharmaceuticals and the environment group and the road map. We've already taken action across all three sort of work streams in the work map. So I think we've, we've taken this issue quite seriously and we continue to take it seriously.
10:08
Speaker 1
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Speaker 1
Okay. So before we move on to Lourdes, question, I just wanted to ask you a little bit about the metabolites breakdown products of fipronil and imidacloprid and academics at Imperial College have said in written evidence that the products, um, that. They break down into can be an entire order of magnitude more toxic. And yet they remain poorly understood and are not part of the current formal risk assessment protocols for veterinary parasiticides. Drew who who would like to comment on that?
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Speaker 4
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Speaker 4
Yeah, absolutely I can I mean, so we know that fipronil and imidacloprid are very toxic. I mean that's the nature of of the of what they're designed to do as, as parasiticides when it comes to the environmental risk assessment. And when we are looking at authorising medicines, we look at the quality, the safety and the efficacy and the safety. We will look at the safety for the, the animal, um, for the human and for the environment. When we're looking at environmental risk assessment, which is Francine's area of expertise.
Um, there are two ways. The two phases with that, there's a phase one and there's a phase two risk assessment. Traditionally and historically any product that is for a companion animal will end at a phase one risk assessment. Um, we now understand that maybe there is more that we need to do to take forward those kind of products through a phase two risk assessment, which has always been reserved for, um, for food producing species. However, in order for us to do that, we have got to develop the exposure models because we can't ask companies to submit data to us without us understanding how we would evaluate that.
And that's exactly the work that we are currently doing. We're developing those exposure models so that we could be in a position to move into a phase two risk assessment for these types of products in the future. Would you like.
Um, there are two ways. The two phases with that, there's a phase one and there's a phase two risk assessment. Traditionally and historically any product that is for a companion animal will end at a phase one risk assessment. Um, we now understand that maybe there is more that we need to do to take forward those kind of products through a phase two risk assessment, which has always been reserved for, um, for food producing species. However, in order for us to do that, we have got to develop the exposure models because we can't ask companies to submit data to us without us understanding how we would evaluate that.
And that's exactly the work that we are currently doing. We're developing those exposure models so that we could be in a position to move into a phase two risk assessment for these types of products in the future. Would you like.
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Speaker 5
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Speaker 5
To I mean, that was that was very well described. We don't have a regulatory framework currently to carry out a phase two risk assessment for companion animals. And we need to ensure that that's in place so that we can assess all of these parasiticides for small animals in the same sort of consistent way. Um, before, before we, we make any decisions. So that's the first step that we're working, working to figure that out.
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Speaker 6
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Speaker 6
I'm a bit concerned that there's certainly no evidence or data collected on the invertebrates because that has a whole trail effect going down on the rest of everything. But maybe you'd like to address that road map for the pharmaceuticals in the environment group has set out evidence gathering activities in the medium term, as I understand it, what progress is made is being made in gathering. This required data, including product sales data, which we think was lacking from what we heard last week.
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Speaker 2
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Speaker 2
Well, I think one of the main ways we're evidence gathering is through the roadmap that was mentioned by the by, Abby from the VMD. The second is importantly, I think, the pharmaceuticals and environment group have already made a lot of progress across the three work streams that they've set up as the priority areas to get more evidence. Um, by the by, Abby, from the VMD. Um, and VMD. And as the priority areas to get more evidence, um, and take more action.
The first of those is communications and education. The second is importantly, I think for your question is evidence gathering. And finally, regulatory action based on that evidence that's been gathering. Um, we do now have some robust studies confirming by the, by, Abby from the VMD. Um, and VMD and the pharmaceuticals in the environment group have already made a lot of progress across the three work streams that they've set up as the priority areas to get more evidence, um, and take more action.
The first of those is communications and education. The second is importantly, I think for your question is evidence gathering. And finally, regulatory action based on that evidence that's been gathering. Um, we do now have some robust studies confirming pet parasiticides are not just a potential source, but a likely contributor, as the Environment Agency has been saying to environmental contamination. Um, but we're also generating new insights into real world use because unless we know how things are actually used, you can't get a clear picture.
Um, we know that routine monthly treatments are now commonplace across all distribution channels. And that risk based prescribing lacks a clear definition and consistent application. So in order to know what we do next and to, to get things into a situation where we can make the right choices that are based on, on evidence and fact, but also are proportionate because this is a one health issue. It's about the environment and it's about animal and human health. We're also looking at the exposure models that, uh, that Abby has mentioned.
So we're taking some practical action, but we're around, um, reviews of distribution categories, for example. But also importantly, working to fill those evidence gaps because we need to fill those evidence gaps if we are to move forward in a proportionate way that's actually going to tackle this problem.
The first of those is communications and education. The second is importantly, I think for your question is evidence gathering. And finally, regulatory action based on that evidence that's been gathering. Um, we do now have some robust studies confirming by the, by, Abby from the VMD. Um, and VMD and the pharmaceuticals in the environment group have already made a lot of progress across the three work streams that they've set up as the priority areas to get more evidence, um, and take more action.
The first of those is communications and education. The second is importantly, I think for your question is evidence gathering. And finally, regulatory action based on that evidence that's been gathering. Um, we do now have some robust studies confirming pet parasiticides are not just a potential source, but a likely contributor, as the Environment Agency has been saying to environmental contamination. Um, but we're also generating new insights into real world use because unless we know how things are actually used, you can't get a clear picture.
Um, we know that routine monthly treatments are now commonplace across all distribution channels. And that risk based prescribing lacks a clear definition and consistent application. So in order to know what we do next and to, to get things into a situation where we can make the right choices that are based on, on evidence and fact, but also are proportionate because this is a one health issue. It's about the environment and it's about animal and human health. We're also looking at the exposure models that, uh, that Abby has mentioned.
So we're taking some practical action, but we're around, um, reviews of distribution categories, for example. But also importantly, working to fill those evidence gaps because we need to fill those evidence gaps if we are to move forward in a proportionate way that's actually going to tackle this problem.
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Speaker 2
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Speaker 2
Well, the there are there are a number of different things going on. The call for evidence, um, concluded on the 11th of June. We're currently assessing that once we've assessed that, we'll have a better idea as to where we are. But there are a number of evidence gaps. As the Environment Agency have already mentioned.
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Speaker 4
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Speaker 4
Um, so we do receive sales data from marketing authorisation holders. Um, but that's through the periodic benefit risk report submitted as part of a pharmacovigilance requirements under the medicines regulations. So the submitted for for a different purpose to maybe the questions being asked here, but the purpose is for statistical analysis of those adverse events to understand what the volume of a product is in comparison to the frequency of an adverse event that is reported. Um, we do have some, some data which I won't read out because it's quite a large table and we're happy to provide that to you subsequently.
Um, but in general, we know that the sales, sorry, the sale. Yes, the sales of fipronil, uh, over the last decade, um, peaked in around 2021 and since then have dropped off. We have to compare that to an increase in the last five years of about a million more dogs who are pets. In the UK, in relation to imidacloprid, um there has been um, a. Steadier use perhaps with, with less in the last few years. Um, but we can give you this specific data if you would like to see a year by year breakdown.
But as I say, it's collected for a slightly different purpose, but it will give you an insight, perhaps in the way that you're asking.
Um, but in general, we know that the sales, sorry, the sale. Yes, the sales of fipronil, uh, over the last decade, um, peaked in around 2021 and since then have dropped off. We have to compare that to an increase in the last five years of about a million more dogs who are pets. In the UK, in relation to imidacloprid, um there has been um, a. Steadier use perhaps with, with less in the last few years. Um, but we can give you this specific data if you would like to see a year by year breakdown.
But as I say, it's collected for a slightly different purpose, but it will give you an insight, perhaps in the way that you're asking.
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Speaker 4
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Speaker 4
So in order to mandate sales data to be collected in that way would take a legislative change. Um, and we'd have to consider that as part of any review of the Veterinary medicines regulations. Um, if we are asking for the data in a voluntary basis and that is something we can consider, but it may not be end up being complete. And with any data collection, we'd have to understand what we want to use it for and whether or not then the burden that we're asking for in terms of it being submitted and us collecting it is, is justified.
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Speaker 3
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Speaker 3
On invertebrate data, I apologize. I did not wish the committee to think we don't collect invertebrate data. We collect an enormous amount of data on invertebrates, largely as part of understanding our progress with the objectives of the Water Framework Directive, which has then been transposed into UK legislation. So we have about 13,000 water quality sites, which we collect data from every year. We collect data not only on what invertebrates are present, but the sorts of levels of population that they are.
So we have very detailed data across the country on invertebrates. The reason I say that it's very hard to prove a causation is because we collect that data, largely driven by the requirement of the Water Framework Directive, to see whether we are making improvements to the water environment. That would be reflected in that biology. When the Water Framework Directive came into force, the major determinants of invertebrates were some of the macro pollutants. The nutrients going into the system, things like ammonia coming out of wastewater treatment works as they were at the time.
And so we've designed our collection of invertebrate data to pick up on those species that are sensitive to those pollutants. We know from studies on toxicology of many of these chemicals that different species respond differently at different levels. And we haven't designed our monitoring system to pick up on every individual chemical. That's why it's very hard to do that causation. So it's not impossible. And maybe someone with a lot of time could mine a lot of the data and start pulling out some of those correlations.
So we have very detailed data across the country on invertebrates. The reason I say that it's very hard to prove a causation is because we collect that data, largely driven by the requirement of the Water Framework Directive, to see whether we are making improvements to the water environment. That would be reflected in that biology. When the Water Framework Directive came into force, the major determinants of invertebrates were some of the macro pollutants. The nutrients going into the system, things like ammonia coming out of wastewater treatment works as they were at the time.
And so we've designed our collection of invertebrate data to pick up on those species that are sensitive to those pollutants. We know from studies on toxicology of many of these chemicals that different species respond differently at different levels. And we haven't designed our monitoring system to pick up on every individual chemical. That's why it's very hard to do that causation. So it's not impossible. And maybe someone with a lot of time could mine a lot of the data and start pulling out some of those correlations.
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Speaker 4
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Speaker 4
In terms of the pharmaceuticals and the environment group, it was set up to look at pharmaceuticals in the environment in totality. The first aim was to look at fipronil and imidacloprid because it is a hot topic for us. And as we said, you know, we're taking it seriously in terms of the data that's been provided so far. But of course, the group will then look at any other chemical that is necessary for us to, to look at, um, if I may just refer to the other product that you're referring to there.
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Speaker 4
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Speaker 4
It's quite, it's quite a tongue twister. Um, we do just have to be cautious. I mean, as I said originally, all medicines, uh, no, there's no medicine that is risk free. There will be, there will always be some risks because that is the nature of the benefit risk assessment. Um and um although um the Isa was, are effective and important treatments, there are some evidence gaps still that we may need to fully understand about the environmental and longer term, um, in effects.
Because these are what we describe as PFAs. So they're persistent in the environment. And that is obviously something that we have to consider as well. Um the benefit risk assessment of them has been sufficient enough for us to enable them to be, uh, authorised as a veterinary medicine. However, we continue to be aware of where there are, there's more evidence that we need to gather or there are reports that we need to consider. Um, we do know from the summary of product characteristics for the, these products that are, um, that is available online for, for vets to consider when looking at a range of products to use on any, um, on any companion animal that is brought to, to their practice or for general public to look at as well, of course, that there will always be a side effect.
And with these type of products, there are concerns about the neurological effects. Um, so that is why in, in our view, the Veterinary Medicines Directorate, we are here to ensure wide availability of products, both in terms of accessibility for all to achieve them, but also in terms of range of choice.
Because these are what we describe as PFAs. So they're persistent in the environment. And that is obviously something that we have to consider as well. Um the benefit risk assessment of them has been sufficient enough for us to enable them to be, uh, authorised as a veterinary medicine. However, we continue to be aware of where there are, there's more evidence that we need to gather or there are reports that we need to consider. Um, we do know from the summary of product characteristics for the, these products that are, um, that is available online for, for vets to consider when looking at a range of products to use on any, um, on any companion animal that is brought to, to their practice or for general public to look at as well, of course, that there will always be a side effect.
And with these type of products, there are concerns about the neurological effects. Um, so that is why in, in our view, the Veterinary Medicines Directorate, we are here to ensure wide availability of products, both in terms of accessibility for all to achieve them, but also in terms of range of choice.
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Speaker 6
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Speaker 6
I'm quite interested in in the in in the fact that there are PFAs products. I work in the insurance industry and PFAs is not much liked by insurers. And I'm a broker trying to get insurance for it. So I'm surprised that the pharmaceutical companies can actually go on finding. A way to get it insured. Just interesting.
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Speaker 3
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Speaker 3
I just to, to clarify further to the earlier evidence that the committee has received, we do monitor for some of these newer chemicals. They've been coming online as part of our targeted monitoring. So we are starting to look for them in water samples. And generally speaking at the moment, uh, the numbers are much, much lower than fipronil and imidacloprid. Um, but we have been monitoring them for we would expect.
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Speaker 3
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Speaker 3
You would expect that if they are new, they are also administered in a different way. They are also very different chemicals. So they will partition differently in different aspects of the environment. So it's not perhaps a surprise that we are finding them in fewer samples. But just to assure the committee that we are looking for some of these new.
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Speaker 7
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Speaker 7
Thank you. Chair, just a very brief question, perhaps initially to you, Doctor Bradburn, uh, who is commissioning research to fill the knowledge gaps because you talked about the lack of evidence that there's a cause effect relationship between fipronil and imidacloprid and insect or invertebrate populations in fresh water. So who's whose job is it to commission research and who is carrying out the research?
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Speaker 3
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Speaker 3
The research base is building all the time, and there are quite a lot of very new papers that are coming out. Looking at the relationship. It is being frankly, it's being funded through a wide range of routes. Some of this in this country and some abroad, and a wide range of research groups. Um, I'm not aware of specific targeted work other than the work that has actually been um, set up through the, Pi programme.
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Speaker 5
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Speaker 5
I think that if it's to become obligatory, then the onus will be on pharmaceutical companies to provide us with the data to carry out that assessment. As it stands, we're still figuring out how to do a phase two assessment, and we're doing some preliminary research. So Baroness Hayman has highlighted we're doing a multidisciplinary study with the University of Plymouth. We have also done quite a bit of behavioural science to understand sort of drivers of use, etc..
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Speaker 1
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Speaker 1
We will expect to see some movement on that front. Will we. Can we. Excellent. And before we move on, I just want to address something. It's been it's been brought to our attention through a number of different routes, but most recently through written evidence from water UK and that that there is an underestimate of the real world risk because the indicator species I think Doctor Bradford, you referred to those indirect indicator species and are not reflective, if you like, of the sensitivity of the real world environment, real world invertebrates in water.
So you're looking at the water flea, Daphnia Magna. And I understand there's some earthworms as well that are native earthworms are very sensitive. And yet the the research is done on a species that is not so sensitive, so, you know, this this whole causation and correlation issue is important. Are we looking at it correctly?
So you're looking at the water flea, Daphnia Magna. And I understand there's some earthworms as well that are native earthworms are very sensitive. And yet the the research is done on a species that is not so sensitive, so, you know, this this whole causation and correlation issue is important. Are we looking at it correctly?
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Speaker 5
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Speaker 5
I can start with this. Um you're correct specifically for imidacloprid. Um that Daphnia Magna, which is the sort of default lab species that we use to test toxicity in surface water, is not particularly sensitive to neonicotinoids. However, the predicted no effect concentrations that we have been using to sort of um gauge toxicity have been based on chironomids. And they are much more sensitive.
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Speaker 3
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Speaker 3
Yes. Just to to note, when we look at the levels I mentioned, the levels where we where we draw a line and say we would expect to see an effect. We have two levels that we've been using to assess the effect. Uh, one is an EU environmental quality standard, which has been set for imidacloprid recently. And that is quite a rigorous process, which looks at a range of species across trophic levels to look at varying different degrees of effects of different concentrations.
So it's not just based on one species. Uh, the, uh, the neck just mentioned, uh, for fipronil is also it follows a very similar process. So they should, those levels should be quite robust reflections of where we would expect to see.
So it's not just based on one species. Uh, the, uh, the neck just mentioned, uh, for fipronil is also it follows a very similar process. So they should, those levels should be quite robust reflections of where we would expect to see.
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Speaker 1
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Speaker 1
Are you confident that you are doing all that is necessary and that you're showing sufficient curiosity about the impacts of the in the environment and trying to draw the distinction between the causation and correlation, because there's real concern out there. We're seeing, um, accumulation of these chemicals in birds nests, for example, let alone along the food chain that humans depend on.
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Speaker 3
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Speaker 3
I, again, as a scientist am always welcoming of new evidence coming along. And there is a lot of new evidence coming along, uh, in this area. The Pi is commissioning some of that and some of it is being driven externally and funded externally to look at these, I think we have to keep looking at that growing body of evidence to, uh, assess. When we can make more certain conclusions about the impacts that that it's being had. Some of the evidence is very new and some of it, uh, I can say using our data is using our data as though it were fully quantitative data, which is pushing the limits of, of, of what you, you might use our data for.
So people are really being very curious about this, and they really are putting in quite a lot of effort. And I appreciate that from the research community.
So people are really being very curious about this, and they really are putting in quite a lot of effort. And I appreciate that from the research community.
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Speaker 1
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Speaker 1
Yes, we are particularly interested in understanding the scale of use. And because as the because the argument that we've heard from, from some of the pharmaceutical representatives is that the PM's used on domestic pets are immaterial because there's not a huge amount being used is. That that's why we are very interested in getting the volume of sales data, because we want to try and understand how. I think it will really help that causation. Correlation. Um, question help us to see what the trends are and try and match them up.
Do you not think. Is that a sensible way forward?
Do you not think. Is that a sensible way forward?
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Speaker 3
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Speaker 3
Seeing how that changes is very important. And, uh, being able to see that's why when we look for these substances, uh, in some of our monitoring, we try to pick a variety of different, uh, freshwater sites to monitor so that we're looking in rural areas, we're looking in urban areas so that we have a representative idea of where these things are turning up. So yes, absolutely. Over time, we might expect to see shifts and changes in that pattern. But I do have to say, when you look at the year on year data, there are it bounces around quite a lot, uh, because these are spot samples.
So it's not easy to spot trends.
So it's not easy to spot trends.
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Speaker 2
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Speaker 2
Sorry, could I also just just briefly add is we are looking at this from a, a pet treatment point of view, but we know that that isn't the only source of these chemicals as well. So we need to make sure that we understand the overall picture. So we know what percentage are likely to be coming from pet treatments. In order to look at what else we need to be doing, to look at the overall.
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Speaker 2
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Speaker 2
Um, we understand that imported textiles is also a particular issue imported which is imported textiles. And that's something that's fairly new. So we're looking at that as well. Because in order, if we're serious about tackling pollution of these particular chemicals, we need to understand the full picture.
10:33
10:33
Speaker 1
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Speaker 1
Could I, could I just um, we don't have time to go into that further, but written evidence on what the department has on information about these chemicals on imported textiles would be really useful for us to use, possibly as an appendix, because it's going to it is something that we have heard now for more than one source, and it is really important to try and understand what extent those might be. Impacting on the the work that we're doing.
10:33
Speaker 6
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Speaker 6
J thank thank you. Thank you very much for being with us today. Question I think is for the Veterinary Medicines Directorate. So for Abigail Seager, perhaps, uh, could you let us know or could you tell us what information you need from manufacturers about products before they are authorised?I think that would be helpful. And then there's a second question, which is perhaps also for Baroness Hayman. Do you think that that process is sufficiently transparent because a number of us here have doubts about the transparency of the process, and we think that there might be a case for rather more transparency than there is at the moment.
But why don't Abigail, you go first.
But why don't Abigail, you go first.
10:34
Speaker 4
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Speaker 4
Yes. Thank you. So overarching, our authorisations process for any medicine requires that a set of data dossier is submitted. This is the same as would be the case within Europe. Um because for many of the companies who are putting products into UK, they're looking to market their products in a continental. Level. Um, we. Ask them to submit data in various sections. Um there is data about quality. So effectively you know what, what is made up of the, of the ingredients as you were, as you like of the medicine and how it's manufactured and the robustness of that against good manufacturing practice.
We look at the efficacy. So will it, will it do what it says on the tin, the pharmacokinetics, the pharmacodynamics, and also the safety. Um now the safety aspects has a number of, of angles of lenses that we look through. One would be safety for the target animal species. One would be for user safety and user risk assessment safety. And I can come on to more detail about that and environmental safety as well. So it's broken down into these three lenses, which reflects the one health approach that Baroness Hayman was referring to earlier.
So there is a set data package that we require from companies when they are putting forward a medicine for an authorisation, the level of data and the level of studies within that will vary depending on the number of species that they want to put the the product to be indicated for, or the number of indications that they want to have on the product in terms of what it is there to do. So there's a varying degree. Degree of, of, of data that's provided. But, but generally within that structure, um, that data is commercially confidential to, to the, to the, to the company.
Um, we treat it as such and we will assess it in a benefit risk way at the VMD. We will look at each one of those packages concurrently and we will bring my assessors, as Francine is one of those assessors together, to then determine whether the overall benefit risk for the product is positive. Now, the benefit of use of the product has got to be for the animal and for the for the, for the disease or whatever it is we're trying to treat balanced against the risk that we are mitigating through risk mitigation measures.
Much of those will be the descriptions that are put into the summary of product characteristics, or in the labelling or on the packaging around either contraindications or, use a risk assessment for for use. And that's how we then balance out to say the value of this product is still beneficial. We know there are some risks, but this is how we are counteracting those in terms of then how we then summarize that we produce on on gov.uk under the Product Information database, a data package which is known as the um, the summary, the product information section.
So a summary of the, of the assessment report, which is not that data package in totality, as we said, that's commercially confidential. However a summary of that is provided. So that will set out the considerations that we have taken. Um a summary of those studies and where we have landed in terms of our benefit risk assessment.
We look at the efficacy. So will it, will it do what it says on the tin, the pharmacokinetics, the pharmacodynamics, and also the safety. Um now the safety aspects has a number of, of angles of lenses that we look through. One would be safety for the target animal species. One would be for user safety and user risk assessment safety. And I can come on to more detail about that and environmental safety as well. So it's broken down into these three lenses, which reflects the one health approach that Baroness Hayman was referring to earlier.
So there is a set data package that we require from companies when they are putting forward a medicine for an authorisation, the level of data and the level of studies within that will vary depending on the number of species that they want to put the the product to be indicated for, or the number of indications that they want to have on the product in terms of what it is there to do. So there's a varying degree. Degree of, of, of data that's provided. But, but generally within that structure, um, that data is commercially confidential to, to the, to the, to the company.
Um, we treat it as such and we will assess it in a benefit risk way at the VMD. We will look at each one of those packages concurrently and we will bring my assessors, as Francine is one of those assessors together, to then determine whether the overall benefit risk for the product is positive. Now, the benefit of use of the product has got to be for the animal and for the for the, for the disease or whatever it is we're trying to treat balanced against the risk that we are mitigating through risk mitigation measures.
Much of those will be the descriptions that are put into the summary of product characteristics, or in the labelling or on the packaging around either contraindications or, use a risk assessment for for use. And that's how we then balance out to say the value of this product is still beneficial. We know there are some risks, but this is how we are counteracting those in terms of then how we then summarize that we produce on on gov.uk under the Product Information database, a data package which is known as the um, the summary, the product information section.
So a summary of the, of the assessment report, which is not that data package in totality, as we said, that's commercially confidential. However a summary of that is provided. So that will set out the considerations that we have taken. Um a summary of those studies and where we have landed in terms of our benefit risk assessment.
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10:37
Speaker 4
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Speaker 4
We we don't authorise everything. We don't say yes to everything. We absolutely will refuse products that we do not feel are sufficiently beneficial. Um, we have a number of stages of that process whereby we will go back and ask questions effectively. We, we run on a clock timetable and we will stop the clock until we have sufficient information that we deem to be um. Enough for us to be able to consider further the product. And we do not always authorise them.
They are not always provided with a licence or they're not always provided with the indications that the company originally wanted to put on there. We may not agree. And as a result, we might have a reduced number of indications or other considerations that are then put in place in terms of the independence of the VMD. We have a veterinary products committee who is an independent advisory group that sits separately to the Veterinary Medicines Directorate and on an annual basis, they will review the robustness of our science.
They will look at a number of our assessment reports against the data and determine whether or not we have been um. Excellent. In the way that we expect ourselves to be. And they have always, um, marked us to the highest level of assurance for our robustness of our science.
They are not always provided with a licence or they're not always provided with the indications that the company originally wanted to put on there. We may not agree. And as a result, we might have a reduced number of indications or other considerations that are then put in place in terms of the independence of the VMD. We have a veterinary products committee who is an independent advisory group that sits separately to the Veterinary Medicines Directorate and on an annual basis, they will review the robustness of our science.
They will look at a number of our assessment reports against the data and determine whether or not we have been um. Excellent. In the way that we expect ourselves to be. And they have always, um, marked us to the highest level of assurance for our robustness of our science.
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Speaker 6
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Speaker 6
And thank you for that. But perhaps Baroness Hayman, I mean, going. Back to the point about transparency, I mean, I can see it's a complicated process and I can see there is some challenge there, but I think the rest of us need to be able to we need to know that this really is going on, that there is transparency about that, that it's more open than it sometimes appears. Is that something which has bothered you as a minister?
10:40
Speaker 2
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Speaker 2
I mean, I can see you coming from the difficulty with dealing with pharmaceutical companies is, is the commercial confidentiality around the products they are developing, the data they use, and so on and so forth. And I mean, I've met regularly with a number of pharmaceutical companies since I became the minister to do with the supply, veterinary medicines into Northern Ireland. And it was very difficult initially to get those meetings because of the commercial confidentiality aspect of it. So there is something they are particularly sensitive about.
Um, however, I would be happy to work with the VMD to explore if there are any options on greater transparency, but it would have to be done within that commercial confidentiality.
Um, however, I would be happy to work with the VMD to explore if there are any options on greater transparency, but it would have to be done within that commercial confidentiality.
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10:41
Speaker 7
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Speaker 7
Thank you, chair, just a very brief question to, um, Abigail. Um, you said that when the pharmaceutical company submits its dossier, there are different elements which include environmental risk assessment. So I'm just missing something here in the sense that you have approved these projects products on the basis of the dossier, which includes environmental risk assessment. But the Environment Agency has told us that there's an evidence gap linking cause and effect to putative environmental damage. So how do you square that circle.
10:42
Speaker 4
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Speaker 4
With the environmental risk assessment that we undertake for companion animals?It ends at a phase one assessment of environmental impact. Um, we and that has been that's internationally approved. Agreed. And that's how we have, have always worked. We recognise that that is possibly now not enough and that we need to move into a phase two, which is what the, the risk assessment level that we undertake for all other types of products for food producing species where the, um, the, the transmission may be different because of the nature of how those animals are farmed.
We can't just move into doing that without having a basis for the exposure model to assess against. And that is what we are actively developing. And we are leading the way with doing that. We know that there are um, others across, certainly across Europe and internationally who are interested in the work that we are doing. We are leading on and driving those international standards, being, uh, amended and being reviewed to allow for that second phase of assessment in the environmental space for companion animals.
But as I said, we need to have something to validate the data that the companies would be producing against. And that is what we're currently developing. This is Francine's area of expertise. If you have anything else specifically.
We can't just move into doing that without having a basis for the exposure model to assess against. And that is what we are actively developing. And we are leading the way with doing that. We know that there are um, others across, certainly across Europe and internationally who are interested in the work that we are doing. We are leading on and driving those international standards, being, uh, amended and being reviewed to allow for that second phase of assessment in the environmental space for companion animals.
But as I said, we need to have something to validate the data that the companies would be producing against. And that is what we're currently developing. This is Francine's area of expertise. If you have anything else specifically.
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10:45
Speaker 9
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Speaker 9
I think so, yeah. If I've made a mistake, correct me. Um, thank you for your evidence. I really welcome the move from the phase one to the phase two. But could I just ask you in relation to applying the precautionary principle, does that does that need to move from one phase to the other kind of show that actually. For whatever reason, when these products were originally approved, we didn't either fully understand the pathways or that we weren't fully aware of the impact.
I'm just wondering if there's kind of might be lessons to be learned from past decisions in this space in relation to these kinds of medicines.
I'm just wondering if there's kind of might be lessons to be learned from past decisions in this space in relation to these kinds of medicines.
10:45
Speaker 2
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Speaker 2
I think that's a very good point. I mean, Francine made the point that actually up till now, um, you know, companion animals, the evidence hasn't been there that veterinary treatments have been causing these kind of environmental problems. So we're now in a different space where we are getting a lot of evidence that demonstrates that, that there are environmental impacts for medicines that are used very, very regularly. And that's why we need to kind of consider a new a new approach, as Abby was saying, um, the phase two aspect has always been with farmed animals because there's more concern around the kind of chemicals that are used in that space.
So again, it's, it's, it's looking at how we increase, if you like the checks and balances for the new medications that are coming through for pet use.
So again, it's, it's, it's looking at how we increase, if you like the checks and balances for the new medications that are coming through for pet use.
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10:46
Speaker 1
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Speaker 1
Thank you. Um, just before we move on to the next question, just want to raise a point that was made to us by academics from Imperial College. They too were very concerned about the transparency of the of these assessments and transparency of user exposure and toxicological risk. I think we've more or less covered that. However, they also expressed some concern about the quality um of. The revised assessments, the revised assessments as of 2018 and saying that they were not applied retrospectively to existing products or to generics, um, approved after this date, leaving much of the existing market.
Um and the genuine sector assessed to the pre 2018 standard instead. In many cases, approval relies on limited and inconsistent user risk assessments that may not reflect current standards. Could you comment on that?May I start with you, Francine?
Um and the genuine sector assessed to the pre 2018 standard instead. In many cases, approval relies on limited and inconsistent user risk assessments that may not reflect current standards. Could you comment on that?May I start with you, Francine?
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10:47
Speaker 5
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Speaker 5
Thanks. Human um, all veterinary medicines undergo a human safety assessment. Um and that is very rigorous. And it has been historically very rigorous. They consider all those that may come in contact with the medicines. So that is including adults and children. Um the process involves identifying the hazards of the medicine and then the likely exposures and sort of comparing those hazards to the exposures and any identified risks.
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10:48
Speaker 1
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Speaker 1
You're saying the, the, the outcomes of those assessments are fully reflected in the user safety information in the leaflets and how many people I think we we discussed this previously. We don't think many people read those leaflets and that that information is not accessible. But maybe we'll come to that whole issue further down the line. And there's just one further question. I think there's an emerging area of research, which is that, inhalation of contaminated dust. And in the home, the impact of that is, is there's there's a dearth of information on that.
Is that an evidence?Is that a research gap that, um, IFIE will also be able to address?
Is that an evidence?Is that a research gap that, um, IFIE will also be able to address?
10:49
Speaker 5
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Speaker 5
I think that that is a, an emerging area of concern, um, that we've recently heard about. I don't know if the pharmaceuticals in the environment group is the correct platform for that, because it's more focusing on the end user as opposed to the wider environment. Um, but it's certainly something we will consider.
10:49
Speaker 1
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Speaker 1
Thank you. All right. We'll move on to the next question. And I will be taking that given. Lord Leonie is not with us yet. Um so we've heard evidence to suggest that the risk of environmental harm from chemicals in pet parasite medication warrants pharmaceutical companies conducting phase two environmental risk assessments. We've touched on that. Will the government commit to ensuring phase two assessments are carried out on all existing and future parasite products?
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Speaker 2
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Speaker 2
Um, we as I say, we finished the call for evidence on the 11th of June. Um, once we've finished assessing all of that, we'll be looking at exactly how we want to take forward any recommendations. And that will include looking at phase two. I think the evidence is strong that that is the direction of travel. So that's certainly something that I will be picking up with the VMD.
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10:51
Speaker 5
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Speaker 5
We have we have 12 weeks to publish findings from the call for evidence. But that's that's feeding into the wider review of the distribution category, which is likely to take longer because it's also looking at the benefits, the environmental risks, etc., and sort of collating everything into an overarching decision.
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Speaker 4
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Speaker 4
It would be beneficial for us to work in an international way against internationally adopted guidelines. Um but we are very happy to be the leader in taking those changes to that forum. Um, we don't have to wait for anybody else to agree the guidelines for us to, um, impose the. Um, within the UK, however, we do have to be mindful of where products are being marketed, um from pharmaceutical companies because one of the aspects that is the VMD responsibility is not just looking at the quality, safety and efficacy of those products, but also about the availability of those products.
And we have to understand that for a pharmaceutical company who is making commercial decisions to put a product into Great Britain and Northern Ireland, especially where Northern Ireland is working under EU regulations, to have two different sets of regulations is not beneficial and conducive necessarily to warranting those products coming onto the market, which is something we've been working on separately, um, to ensure the continuation of products in Northern Ireland. So we have to take that into account, but we don't have to wait for anybody else in order to proceed with looking at the evidence that we would need and developing those exposure models that would enable us to have a phase two risk assessment.
And we have to understand that for a pharmaceutical company who is making commercial decisions to put a product into Great Britain and Northern Ireland, especially where Northern Ireland is working under EU regulations, to have two different sets of regulations is not beneficial and conducive necessarily to warranting those products coming onto the market, which is something we've been working on separately, um, to ensure the continuation of products in Northern Ireland. So we have to take that into account, but we don't have to wait for anybody else in order to proceed with looking at the evidence that we would need and developing those exposure models that would enable us to have a phase two risk assessment.
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Speaker 7
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Speaker 7
Thank you, Lord chair. Um, one of the points that was made to us by witnesses earlier on is that when you do move to phase two assessments, which I understand is the direction of travel, and we touched earlier on the fact that Daphnia Magna are generally less sensitive to these chemicals than other invertebrate species. So are you able to commit to the um. Suggestion that if you implement phase two assessment, you will look at a wide range of invertebrate species, not just at one single species.
10:55
Speaker 4
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Speaker 4
That once we have the exposure model that would enable us to look at companion animals, um, in that phase two environmental risk assessment space, it would be possible for us to look at then a range of um, of either chemicals or types of products, because it will give us that platform to work against. But I. Expertise.
10:55
Speaker 5
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Speaker 5
I can answer this. Um, it's very interesting when you do environmental risk assessment, when you usually start with the Daphnia magna. And if a risk is highlighted, then you have to do sort of higher tier testing, which is generally considering um, more, more subtle toxicities or longer term exposures, etc.. And you find that if a product is truly toxic, then, um, this is this sort of pattern continues as you progress through the tiers. Um, so yeah, we would look at a range of species.
If by the time you get to sort of tier C, you're looking at species sensitivity distributions, which looks at a whole range of invertebrate. Um, and then does starts to find a sort of suitably protective predicted no effect concentration.
If by the time you get to sort of tier C, you're looking at species sensitivity distributions, which looks at a whole range of invertebrate. Um, and then does starts to find a sort of suitably protective predicted no effect concentration.
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10:56
Speaker 4
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Speaker 4
I think, I think the, our commitment is that we will look at when we are assessing the safety of a product. We Product. We looked at the safety of the product for the for the animal. For the target species, for the humans and the user and for the environment. If we have an ability to look at a greater extent to any one of those components. In this case, of course, we're referring to the environment. We absolutely will do that.
10:57
Speaker 1
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Speaker 1
Thank you. Before we move on to Brandis Whitaker's question, I wonder if I can put this to you. And that is that the Environment Agency has also worked with the VMD through the Pi R group. To develop a strategy to manage the impacts of veterinary medicines and pharmaceuticals on unintended receptors, i.e., wild fauna. The outcome of this work has not yet been published. When can we hope to see that?
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Speaker 8
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Speaker 8
Thank you very much for coming in and for all that. Um, very helpful information. We have nevertheless had a fair amount of evidence that the process of pharmacovigilance reporting is not working. Things like, um, these are really questions for the directorate. I think that um new evidence is only considered if it's provided by the manufacturers and relying only on the end user to report treatment failure, which. So there's an underestimate and I have to say there's been a certain amount of disquiet about the way commercial interests seem to be impeding freedom of information requests about formal.
Data. Um, so tell us how you would respond to the criticism and also how frequently environmental risk assessments are reviewed. Post authorisation. And I would like a remark if you have any information on human health, not as caused by parasites, but possibly caused by the treatment, which appears to be relatively uncovered. So that's quite a quite a task. But it is what you can. Plan.
Data. Um, so tell us how you would respond to the criticism and also how frequently environmental risk assessments are reviewed. Post authorisation. And I would like a remark if you have any information on human health, not as caused by parasites, but possibly caused by the treatment, which appears to be relatively uncovered. So that's quite a quite a task. But it is what you can. Plan.
11:01
Speaker 4
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Speaker 4
Okay. Thank you. Um, so all authorised veterinary medicines are kept under continuous review through the pharmacovigilance system that you refer to and through any emerging scientific evidence. And that information can trigger either regulatory evaluation, including reassessment where that is appropriate. So we would look again at the at the product. Um pharmacovigilance encompasses the collection and assessment of reports across a range of outcomes, including lack of efficacy, adverse events in animals and impacts on human health, as you refer to.
And of course, environmental.
And of course, environmental.
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Speaker 4
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Speaker 4
So for user safety, um, we have pharmacovigilance data that indicates that fewer than one adverse event in humans is reported per ten 000 doses administered for fipronil and imidacloprid spot on treatments. Um, and we are working with environmental, other environmental agencies to consider monitoring more data alongside those pharmacovigilance reports, because we recognise that there are limitations in the consistency and coverage and attribution of environmental monitoring data. So we're working with partners to better establish that. In terms of general pharmacovigilance reporting, um, that can be through a number of sources, whether it is through the companies themselves or through, um, through vets or through, um, the.
End users, the, um, the, the pet owners would be in this case, and we would collate a number of those reports. We have various signal detections that we look at to understand whether there is a trend that we need to investigate. And at that point we would then look and have a number of steps that we can take, which may well end up being a regulatory change or a change to that product, whether it is. An extra line on the, on the summary of product characteristics and additional warning or a change that would require something more substantial, including removing the product.
If we felt that there was a significant safety concern. Um, so that is how we would be monitoring post authorisation, any product through a number of those lenses and through a number of ways in which we gather that data.
End users, the, um, the, the pet owners would be in this case, and we would collate a number of those reports. We have various signal detections that we look at to understand whether there is a trend that we need to investigate. And at that point we would then look and have a number of steps that we can take, which may well end up being a regulatory change or a change to that product, whether it is. An extra line on the, on the summary of product characteristics and additional warning or a change that would require something more substantial, including removing the product.
If we felt that there was a significant safety concern. Um, so that is how we would be monitoring post authorisation, any product through a number of those lenses and through a number of ways in which we gather that data.
11:03
11:03
Speaker 4
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Speaker 4
Know where we have. So we have so at the VMD we have um a research and development budget which we utilise across a range of um of subject areas depending on the policy question or the surveillance area that we need to focus on at the time. The Vmds remit is quite broad, includes antimicrobial resistance as a very important topic. So a number of our research projects are in that space, but we do have research projects, as we refer to here. And as per the University of Plymouth, that we fund to look into answering questions that we know are evidence gaps.
Uh, exactly. For this purpose. If we feel that there is something that we need to ask the company very specifically in relation to, um, a concern that is raised, then we will do so. And perhaps ask them to undertake additional very specific studies. We would not fund that. That's that's different to research and development that would be on the company to undertake that are their own cost.
Uh, exactly. For this purpose. If we feel that there is something that we need to ask the company very specifically in relation to, um, a concern that is raised, then we will do so. And perhaps ask them to undertake additional very specific studies. We would not fund that. That's that's different to research and development that would be on the company to undertake that are their own cost.
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Speaker 5
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Speaker 5
From I mean, again, I'm an environmental risk assessor, not a user safety specialist, but from what I do know, Fipronil and imidacloprid have an incredibly high mammalian safety threshold. That's why they're authorised for use on cats and dogs. So they're designed specifically to kill insects. And we don't have the same sensitivity as mammals.
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Speaker 10
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Speaker 10
Thank you very much. Chair. Just on the pharmacovigilance, um, that would normally be a reactive process, right?Where animal owners in this case would report an adverse reaction. So how do you gather any environmental insults through that system?Or do you have a a system of alert, if you like to environmental damage?
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Speaker 4
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Speaker 4
Um, in terms of environmental incidents, we, you know, we have a system whereby those can be reported, but we do recognise that there is a data gap here. And perhaps some more evidence can be garnered through us working collaboratively with other agencies who may well have access to that data, because it is that bigger picture that we need to have that will enable us to take, um, the, the correct course of action in light of all the information that is presented to us.
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11:08
Speaker 1
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Speaker 1
Yeah. Okay. Um, why don't I. Put this to you?Because it is, it is something that's on my mind. Um, we've heard from several sources that there is no process of continuous ongoing benefit risk assessment review. And Guy Woodward from Imperial College said that he's concerned that there's no kind of curiosity or reflection or looking back at the massive accrual of huge amounts of environmental and scientific evidence in the interim, which clearly shows that these things are present in the environment in high concentrations, and they're leaking into the environment.
Could you just respond to that concern?
Could you just respond to that concern?
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Speaker 4
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Speaker 4
So when there has been something that has been noted as an environmental concern, just as this topic has been, there has been no hiding of the work that we have been doing to face into it. That's what we publicly set up the pharmaceuticals and environment Group to bring everybody together, to make sure that all of those voices were heard. We publish the minutes of those meetings, the notes of those meetings, the actions of those meetings, and the roadmap from that. So in terms of us not facing into an environmental concern when it's raised, I would counter that with actually we are this is evidence of exactly what we are doing.
We're not hiding behind, um, hiding behind anything. We have a pharmacovigilance system by which we gather that information.
We're not hiding behind, um, hiding behind anything. We have a pharmacovigilance system by which we gather that information.
11:10
Speaker 1
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Speaker 1
I think, I think you can appreciate from the point of view of scientists that they don't want to see the distilled information through through yourselves. They want to see the raw information that you're you're then assessing. So let me leave that there. They aren't getting the information that they need. They are getting the information through a lens. And I think that is the issue. Um, so can we move on to Baroness McIntosh. Thank you.
11:11
Speaker 11
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Speaker 11
And welcome to, to the panel. Um I should declare that I'm an honorary associate of the British Veterinary Association. Also I think I was probably in the European Parliament when the original Water Framework Directive was adopted. So I've taken quite an interest in it since then. I'd like to ask a question in two parts, initially to to Doctor Bradburn, and if anyone else wants to pitch in, that would be great. Um, we seem to have identified in our evidence another, uh, research gap, and that is the fact that, um, a lot of the, um, particularly this unpronounceable ice ox.
I've been rehearsing, um, actually go to the bottom of the river bed and are very difficult for that reason. Um. Present themselves. So do you have plans to increase the scale of monitoring in waterways, soil and sewage sludge for these chemicals of concern?And could I ask you, are we testing and monitoring at the right levels?Because in response to the first question from Lord chairman, we had some pretty graphic percentages of what you are finding. If we were to reduce that, um, might we be even more horrified than we already are?
I've been rehearsing, um, actually go to the bottom of the river bed and are very difficult for that reason. Um. Present themselves. So do you have plans to increase the scale of monitoring in waterways, soil and sewage sludge for these chemicals of concern?And could I ask you, are we testing and monitoring at the right levels?Because in response to the first question from Lord chairman, we had some pretty graphic percentages of what you are finding. If we were to reduce that, um, might we be even more horrified than we already are?
11:12
Speaker 3
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Speaker 3
Okay, so I'll take I'll take that question in two parts. And it's a very good question because, um, every chemical in the environment behaves differently. Pathways into the environment are different. Um, and where the chemicals end up in the environment are also different. Um the chemicals in question here, we do have some ongoing research at the moment into the fipronil and imidacloprid, uh, to understand how those are travelling through the environmental system. So there's a great program called the Chemicals Investigation Programme.
The committee may have heard about this. This is the water industry's response to emerging threats, emerging problems that might be having an impact on the water system. Um, and they do that very collaboratively with the regulators and with the UK Water Industry Research Programme. Um, one of the projects that they've got running at the moment, they started looking at imidacloprid and fipronil back in about 2020. But one of the projects we've got running with them at the moment is looking very specifically at how those chemicals partition between the different things, between sewage sludge and the water that goes through the sewage system.
And then what happens when it's in the river, looking into the sediment, etc.. So, um, it's, it's a good thing to do. It's quite a big programme of work. Um, as far as I'm aware, we haven't yet started to look at the newer chemicals that are on the market in such detail. Um, and I think, uh, using and working with the chemicals investigation programme might be a good way to do that because it gives you access to the real life, uh, sewage works, the real life situation so that you can actually see what's really happening rather than doing it in a laboratory.
So that's certainly something we can explore with them. As I say, it's collaborative. So they set the, uh. Uh, some of the research requirements, but we, we work with them on that. Um, on the question of monitoring, um, I suppose my question with monitoring is always, um, the utility of the information that we get out of the monitoring. So I will say to the committee that, um, in most areas that I end up, uh, talking to people about, I will almost always, somewhere in the conversation get asked, why don't you do more monitoring?And if I added that all together, we already spend around about £90 million a year monitoring the water environment.
It's a huge amount of effort, employing about 1000 of our staff. So it's an enormous programme. Um, and we have added the these new chemicals to that wider watch list. Should we increase the number of sampling sites. I'm not sure currently that it would give us further information to enable us to take a different step or a different set of actions.
The committee may have heard about this. This is the water industry's response to emerging threats, emerging problems that might be having an impact on the water system. Um, and they do that very collaboratively with the regulators and with the UK Water Industry Research Programme. Um, one of the projects that they've got running at the moment, they started looking at imidacloprid and fipronil back in about 2020. But one of the projects we've got running with them at the moment is looking very specifically at how those chemicals partition between the different things, between sewage sludge and the water that goes through the sewage system.
And then what happens when it's in the river, looking into the sediment, etc.. So, um, it's, it's a good thing to do. It's quite a big programme of work. Um, as far as I'm aware, we haven't yet started to look at the newer chemicals that are on the market in such detail. Um, and I think, uh, using and working with the chemicals investigation programme might be a good way to do that because it gives you access to the real life, uh, sewage works, the real life situation so that you can actually see what's really happening rather than doing it in a laboratory.
So that's certainly something we can explore with them. As I say, it's collaborative. So they set the, uh. Uh, some of the research requirements, but we, we work with them on that. Um, on the question of monitoring, um, I suppose my question with monitoring is always, um, the utility of the information that we get out of the monitoring. So I will say to the committee that, um, in most areas that I end up, uh, talking to people about, I will almost always, somewhere in the conversation get asked, why don't you do more monitoring?And if I added that all together, we already spend around about £90 million a year monitoring the water environment.
It's a huge amount of effort, employing about 1000 of our staff. So it's an enormous programme. Um, and we have added the these new chemicals to that wider watch list. Should we increase the number of sampling sites. I'm not sure currently that it would give us further information to enable us to take a different step or a different set of actions.
11:14
11:14
Speaker 3
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Speaker 3
Um, I believe that we have representative um, samples from across the various different sources. As we're explaining earlier, we're looking in urban and rural situations, we're trying to pick the points, uh, where we can get the most information. Um, we have a system called the harmonised Monitoring scheme. For example, which looks at quite a small subset of rivers, but is designed in a way to capture the overall picture of the rivers. Um, so with, you know. Depending on measurements, there's 200,000km of watercourses in England.
It's, it's a lot of water to, to measure. So we try to do it statistically to do that for these watch watchlist chemicals. It's not a statistically designed survey. We take opportunities where we're using monitoring in other places. So I think at the moment I feel comfortable that we are getting a good picture. I'm not sure that we need to throw lots more sampling sites at it, but we'll keep that under review as new chemicals come along.
It's, it's a lot of water to, to measure. So we try to do it statistically to do that for these watch watchlist chemicals. It's not a statistically designed survey. We take opportunities where we're using monitoring in other places. So I think at the moment I feel comfortable that we are getting a good picture. I'm not sure that we need to throw lots more sampling sites at it, but we'll keep that under review as new chemicals come along.
11:16
Speaker 11
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Speaker 11
Just before I move on to the next part of the question, could I just ask?Um, it has caused great concern in areas like North Yorkshire where sludge is. Put on the fields and it does appear, from the evidence we've received, that if it does contain ISO. Oily substance, should we end the practice until we know what particular damage it is caused?It is. I'm sure Baroness Hayman will be aware of this. It does cause a lot of grief in rural areas when this happens.
11:16
11:16
11:16
11:17
Speaker 2
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Speaker 2
Mean sludge spreading is one of those issues that a lot of people have quite strong views on. Um, and obviously it's currently permitted. There are also, um, as you know, rules around using it as well. I think as we get more evidence as the kind of chemicals that could be present in sludge, we need to, to look at that very, very carefully.
11:17
Speaker 11
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Speaker 11
For those interested to see him did a study on what we could use other substances for which I, which I chaired. It was a very good study. Um, can I just move on to the Water Framework Directive and the fact that environmental quality standards which are set are legally binding, substance specific concentration limits for pollutants in water. And we've heard that the lack of an agreed EQS for fipronil. And imidacloprid did whatever. I'm not with it in the UK indicates that there is still uncertainty around these.
Do you share the concern about that?And obviously the EU are updating or have updated the Water Framework Directive to introduce a predicted no effect concentration for fipronil and IMO. So. Do you think that we should go down the path. And before you reply, could I just flag up some evidence?We literally just got uh, as we were preparing for this week from, um, water. UK and Yorkshire Water, obviously I declare an interest as a former Yorkshire MP.
Um, that the figure that they put um. Water UK on treating this um particularly if you were to remove PFAs from, from the water ways it's been estimated by the UK. We're a net present value cost of £21 billion for the UK. I mean my argument would be we shouldn't be putting these substances in the water in the first place, asking water companies and customers to dig it out and then water UK um say. That um current wastewater treatment processes are able to partially reduce concentrations of pet parasitoids, but they do not fully remove them.
It would put an enormous responsibility on water companies, their customers and everybody else if that was to change. You alluded to the Northern Irish situation as well. So there's a lot in that question.
Do you share the concern about that?And obviously the EU are updating or have updated the Water Framework Directive to introduce a predicted no effect concentration for fipronil and IMO. So. Do you think that we should go down the path. And before you reply, could I just flag up some evidence?We literally just got uh, as we were preparing for this week from, um, water. UK and Yorkshire Water, obviously I declare an interest as a former Yorkshire MP.
Um, that the figure that they put um. Water UK on treating this um particularly if you were to remove PFAs from, from the water ways it's been estimated by the UK. We're a net present value cost of £21 billion for the UK. I mean my argument would be we shouldn't be putting these substances in the water in the first place, asking water companies and customers to dig it out and then water UK um say. That um current wastewater treatment processes are able to partially reduce concentrations of pet parasitoids, but they do not fully remove them.
It would put an enormous responsibility on water companies, their customers and everybody else if that was to change. You alluded to the Northern Irish situation as well. So there's a lot in that question.
11:19
11:20
11:20
Speaker 3
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Speaker 3
Okay, I will, I will treat this more briefly then. So, uh, EQS are, uh, particular. Tools that we use to enable us then to set things like permit limits on what can come out of a company of water water treatment sites. So as such, where we know that there are particular limits that we don't want breached in the environment, they can be very powerful tools. We then have to monitor very, very quantitatively for those substances to ensure that those permit limits are being respected.
You hit the nail on the head when you say actually treating, uh, water treatment is currently the primary and secondary treatments are not going to remove a lot of these chemicals. Putting in the tertiary quaternary treatments is going to be very expensive. I know that this is something that you're okay.
You hit the nail on the head when you say actually treating, uh, water treatment is currently the primary and secondary treatments are not going to remove a lot of these chemicals. Putting in the tertiary quaternary treatments is going to be very expensive. I know that this is something that you're okay.
11:21
11:21
11:21
11:21
11:22
Speaker 2
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Speaker 2
Um, I'm presumably that's come from the evidence from the vets that came. I mean, do we know that all vets don't use it?I'm just thinking, I mean, I think it's important to to look at access here as well because um, most vets have easy access to alternative treatments. I used to, for example, I understood this better. I would give my dog a pill rather than use this bottle. But many people don't have necessarily have access to that. They don't necessarily have the ability to go and see the vet.
They don't necessarily have the funding to start paying for prescriptions. So which is part of the reasons why we need to understand this situation better and understand any unintended consequences, because what we don't want is if we banned it to see a lot of people currently just stopping using it, and then you've got an issue with fleas and ticks going forward. So we need to do it in a proper considered way so that when we move forward to make decisions on what to do about these chemicals and try and move usage into a different area.
They don't necessarily have the funding to start paying for prescriptions. So which is part of the reasons why we need to understand this situation better and understand any unintended consequences, because what we don't want is if we banned it to see a lot of people currently just stopping using it, and then you've got an issue with fleas and ticks going forward. So we need to do it in a proper considered way so that when we move forward to make decisions on what to do about these chemicals and try and move usage into a different area.
11:23
11:23
11:23
11:23
Speaker 9
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Speaker 9
You very much for being with us on such a warm morning. Um, my question really was about, um, information to pet owners. Sorry, I can't use companion animals. Um, and I declare my interest as having a couple of dogs in this space. So obviously the VMD has updated their information given to pet owners. Um, and I guess you've increased the, the time that you suggest pet owners don't allow their dogs to go in the water from 2 to 4 days.
But in terms of understanding the pathways for these medicines, I guess the basic question really is that advice good enough when there's seems to be pretty clear evidence that these treatments can last for longer periods of time, there's some suggestion that could be 28 days or more in the home. And obviously, as we know, dogs go on beds and sofas and all sorts of other stuff and humans interact with them. Um, and then there's an issue as well about, about the waterways. I've got a second question, but maybe if I just start with that, what more really is this?
But in terms of understanding the pathways for these medicines, I guess the basic question really is that advice good enough when there's seems to be pretty clear evidence that these treatments can last for longer periods of time, there's some suggestion that could be 28 days or more in the home. And obviously, as we know, dogs go on beds and sofas and all sorts of other stuff and humans interact with them. Um, and then there's an issue as well about, about the waterways. I've got a second question, but maybe if I just start with that, what more really is this?
11:24
Speaker 2
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Speaker 2
This is something we've been discussing. Clearly. It's an important part of the call for evidence because, I mean, it came up earlier about reading the leaflet. There is there is plenty of information on the packets, on the leaflets. How much notice do people take of it?Do they actually act on what's put on the leaflet?You know, do they you stop your dog swimming. You know, it's, it's, it's all very well to provide information, but you need to understand how people use that information and if they even recognise the information they're being given.
So then you look at do you provide information at the point of sale?How does that work with online sales?Do you work with vets more to do more?It's quite a complex area because sometimes the things that you think people are going to take account of don't actually work. So we have to be you have to sort of think quite openly. So this is something that the VMD and I've been talking about in some detail and will be an important part of, of our response to the call for evidence.
So then you look at do you provide information at the point of sale?How does that work with online sales?Do you work with vets more to do more?It's quite a complex area because sometimes the things that you think people are going to take account of don't actually work. So we have to be you have to sort of think quite openly. So this is something that the VMD and I've been talking about in some detail and will be an important part of, of our response to the call for evidence.
11:25
Speaker 9
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Speaker 9
I mean, if I could just I welcome that. And I think that's an important part of this space. I mean, I think a lot of dog owners don't know and don't have access to good evidence. I think, you know, a 2.6m leaflet, you can't read and nobody opens up. You know, would you be pushing for more kind of visuals on packaging?Should also we be moving away from, uh. The manufacturers pushing people to be using these medications monthly?Should we be looking at possibly increasing the length of time that we encourage people not to be overly interacting with their pets or having them sleeping on sofas is all that kind of active in your space for consideration?
11:26
Speaker 2
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Speaker 2
Absolutely. I mean, it's not just, um, you know, how, how you use it, it's how often you use it. It's, it's looking at that, that bigger picture of, of usage and why people are using it in the way that they do. Um, as you say, there is advice to use it monthly. Is that necessary?You know, we need to, to consider all of these questions and we will be looking at, um, at that as part of the call for evidence and whether or not we need, you need revised guidance as well.
Um, and what you would be saying in that space.
Um, and what you would be saying in that space.
11:27
11:27
Speaker 7
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Speaker 7
Thank you very much, chair. And thank you to our witnesses for coming this morning. Um, one of the things that struck us in the last few weeks taking evidence, is how the industry is very closely involved in the regulatory process. For example, the VICH the UK has two representatives, the VMD and Noa, which represents the pharmaceutical industry. And we become a bit worried about um regulatory capture here. So I'd like to hear from you, Abigail, what your view of that is.
And also note that the treasurer of of the Responsible Use of Medicines Alliance, companion animal and equine is a voluntary cross-sectoral alliance of stakeholders. And the treasurer is the chief executive of the industry body, Noah. So just, you know, my experience is from the food industry. When I was chairman of the Food Standards Agency, and we tended to keep the food industry at arm's length, whereas here there seems to be a warm embrace.
And also note that the treasurer of of the Responsible Use of Medicines Alliance, companion animal and equine is a voluntary cross-sectoral alliance of stakeholders. And the treasurer is the chief executive of the industry body, Noah. So just, you know, my experience is from the food industry. When I was chairman of the Food Standards Agency, and we tended to keep the food industry at arm's length, whereas here there seems to be a warm embrace.
11:28
Speaker 4
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Speaker 4
So we do work, um, in a way, which is collaborative. Absolutely. And I, I stand by that as a value of, of the VMD in terms of how we cooperate with, with anybody, whether it is the pharmaceutical industry or other government departments, other stakeholders, the veterinary associations, because we have the animal health sector is relatively small in comparison, you know, about 3% the size of the human health sector, for example. Um, we have to understand what is happening. We have to understand the nature of products that are being developed.
We have to understand, um, the nature of the diseases that are being, uh, that, you know, the disease incursion that we are facing into with greater speed, perhaps because of, because of climate change. Um, it's important that we work together. It's important that we understand what the regulatory barriers are to pharmaceutical companies delivering the products that we need at the supply level, that we need them. One of the other issues that we have been facing at the VMD, on the vaccine side, has been around concerns around shortage of supply and shortage of innovation, and we're facing into that by addressing that directly with that multi stakeholder group, which includes the pharmaceutical industry.
We are, though independent from them. And as I referred to earlier, we will refuse applications. We do not blindly send through any data package that is sent to us. We are renowned globally for the robustness of our science. Um, and I absolutely stand by the fact that all of the scientists at the VMD will look at the science based on the data that is provided and challenge it, regardless of who the of who the applicant is. However, we do work in a way that is not as arm's length as, as maybe other sectors that you might have experience of, because it's important for us to, um, have a common goal here, which is to have safe medicines available on the market.
And that takes a number of, um, parties to be working in the same direction to achieve that.
We have to understand, um, the nature of the diseases that are being, uh, that, you know, the disease incursion that we are facing into with greater speed, perhaps because of, because of climate change. Um, it's important that we work together. It's important that we understand what the regulatory barriers are to pharmaceutical companies delivering the products that we need at the supply level, that we need them. One of the other issues that we have been facing at the VMD, on the vaccine side, has been around concerns around shortage of supply and shortage of innovation, and we're facing into that by addressing that directly with that multi stakeholder group, which includes the pharmaceutical industry.
We are, though independent from them. And as I referred to earlier, we will refuse applications. We do not blindly send through any data package that is sent to us. We are renowned globally for the robustness of our science. Um, and I absolutely stand by the fact that all of the scientists at the VMD will look at the science based on the data that is provided and challenge it, regardless of who the of who the applicant is. However, we do work in a way that is not as arm's length as, as maybe other sectors that you might have experience of, because it's important for us to, um, have a common goal here, which is to have safe medicines available on the market.
And that takes a number of, um, parties to be working in the same direction to achieve that.
11:29
Speaker 7
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Speaker 7
Thank you. Um, just sort of very brief, if I may, Lord. Chair. Second question. In some other areas of risk assessment and informing regulation, there are independent scientific committees like the Committee on Toxicity, the Committee on Medical Effects of Air Pollution, and so on. Does the VMD have an independent scientific committee that is populated by academics and other experts?That helps to summarise and inform you on on scientific advice.
11:30
Speaker 4
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Speaker 4
We have access to the Veterinary Products Committee, which is an independent group made up of academics of very specific scientific expertise who may work in various fields, includes also veterinary prescribing nurses. It includes veterinary surgeons from large animal practices and various species groups so that we can get that whole sector, um, response when we are asking them any particular question, we may well take issues to the Veterinary Products Committee to, to ask them to consider. It's possible, as I referred to earlier, that the products Committee could be asked to look at a decision that we have taken.
If they if the company does not agree with it, they can look at it through, um, as as an appealing body. Um, so we have access through that in that regard to an independent group. Um, but we also do work, of course with other scientists across other government departments when we need to, uh, noticeably in, um, with the food standards agency when that's required, obviously not in the, in the pet space. Um, and, uh, and others as we need to, when we recognise that there is some scientific expertise that we might need to tap into, we would absolutely be able to do that, not necessarily through specific committees in quite the detail that you describe, but certainly with the products Committee that exists for that purpose.
If they if the company does not agree with it, they can look at it through, um, as as an appealing body. Um, so we have access through that in that regard to an independent group. Um, but we also do work, of course with other scientists across other government departments when we need to, uh, noticeably in, um, with the food standards agency when that's required, obviously not in the, in the pet space. Um, and, uh, and others as we need to, when we recognise that there is some scientific expertise that we might need to tap into, we would absolutely be able to do that, not necessarily through specific committees in quite the detail that you describe, but certainly with the products Committee that exists for that purpose.
11:31
11:31
Speaker 4
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Speaker 4
There are no industry representatives that sit on the products committee. It is made up of, um, of experts, as I say, that are either species group experts, vets in practice, a range of, um, whether they're equine vets, large animal vets, small animal vets, um, the distribution category channel, um, anybody else who's working in the animal health sector, but there are no um representatives from the pharmaceutical industry that sit in that space, sit on that committee.
11:31
11:31
Speaker 10
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Speaker 10
I want to come back to the whole monitoring issue because it's hugely important. You, uh, sample over a thousand sites, don't you?Regularly. And you archive those, you freeze those and you make them available to, uh, other researchers. Right. And, and that has produced all the data. We have very valuable data on the concentration of various chemicals, including fipronil and imidacloprid. But do you have any remit?And does anybody to sample and measure the, the amount of animal life in particularly the invertebrates in samples that you are taking and can take and to look.
At those geographically, spatially and temporally?We have lots of evidence. There is pollution with the chemicals, but we're trying to get to the basis of what is the effect on the real environments in the waterways, in the ponds, in the lakes, in the rivers.
At those geographically, spatially and temporally?We have lots of evidence. There is pollution with the chemicals, but we're trying to get to the basis of what is the effect on the real environments in the waterways, in the ponds, in the lakes, in the rivers.
11:33
Speaker 3
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Speaker 3
Um, so, uh, I, we do not store all of the water samples that we take. Uh, physically that would be impossible because most of the samples are about a litre of water. Um, and if we take, if we take, uh, somewhere up to 100,000 samples a year, you can imagine it's impossible to store them. We do store certain aspects of the samples that we take if we've, uh, passed water through filters, we can store those and freeze those. So there are some places where academics can go back.
Um, we make the data open, uh, as quickly as we can.
Um, we make the data open, uh, as quickly as we can.
11:33
11:33
Speaker 3
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Speaker 3
Yes. So when we. quantify them. Yes. So when we go to sites, we will take a water sample and we can do the chemistry on that water sample. Often at the same site we will do what's called a kick sample, which is where someone actually physically gets into the river and kicks up the, the, the base of the river and catches all of that. That goes into a net that then goes off to one of our area labs, usually where it's spread out into big trays, and physically someone will go through and they will identify and count all of the invertebrates in those samples.
So it's a it's a very laborious process. We're also looking now at new technologies like environmental DNA. So all of these animals emit DNA into the environment. And we can pick that up and we can measure that. So we're testing that as well. So we're really trying to get a very good view. We also do that for plant species. Um and for microscopic plant species as well. So we really are trying to understand.
So it's a it's a very laborious process. We're also looking now at new technologies like environmental DNA. So all of these animals emit DNA into the environment. And we can pick that up and we can measure that. So we're testing that as well. So we're really trying to get a very good view. We also do that for plant species. Um and for microscopic plant species as well. So we really are trying to understand.
11:35
11:35
Speaker 3
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Speaker 3
No, no, no, I mean the data we, we put out as soon as we can, we have to do certain safety checks because some of this data is sensitive because it's about our water supplies. So, uh, you know, we do a risk assessment on that, but as soon as it's available and as soon as we quality assured it, then it's up on the, the Defra open data website, what we usually have to do though, is we have to spend quite a lot of time turning that into useful information, because just being able to know that there's a certain amount of phosphate in, in a water sample, when you don't know anything about the river, doesn't tell you an awful lot.
So for an example, uh, if we're taking a. Understanding invertebrates for the water Framework directive, that will take three years of sampling in the spring and the autumn, different samples within that water body, which then get combined through a statistical tool to produce an overall value for how good that ecology is. So it's quite an involved process. But yes, all of the data is open. You can go, you can download it in spreadsheets. And we are investing in the IT at the moment to make that much more available and much more readily accessible to a wider audience.
And we also encourage citizen scientists also to engage, especially in invertebrate monitoring. We've got new protocols for them. So we're gathering more data all the time on the biological effects.
So for an example, uh, if we're taking a. Understanding invertebrates for the water Framework directive, that will take three years of sampling in the spring and the autumn, different samples within that water body, which then get combined through a statistical tool to produce an overall value for how good that ecology is. So it's quite an involved process. But yes, all of the data is open. You can go, you can download it in spreadsheets. And we are investing in the IT at the moment to make that much more available and much more readily accessible to a wider audience.
And we also encourage citizen scientists also to engage, especially in invertebrate monitoring. We've got new protocols for them. So we're gathering more data all the time on the biological effects.
11:36
11:36
Speaker 3
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Speaker 3
So um over we've done some studies looking back and over the last 30 or so years, there's been a significant improvement in most of our rivers in the invertebrate quality of life. As some of the major pressures from some of our sewage works, which have been cleaned up over that time have decreased. Um, and that has produced a really substantial improvement, uh, in, in biodiversity that has in some cases levelled off in places. There is more that we could do, but it is an awful lot better than it was, uh, a couple of decades ago.
11:36
11:37
11:37
Speaker 10
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Speaker 10
Yes. Sorry. Very quickly. Yeah. My question maybe well, maybe to Abby or the ministers about labelling, really. I mean, we've just recently done a little mystery shopping and bought imidacloprid. Oh, online. It's it's, um, non-food animal, but a veterinary or farm pharmacist or SQP uh, product, but the purchaser has received no, uh, advice. Directly to them about using that product. There is no prescription appears apparently required.
We don't know what the scoop is said or done and how they've been trained. Do you think that's a satisfactory way of distributing products which are potentially, uh, quite harmful to the environment at least?
We don't know what the scoop is said or done and how they've been trained. Do you think that's a satisfactory way of distributing products which are potentially, uh, quite harmful to the environment at least?
11:38
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11:38
11:38
11:38
Speaker 2
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Speaker 2
I mean, obviously, I mean, looking at online sales is absolutely part of the call of evidence and something that we are looking at because, I mean, online sales causes problems in a number of areas. Yeah. It's not necessarily just about labelling actually. It's about making sure that you have proper checks in place and that people understand what to look for when they are purchasing online. Um, it's absolutely something that we need to, to do more work on. Um, because people don't necessarily know what they're buying and it's, and when you're looking at medication, it's critical that we have clear understanding from purchasers as to what they're purchasing.
11:39
11:39
Speaker 4
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Speaker 4
Yes, absolutely. I mean, distribution categories, allowing for any product to be, uh, to be distributed other than directly through a veterinary practice, um, were first introduced to enable that wider accessibility. Um, however we do, um, appreciate that we now need to look at those distribution categories, which is exactly the call for evidence that we are currently running or has currently just closed. Um, because we need to understand if they do remain appropriate and whether the point of sale advice that we're expecting to be given is actually happening in practice, or whether in some cases, perhaps for a range of products that are greater point of sale advice needs to be provided.
Um, so I think that's, it's exactly the question and answer to your question. No, we don't think necessarily it's sufficient, which is why we're asking more broadly for evidence to, to support us looking into that.
Um, so I think that's, it's exactly the question and answer to your question. No, we don't think necessarily it's sufficient, which is why we're asking more broadly for evidence to, to support us looking into that.
11:40
11:40
Speaker 4
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Speaker 4
And absolutely. Um, I think that we, we appreciate that this is about a societal behavioural shift and writing something on a leaflet, whilst that traditionally has been how we have always handled a change, we appreciate from a number of sources just around the room may not actually deliver the benefits that we need to realize. And as a result, we're looking at how we can better that, which is why one of the strands of our roadmap is about communication and education. We have a current campaign, be Spot on Aware campaign, which reaches people in an informative way through the media, in channels, perhaps where their understanding then the the risks associated with with products to the environment in a in a greater capacity than they would have done, perhaps if we just relied on them to read the leaflet.
So we absolutely appreciate that that is a challenge and why we're addressing it through a multitude of different ways out with our normal regulatory activity, which would be to ask companies to change labelling, which may not have the material impact that we're looking for.
So we absolutely appreciate that that is a challenge and why we're addressing it through a multitude of different ways out with our normal regulatory activity, which would be to ask companies to change labelling, which may not have the material impact that we're looking for.
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Speaker 5
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Speaker 5
Just just to add in terms of the communication campaign, it is focusing on appropriate use as opposed to sort of risk based use. Um, while some of our research, Perkins research specifically has shown that down the drain emissions happen, um, throughout the time that the product is on the animal, our own behavioural research and research with Plymouth has also shown that compliance with. Product literature is, is very, very inconsistent. And a lot of people just don't. Don't do what what they should be doing.
And so it's very much a first step to a raise awareness and B, get people to start using these products more responsibly.
And so it's very much a first step to a raise awareness and B, get people to start using these products more responsibly.
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Speaker 4
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Speaker 4
Training there is SQP absolutely. There's training for s q. And we work with the the bodies associated to ensure that the training is sufficient. Again our call for evidence may well help in this case to understand whether there needs to be further training or specific um areas of expectation that we would set in terms of how that communication would happen at the point of sale. Um. Yeah.
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Speaker 7
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Speaker 7
Thank you, Lord chair. Um, I just want to come back to, um, a topic we've touched on earlier. The Isoxazoline, um, medications that seem to be in some degree replacing fipronil and imidacloprid. And what I wondered was whether your, um, consultation exercise that you were undertaking and any action that you propose to take as a consequence will include the possible effects of these newer drugs that are taken in pill form rather than spot on.
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Speaker 4
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Speaker 4
I mean, I think with the Isoxazolines, we recognise that there are evidence gaps and particularly around that environmental impact, as I referred to earlier. So, um, we, we need to understand that from a, as we refer to the PFAs aspect of that. I think once we have um, undertaken the analysis of the data that we've received through the call for evidence, and of course, hopefully that will land at a similar time to the report from, from your, from yourselves, we'll be able to bring that together and understand what our next steps may well look like in the regulatory space and whether or not that will cover a range of products or whether we will be focusing specifically on the spot ons.
Its front end area.
Its front end area.
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Speaker 5
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Speaker 5
I can't give exact statistics, but this is a really interesting issue. Um, surely historical levels from agriculture will have gone down. So there was there was a study recently published, I can send it as part of the written evidence retrospectively that showed um, even on an organic farm, that imidacloprid was present in soil.
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