Insects and Insecticides

Written evidence submitted by the Department for Environment,

Food and Rural Affairs

Summary

· Defra is pleased to have the opportunity to present its thoughts on this issue and to set out some of the work we are doing. 

· Bees and other insect species are an essential facet of the natural world and play a very important economic role as pollinators.  We therefore carry out a considerable amount of work to conserve important insect groups and some of that work is outlined in this memorandum.

· Some insects, however, are a problem for economic activity in several areas, including agricultural production and food hygiene.  Insecticides are therefore valuable tools and farmers and others should be able to use them when this can be done without putting people or the environment at risk.  Defra therefore supports and maintains strict regulation of insecticides and other pesticides.  The basis of the regulatory system is the assessment and management of risks to human health and the environment.

· Published studies have indicated that neonicotinoid insecticides could have sub-lethal effects on bees which are sufficiently disruptive of their normal functions to have adverse consequences for populations. Some stakeholders have pressed us to respond to this by banning neonicotinoids, others have argued against such a course. Defra’s role in this case is to assemble all the evidence, consider it carefully and fully and to reach a decision on the best course. We have consistently made it clear that we will restrict or withdraw authorisations of pesticides containing neonicotinoids if the evidence calls for this.

· We therefore ensure that new research is assessed alongside the existing evidence. The most recent such assessment was completed in September, under the direction of Defra’s former Chief Scientific Adviser, Professor Sir Bob Watson. The work was carried out by Government scientists and independent experts, taking full account of parallel work by the European Food Safety Authority. Their findings were considered by Professor Watson. His successor, Professor Ian Boyd, was sighted on this final stage and was content with the approach taken and overall conclusions drawn. Following Professor Watson’s recommendations, the Government drew three key conclusions.

· First, it was time to update the process for assessing the risks of pesticides to bees in the light of developments in the science - including the latest research. This exercise should include the development of a new risk assessment for bumble bees and solitary bees, alongside an updated risk assessment for honey bees. This work is being taken forward in Europe and UK experts are active in this. The aim is to complete this highly complex task by the end of 2012.

· Second, further research was needed to fill identified evidence gaps, including the questions raised about the relevance of the recent studies to field conditions. The Government had already put new research in place to explore further the impacts of neonicotinoids on bumble bees in field conditions and to understand what levels of pesticide residues and disease in bees are normal.

· Third, the studies considered did not justify changing existing regulation. However, the research that we had put in hand and the on-going work in Europe to develop the risk assessment could change the picture and it would always be possible that further new evidence may emerge. As our knowledge developed, we would continue to consider the need for further research and for any changes to the regulation of pesticides containing neonicotinoids.

· Contrary to some reports, the action we have taken to date and the conclusions we drew from the September review are in step with most of the other regulatory bodies in Europe.

· Further research under the Insect Pollinators Initiative, which is part-funded by Defra, was published online on 21 October (Gill et al, Combined pesticide exposure severely affects individual- and colony- level traits in bees, doi:10.1038/nature11585). Defra has taken the views of the independent Advisory Committee on Pesticides on this study. The Committee advises that the study reinforces existing knowledge that sub-lethal effects with potential implications for colony survival are found in the conditions applied in laboratory studies. However, it does not fill gaps in knowledge about exposure in the field and about evidence of actual damage in the field.

· Defra has work in place to address these points. We have asked the researchers to complete their work as quickly as possible without jeopardising its quality. We expect this to be done by the turn of the year. In the meantime, we are examining the human health, environmental and economic consequences of possible options for regulatory action.

· This issue is not closed and we do not regard all the questions as answered. We recognise that there are real concerns which need to be addressed as fully and rapidly as possible. We are bringing forward our own research and will consider its results and implications for the assessment of risk as soon as they are available. We are also ensuring we have clear view of which options for regulatory action might prove effective and proportionate.


Introduction

1. In announcing its Inquiry into the impact of insecticides on bees and other insects, the Committee said that it would examine the analysis published by Defra on 18 September on the effects of neonicotinoid insecticides on bees. Under this heading, the Committee highlighted several issues: the basis on which Defra decided not to change existing regulations at this stage, whether this decision is justified by the available evidence, and why the Government decided not to follow other European countries in temporarily suspending the use of insecticides linked to bee decline. The Committee also identified other specific issues for particular examination:

· The application of real-world – "field" – data. What monitoring there is of actual – rather than recommended - levels of pesticide usage, and the extent to which that influences policy on pesticides

· Any potential impacts of systemic neonicotinoid insecticides on human health

· What alternative pest-control measures should be used, such as natural predators and plant breeding for insect-resistance, in a bid to make UK farming more insect- and bee-friendly

2. This Memorandum sets out:

(a) relevant background information on the regulatory system for pesticides;

(b) the current regulation of neonicotinoids in the EU, UK and other Member States;

(c) the Defra review published in September;

(d) the further work we have carried out since September, including examination of the Gill et al paper in Nature, and our future plans;

(e) the use of real-world monitoring data;

(f) potential impacts of neonicotinoids on human health;

(g) the scope for making UK farming more insect-friendly, including the use of alternative pest-control methods.

A. The regulatory system for pesticides

3. Pesticides have been regulated in the UK for 25 years, regulation replacing an earlier non-statutory scheme. Over the past 20 years, they have increasingly been subject to EU rules. These rules distinguish between two types of pesticides: plant protection products (PPPs, which include most pesticides used in agriculture and horticulture) and biocidal products (intended to destroy or control organisms in a range of non-agricultural situations). Some insecticides are biocides, for example products for controlling house flies or ants. However, the main concerns related to exposure of bees have been in relation to plant protection products and so this is the system described in this memorandum.

4. Under Regulation (EC) No 1107/2009, plant protection product active substances are approved at EU level. Active substance approvals are normally for ten years and are then subject to complete reassessment according to current standards. Both the EU and individual Member States are able to carry out an earlier reassessment if new information of concern comes to light.

5. If an active substance meets EU safety requirements, products containing that active substance can be authorised at Member State level. This authorisation is carried out according to common rules set by EU regulation, but there is a degree of discretion to take account of national circumstances. 

6 . Regulation 1107/2009 sets out the circumstances in which Member States may review authorisations and may withdraw or amend authorisations. The Regulation also sets out the circumstances in which it is possible to prohibit the use of treated seeds .

(a) Risk assessment

7. Authorisation or approval is only granted following assessment of scientific data on risks. This risk assessment covers:

· risks to human health through all routes of exposure, including air, water and food

· risks to the environment – taking account of the pesticide’s fate and distribution in the environment (including water, air and soil), its impact on non-target species and its impact on biodiversity and the ecosystem

· the efficacy of the product. This part of the assessment considers whether the product is effective in controlling agronomically significant pests. Approval will be refused if the product is not sufficiently effective or if the target pest is not a significant economic threat.

8. The human health assessment is outlined at paragraphs 59 to 64 below. The environmental risk assessment evaluates risks to honey bees and to two other non-target arthropods as representative species (this part of the risk assessment is outlined in Annex 1) but not, separately or specifically, risks to other bee species.

9. It is recognised that risk assessment cannot fully reflect what will happen in real life situations. For example, it is not considered appropriate to carry out tests of the toxicity of pesticides on people and so careful use is made of animal tests with an additional factor built in to take account of inter-species variation. In the case of environmental risk assessment, it is clearly not possible to take full account of every variable. Uncertainty factors and conservative assumptions are therefore used with the aim of achieving a high degree of confidence that decisions are sufficiently protective.

(b) The approvals procedure for active substances

10. It is the job of the company which wishes to gain approval to put together the necessary scientific data to support its application. To this end, companies commission and fund the studies that are submitted to the pesticides regulatory authorities. The studies must be conducted to internationally recognised guidelines and have verified Good Laboratory Practice and quality assurance certification.

11. The studies commissioned in support of an approval application are sometimes described as secret, but that is not an accurate portrayal. These studies carry data protection rights under EU legislation, which means that they cannot be used by other companies to gain authorisation. However the data is accessible through access to information arrangements such as those under the Freedom of Information Act and Environmental Information Regulations. These access rights to the regulatory studies have been used in respect of neonicotinoids.

12. In addition the Government recognises the value of having the data more readily available for wider review and has suggested to the pesticide manufacturers that it would be a good idea to publish their studies. Syngenta tell us that their long-term over-wintering bee field trial data has been submitted for publication to a scientific journal and is currently going through the peer review process.

13. The applicant submits all of the information including study methodology and data generated, together with their own conclusions, in the form of a Dossier. The Dossier need not consist only of studies commissioned by the applicant for regulatory purposes. It will also include published data, including academic studies where these exist and are relevant. There is a specific requirement for this in article 8(5) of Regulation 1107/2009, which states:

"Scientific peer-reviewed open literature, as determined by the Authority [meaning the European Food Safety Authority], on the active substance and its relevant metabolites dealing with side-effects on health, the environment and non-target species and published within the last 10 years before the date of submission of the dossier shall be added by the applicant to the dossier."

14. The Dossier is scrutinised and assessed by a regulatory authority's experts in all of the various scientific disciplines involved. The regulatory authority's opinion - which may or may not coincide with that of the company – is set out in a Draft Assessment Report (DAR). The DAR produced by the regulatory authority of a Member State is then submitted to the European Food Safety Authority (EFSA), which organises a further scrutiny (known as peer review) by experts from all of the EU Member States. Following this peer review, EFSA sends its conclusions to the Commission. This is used as the basis for a proposal from the Commission for approval or not of the substance and any associated conditions. This proposal is adopted (or not) by qualified majority vote of Member States. The DARs and EFSA conclusions are published on the EFSA website (http://www.efsa.europa.eu).  Commission decisions are published in the Official Journal of the European Union and on their website.

(c) The role of EFSA

15. EFSA was set up in January 2002, as an independent source of scientific advice and communication on risks associated with the food chain. For pesticides work, EFSA deals with risk assessment issues, including for the environment, and the European Commission is responsible for the risk management decision. EFSA is responsible for the peer review of active substances used in pesticides. It also gives scientific advice on broader issues that cannot be resolved within the peer review of active substances and provides scientific guidance on more generic issues, commonly in the fields of toxicology, eco-toxicology or the fate and behaviour of pesticides. The EU rules for the authorisation of pesticides allow the Commission to seek EFSA’s views on new evidence on the safety of a pesticide or active substance; it is this provision that the Commission used in asking EFSA to review the recent studies on neonicotinoids and bees.

(d) The overall picture on approvals

16. Since the European system came into force in the early 1990s, the number of active substances approved for use in PPPs has reduced from over 900 to around 400. Some new active substances have been approved, but many more existing active substances have had their approvals withdrawn. In some cases this was because concerns were identified. In others, companies have taken the view that the costs of taking a substance through review are not justified by the likely future income from sales.

17. The picture is similar for product authorisations. In particular, the costs of authorisation have seen a steady reduction in the range of products available to tackle pests, weeds and diseases in the horticulture sector. This has implications for the ability of growers to produce crops and there are ongoing initiatives (both nationally and at EU level) to tackle the issue.

(e) PPP authorisations in the UK

18. In the UK, Defra has lead responsibility for plant protection products. The regulatory system is run, under our direction, by the Chemicals Regulation Directorate of the Health and Safety Executive (CRD). Plant protection products can only be sold or used if they are authorised and conditions are routinely attached to authorisation (for example specifying crops, dose rates, timing and protective equipment) to ensure protection of human health and the environment (including wildlife). The Advisory Committee on Pesticides (ACP) provides independent, impartial and expert advice on pesticides and the control of pests.

B. The regulation of neonicotinoids

(a) EU approvals for neonicotinoids

19. Five neonicotinoids have been approved by the EU according to the process set out in section A above. EU legislation agreed in 2010 sets specific provisions relating to the use as seed treatments of three neonicotinoids (clothianidin, imidacloprid and thiamethoxam) and a non-neonicotinoid pesticide called fipronil which has some similar properties. These provisions relate to labelling of pesticide-treated seed, a requirement for professional application of seed treatments to seed, and monitoring for possible impacts on bees. These requirements were not applied to acetamiprid and thiacloprid, which are little used as seed treatments (and not at all in the UK) and show acute toxicity to bees several orders of magnitude less than the other three neonicotinoids (acetamiprid and thiacloprid are cyano-substituted neonicotinoids while the others are nitroguanidine-substituted).

(b) Authorisations of neonicotinoids in the UK and other individual EU countries

20. The UK has authorised products containing each of the five neonicotinoid active substances approved by the EU. It is often reported that neonicotinoids have been banned in a number of EU countries and that the UK is thus out of line. The facts are rather different. All 27 EU member states allow the use of neonicotinoids. Four of these countries currently restrict particular uses and our understanding of their position is as follows:

· France. Imidacloprid suspended for seed treatments on sunflower (since 1999) and maize (since 2004). One seed treatment for oilseed rape (Cruiser OSR, containing thiamethoxam) was banned earlier this year.

· Germany. Clothianidin, imidacloprid and thiamethoxam suspended as seed treatments for maize since 2008. Some emergency authorisations (allowing short term use to address particular pest pressures) have since been granted for this use.

· Italy. Clothianidin, imidacloprid and thiamethoxam suspended as seed treatments for maize since 2008. Suspensions reviewed annually.

· Slovenia. Clothianidin and thiamethoxam suspended as seed treatments for maize.

21. The suspensions in Germany, Italy and Slovenia followed particular incidents in which poor practice in treating and sowing seed led to bee kills due to the creation of excessive dust contaminated with neonicotinoids. Our assessment is that the risk of similar incidents in the UK is negligible. There are several reasons for that conclusion. First, the dose rates used in the seed treatment in Germany were almost double those which would be used in the UK. Second, the problems related to maize and drilling was taking place at an unusual time of year when adjacent crops were in flower. Third, seed treatments in the UK are carried out by professional contractors, which minimises the risk of a sticker not being applied (stickers help the pesticide adhere to the treated surface). Fourth, drilling equipment in the UK is either built differently or has been adapted so that it directs dust towards the ground, thus minimising the risk of drift.

22. The issues raised by the German, Italian and Slovenian incidents have been addressed by the additional controls set out in the EU legislation outlined at paragraph 19 above).

23. The basis for the recent French action is not entirely clear. The statement made cites a review by the French agency ANSES. However, ANSES did not call for a ban and its review (which covers similar ground to our work and that of EFSA) does not appear to justify the action. France asked the Commission to take action to apply across the EU (this being a necessary step before national action can be taken). The Commission and most Member States were not in favour of EU wide action at this time. They noted that EFSA were carrying out the urgent consideration of the bee risk assessment process and were revisiting the current risk assessments for neonicotinoids.

24. Restrictions on neonicotinoids in other EU countries could provide an opportunity to study the benefits for pollinators (although any improvement in bee health could not simply be read across to the UK situation since the actions taken were in the most part related to problems that do not apply here). Italy has collected information through the APENET monitoring and research project. This was reviewed by EFSA (their statement is at http://www.efsa.europa.eu/en/efsajournal/pub/2792.htm). EFSA concluded that there were deficiencies in the study designs, weakness in the statistical analysis and incompleteness in the reporting of results. It was therefore not possible to draw a definitive conclusion. However, potential concerns were identified (including effects from dust exposure, sub-lethal effects and interactions with pathogens). These are being carried forward into the updating of the risk assessment procedure for bees.

C. The Government’s analysis of the evidence and the conclusions drawn in September 2012

(a) The evidence considered

25. Insecticides by their nature are toxic to insects. The regulatory process seeks to establish whether the likely exposure of key species to insecticides is less than the amount that will cause harm. Over recent years, a number of academic studies have been published that suggest that neonicotinoids may have adverse effects on bees and – by implication – on other pollinator species. The suggestion is that these effects are sub-lethal but cause sufficient disruption to the normal functioning of bees to be a threat at the colony level.

26. Most of the studies have looked at the effect of a specific neonicotinoid on a specific species, normally honey bees or the buff-tailed bumblebee, Bombus terrestris. However, some have looked at combinations of pesticides or at the possible interaction of pesticides and diseases of bees.

27. A number of the studies were summarised in the Defra document published online on 18 September. These studies – which are not all of those that have been considered – are listed at Annex 2. The two most widely publicised studies, both published in Sciencexpress on 29 March 2012, are:

· Henry et al "A common pesticide decreases foraging success and survival in honey bees"

· Whitehorn et al "Neonicotinoid pesticide reduces bumble bee colony growth and queen production"

(b) Defra’s use of the evidence

28. The regulatory controls on pesticides, explained in section A above are strong. However, the Government is not complacent and takes very seriously any threat to bees and other pollinators.  Defra therefore looked very closely at the developing evidence with the aim of:

(a) identifying what is known about the various risks identified and their implications;

(b) what is not known and requires further investigation. Defra has funded a range of research on these issues in recent years;

(c) whether regulatory action is required. This could include restricting or withdrawing product authorisations; such measures have been taken in previous cases when found to be necessary.

29. Accordingly, the recent studies were assessed, along with the existing evidence (including Defra-funded research and the regulatory studies), by: the Chemicals Regulation Directorate (CRD) of HSE; bee experts in Defra’s Food and Environment Research Agency (Fera); and the independent expert Advisory Committee on Pesticides (ACP). The ACP drew on the advice of CRD and Fera. Defra's Science Advisory Council (SAC) also reviewed ACP's use of some of the evidence; whilst SAC did not seek to reach conclusions on the evidence, it did identify a number of issues which the ACP took into account in drawing its own conclusions. The outcomes of the ACP’s work are reported at paragraphs 30 to 33 below. UK experts have also been involved in work carried out by the European Food Safety Authority (EFSA) (paragraph 40 below) and drew on this in their own consideration. Alongside the consideration of the new studies, work has also been put in hand (see paragraphs 37 to 39) to fill several evidence gaps that have been identified.

The ACP’s assessment

30. The ACP considered the issue at its meetings on 15 May and 3 July. The recommendations agreed following the 3 July meeting are set out in full at Annex 3. In summary, the ACP concluded that the current UK risk assessments are secure and recommended that there is no justification for regulatory action at present. Furthermore, there is no evidence as yet of neonicotinoid impacts on bees in the UK. However, the ACP will consider any new information as it arises and keep the situation under close review. The Committee supports the evidence gathering and development of the risk assessment that is in hand here and in Europe.

31. The ACP’s conclusion was based on reconsideration of studies supporting the current authorisations for thiamethoxam products and on detailed examination of the recent publications in the scientific literature, with one of the ACP’s environmental experts carrying out a careful examination of the raw data.

32. The regulatory field studies comply fully with current rules and also cover some additional aspects, such as over-wintering. The power of the studies to detect statistically significant changes is not established and they would not specifically detect all of the individual sub-lethal effects suggested by academic studies. However, hives exposed to treated crops did not show any gross effects on a wide range of important endpoints when compared to control hives exposed to untreated crops.

33. While noting questions concerning aspects of the published studies by Henry et al and Whitehorn et al, the ACP does not discount their findings. The Committee believe these studies should be considered in the development of future regulatory guidance. Further research is merited to clarify the findings and their relevance to the UK field situation. The ACP noted that relevant work is already being taken forward with urgency. The Committee will keep this research, and its potential implications for authorisations, under review.

Defra’s conclusions

34. Defra’s conclusions, as set out in the 18 September published document, were:

"The new research has been considered alongside existing knowledge, including the studies submitted to support current regulatory approvals for the neonicotinoids. This work has been carried out by Government and independent experts, taking account of parallel work in Europe. The broad conclusions of this work are as follows:

· Some of the new studies provide evidence of sub-lethal effects of neonicotinoids in the conditions applied in the research.

· However, none of the studies gives unequivocal evidence that sub-lethal effects with serious implications for colonies are likely to arise from current uses of neonicotinoids.

· Existing studies submitted in support of the present regulatory approvals fully meet current standards. They do not explicitly address all the sub-lethal effects suggested by the academic research. However, they do cover a wide range of important endpoints and, in these studies, hives exposed to treated crops did not show any gross effects when compared to control hives exposed to untreated crops.

"Based on these findings, Defra has concluded that:

· It is appropriate to update the process for assessing the risks of pesticides to bees in the light of developments in the science - including the latest research. This exercise should include the development of a new risk assessment for bumble bees and solitary bees, alongside an updated risk assessment for honey bees. This work is being taken forward in Europe and UK experts are active in this. The aim is to complete this highly complex task by the end of 2012.

· Further research will be carried out to fill identified evidence gaps, including the questions raised about the relevance of the recent studies to field conditions. The Government has already put new research in place to explore further the impacts of neonicotinoids on bumble bees in field conditions and to understand what levels of pesticide residues and disease in bees are normal.

· The recent studies do not justify changing existing regulation. However, the research that we have put in hand and the on-going work in Europe to develop the risk assessment could change the picture and it is always possible that further new evidence may emerge. As our knowledge develops, we will continue to consider the need for further research and for any changes to the regulation of neonicotinoids."

The precautionary principle

35. The precautionary principle is normally taken from the text of the Rio Declaration on Environment and Development 1992. Principle 15 of the Declaration states "Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."

36. Defra fully accepts that the precautionary principle is applicable to considering the appropriate response to the potential effects of pesticides. In the present instance, it has a clear bearing on the issue of neonicotinoids and bees. Defra does not accept the suggestion that has been made that the application of the precautionary principle must lead inevitably to a decision to ban neonicotinoids. The precautionary principle guides decision-making when a serious potential risk has been identified and where, following the best possible risk assessment, there remains scientific uncertainty. It does not dictate the appropriate decision.

(c) Continuing to fill the evidence gaps

37. Defra has carried out research and development (R&D) around these issues over a number of years. The most recent completed projects include:

· PS2366 "Assessing the impact of guttation on non-target arthropods, design of extended lab and field studies".  The aim of this project was determine whether the current methodology for risk assessment for sprayed applications can be adapted to include the residues present on the surface of leaves following systemic pesticide applications. Previous research indicated that the exposure of honey bees to pesticide residues in guttation fluid was unlikely to be a problem but it may be a problem to other non-target arthropods. 

· PS2367 "Assessing the impact of pesticides on honeybee brood – evaluation of effects" was a literature review undertaken to identify the potential effects of pesticides on honeybee brood, for example mortality, reduced lifespan and their implications at the colony level. The report makes some recommendations for changes in the honeybee brood study design and concluded that the greatest determinant of over-winter survival is the health/age of the queen. The findings of this research were incorporated into the EFSA scientific opinion and will be used in designing future honey bee brood studies.

· PS2368 "Potential impacts of synergism between systemic seed treatments and sprayed fungicides in crops". This found, in certain cases, a degree of synergy between an insecticide and a fungicide in terms of acute lethal effects.

38. All these reports have been sent to EFSA. Two further projects have been commissioned from Defra’s Food and Environment Research Agency (Fera), both due to be completed and published by March 2013. Fuller project details can be found on the Defra website. In brief:

· PS2370 is focusing on the interpretation of pesticide residues and disease in honey bees. Dead bees are sometimes submitted under the Wildlife Incident Investigation Scheme. These are routinely screened for pesticides and low levels of pesticides are often found (an outline of recent data is at Annex 4). These residues are unlikely to have been the cause of death, but there is little scientific information on the ir significance. This new research will help us interpret the wildlife incident results by obtaining some apparently "healthy" bee samples from the bee inspectors own bee hives in both urban and rural environments and analysing them for pesticide residues and for disease levels. The hives will be inspected in summer, autumn and again early in 2013 to ensure that the bees survived the winter. For the major pesticide classes detected , the half life of the parent pesticides in live bees will be assessed to assist in interpretation of residues in live bees.

· PS2371 is designed to explore the findings of the Whitehorn et al study, using more realistic conditions.  It is looking at real life edge-of-field exposure of bumble bees to neonicotinoid treated flowering oilseed rape (both spring sown and winter sown). The key objectives are:

o To assess exposure of bumble bee colonies in clothianidin and imidacloprid treated oilseed rape

o To assess the effects of exposure on colony development and production of drones and queens

o To determine whether the effects reported following laboratory exposure of bumble bee colonies to neonicotinoid treated sucrose and pollen are observed following field exposure to flowering oilseed rape grown from neonicotinoid treated seed

39. We have just commissioned some new research from Professor Goulson’s team at Stirling University. PS2372 "Quantifying exposure of bumblebees to neonicotinoids and mixtures of agrochemicals" is due to start in February 2013 and will run for three years. The aim of this research is to quantify the actual exposure of wild bumblebees to sub-lethal doses of neonicotinoid insecticides in UK landscapes. Specifically the objectives are to:

(a) determine levels of neonicotinoids in the nectar and pollen of the main UK flowering crops and in a selection of field margin/hedgerow wildflowers favoured by bumble bees (information on this is currently limited and this has been an issue in interpreting the findings of some of the recent academic research);

(b) quantify the doses of neonicotinoids to which bumblebee colonies are exposed when naturally foraging in UK farmland;

(c) quantify and compare exposure of wild bumblebee species.

(d) Developments in Europe

40. As pesticide regulation is harmonised across Europe, the EU dimension to consideration of this issue is important. The European Food Safety Authority (EFSA) is carrying out a number of pieces of work (in which UK experts are involved) including:

· EFSA’s Panel on Plant Protection Products and their Residues published a Scientific Opinion on the science behind the development of a pesticide risk assessment for honey bees, bumble bees and solitary bees on 23 May. This is available at http://www.efsa.europa.eu/en/efsajournal/doc/2668.pdf and is a very substantial and significant review and analysis of the state of the science.

· The Opinion will be the basis for a Guidance Document for applicant companies and regulatory authorities in the context of the review of Plant Protection Products (PPPs) and their active substances under EU law. This guidance is due to be drawn up by the end of December and the draft issued for public consultation on 20 September is at http://www.efsa.europa.eu/en/consultations/call/120920.htm

· EFSA published a Statement on 1 June addressing the significance of the Henry et al and Whitehorn et al studies. This Statement is available at: http://www.efsa.europa.eu/en/efsajournal/doc/2752.pdf. In brief, their findings were:

Comparing the Henry et al study with possible real life exposures, EFSA conclude that sub-lethal effects cannot be fully excluded in worst case situations. However, they note several uncertainties regarding the results. In particular, in the study, bees consumed the total amount of active substance within a relatively short period rather than during the course of a day. Depending on the substance properties and how fast the substance can be metabolised by the bees, this method of exposure could lead to more severe effects than may occur when bees are foraging.

The concentrations tested on bumblebees by Whitehorn et al. were in the range of the maximum plausible exposure levels from imidacloprid in pollen and nectar. However, it is uncertain as to what extent the exposure situation in the study is representative of field conditions since bumblebees would need to forage for two weeks exclusively on imidacloprid-treated crops in order to be exposed to the same extent as in the study. Further consideration would be necessary to understand whether this situation may occur in intensive monoculture landscapes.

The Defra research project PS2371, referred to in paragraph 39 above, will help to address the issues raised by EFSA on the Henry et al and Whitehorn et al studies.

· EFSA are reviewing the bees risk assessment for the three neonicotinoid active substances that have high acute toxicity to bees; this work is due to be completed by the end of 2012.

· A scientific report on "Interaction between pesticides and other factors in effects on bees" was published on the EFSA website in September.  The report (by Fera) is at: http://www.efsa.europa.eu/en/supporting/pub/340e.htm

D. Defra’s further work following the publication of the Gill et al paper in Nature in October 2012

(a) The Nature paper

41. A paper by Gill et al "Combined pesticides exposure severely impacts individual- and colony-level traits in bees" was published in Nature on 21 October (doi:10.1038/nature11585). The study reported in the paper was funded under the Insect Pollinators Initiative (IPI), which was set up in 2009 to help to identify the main threats to bees and other insect pollinators. Defra provides about 25% of the funding for the IPI. The study is part of an IPI project looking at the impact of sub-lethal exposure to chemicals on the learning capacity and performance of bees.

42. The study considered the potential effects of exposing bumble bees (Bombus terrestris) to lambda-cyhalothrin (a pyrethroid insecticide) and to imidacloprid (a neonicotinoid insecticide). Early stage bumble bee colonies received long-term (4-week) exposure to imidacloprid and lambda-cyhalothrin, both individually and in combination. There were ten control colonies, ten colonies exposed to imidacloprid only, ten to lambda-cyhalothrin only and ten to a combination of imidacloprid and lambda-cyhalothrin. Bees from all colonies were able to forage outdoors. Foraging behaviour of individual workers was recorded using radio frequency identification tags (RFID).

43. The authors report that effects were seen on the behaviour of individual bees in the colonies treated with imidacloprid (either alone or in combination with lambda cyhalothrin). Effects at the colony level were seen in all the treated colonies (including those treated only with lambda-cyhalothrin) and these were most pronounced for the colonies treated with both pesticides. The observed effects for each treatment group are summarised in the table below.

Effect level

Effect type

Imidacloprid

Lambda Cyhalothrin

Mixture

Effects on individual behaviour

Number of foragers

Foraging bout frequency

Amount of pollen collected

Duration of pollen foraging bouts

+

ND

-

+

ND

ND

ND

ND

+

-

-

+

Effects at colony level

Worker production

Brood number

Nest structure mass

Worker mortality

Worker loss

Worker mortality and loss

Colony loss (n lost/n survived)

-

-

ND

ND

+

ND

0/10

ND

ND

ND

+

-

+

0/10

-

-

ND

+

+

+

2/8

Significant increase (+) significant decrease (-) and no detected effect (ND) at the 5% significance level

(b) The issues raised by the study

44. Dr Raine, one of the study authors, commented in the press release accompanying its publication:

"Policymakers need to consider the evidence and work together with regulatory bodies to minimize the risk to all bees caused by pesticides, not just honeybees. Currently pesticide usage is approved based on tests looking at single pesticides. However, our evidence shows that the risk of exposure to multiple pesticides needs to be considered, as this can seriously affect colony success".

45. This raises three issues:

(a) policy makers need to consider the evidence and work together with regulatory bodies. Defra completely agrees and this is very much our approach, as outlined in paragraphs 28 and 29 above;

(b) addressing the risk to all bees, not just honey bees. Again, Defra agrees that this is important. The fact that the current pesticides risk assessment only explicitly addresses the risks to honey bees and not to other types of bees is being addressed by the review being carried out by EFSA (see paragraphs 34 and 40);

(c) exposure of bees to multiple pesticides. Foraging bees may indeed be exposed to crops treated with different pesticides. The regulatory system does not look at every possible combination effect of multiple active substances – which would clearly be impractical with several hundred active substances and many more products.  Risks are considered when multiple active substances are combined in the same product. The regulatory risk assessment builds in uncertainty factors and conservative assumptions, with the aim of ensuring that individual pesticides carry a very low risk of adverse effects.

(c) Defra’s consideration of the Nature paper

46. The research which Defra has put in hand will produce results early in 2013 and should give greater clarity about the effects of neonicotinoids on bumble bees in field conditions. However, we have made it very clear that we will continue to assess any new substantial evidence that emerges. We have therefore carried out an urgent assessment of the Gill et al paper, informed by the views of CRD and the advice of the Advisory Committee on Pesticides.

47. The advice of the ACP is as follows.

"Recent research published in Nature by Gill et al was agreed to be well conducted. It adds additional information in suggesting a possible mechanism by which neonicotinoids may have an effect at population level. As such it reinforces the concerns already identified on the basis of the previously considered evidence.

"However it does not change the balance of evidence sufficiently to lead the ACP to recommend regulatory action on neonicotinoids in the absence of the additional work identified by the committee in July. The Committee advises that there are three key ‘tests’ required to assess the balance of evidence; toxicity, exposure, and evidence of effects occurring in the field.

"There is now a good body of evidence that enables an understanding of the toxicity of the neonicotinoids to bees. Critically, there is still a need to address the current gaps in knowledge about the extent to which the laboratory exposures in the current published data reflect the exposures experienced in the field. Ideally there is also a need to establish whether there have been any impacts on UK bee populations. The field work undertaken earlier this year and data on the health of UK bee colonies over the period during which the neonicotinoids have been used in UK agriculture will help to address these knowledge gaps. Results are awaited in early January.

"The Committee expects to be in a position to consider these data in January, and have noted that this short delay would not prevent effective regulatory action if the data indicate that this is required. The ACP noted that treated seed had already been sown this autumn, and that the much smaller proportion of spring sown seed would already be in the supply chain for the 2013 harvest. Any regulatory action on treated seed would thus mainly impact from the 2013 autumn sowings onwards.

"The ACP also considered a range of possible approaches that could be applied if restrictions on neonicotinoid use are required. The Committee asked the Chemicals Regulation Directorate to develop some more detailed scenarios taking into account a range of relevant factors."

(d) The next steps

48. There is good evidence of potentially serious sub-lethal effects on bees in the conditions applied in several studies. However, there still remains very little evidence in two crucial areas:

· First, the likelihood that effects seen in the laboratory would be seen in the field. Further information on this crucial issue will be provided by the Fera study PS2371 outlined at paragraph 38 above and the researchers are pulling out all the stops to get this completed quickly. There is still a degree of uncertainty as to how rapidly some of the analytical work can be completed, but the aim is to have a complete set of results for consideration at the turn of the year.

· Second, there is a lack of evidence of actual damage caused to bees by neonicotinoids in UK field conditions. This is also being tackled through Fera work to examine historic trends in neonicotinoid usage and honey bee health.  This work will be carried through on the same timescale as the bumble bee study.

49. We have consistently said that we are fully prepared to act if the evidence on neonicotinoids shows a need. However, it currently remains the case that the main field data we have available for honey bees suggests an absence of effects, while field data on bumble bees is lacking. This is why PS2371 is important.

50. If and when the evidence indicates that action was needed, it would be important that careful consideration is given to several issues. It would clearly be necessary to ensure that any action taken was likely to be effective in removing unacceptable risks to bees from neonicotinoids. It would also be important to ensure that action did not have undesirable consequences for the environment or human health. Further, it should be proportionate. For example a blanket ban should not be imposed if more limited and targeted action would be effective. Defra has instructed CRD to put work in hand to enable us to understand better the likely consequences of possible regulatory options including the implications of alternative pesticides or pest control measures being taken. This work will be completed by the end of the year, so that the results are available for consideration alongside the results of the Fera bumble bee study.

51. The ACP has considered CRD’s initial analysis of relevant issues when considering potential restrictions on the use of neonicotinoids. The Committee offered views on the further work needed. As part of the exercise, CRD are approaching several parties who may have useful information about the agronomic and economic implications. In doing so, CRD are making it clear that no decision has been taken and that their approach is not about the merits of taking regulatory action but about understanding its consequences.

52. We will move quickly to consider the new scientific and technical information when it is available. The Fera data is designed to address the absence of field evidence and, in line with our consistent stance, we will be ready to act if this research gives cause.

E. The use of real-world data and monitoring of actual levels of pesticide usage

53. There is a considerable body of monitoring work carried out. This looks at the quantities of pesticides used, how they are used, where they are found and the effects they have on people, wildlife and the wider environment. The main elements of this monitoring (the key schemes are described in more detail at Annex 5) include:

· Monitoring of pesticides residues in food.

· Pesticides Usage Surveys.

· Wildlife Incident Investigation Scheme.

· A variety of schemes monitoring human health, including the National Poisons Information Scheme (NPIS), Human Health Enquiry & Incident Survey (HHEIS) and Pesticides Incidents Appraisal Panel (PIAP).

· Tests of pesticide formulations – to see whether the pesticide products being sold are formulated in accordance with their authorisations,

· Monitoring of pesticides in surface and ground water undertaken by the Environment Agency for England and Wales and equivalent bodies in Scotland and Northern Ireland.

· Cross-compliance checks. Pesticides rules are covered in one of the Statutory Management Requirements which farmers need to meet in order to qualify for the full single payment and other direct payments.

54. The various current schemes for human health monitoring are being reviewed by the Pesticides Adverse Health Effect Surveillance Scheme Working Group (PAHES), a sub-group of the ACP. PAHES aims to define the strengths and weaknesses of existing systems for reporting of adverse health effects related to pesticides exposure and to assess the feasibility of developing an integrated system for the reporting, investigation and evaluation of exposure to pesticides in relation to human health. The PAHES report is currently being finalised.

55. The current suite of monitoring serves several purposes. The most important are:

· To allow the Government to verify that pesticides are being used according to their approvals; and

· To provide a check on the effectiveness of the regulatory risk assessment. When a pesticide is used in accordance with the terms of its approval, are the consequences as expected?

56. Information on usage is particularly valuable as a trigger for consideration of the reasons for change. Increases and decreases in use can result from changing pest pressures, the development of pest resistance or changes in user preferences between types of product and classes of chemicals.

57. Monitoring results are considered by CRD, the ACP and the Pesticides Forum. The Forum brings together a wide range of organisations representing those who make, use or advise on pesticides as well as environmental, conservation and consumer interests. It provides a mechanism for exchanging ideas and for encouraging joint initiatives to address particular issues. It also provides advice to Government on pesticide usage matters. In particular, it advises Ministers and others on how best to monitor the impacts arising from the use of pesticides (including the use of indicators).

58. Two examples of changes of approach to particular pesticides arising from monitoring are:

· the revocation of herbicides containing isoproturon (IPU) which was highlighted as a problem in water through monitoring as well as through risk assessment. In this case there was clear evidence on the effects of IPU on aquatic organisms, the standard risk assessment identified an unacceptable risk and water monitoring data indicated that IPU was found in UK waters at levels that would be expected to impact on aquatic organisms.

· stewardship measures introduced by industry for the potato sprout suppressant chloropropham following residues monitoring findings.

F. Potential impacts of systemic neonicotinoid insecticides on human health

59. Before any pesticides are authorised there is an extensive range of safety tests including investigations of acute toxicity, long term toxicity, carcinogenicity, reproductive toxicity, genotoxicity and neurotoxicity (most insecticides are neurotoxins). Safe exposures for people are usually determined using a 100 fold factor on no effect doses in experimental animals. In some specific cases higher factors are used. These factors are to take account of inter-species variation and variation in the response of different individuals (intra-species variation). Products are not authorised if the exposure estimates are above the safe levels.

60. There are two very broad circumstances in which people may be exposed to pesticides. First, they may be in or close to the treated area – as the person applying the pesticide, as a farm worker harvesting or handling a treated crop, as a bystander or as a local resident. Second, they may eat treated food. The pesticides risk assessment for human health considers the risks in these two main parts.

61. For ‘occupational’ exposures, no observed adverse effect levels derived from appropriate in vitro and in vivo animal studies are compared with estimates of exposure for users, bystanders and other workers, derived from models, or in some cases, from exposure studies.

62. The consumer risk assessment is based on exposure estimates developed from an understanding of the residues of the active substance and relevant metabolites that might occur in foodstuffs (including those of animal origin) that are derived from treated crops. This draws on data on actual worst case residue samples, and from surveys of the national diet. The resultant estimates are compared to relevant no effect levels from animal studies. Both acute and chronic dietary risk assessments are carried out.

63. The impacts of neonicotinoids on insects are largely the result of strong binding of the compounds to nicotinic receptors. The available data strongly suggests that the binding of neonicotinoids to mammalian nicotinic receptors is much weaker than to insect receptors. In addition, scientific studies show that neonicotinoids are not as potent in vertebrates (including humans) as they are in insects. Although this does not mean there are no effects in mammals, there is a higher margin between doses required to kill insects and doses of potential concern for people than is the case for some of the older insecticide active substances such as organophosphate compounds.

64. For each of the neonicotinoids clothianidin, imidacloprid and thiamethoxam, the table below illustrates the following three human health exposure scenarios:

(a) ADI - Acceptable Daily Intake. The ADI is the amount of a substance which can be ingested every day of an individual's entire lifetime without harm. The ADI is expressed as milligrams (mg) of chemical per kg body weight of the consumer. The ADI is derived from the most appropriate No Observed Adverse Effect Level (NOAEL) by applying an assessment factor, normally 100.

(b) ARfD - Acute Reference Dose. This is the quantity of a substance in food or water, expressed on a bodyweight basis, that can be ingested over a short period of time (usually one meal or one day) without appreciable health risk to the consumer.

(c) AOEL - Acceptable Operator Exposure Limit. This is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed in mg of the chemical per kg body weight of the operator per day. The AOEL is usually derived in terms of a systemic dose and is based on the most appropriate NOAEL by applying an assessment factor, normally 100, and any necessary correction for the extent of oral absorption.

ADI (lifetime dietary)

ARfD (acute dietary)

AOEL (Operator or Bystander)

Clothianidin

mg/kg bodyweight

0.097

0.1

0.1

% used *

<1

1.0

<1

Imidacloprid

mg/kg bodyweight

0.06

0.08

0.08

% used *

10

20

6

% used #

0.5

32

-

Thiamethoxam

mg/kg bodyweight

0.026

0.5

0.08

% used *

5.0

‘no risk’

<1

* based on exposure estimates made as part of the regulatory risk assessment 

# EFSA monitoring of pesticide residues in food for 2009 (only imidacloprid cited)

G. Scope for using alternative pest-control methods to make UK farming more insect-friendly

65. Insects face a number of threats. These include the loss, fragmentation and degradation of habitats, pressures from non-native species and diseases, climate change and pollution. Defra has a number of activities that aim to counter some of these threats. Some of these are outlined in Annex 6.

66. There is a need to control insect damage to agricultural crops. The significant role currently played by neonicotinoids in this is summarised in Annex 7.

67. The UK has a longstanding policy of minimising the impacts of pesticide use. This begins with the regulatory system but also includes a number of additional non-regulatory actions to develop and encourage best practice. This work is drawn together in the UK Pesticides Strategy. The Voluntary Initiative (VI) has played a significant role in this work. It was set up in 2001 to promote and ensure best practice in the use of pesticides, with a focus on benefits for water protection and biodiversity. Working in collaboration with crop assurance schemes and wider stakeholders, the VI has achieved a number of successes, in particular the establishment of training systems for users and testing programmes for pesticide application equipment.

68. The EU has now set out a similar approach in Directive 2009/128/EC on the sustainable use of pesticides. It includes a number of the measures that already feature in the UK Strategy. The Directive requires the UK and other Member States to draw up and publish a National Action Plan setting out our proposals to reduce risks and impacts of pesticide use on human health and the environment. A public consultation on the draft plan has just closed and the plan will be published in late November.

69. The Directive includes provisions on Integrated Pest Management (IPM). IPM sets a framework to minimise the use of pesticides and encourage the use of alternatives. Our approach to IPM and to the development of alternatives is set out below.

( a ) Integrated Pest Management

70. Integrated Pest Management (IPM) describes a broad approach to plant protection that discourages the development of populations of harmful organisms, keeps the use of pesticides other forms of intervention to levels that are economically and ecologically justified and reduces or minimises risks to human health and the environment. IPM emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems and encourages natural pest control mechanisms;

71. IPM is well established in the UK and many farmers and growers adopt practices which are in line with IPM principles, particularly due to the requirements of farm assurance schemes, retailer requirements or other national or international production standards. The promotion of IPM principles is a key feature of the EU Directive on the sustainable use of pesticides and the summary of IPM principles set out in the Directive is at Annex 8. Member States are required to implement the provisions on IPM by 1 January 2014.

72. National legislation (The Plant Protection Products (Sustainable Use) Regulations 2012) requires all users to be trained. Only courses for users and advisors which provide training on integrated approaches will receive accreditation.

73. Non-regulatory schemes such as Assured Food Standards Schemes require growers to adopt practices consistent with the general principles of IPM. Specific standards are set for individual crops. Work is underway with the key industry stakeholders to develop an IPM self-assessment tool for farmers (an IPM Plan) to encourage the use of IPM tools and techniques such as decision support systems and pest and disease monitoring systems.  

74. In woodland, initiatives such as the UK Woodland Assurance Scheme and the Forestry Commission’s practical Guide to Reducing Pesticide Use in Forestry promote practices consistent with the aims of the Directive and national policy, but specifically require owners/managers to implement effective IPM strategies.

75. Government also provides support to farmers wishing to convert to organic methods of production under the Organic Entry Level Scheme. The production of organic food must be done in accordance with Council Regulation 834/2007 and enforced under national legislation (the Organic Products Regulations 2009). Growers are inspected by private Defra-licensed Organic Inspection Bodies each year.

76. There is also extensive research into alternative methods of pest, weed and disease control, outlined at paragraphs 81 to 91 below.  Government-funded pesticides work includes a significant programme of work to reduce reliance on chemical pesticides by developing novel alternative technologies that do not pose unacceptable risks to human health, non-target organisms, and the environment. This provides the scientific basis to enable companies to develop further measures for integrated or biological control in arable and horticultural commodities, thereby encouraging sustainable crop protection and potentially also benefitting other production systems such as organic production.

IPM and seed treatments

77. Treated seeds are sown before the onset and extent of the developing pest population can be known.  In other words, the treated seed is sown in anticipation of a problem.  It is sometimes suggested that the use of seed treatments is prophylactic and often unnecessary and that it is therefore inconsistent with Integrated Pest Management.

78. The regulatory system does consider whether a seed treatment is appropriate and consistent with the principle of minimising pesticide use. Proposed seed treatment uses are refused if the pest does not occur frequently enough to warrant it, and where a foliar spray would be more appropriate.  Assessment is based on:

· whether the target consistently occurs each season or is only a sporadic pest.

· whether the target is highly localised or is wide ranging on the particular crop.

· whether the target, if present, causes economic damage that would warrant treatment. 

· where the target requires early/immediate measures – controlling aphids which are virus vectors is one example because of the speed with which viruses can be transmitted.

79. Current uses of the neonicotinoid seed treatments (and indeed other insecticide seed treatments) are considered appropriate. The principal uses are for autumn control of cereal aphids (vectors of BYDV), aphids on sugar beet or OSR (vectors of virus yellows), and assisting crop establishment at sowing by controlling/reducing soil pests.  The degree of protection afforded by seed treatments also means that the number of subsequent foliar sprays required is reduced. 

80. Due to the long established problems of Myzus persicae resistance to pirimicarb, growers rely completely on neonicotinoid seed treatments in sugar beet to prevent virus infection.  There is also the developing new situation of pyrethroid resistance in cereal aphids which means, again, that autumn sown cereals will rely heavily on neonicotinoid seed treatments for BYDV control.

(b) Development of alternatives to chemical insecticides

81. Defra funds research to develop alternative approaches to reduce reliance on chemical pesticides. There is close collaboration with industry and other stakeholders in carrying out the research and in carrying through the subsequent knowledge transfer. For those insect pests against which neonicotinoids are currently used in the UK (principally aphids, beetles and moths), the main approaches can be summarised as follows:

Biopesticides

82. The three main groups of biopesticide products are semiochemicals, microorganisms/fungi, and natural chemicals, such as plant extracts. Semiochemicals include biologically active compounds produced by pests to communicate with each other, such as sex or aggregation pheromones. Synthetic versions disrupt pest feeding and other behaviours in the case of aphids, and also attract their natural enemies. Aphid pests in arable crops (cereals, oil seed rape and beans) have been the main targets of Defra research, but the more promising outcomes have yet to be translated into commercial practice.

83. In terms of microorganisms and fungi, entomopathogenic fungi have shown the best prospects for aphids, and also some beetle pests including vine weevil against which neonicotinoids are used. Defra is currently supporting work to help bring this work to commercialisation. Specific promising examples include using artificial vine weevil refugia to spread a highly effective fungal disease of the beetle, and enhancing biopesticide usage for the control of aphids - especially in horticultural crops, through better understanding of combinations of biopesticides and chemical pesticides, including neonicotinoids.

Enhancing natural plant defences

84 . C rop plants produce compounds to defend themselves against pests. This process can be enhanced by treating crops with synthetic versions of these compounds. These same chemicals often also attract natural enemies of the pests. The alternative s programme has funded research on jasmonic acid and related compounds. The main targets to date have been aphids and to a lesser extent beetle pests in cereals (winter wheat), summer beans and oilseed rape. Some work has also been done in intensive horticulture, mostly with aphids. Th is work has led to jasmonic acid seed treatments being commercialised, and this could provide an alternative to neonic otinoid seed treatments.

Development of new modes of action for insecticides

85 . Most of the major insecticides used worldwide, including neonic otinoids , are neurotoxins, and the number available for use in agriculture is decreasing with stricter regulation. The Defra-funded work is still at the development stage but offers promise of insect pest control that will provide alternatives and thereby help reduce reliance on neurotoxins.

86 . One element of this work has been particularly promising is to disrupt the immune system of insects, thereby reducing their resistance to diseases, including the world’s most widely used biopesticide, Bacillus thuringiensis (Bt) , and insect pathogenic fungi. In other research, fusion proteins as carriers for biologically derived toxins are being developed as delivery systems to target key pests; commercial partners have already been involved in this work.

87 . A second major part of this research on new insecticides has been to develop options that interfere with the pests’ internal systems that regulate feeding, moulting, reproduction and other biological processes. Insect feeding is of obvious interest, given that it is feeding by a pest that causes the damage to crop plants. Advanced molecular biology (genomics) has permitted greater understanding of the processes involved in feeding, thereby exposing weak-spots where these processes might be disrupted. The compounds involved have been characterized with support from the Defra alternatives programme, and preliminary work has yielded promising results. Target pests include aphids and beetles, again from pest groups against which neonicotinoids are used.

88 . Lastly, Defra is supporting new research to help address the issue of insect pest resistance to neonic otinoid s which is increasing in the UK and elsewhere in Europe. Examples include several major UK aphid pests. A pilot trial will evaluate certain naturally-derived compounds that may prevent resistance mechanisms in the pests from operating, and therefore when used in combination with neonic otinoid s will permit lower levels of the latter being used.

( c ) Bringing alternative products to the market

89 . Bio-pesticides cover a range of products . It is generally the case that they offer various benefits over conventional chemical pesticides such as reduced environmental impact, shorter harvest intervals, minimal residues . However , they also tend to be fairly narrow in their spectrum of activity, are slower to act and may have limited shelf life and specific storage requirements. They therefore require much more knowledge and management input to work effectively and , as a result, they tend to be most used in higher value horticultural crops.

90 . Biopesticides and other alternative products may be developed for relatively niche purposes, may be produced by companies that do not deal frequently with pesticide regulation, and may make different demands of the regulatory risk assessment. To tackle these issues, CRD has for several years run a scheme to help biopesticide producers gain approvals for their products. The scheme includes:

· A 'Biopesticide Champion' to provide initial contact for product innovators or manufacturers, and help them through the approval process.

· Provision of specific guidance to applicants (via free pre-submission meetings) identifying the best way forward. Potential applicants are encouraged to make contact at the earliest possible stages of product development.

· Reduced costs for evaluations.

91. Since the biopesticides scheme was introduced the number of authorisations for these products has increased significantly. Numbers now compare favourably with other EU countries, given the size of the horticulture sector in the UK. The scheme is currently being reviewed to make the approach simpler, although the EU regulatory requirements cannot be avoided .


Annex 1

Honey bee risk assessment under EU pesticide regulations

For pesticides that are applied as a spray

1. Data on the acute oral and contact toxicity of the pesticide is always submitted when foraging honey bees are likely to be exposed. Exposure could result from honey bees foraging the crop that is being sprayed or foraging weeds in the crop.

2. These data are generated via the use of internationally agreed test guidelines [1] . The endpoints from these studies are LD50, i.e. the median lethal dose that results in 50% mortality of the test population. Two separate studies are conducted: acute contact toxicity is determined by placing a dose of the pesticide on to the thorax of the bee; – acute oral toxicity is determined by feeding bees treated sucrose. These are laboratory based studies that are carried out under controlled conditions and use either the active substance or the formulated pesticide product.

3. The LD50 is then used to derive a ‘hazard quotient’ – the application rate of the pesticide in g/ha divided by the LD50 in µg/bee. If the resulting ratio is less than a trigger value of 50 [2] , it is considered that an unacceptable level of mortalities are unlikely to occur and the pesticide can be authorised without any restrictions regarding the risk to honey bees. If the ratio is greater than 50 then the product is either restricted to a time when honey bees are not foraging or further data are requested to enable a decision to be made on authorisation.

4. If a restriction is imposed, the UK product label will state:

Dangerous to bees. To protect bees and pollinating insects do not apply to crop plants when in flower. Do not use where bees are actively foraging. Do not apply when flowering weeds are present.

5. If further data are requested, these take the form of either semi-field studies (sometimes referred to as cage studies) or field studies. Semi-field studies use a small colony of about 5,000 bees, which is placed inside the enclosure a few days before the crop is sprayed. The crop is sprayed once the bees have become accustomed to the enclosure and are actively foraging the crop. The following endpoints are considered – mortality, foraging activity and survival of the colony. Semi-field studies usually last only a few days. There is always a control enclosure and there should be sufficient replication to permit statistical analysis.

6. Field studies are large scale and involve an unenclosed crop where honey bee colonies are placed adjacent to the crop. If a study was being conducted on oilseed rape then a plot of approximately 1 ha would be used. Colonies are used that contain at least 10,000 bees and each colony should cover at least 10–12 frames, including at least 5–6 brood frames. The crop is sprayed once the bees have become accustomed to the crop and are actively foraging. The major effects that are monitored as part of a field study are effects on mortality, foraging activity and survival of the colony. Further details regarding how these studies are carried out is provided in internationally developed guidance [3] .

7. The effects observed in the semi-field or field study will determine whether the pesticide is authorised and whether restrictions are applied.

For pesticides that are applied as seed treatments or as a solid formulation

8. Some pesticides are applied directly to seed prior to drilling in order to protect them from soil pests and soil borne diseases. If the pesticide is systemic (i.e. it can move into the plant and hence occur in the flower) then honey bees may be exposed to it. If this is considered likely, then a risk assessment is carried out. The above ‘hazard quotient’ approach is not appropriate for assessing this risk and so reliance is currently placed on semi-field and field studies, similar design in design to those outlined above. A similar approach is used for pesticides formulated as granules or pellets. The effects observed in the semi-field or field study will determine whether the pesticide is authorised and whether restrictions are applied.

Development of the risk assessment

9. The risk assessment continues to be developed. Applicant’s will in future need to submit additional data covering: effects on honey bee brood development and other honey bee life stages (this information will enable an assessment of any effects on the development of the brood); and potential chronic effects on adult bees.

10. An EFSA review (http://www.efsa.europa.eu/en/efsajournal/pub/2668.htm) examines the science behind the development of a risk assessment of plant protection products on bees (honey bees, bumble bees and solitary bees). Following the review, EFSA, the Commission and Member States have been developing guidance to be used in the authorisation process. UK experts are actively involved in this work. A draft guidance document was put to public consultation on 20 September (http://www.efsa.europa.eu/en/consultations/call/120920.htm) and is due to be revised and completed by the end of 2012.

Risk assessment for other non-target arthropods

11. The risk to non-target arthropods is assessed using laboratory data on two standard species – Aphidius rhopalosiphi and Typhlodromus pyri. The endpoints from these studies (expressed as g/ha) are compared to exposure data (also expressed as g/ha). The risk assessment covers both in and off-field assessments and, depending on the results, data on additional species may be requested. These additional data may be in the form of extended laboratory, semi-field and/or field studies. In addition to data on additional species, risk mitigation may be used to enable the population to recover from within the crop itself as well as protecting off-crop species. This risk assessment, as set out in the Terrestrial Guidance Document, is being revised following the ESCORT 3 workshop, in which UK regulatory scientists participated.


Annex 2

Recently published research   listed in the Defra document " Neonicotinoid insecticides and bees: The state of the science and the regulatory response "

 

1. Mickaël Henry, Maxime Beguin, Fabrice Requier, Orianne Rollin, Jean François Odoux, Pierrick Aupinel, Jean Aptel, Sylvie Tchamitchian and Axel Decourtye (2012). A common pesticide decreases foraging success and survival in honey bees . Sciencexpress/29 March 2012/Page 10.1126/science.1215039

2. Penelope R. Whitehorn, Stephanie O’Connor, Felix L. Wackers, Dave Goulson (2012). Neonicotinoid pesticide reduces bumble bee colony growth and queen production . Sciencexpress/ 29 March 2012/Page1/10.1126/science.1215025

3. Pettis J S, van Engelsdorp D, John J and Dively G. Pesticide exposure in honey bees results in increased levels of the gut pathogen Nosema (2012).  Naturwissenschaften, 2012 Feb; 99(2): 153-8 Epub 2012 Jan 13.

4. Lu C., Warchol K.M. and Callahan R.A (2012). In situ replication of honey bee colony collapse disorder . Bulletin of Insectology 65 (1): 99-106, 2012 ISSN 1721-8861.

5. Vidau C., Diogon M., Aufauvre J., Fontbonne R., Vigues B., Brunet J-L., Texier C., Biron D.G., Blot N., El Alaoui H., Belzunces L.P., Delbac F (2011). Exposure to sub-lethal doses of fipronil and thiacloprid highly increases mortality of honey bees previously infected by Nosema ceranae.  PloS ONE 6(6): e21550. Doi 10.1371/journal.pone.0021550.

6. Cresswell J.E., Desneux N and van Engelsdorp (2012). Dietary traces of neonicotinoid pesticides as a cause of population declines in honey bees: an evaluation by Hill’s epidemiological criteria . Pest Management Science (2012), Vol. 68, Issue 6, pp 819-827.

7. Wu J.Y., Smart M.D., Anelli C.M., Sheppard W.S (2012). Honey bees (Apis mellifera) reared in brood combs containing high levels of pesticide residues exhibit increased susceptibility to Nosema (Microsporidia) infection.  Journal of Invertebrate Pathology 109 (2012) 326-329.

8. Mommaerts V., Reynders S., Boulet J., Besard L., Sterk and Smagghe G (2010). Risk assessment for side-effects of neonicotinoids against bumblebees with and without impairing foraging behaviour.  Ecotoxicology (2010) 19:207-215 Doi 10.1007/s10646-009-0406-2

9. Tapparo A., Marton D., Gioio C., Zanella A., Solda L., Marzaro M., Vivan L. and Girolami V (2012). Assessment of the environmental exposure of honey bees to particulate matter containing neonicotinoid insecticides coming from corn coated seeds . Environmental science and technology ACS dx.doi.org/10.1021/es2035152 Envion Sci Technol.

10. Johnson R.M., Mao W., Pollock H.S., Guodong N., Schuler M.A., Bernbaum M.R (2012). Ecological appropriate xenobiotics induce cytochrome P450s in Apis mellifera . PLoS ONE 7(2): e31051. Doi:10.1371/journal.pone.0031051.

11. Schneider C.W., Tautz J., Grunewald B., Fuchs S (2012). RFID Tracking of Sub-lethal Effects of Two Neonicotinoid Insecticides on the Foraging Behavior of Apis mellifera . PLoS ONE 7(1): e30023. Doi:10.1371/journal.pone.0030023.

12. Brittain C., and Potts S.G (2011). The potential impacts of insecticides on the life history traits of bees and the consequences for pollination . Basic and applied ecology 12 (2011) 321-331

13. Teeters B.S., Johnson R.M., Ellis M.D. and Siegfried B.D (2012). Using video-tracking to assess sub-lethal effects of pesticides on honey bees (Apis mellifera L.)  Environmental Toxicology and Chemistry, Vol. 31, Issue 6, pp 1349-54.

14. Aufauvre J., Biron D.G., Vidau C., Fontbonne R., Roudel M., Diogon M., Vigues B., Belzunces L.P., Delbac F., & Blot N (2012). Parasite-insecticide interactions: a case study of Nosema ceranae and fipronil synergy on honey bee.  Sci. Rep. 2, 326; DOI:10.1038/srep00326 (2012).

15. Blacquiere T., Smagghe G., van Gestel C.A.M and Mommaerts V (2012). Neonicotinoids in bees: a review on concentrations, side-effects and risk assessment . Ecotoxicology (2012) 21:973–992 DOI 10.1007/s10646-012-0863-x


Annex 3

ACP advice on neonicotinoids and bees  issued July 2012

Overall, the ACP were agreed that the current risk assessments are secure and have concluded that there is no justification to take regulatory action at present. Furthermore, there is no evidence as yet of neonicotinoid impacts on bees in the UK. However, the ACP will consider any new information as it arises and keep the situation under close review. An explanation of the work leading to this advice is set out below.

1. The ACP has examined in detail the recent publications in the scientific literature. They identified a number of points at a first discussion of this topic at the May 2012 meeting which have now been followed up.

2. Members have carefully reconsidered the data (including an examination of the raw data) supporting the current authorisations for thiamethoxam products in the light of findings from recent published data (specifically the paper by Henry et al) and EFSA discussions. The field studies submitted by the applicants are fully compliant with current regulatory guidance and additionally cover some aspects not required by the current guidance (e.g. over-wintering). In line with current guidance the regulatory studies were not designed with detailed statistical analysis in mind, and their power to detect statistically significant changes is not established. Also, they would not show some of the specific sub-lethal effects suggested by academic studies, such as disorientation over distances. However hives exposed to treated crops did not show any gross effects on a wide range of important endpoints when compared to control hives exposed to untreated crops.

3. While noting there were some questions concerning aspects of the two published studies (by Henry et al and Whitehorn et al), the ACP cannot discount their findings. The Committee believe these studies provide interesting information that should be considered in the development of future regulatory guidance. Some further research is merited in the light of these papers and others to clarify the findings and their relevance to the UK field situation. The ACP is pleased to note that relevant work is already underway.

4. This further work will need time to be completed. In particular the ACP is aware that the study on bumble bees (Defra project PS 2371) is currently in its field phase and it is expected results will be reported in March 2013. The ACP has asked for preliminary information to be made available as soon as possible following the field phase this autumn/winter. The study examining residues in honey bees (Defra project PS2370) to assist in the interpretation of the relationship between pesticides residues and disease in bees is also expected to report in March 2013. A preliminary examination of bee health statistics following the introduction of the neonicotinoids is expected to become available later this summer. Finally the EFSA work re-evaluating all of the neonicotinoid insecticides in the light of the latest research and the development of the revised guidance on assessing risk to bees are both due by the end of this year. The ACP will keep this work and its potential impact on authorisations under review

5. The ACP also identified a number of other possible areas for research into the possible impacts of neonicotinoid insecticides. These include some work on bee toxicokinetics to examine factors related to dose and exposure period, a true field study looking at disorientation (while recognising the very real practical difficulties might make this impossible to do). The ACP also asked their Environmental Panel to look at work on guttation as a potential source of exposure to other non-target arthropods.

6. Although the ACP has considered thiamethoxam in detail, the Committee agreed that the conclusions reached can be applied broadly to the authorisations of other neonicotinoid insecticides because:

· The acute toxicity of thiamethoxam, clothianidin and imidacloprid are all of a similar order of magnitude, with similar extent of use. Acetamiprid and thiacloprid are significantly less acutely toxic and are used on a significantly smaller area.

· The chemical properties of all of the neonicotinoid insecticides are very similar and the mode of insecticidal action is identical for them all.


Annex 4

Pesticide detection in dead bees submitted under the Wildlife Incident Investigation Scheme

1. The Wildlife Incident Investigation Scheme (WIIS) examines incidents in which it is suspected that animals may have been poisoned by pesticides. Carcases submitted are routinely analysed for a range of pesticides. A total of 51 cases involving bees have been reported in the past four years (out of an overall total of 745 cases). Of these, two cases appeared to have been a result of the use of a pesticide in accordance with its approval; neither of these involved neonicotinoids. There were two instances of abuse (use of pesticides to deliberately poison bees) and three of misuse (careless incorrect use leading to poisoning). One of the misuse cases involved a neonicotinoid (imidacloprid) along with three other pesticides.

2. Analysis of dead bees submitted in WIIS cases has brought 100 detections of pesticides (and the full list is in the table below). Of these, 10 are neonicotinoids (7 detections of thiacloprid and 3 of imidacloprid). It is notable that many of the pesticides detected most frequently are biocidal products (for example, products authorised for control of feral bees) rather than plant protection products used in agriculture and horticulture. In the majority of cases, the pesticides detected were not clearly the cause of death.

Active substance

Number of detections

Bendiocarb

Propiconazole

Permethrin

Chlorpyrifos, fluvalinate and thiacloprid

Tebuconazole

Boscalid

Dieldrin, dimethoate, imidacloprid

Azoxystrobin, carbendazim, diazinon, fipronil, gamma-HCH, lambda-cyhalothrin

Bifenthrin, cypermethrin, DDE, DDT-pp, deltamethrin, glyphosate, MCPA, mecoprop-p, methomyl, myclobutanil, penconazole, pirimicarb, pirimiphos-methyl, prothioconazole

14

12

9

7

5

4

3

2

1


Annex 5

Monitoring schemes for pesticides

Pesticide residues in food

1. Responsibility for monitoring residues in food rests with the Committee on Pesticide Residues in Food (PRiF). Its terms of reference are to:

· provide independent advice to the Health and Safety Executive and the Food Standards Agency (FSA), and UK Ministers on:

o the planning of surveillance programmes for pesticide residues in the UK food supply;

o the evaluation of the results; and

o procedures for sampling, sample processing and new methods of analysis.

· make its findings and recommendations available to Government, consumers and the food and farming industries in a way which aims to be comprehensive, understandable and timely.

2. The full 2012 monitoring programme can be found at: http://www.pesticides.gov.uk/guidance/industries/pesticides/advisory-groups/PRiF/PRiF-archive/2012/2012_programme.htm

3. Monitoring results are compared against Maximum Residue Levels (MRLs). MRLs are the maximum concentration of plant protection product residues legally permitted in food and animal feeds. The prescribed levels are based on good agricultural practice (GAP); if the user follows the GAP the level of plant protection product in the crop at harvest should not exceed the MRLs. MRL exceedances are followed up with the suppliers.

4. MRLs are intended primarily as a check that the GAP is being followed and to assist international trade in treated produce. The GAP (and hence the MRL) are always set in such a way that adherence to the GAP will not lead to dangerous residue levels. But MRLs are not safety limits in themselves and are usually set well below what would be a "safe" level. It thus follows that residues in excess of an MRL are not necessarily a risk to health, and the Acceptable Daily Intake (ADI) and Acute Reference Dose (ARfD) are used to assess in a precautionary manner appropriate long and short term exposure to residues in foodstuffs.

5. MRLs are set through a long-term EC programme establishing individual limits for different active substance/food commodity combinations. The aim is to establish an MRL reflecting all the authorised uses of pesticides within the Community as well as MRLs that are required to take account of imports into the Community. If a specific MRL is not established then a default level of residue (which is effectively zero) is the statutory maximum permitted.

Wildlife Incident Investigation Scheme

6. The Wildlife Incident Investigation Scheme (WIIS) makes enquiries into the death or illness of wildlife, pets and beneficial invertebrates that may have resulted from pesticide poisoning. The scheme has two objectives:

· To provide information to the regulator on hazards to wildlife and companion animals and beneficial invertebrates from pesticides; and

· To enforce the correct use of pesticides, identifying and penalising those who deliberately or recklessly misuse and abuse pesticides.

7. In practice "companion animals" usually refers to cats and dogs, and "beneficial invertebrates" refers to honeybees, bumble bees and earthworms. Also included in the Scheme are suspect baits, where it is thought that pesticides have been inappropriately applied or used, and spillages of pesticides where this poses a risk to wildlife or companion animals.

8. WIIS monitors the unwanted effects on wildlife through misuse, abuse or approved use of pesticides. The scheme helps monitor the way pesticides are used and their effect. It allows us to assess how people use pesticides and how well they understand the laws relating to these chemicals and protecting wildlife. WIIS also helps us assess whether pesticides are behaving as predicted once released into the environment. So it shows how well the risk assessment and approval process is working.

9. The Scheme is essentially a monitoring tool to inform the pesticide approval process. However, where there is clear evidence of a breach of pesticide law enforcement action may be taken.

10. If the information collected on an incident indicates that pesticide laws may have been broken, a range of regulatory action is considered. If there seems to be enough evidence of illegal activity, cases are referred to be investigated and court action may be taken. Any fines and costs that have to be paid, together with the publicity such cases attract, encourage others to use pesticides safely.

11. Even if there is not enough evidence for a formal investigation or prosecution, other action (for example, using enforcement notices or sending out warning letters) may be taken. Also, it may sometimes be appropriate to refer an incident to another authority, such as the police. In these circumstances, Defra will offer help and advice to that authority.

12. Where suspected pesticide poisoning is reported, a combination of field work, veterinary examination and chemical analysis is used to try to determine the cause of death. Cases accepted for further investigation usually fall into one of the following categories:

· Approved use - a pesticide is used in accordance with its conditions of authorisation.

· Misuse – the product has not been used according to the conditions of its authorisation, but the breach is careless or accidental, without the intention of harming animals.

· Abuse – a pesticide has been deliberately used in an illegal manner to poison, or to try to poison animals.

13. In some cases pesticides may be found but the origin of the substance is unclear and the cause of death will be unknown or unspecified.

14. WIIS is supported by targeted publicity that aims to reach countryside users and influencers, for example veterinary practitioners. The campaign explains how to identify and report potential incidents. It also makes clear that those who deliberately abuse or misuse pesticides in a way which could harm birds, mammals and bees will be prosecuted.

Pesticides Usage Survey

15. The Pesticide Usage Survey (PUS) collects quantitative and qualitative data on pesticides used in agriculture, horticulture and food storage. This data has been collected in the UK for the last 40 years . Since the entry into force of the EU Statistics Regulation (1185/2009/EC), PUS data are now collected as part of the requirement for the collection of data on sales and usage of pesticides. The sampling and data gathering approaches uses fully meet the requirements of the UKSA Code of Practice for Official Statistics.

16. Surveys currently collect data on pesticides used on arable crops, vegetables, glasshouse crops, soft fruit, top fruit, fodder and forage, stored top fruit and potatoes. The surveys provide accurate information concerning regional and national pesticide usage including: the range of chemicals used, the amount of active ingredients applied, the total treated area, the proportion of crops treated, and the methods and timing of application.

17. The data collected provide essential information for a number of purposes including:

· Informing the pesticide risk assessment (approval) process, including the UK and EU review programmes of older pesticide active substances.

· Policy, including assessing the economic and/or environmental implications of introduction of new active substances and the withdrawal/non-approval of pesticide products (the data reported to organisations such as the OECD and EU enabling the UK to honour international agreements); evaluating changes in growing methods and Integrated Pest Management where this has an impact on pesticide usage.

· Informing the targeting of monitoring programmes for residues in food and the environment.

· Contributing to assessing the impact of pesticide use, principally as part of the Pesticide Forum’s Annual Report.

· Providing information to assist research projects which can support all of the above activities.

· Training/teaching programmes which are designed to improve practice in the use of pesticides by the farming/training industries.

· Informing the Wildlife Incident Investigation Scheme (WIIS) programme to help identify potential misuse of pesticides.

18. Surveys in England and Wales are carried out by the Food and Environment Research Agency (Fera) and GfK Kynetec, with parallel surveys being carried out in Scotland by the Science and Advice for Scottish Agriculture (SASA) and in Northern Ireland by the Agri-Food & Biosciences Institute (AFBI). Since 2011, published reports cover usage throughout the United Kingdom.

National Poisons Information Service (NPIS)

19. The primary function of the NPIS is to give information to enquiries from health professionals. All health care providers have free access to the UK on-line poisons database TOXBASE and the number of TOXBASE accesses can be counted. Should this not be immediately available (e.g. unregistered NHS user) or be insufficient for their needs enquirers will ring the NPIS help line. All telephone enquiry data are entered into a confidential national database collection system, the UK Poisons Inquiry Database (UKPID). This includes agent, patient demographics, symptoms, where available clinical laboratory results, treatment advice and, generally in more severe cases, follow up (although follow up of cases is not funded routinely).

20. The NPIS also is associated with the UK Teratology Information Service (UK TIS) and this service will receive specific enquiries about exposures in pregnancy, either directly or be referred them by the NPIS. Data on these cases are also collected in a dedicated database. In the case of pregnancy enquiries the NPIS follows up all pregnancies where it is possible to ascertain the pregnancy outcome but these are few in number for data protection reasons.

21. Regular reports are produced which provide an overview of accidental and deliberate exposures, the agents involved, and outcomes. Severity gradings are consistent with standardised international criteria, the WHO Poisoning Severity Score and symptom details are also collected. These datasets thus allow analysis of the symptoms and severity of accidental and deliberate exposures to individual agents and comparative toxicity to be assessed between agents of the same type, for example herbicides or insecticides. In 2010-11, NPIS systems collected information on approximately 1,300 pesticide and biocide exposures out of a total of 500,000 enquiries for all poisonings.

22. NPIS primarily answers questions on acute exposure, but will collect information on chronic effects of poisoning when enquiries are received from concerned medical practitioners wishing to ascertain whether or not a patient’s symptoms may be related to previous pesticide exposures.

Human Health Enquiry & Incident Survey (HHEIS)

23. This system was initiated in 2002. It is largely the work of pesticide approval holders. The approval holders keep records of contacts and enquiries they receive usually from users following product label contact advice. These records are required to be submitted annually to CRD. It has several positive features but reports on only a fairly small number of incidents each year.

Pesticides Incidents Appraisal Panel (PIAP)

24. Post-approval surveillance of pesticide products is essential to detect any health effects that may not have been identified by the initial screening process. PIAP forms part of the post-approval surveillance of pesticide products. It is set up within the HSE and collects information mostly from the public and occasionally employees as they occur continuously through the year. Information is assessed by a committee consisting of experts in this area from both within and without the HSE. Data are analysed and published as an annual report.

25. PIAP considers all incidents of ill health reported to the HSE which are alleged to have been caused by exposure to pesticides used at work/in a work activity. Each report is assessed by a suitably trained member of HSE staff who will investigate each report where appropriate and if necessary seek extra information about the event, especially details of exposure and short and medium term follow up. The PIAP committee is informed of these incidents only when the investigation has been completed, at which time it is supplied with copies of the investigation/follow up reports.

26. PIAP itself does not carry out any further enquiries or investigation and relies entirely on the information collected by HSE staff. PIAP considers each incident report, not to establish causation or blame, but to judge the strength of association between the alleged exposure and alleged ill health. The final decision is based on the balance of probabilities. This enables PIAP to detect any patterns or trends of ill health associated with either individual pesticides or particular groups of pesticides and to assess the reliability of such trends. PIAP reports its findings to the ACP.


Annex 6

What Defra is doing to protect insects

Honey bees

1. Honey bees differ from other insects in that they are essentially a managed species. Defra has a role in helping bee keepers to succeed. The Healthy Bees Plan was launched in March 2009 by Defra and the Welsh Government following publication of the National Audit Office’s report on ‘The Health of Livestock and Honeybees in England’. The overall aim of the Plan is to achieve a sustainable and healthy population of honey bees for pollination and honey production in England and Wales. It provides a fresh impetus for government, beekeepers and other stakeholders to work together to respond effectively to pest and disease threats and to sustain honey bees and beekeeping for the future. Defra funding (£4.6m since 2009) currently runs until 2015.

2. A key priority of the Healthy Bees Plan is to deliver an enhanced training and education programme for beekeepers, driving up husbandry standards and the management of pests and diseases.  Defra (Fera) has so far co-funded education and training initiatives with beekeeping associations e.g., 400 new beekeeper trainers and a suite of new training materials and courses. Jointly funded programmes will be a key feature of the work going forward.

3. Defra also provides £1.3m each year to Fera’s National Bee Unit’s (NBU) to deliver its bee health programme. The programme includes the provision of a free apiary inspection and diagnostic service for statutory diseases and pests, and a free training and education programme to enable beekeepers to become more self-reliant in combating disease through improved bee husbandry. The programme aims to control the spread of endemic notifiable diseases of honey bees and to identify and manage the risk associated with new exotic pests and diseases that may be introduced. The NBU manages BeeBase ( www.nationalbeeunit.com ), the voluntary national database of beekeepers which also serves as a management tool for planning and executing the inspection programme.

4. There are approx. 28,300 beekeepers currently registered on BeeBase. Increasing the number of beekeepers registered is a key objective of the Healthy Bees Plan. The Plan includes a number of actions to increase registrations including enhanced communications activities and collaboration with beekeeping associations to encourage their members to register. So far this year, there have been 4,081 new registrations of which 1989 have self-registered.

Bumble bees and other pollinators

5. Bees and other pollinators are an essential part of our natural ecosystems, and their conservation has become part of biodiversity conservation efforts. Declines in pollinator numbers have significant economic impact, estimated of the order of £500 million, as the crops they pollinate – such as oilseed rape, orchard fruit and beans – support our agricultural systems.

6. Since 1900, the UK has lost 20 species of bee, 62 species of moth, and several butterflies including the mazarine blue and the black-veined white. A further 35 bee species (out of 251) are considered to be under threat of extinction. There has been a severe decline in the diversity of wild bees in the countryside.

7. Wild pollinators require a range of habitats and food sources throughout the year – not just flowers. They need places to nest, feed and forage during the various stages of their life cycle. Over the last 50 years there have been dramatic changes in our countryside due to agricultural intensification, commercial forestry and urban development. These have caused widespread habitat losses. Flowers planted in high streets, parks, gardens, etc are often selected to be low maintenance, long-lasting and pest and disease free. They are also devoid of nectar and pollen which creates extensive areas where wild pollinators cannot survive.

8.            Defra is working to protect pollinators and wildlife in general through Biodioversity 2020:  A strategy for England’s wildlife and ecosystem services. In particular, Outcome 3 of the strategy states that "by 2020 we will see an overall improvement in the status of our wildlife and will have prevented further human induced extinctions of known threatened species"The species of principal conservation importance (listed on s41 of the NERC Act 2006) currently includes 17 species of bee, of which 16 species currently occur in England, as well as many other wild pollinators.

9.            Natural England promotes the conservation of wild pollinators though Environmental Stewardship, which advises and supports farmers to provide the habitats these animals need, for example flower-rich meadows and buffer strips. It runs conservation projects to support Biodiversity 2020 and other priority species, including pollinators such as bumble bees. For example the short haired bumble bee, extinct in the UK, was recently reintroduced from New Zealand.

Pollinating Insects and Environmental Stewardship

10. The need to address declines in pollinating insect populations was recognised when Environmental Stewardship was designed. There are relatively few opportunities to do this within modern, intensive arable and grassland management systems, so attention turned to providing habitat for these insects around the margins of fields.

11. Entry Level Stewardship (ELS) therefore pays for the establishment of nectar flower mix in blocks or strips. The design is intended to provide a large quantity of nectar from a small area, to mimic some of the nectar-bearing crops that were once a feature of more traditional agricultural systems and to limit the genetic impact on native wild flower species of the widespread sowing of commercial seed. The sown mixes should be actively managed and re-established as necessary to maintain the nectar supply over the five years of the ELS agreement. Within Higher Level Stewardship, a wider range of options is available, including floristically enhanced grass margins and conservation headlands.

12. ELS nectar flower strips or blocks provide additional nectar sources, particularly for long-tongued species of bumblebees. However, retaining healthy populations of pollinating insects requires a variety of habitats across the farm. For example, tall grass buffer strips provide protection for over-wintering insects.

13. Uptake of ELS nectar flower strips or blocks has been lower than expected. Natural England and the Campaign for the Farmed Environment have therefore been specifically promoting the selection of options of benefit for pollinating insects.

14. Within livestock farming, a new ES option for legume- and herb-rich swards will be available from 1 January 2013. The new option is intended to provide habitat and food for invertebrates including crop pollinators, benefit soil structure, mitigate climate change by reducing nitrogen fertiliser use and provide productive high quality forage for livestock. It is one of a number of changes to ES to improve its delivery and to better meet its environmental objectives.

Campaign for the Farmed Environment

15. The Campaign for the Farmed Environment is an industry-led voluntary approach. It encourages arable farmers to take up key in-field Environmental Stewardship (ES) options and deliver voluntary environmental action. The key objective of the Campaign is to retain and exceed the environmental benefits that were provided by the previous set-aside scheme. The Campaign was proposed by farming organisations as an industry-level alternative to regulation. The Campaign was launched in November 2009 and is currently funded until the end of 2012.

16. The Campaign promotes a range of in-field ES options. It also encourages farmers to leave 3-4% of their least productive land uncropped and provides a range of voluntary environmental management measures which can deliver similar benefits to ES on this land. The options and measures aim to deliver benefits in line with the three campaign themes of farmland birds, farm wildlife and resource protection. Among the many options that contribute to wider biodiversity and farm wildlife (which includes insects) are grass buffers, managed field corners, pollen and nectar flower mixes, sown wildflower headlands and beetle banks.

17. There is general agreement that, while environmental benefits are not being maximised, farmers participating in the Campaign are delivering benefits for the environment. Discussions are taking place on whether and how the Campaign might evolve beyond the current delivery approach to continue the good work by the industry, extend to link with other industry-led initiatives (such as the Voluntary Initiative for pesticides) and provide a transition period until CAP reform. Defra will take a view on these questions shortly.

The review of advice, incentives and voluntary initiatives

18. Farmers need clear advice to help them improve farm practices, get the most from their land and understand environmental issues. Following a commitment made in the Natural Environment White Paper, Defra is undertaking a review to understand best practice in relation to advice provision and voluntary initiatives. The aim is to publish, by March 2013, plans for a streamlined framework of advice, incentives and voluntary initiatives to enable farmers and land managers to be more competitive and yield better environmental results.


Annex 7

The role of neonicotinoids in controlling crop damage by insects

1. Neonicotinoids are widely used in UK agricultural and horticultural crops, with seed treatments, soil treatments and foliar treatments available.   They prevent damage and yield losses by controlling a range of pests, such as aphids.  When aphids feed on the crop they transmit viruses which cause diseases such as barley yellow dwarf virus (affecting cereals) and beet yellow virus (affecting sugar beet). These diseases can have serious effects on crop yields and quality.   

2. Neonicotinoid seed treatments are used extensively in cereals, oilseed rape, and sugar beet where they provide protection against a range of foliar and soil dwelling pests, assisting crop establishment at the time of sowing.  Where seed treatments have been used they generally reduce the need for subsequent insecticide foliar treatments.  They are also very targeted. Neonicotinoids are also important because they provide an alternative mode of action in the overall insecticide treatment programme, particularly to the pyrethroid and organophosphate insecticides. They therefore play a key role helping to prevent the build up of resistance in the pests concerned.  

3. The last decade has seen a significant reduction in the number of available insecticide active substances with different modes of action, particularly those with very broad activity controlling a wide range of insect species.  There are a variety of factors behind this, but principal ones are the impact of the EU programme for regular review of pesticides approvals and the development of resistance in some key insect pests to the older established chemistry, including pyrethroids, organophosphates and carbamates.  (The approval of new active substances has provided replacements for some uses, but they tend to be more specialised with a narrower range of activity).  In many situations insect control is reliant on one or two modes of action, with neonicotinoids being a key component in the overall treatment programme. 

4. As an example, widespread pyrethroid resistance in pollen beetle has emerged across Europe leading to wide scale significant economic losses.  In the UK there has been a slower, but continuing, shift in sensitivity and the development of fully resistant populations.  The first populations were identified in small pockets of Eastern England but have now been recorded in the Midlands and Scotland, and neonicotinoids have played a major role in for containing resistant communities.

5. Proactive resistance management strategies have been put in place, including restrictions on use in certain crops, to promote the sustainable use of neonicotinoids.  These have been developed in close partnership between CRD and the other members of the Insecticides Resistance Action Group (IRAG), which includes industry, growers and independent academic researchers. 


Annex 8

General principles of integrated pest management

(as set out in the EU Directive on the sustainable use of pesticides)

1. The prevention and/or suppression of harmful organisms should be achieved or supported among other options especially by:

· crop rotation,

· use of adequate cultivation techniques (e.g. stale seedbed technique, sowing dates and densities, under-sowing, conservation tillage, pruning and direct sowing),

· use, where appropriate, of resistant/tolerant cultivars and standard/certified seed and planting material,

· use of balanced fertilisation, liming and irrigation/drainage practices,

· preventing the spreading of harmful organisms by hygiene measures (e.g. by regular cleansing of machinery and equipment),

· protection and enhancement of important beneficial organisms, e.g. by adequate plant protection measures or the utilisation of ecological infrastructures inside and outside production sites.

2. Harmful organisms must be monitored by adequate methods and tools, where available. Such adequate tools should include observations in the field as well as scientifically sound warning, forecasting and early diagnosis systems, where feasible, as well as the use of advice from professionally qualified advisors.

3. Based on the results of the monitoring the professional user has to decide whether and when to apply plant protection measures. Robust and scientifically sound threshold values are essential components for decision making. For harmful organisms threshold levels defined for the region, specific areas, crops and particular climatic conditions must be taken into account before treatments, where feasible.

4. Sustainable biological, physical and other non-chemical methods must be preferred to chemical methods if they provide satisfactory pest control.

5. The pesticides applied shall be as specific as possible for the target and shall have the least side effects on human health, non-target organisms and the environment.

6. The professional user should keep the use of pesticides and other forms of intervention to levels that are necessary, e.g. by reduced doses, reduced application frequency or partial applications, considering that the level of risk in vegetation is acceptable and they do not increase the risk for development of resistance in populations of harmful organisms.

7. Where the risk of resistance against a plant protection measure is known and where the level of harmful organisms requires repeated application of pesticides to the crops, available anti-resistance strategies should be applied to maintain the effectiveness of the products. This may include the use of multiple pesticides with different modes of action.

7. Based on the records on the use of pesticides and on the monitoring of harmful organisms the professional user should check the success of the applied plant protection measures.

22 November 2012


[1] See Organisation for Economic Cooperation and Development guideline for the testing of Chemicals – honey bees, acute oral toxicity test (OECD 213) and acute contact test (OECD 214).

[2] This value of 50 has been validated see Aldridge, C. A., and A.D.M. Hart. 1993. Validation of the EPPO/CoE risk assessment scheme for honeybees, Appendix 5. Proceedings of the 5 th International Symposium on the Hazard of Pesticides to Bees, 26Ð28 October 1993, Plant Protection Service, Wageningen, The Netherlands.

[3] See European and Mediterranean Plant Protection Organisation (EPPO) Side effects on honey bees PP 1/170(4).

Prepared 3rd December 2012