TECHNICAL REPORT. European Food Safety Authority 2, 3. European Food Safety Authority (EFSA), Parma, Italy

Transcription

1 EFSA supporting publication 2013: EN-452 TECHNICAL REPORT Outcome of the Second Round of Public Consultation on the draft Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees) 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT EFSA has performed a public consultation on the draft Guidance Document on the risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees). The draft Guidance document which was sent out for public consultation in September 2012 was intended to address the risk to bees from exposure of bees from direct contact and from oral uptake of residues in pollen and nectar. After new information became available it was possible to develop a method on how to integrate the assessment of contaminated water and metabolites. In addition the chapter on uncertainty analysis was finalised. In order to give stakeholders the opportunity to comment on these new approaches a second round of public consultation was launched. This report presents statistics on the comments received and lists all comments together with detailed answers to them. The stakeholders submitted many valuable and detailed comments, which were taken into account when finalising the Guidance Document. EFSA thanks all stakeholders for their contributions. European Food Safety Authority, 2013 KEY WORDS Honey bees, risk assessment, Guidance Document, Pesticides, Apis mellifera, Bombus, Solitary bees 1 On request from European Commission, Question No EFSA-Q , approved on 27 June Correspondence: pesticides.ppr@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the members of the Working Group: Gérard Arnold, Jos Boesten, Mark Clook, Robert Luttik, Fabio Sgolastra and Jacoba Wassenberg for the preparatory work on this technical report and EFSA staff: Maria Arena, Franz Streissl, Agnès Rortais, Csaba Szentes and Olaf Mosbach-Schulz for their support. Suggested citation: European Food Safety Authority, 2013; Outcome of the Second Round of Public Consultation on the draft Guidance Document on the Risk Assessment of Plant Protection Products on Bees (Apis mellifera, Bombus spp. and solitary bees). EFSA supporting publication 2013:EN pp. Available online: European Food Safety Authority, 2013

2 SUMMARY EFSA was asked by the European Commission to develop a Guidance Document on the risk assessment of Plant Protection Products on bees. The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of Plant Protection Products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees) (EFSA, 2012a) (EFSA Panel on Plant Protection Poducts and their Residues (PPR), 2012a) provided the scientific basis for the development of the Guidance Document. EFSA has performed a public consultation on the draft Guidance Document on the risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees). The draft Guidance document which was sent out for public consultation in September 2012 was intended to address the risk to bees from exposure of bees from direct contact and from oral uptake of residues in pollen and nectar. After new information became available it was possible to develop a method on how to integrate the assessment of contaminated water and metabolites. In addition the chapter on uncertainty analysis was finalised. In order to give stakeholders the opportunity to comment on these new approaches a second round of public consultation is launched. This report presents statistics on the comments received during and lists all comments together with detailed answers to them. The stakeholders submitted many valuable and detailed comments, which were taken into account when finalising the Guidance Document. EFSA thanks all stakeholders for their contributions. EFSA supporting publication 2013:EN-452 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by European Commission... 4 Terms of reference as provided by the European commission... 4 Assessment Introduction Screening and Evaluation of the comments received Comments received... 5 Glossary and abbreviations References EFSA supporting publication 2013:EN-452 3

4 BACKGROUND AS PROVIDED BY EUROPEAN COMMISSION EFSA is currently revising the European Guidance Document on terrestrial ecotoxicology elaborated by the Commission and experts from Member States. In the context of this revision, the bees risk assessment will also be addressed. Members of the European Parliament and beekeepers associations have expressed their concerns to the Commission as to the appropriateness of the current risk assessment scheme, and in particular on the EPPO4 Environmental risk assessment scheme for Plant Protection Products Chapter 10: honeybees revised in September 2010 with ICPBR5 recommendations. Considering the importance and the sensitiveness of this issue, and in line with the aim of the Commission Communication on Honeybee Health (COM (2010) 714 final)6 adopted on 6 December 2010, the Commission considers that the revised EPPO assessment scheme would need further consideration by EFSA in an Opinion on the science behind the risk assessment for bees and that a Guidance Document on the risk assessment of Plant Protection Products on bees should be developed. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION A scientific Opinion of the PPR Panel on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees) will be prepared. In particular the following issues will be addressed: the assessment of the acute and chronic effects of Plant Protection Products on bees, including the colony survival and development. the estimation of the long-term effects due to exposure to low concentrations the development of a methodology to take into account cumulative and synergistic effects the evaluation of the existing validated test protocols and the possible need to develop new protocols, especially to take into account the exposure of bees to pesticides through nectar and pollen. In order to have the possibility for stakeholders and the interested public to comment on the draft Guidance Document, we propose to include a round of public consultations on the draft Guidance Document. An Opinion on the science behind the Guidance Document could be delivered by April 2012 and a final Guidance Document in December EFSA supporting publication 2013:EN-452 4

5 ASSESSMENT 1. Introduction The draft Guidance document which was sent out for public consultation in September 2012 was intended to address the risk to bees from exposure of bees from direct contact and from oral uptake of residues in pollen and nectar. In the meantime new information on the exposure to guttation became available from the ongoing peer-review on neonicotinoids. This information helped to develop an approach to address guttation exposure. In parallel the working group updating the aquatic Guidance Document has developed a method on how to integrate the assessment of metabolites. This enabled the working group for the bee risk assessment to make recommendations for harmonised assessment of metabolites also in the risk assessment for bees. In addition the chapter on uncertainty analysis was finalised. In order to give stakeholders the opportunity to comment on these new approaches a second round of public consultation is launched. The public was invited to submit comments on the additional chapter of the Draft Guidance Document via an online form available at from 15 Febraury to 18 March Risk assessors, risk managers, stakeholders and the scientific community were additionally informed via s and via presentations at scientific events about the open public consultation. 2. Screening and Evaluation of the comments received 2.1. Comments received All the comments received were scrutinised and subsequently tabulated with reference to the author(s) and the section of the draft Guidance Document to which each comment referred. Duplicate comments received from the same contributor appear only once in the table and where there was more than one comment from the same contributor but for different sections of the Guidance, the comments were separated and added to the relevant section. The references to chapters and appendices in the comments and the answers to the comments refer to the draft Guidance Document and not to the final Guidance Document. The final number of comments was 176. Comments submitted by individuals in their personal capacity are listed anonymously. Comments submitted formally on behalf of an organisation appear with the name of the organisation. A statistical summary of the comments received is provided in Tables 1 and 2. Table 1: Comments received on the draft Guidance Document per section Sections Number of comments General comments 26 Chapter 1. Introduction 0 Chapter 2. Assessment of risk contaminated water Assessment of risk surface water Assessment of risk water in puddles 16 Chapter 3. Risk assessment scheme for metabolites Alternative information replacing experimental studies Risk assessment for metabolites 2 Chapter 4. Uncertainty analysis 10 EFSA supporting publication 2013:EN-452 5

6 4.1. Approaches for characterising uncertainty in higher-tier assessments Risk characterisation and weight of evidence assessment 6 Appendix A. Background to the exposure estimates and trigger values used in the risk assessment for guttation 11 Appendix B. Test Protocols to assess the effects of pesticides in guttation on honey bees 10 Appendix C. Assessment of uncertainty 8 Appendix D Trigger values 3 References 2 Total 176 Table 2: Comments received on the draft Guidance Document by organization Organization Country Total the Netherlands (NPPO, Ctgb, RIVM, Bijen@wur) NLD 9 Agricultural research PER 1 Anonymous DEU 9 Anonymous ESP 1 ANSES FRA 18 Bumblebee Conservation Trust GBR 4 CARI BEL 8 Chemicals Regulation Directorate GBR 6 COAG ESP 5 Danish EPA DNK 10 ECPA BEL 16 European Beekeeping Coordination BEL 4 Experimental Toxicology Services (ETS) Nederland BV NLD 1 Federal Office for Consumer Protection and Food Safety (BVL) DEU 7 Federal Public Service Health, Food Chain Safety and Environment, Pesticides and Fertilizers Service BEL 3 FVE FRA 2 IDRG DEU 1 INIA ESP 22 INRA FRA 1 Julius Kühn-Institute DEU 9 National Farmers'' Union of England and Wales GBR 6 Pesticide Action Network Europe BEL 5 SBM Développement FRA 2 Science in Water B.V. NLD 1 The Swedish Chemicals Agency SWE 19 Twicenham & Thames Valley Beekeepers Association GBR 2 UNAAPI-Unione Nazionale Associazioni Apicoltori Italiani ITA 3 University of Turin - DISAFA ITA 1 Total number of comments 176 EFSA supporting publication 2013:EN-452 6

7 Table3: Comments received on the draft Guidance Document on the risk assessment of PPPs on bees and responses by EFSA WG N COMMENT ORGANISATION COUNTRY CHAPTER COMMENT 1. UNAAPI - UNIONE NAZIONALE ASSOCIAZIONI APICOLTORI ITALIANI ITA 2. Assessment of risk contaminated water General comments about "assessment risk contaminated water": Foraging water exposes the bees in many and relevant ways to potential sources of contamination. The proposed assessment does not consider the various risks (acute, chronic, adult, larvae...) due to the persistence of the various families of different pesticides in the water within the range of foraging hive. Furthermore, it is not considered the risk contaminated water present in: dew, irrigation and spray under canopy. These are sources for bees and pollinators in times of great activity and foraging in the presence of climate drought, as happens more and more in Italy with recurring effects, punctual and chronic, disastrous for bees. EFSA: Residues found in guttation droplets are greater than in other sources of water. The proposed RA is considered as worst case and should cover exposure to other contaminated sources of water. 2. Danish EPA DNK 3. Danish EPA DNK 4. Danish EPA DNK 5. Danish EPA DNK l Growth dilution and amount of as on seeds could be considered prior to experiments. EFSA: It is possible to refine the exposure estimates with measurements from field experiments. After enough data are available for different crops it may be possible to develop a generic formula for growth dilution. l Unclear why the approach taken here for TWA is different from approach for birds and mammals. EFSA: The same considerations as for birds and mammals are valid to decide on whether a TWA approach is justified or not. l The ETR values mentioned have no common ground (the values are meaningless ) therefore a proper explanation should be included in the main guidance instead of referring to the appendix. Furthermore the values are not clearly explained in the appendixes. Acute ETR of is mentioned in Appendix A with reference to App. D but it is not clear how the value has been derived. Chronic ETR of 0.03 is explained in app. D whereas larval ETR of 0.2 appears nowhere. EFSA: This will be explained better in the final GD. l Guttation PECs (from appendix A l ) seems to be based on very worst case calculations derived from one crop (maize) for 1 substance (thiamethoxam) for which the concentration is considered to be 1000 mg/l. If this is recalculated for one seed that contains 1 mg as then a plant could produce only 1 ml guttation fluid containing the entire amount of as on the seed. Furthermore the PEC is independent of the dose applied (instead based on solubility) which is not considered appropriate/in line with other risk assessments. Appendix A states that conc. In other crops are considerably lower this should be reflected in the risk assessment scheme. EFSA: The screening step is based on water solubility as the water solubility will limit the concentration. This approach is sufficiently protective if compared to available residue data. The next step would be refinement based on measured resides. EFSA supporting publication 2013:EN-452 7

8 6. Danish EPA DNK 7. Danish EPA DNK 8. Danish EPA DNK 9. Danish EPA DNK 10. private DEU l Is negligible exposure defined as application after guttation period (Figure 1) or could other options be considered? EFSA: Other options could be also considered if justified. l Please refer to Figure 1 l The statement concerning very high conc. of pesticides in treated crops seems to be based on limited data/very worst case assumptions from a few crops or perhaps only maize. The proposed assessment scheme should provide options for different crops/groups of crops. EFSA: The available data were not sufficient to develop a generic set of assessments for different crops in the first tier. However, it is possible to refine the exposure estimate for different crops based on measured residues. l The information provided on guttation in different crops is very sparce. An attempt to collect further information should be undertaken Assessment to exposure of : Line 146 Guttation fluid is hardly consumed; it is collected as water in a contaminated form. And used for temperature regulation in case of overheating and as the dilutant if the concentration of the content of the social stomach is to high. In the latter case it can also be incorporated in to the food fed to the larvae. The other use -for cooling- results in the evaporation of the water in the guttation droplets. Leading to a concentration of the fluid on the cell-rims. It can be expected, that the actual concentration of the PPP in those remainders will be in equilibrium with air humidity inside the hive. Still Line 146 The above... indicates, that it appears doubtfull that this part of the proposed RA will deliver a robust scheme. Why bring it into the public consultation at htos moment? Line 205 Why propose a concentration of 40% of the water solubility. There are data available from the past years on field concentrations eg. JKI, Bayer. Line 213 Why use the lower 22% for the chronic RA? Line 221 Why use 29% for larval food?? What background or database to do so?? In those three cases. Line 285 Flow Chart Box 7 from study with largest effects This phrase I do not understand, where should these largest effects come from? Line 301&302 Why not oblige the applicant to deliver data on the guttation from clearly prescribed experimental conditions? To be used for the RA. Line 311 There is literature on guttation as a way the plant loses AI. Why use the soil as intermediate, as there must be also enough literature on the flow of sprayed systemics inside the plant; missing might be the fate of the drop-off. Granulates are usually put in the sowing rim, so it can be expected to act comparable to coating on seeds. Line 355 Up to my knowledge the distance to the water-source is the main factor that drive the water collecting bees.?missing Literature? Line I do not understand how to find, or what is ment with distance equal or larger than the 90th percentile case in the area of use of the substance I suppose some words are missing in the phrasing. Line It is difficult to provide colonies with for the colony acceptable/prefarable water sources in an area. EFSA supporting publication 2013:EN-452 8

9 11. COAG ESP Line How true! EFSA: Residues found in guttation droplets are greater than in other sources of water. The proposed RA is considered as worst case and should cover exposure to other contaminated sources of water. The available data were taken into account. More details are given in Appendix A. The screening step is based on water solubility as the water solubility will limit the concentration. This approach is sufficiently protective if compared to available residue data. The next step would be refinement based on measured resides. General recommendations for field studies are included in the final GD. Literature which could help to define the distance at which permanent water bodies would be preferred over guttation droplets would be very useful. The location of a field study should represent a 90 th percentile case for distances to permanent water bodies. Such a location should cover 90% of locations where permanent water bodies are equally close or closer to the field than in the experiment. We do not agree with the risk assessment scheme proposed for for various reasons: - Half-life is used to estimate the PEC to be used in chronic terms. Despite of the fact that we understand the logic behind these calculations, we are concerned about the conclusions that might be extracted by people with no bee expertise. One could think that with a half-life of 3 days, the risk of the exposure to is reduced. However, the various studies shown in figures H1 to H7 of the Scientific Opinion show enormous values of residues initially (around 100 ppm or higher) going down to 10 ppb, high enough to trigger acute mortality or sublethal effects one month or even three months after emergence (for winter OS R even 8 months). As a result, we wonder about the toxicological relevance of the concept of half-life and its use in risk assessment. One who does not have the complete information about the evolution of the residues in might be tempted to say that there is no problem with since its T50 is only 3 days. Same would happen for residues in soil. We do risk assessment on the basis of more or less standardise parameters, without questioning the real environmental relevance in terms of exposure. In contrast, a more correct approach would be to continue measuring residues in whatever matrix under study, and use for exposure determination the information of residue amount and time until disappearance or non-toxicity. - As a result, we would like to propose directly to run tests in controlled conditions (e.g. greenhouses) with the formulated product in the application form subject to authorisation. Based on these, guttation residues should be collected and their evolution registered in time. In doing so, not only both the applicant and the risk assessors would have a clear picture of the systemicity of the products under test, but also they would have interesting information from an efficacy point of view. EFSA: Residues found in guttation droplets are greater than in other sources of water. The proposed RA is considered as worst case and should cover exposure to other contaminated sources of water. If research shows that the residues from studies under greenhouse conditions are comparable to field situations then it can also be done in greenhouse (e.g. covering situations which favours guttation and high residues in guttation fluid. EFSA supporting publication 2013:EN-452 9

10 12. COAG ESP 13. ECPA BEL We do not agree with the risk assessment scheme proposed for for various reasons: - Line 191 Check whether guttation occurs for <10% of crop/calendar-year combinations. This proposal in our opinion has no sense in landscape/real terms. It needs to be reminded that risk assessment of a pesticide is done for one active ingredient/product applied to one crop. In the environment, following the authorisation of the active ingredient/ product for a variety of crops and application methods, the exposure is likely to be higher or longer because of the possibility of contemporary-occurring contaminated guttation droplets in the area of influence of a colony. However, it is almost impossible to describe this exposure a priori for all the agricultural areas in the EU. EFSA: This assessment scheme has to be applied to each crop for which a registration is requested. Maybe we are misunderstanding the proposal. In this case, we propose to further clarify. - First tier assessment of the exposure is based on using 40% of water solubility of the acute assessment, 22% of the chronic PEC for adults and 29% for the chronic PEC for larvae. These figures are further explained in the annex A where we see that the 40% rule is only based on the data of neonicotinoids. However, this relationship is not applicable to other pesticide families: carbamates (methiocarb) or phenyl-pyrazols (fipronil). We have rechecked the residue values included in Table H1 of EFSA, 2012a, and we have seen that the residues of fipronil come from the application of the commercial formulation Regent. No information found for methiocarb application. Copolymers exist that enhance the systemicity of active ingredients when formulated together (Dieckmann et al., 2010). As a result, the reason for the awkward behaviour of residues in guttation of these substances could well be because of the presence in the formulation of these molecules instead of the unreliability of measurements as stated in the document. Therefore, little could be estimated from the solubility of the initial active ingredients. This is another reason for not finding the proposed approach adequate. EFSA: We based the guidance on available data and did not have data for these other pesticide families mentioned in the comment above. We consider it unlikely that for other pesticide families the concentrations will exceed the maximum water solubility. In the final GD the maximum water solubility is used. The alternative is to skip this first tier and to ask for measured concentrations in the guttation water for all substances : See comment above. How is the versatile character of water bodies in the risk assessment going to be taken into account by risk managers? For risk managers the sentence translates into the following dilemna: - There is a low risk due to for honey bees that would be placed close to a nonflowering crop [certainty of the scenario?] due to the presence of permanent water sources [which is the default assumption in a risk assessment to aquatic organisms but there are buffer zones which I need to consider and compare to the 90th percentile situation as for exposure of bees, and adjust towards the protection of bees or aquatic organisms] - There is a possible risk due to for the honey bees that would be placed close to a non-flowering crop [certainty of the scenario?] due to the absence of permanent water sources [and therefore no risk for aquatic organisms] The opinion of risk managers on these situations that may derive from the proposed risk assessment is welcome : To which information is referred to in this paragraph? Most reports from field- and monitoring studies (EFSA, 2012, Scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees), pp. 2012) found no guttation related adverse effects. EFSA: In semi-field studies no adverse effects on bees were observed when alternative sources of EFSA supporting publication 2013:EN

11 water were provided. 14. ECPA BEL : A dedicated risk assessment for each zone is new in the risk assessment. The rationale to call for data in each of the three zones should in first place rely on evidence that these data are expected to be significantly different. EFSA: The worst case pore water concentration out of the 3 zones can be used to address the risk to all zones : Note that field studies where exposure occurs through pollen or nectar may thus cover a potential exposure to guttation droplets for the reason that the crops are very likely to be visited by bees. The rationale to call for field studies to address exposure to guttation droplets as being not covered by a major route of exposure should be provided before to undertake such studies, for the reason that no recommendation regarding the design of these studies can be provided it is uncertain as to how practical these are, for example there is a lack of experience to indicate the precise environmental conditions required to ensure that guttation occurs. EFSA: 5 studies are recommended and the worst case concentrations should be used in the risk assessment. The highest residue value out of the 5 studies is considered a good estimate of the 90 th percentile : Could EFSA provide guidance on the growth stages after which guttation is not likely to occur - on a crop basis? EFSA: The available information is not sufficient to give guidance on the growth stages for each of the crops : It should be considered in the risk assessment that honey bees have during periods of low temperatures a reduced need for collecting water outside of the hive due to the presence of condensed water inside of the hive : Could EFSA provide references for the models mentioned in this sentence? EFSA: it is mentioned that there are no models readily available : Considering the lack of recommendations to run field studies to reproduce guttation occurrence for annual crops under conventional or reduced tillage how are these cases to be considered on a risk management perspective? EFSA: Risk management is outside of the scope of the GD : If the simulations with the numerical models do not result in acceptable risk, the next step is to perform field experiments to assess the 90th percentile concentration in the (box 5). Considering the impossibility to propose recommendations on how to reproduce guttation occurrence in field conditions this options cannot be considered as a recommendation at the moment. EFSA: The information available was not sufficient to give more detailed recommendations. For annual crops the vulnerability of the selected sites can be demonstrated using the databases of EFSA Panel on Plant Protection Poducts and their Residues (PPR) (2012b) : The next step is to perform semi-field studies in tunnels in which the is the only water source (box 6) and in which both exposure concentrations and effects on the bees are measured. Considering that nectar is a source of water in first place more guidance on how to maintain honey bees in semi-field conditions with guttation as a sole source of water is needed. As for EFSA supporting publication 2013:EN

12 15. ECPA BEL field testing, considering the impossibility to propose recommendations on how to reproduce guttation occurrence in field conditions this options cannot be considered as a recommendation at the moment. EFSA: We note your point. Guidance was provided as much as possible on the basis of the available information : However, if given the choice bees prefer permanent water sources (streams, ditches, ponds, rivers) over temporary water sources like guttating plants. Sentence truncated. Guidance on how to define the distance to the nearest water source as equal or larger than the 90th percentile case in the area of use of the substance should be provided. The opinion of risk managers on how this translates into a risk management recommendation would be useful : The sentence is unclear: if the risk assessment is performed for the treated crop, which is considered to pose a greater risk, then the other plants are actually covered : The study conducted by Free & Spencer-Booth was done under fairly artificial conditions and, with all necessary respect to the authors is more than 50 years old and a lot new knowledge concerning the water collection was obtained. When looking at the experimental setup, honeybees were feeding from a permanent water source a fact that hardly allows extrapolation to infrequent occurrence of guttation. Furthermore, it is highly questionable to extrapolate water consumption from a cage test (cages: 6 x 5 x 9 cm) with up to 200 bees and no brood present to conditions in the colony where brood is present and honeybees are free to move around to potentially cooler areas of the hive (EFSA, in lines even refers to Becher et al. (2010) who mentions that temperature in the hive is decreasing linearly with increasing distance to the brood nest). In addition, the worst case daily water consumption rate mentioned by EFSA was taken from the results of one replicate cage. No explanation is given on the reason for that. Please explain. Cooling is considered a colony level response and does not only include cooling by evaporation of water but also cooling by ventilation. Regarding this, more realistic and up-to-date information on water consumption needs to be available in order to conduct an appropriate risk assessment. EFSA: Unfortunately no reference to a new study on water consumption was provided. 191&275: Unclear what is meant by the term crop/calendar-year combination. An explanation needs to be given in the document. EFSA: This is explained better in the final GD. 214: Note that the 10-day test is currently not performed as not covered by an international test guideline. Therefore this risk assessment cannot be performed. EFSA: Noted : Because this approach has so far not been tested, it is proposed to multiply simulated peak concentrations in the transpiration stream with a model uncertainty factor. The approach proposes to address the lack of evidence regarding transfers of chemicals into the transpiration system through the application of a safety factor arbitrarily defined as equal to 5. This approach is contradictory with an analysis of uncertainties thereafter described by EFSA and arbitrarily considers that exposure can only be higher than expected from the % of water solubility, without any evidence. It is our opinion that this risk assessment scenario relies on assumptions and not scientific evidence. EFSA: Noted EFSA supporting publication 2013:EN

13 16. ECPA BEL 222: Please provide reference to a test guideline that would derive a 5-day NOEC. EFSA: In the final GD this is explained better : The text suggests that the concentration estimates to be considered in guttation droplets may vary, pending on the risk assessment purpose. This is a new notion in risk assessment i.e. to consider different level on residues based on the target. Is there a rationale behind this? EFSA: The decrease in concentration over time is considered. It would be too conservative to assume that the peak concentration in guttation last for 5 days or 10 days : Options for exposure refinement The location, growth stage and environmental conditions need to be considered. Can EFSA provide indication on how to consider this information in a refined risk assessment related to the occurrence of guttation droplets? EFSA: This is explained in : for the seed treatments five semi-field tests are needed to cover a range of locations and experimental conditions and for the spray and granule applications locations and environmental conditions are dealt with by scenario calculations : Can EFSA provide information on how to define the peak concentration for an event guttation droplets the occurrence of which is cannot be clearly established? Considering the sporadic frequency of the event, does EFSA supports the idea that honey bees would keep collecting droplets over a period of 10 days in a crops being non attractive? Could references be provided in support of the above scenario? EFSA: The peak concentration can be assessed by following the course of time of the concentration in the during the development of the crop (see the examples in Figures H2-H5 and H7 of opinion on the science behind the risk assessment of bees - EFSA, 2012). box: The first tier approach concerning guttation is overly conservative due to a number of reasons. The guttation liquid is considered as the only water supply for bees, all crops are producing guttation fluid and bees always collect and consume. In different parts of the document EFSA mentioned that these assumptions are not realistic. With new information it will be possible in future to refine the conservative assumptions in the first tier. box: Please justify the assumption that guttation fluid is used for royal jelly and brood food. No scientific information on the role of water in general in the production of royal jelly and brood food are presented. EFSA: If data or published literature is made available which demonstrates that residues in water from guttation does not end up in larvae food then this could be taken into account in the risk assessment. box: Whilst these assumptions are true, the extent to which they occur is unknown and hence this leads to uncertainties in the scheme. It is recommended that more certainty is established before the inclusion of this issue into a risk assessment: risk assessment is not meant to evaluate risks the occurrence of which is theoretical, for the reason that this lead to an impossibility to reproduce the conditions to check for the occurrence of these risks, and to the impossibility to propose a risk assessment scheme. box: Guidance is provided regarding how to carry out higher tier exposure and effect studies, however it is uncertain as to how practical these are, for example there is a lack of experience to indicate the precise environmental conditions required to ensure that guttation occurs and that the concentration in EFSA supporting publication 2013:EN

14 17. ECPA BEL the fluid is appropriate (i.e. equivalent to a 90th percentile). This sentence underlines the uncertain character of the occurrence of guttation droplets which is contradictory with the degree of standardisation an experiment shall display in order to be used in a decision-making scheme. If there is no certainty regarding the occurrence of an event, it cannot be systematically reproduced in a standardized test system and the uncertainty regarding its occurrence itself shall be a weight of evidence to not trigger a risk assessment. EFSA: Conducting 5 field studies and taking the worst case should be sufficiently conservative and close to the 90 th percentile : It is not possible on the basis of the available information to rule out exposure to guttation droplets from certain crops or under certain conditions and therefore this, along with potentially high residues, means that the assessment has to currently be conducted for all crops and uses. See comment above, similarly it is uncertain as to how practical these are, for example there is a lack of experience to indicate the precise environmental conditions required to ensure that guttation occurs. A risk assessment scheme is of no help if built on such uncertainties. EFSA: in this case the precautionary principle was followed : From available information (data from industry and MS monitoring) it is evident that effects to colonies, in realistic worst case scenarios is at a low level, and effects on colony strength, brood development and overwintering have been not observed. It is also clear that collection of guttation fluid is not an exposure scenario comparable with exposure from nectar and pollen. Risk is likely to decrease with the distance of the colonies from the treated crops and the availability of alternative water sources nearby. Even for maize, where guttation occurs frequently, the available studies sufficiently demonstrate that under experimental conditions, bees are rarely observed collecting guttation fluid. EFSA: Noted It is already recognised by EFSA that this is just an overly conservative theoretical risk assessment scheme that will lead to more unnecessary higher-tier field experiments. A sound science proposal for initial tiers of the scheme should give an approximation of how close the likely exposure of bees is to a toxicologically significant level and not only based on precautionary. The proposed ETR threshold values should have been verified by extensive practical experience (field trials and incident data) of different plant protection products and use patterns. Otherwise, this scheme appears to be arbitrary. EFSA: Noted Besides, further information is still required by EFSA to make a judgement on its own approach, such as likely occurrence of guttation in terms of crop/calendar year combination and likely use of guttation fluid by honeybees. It is even required by EFSA feedback on the design of higher tier studies. On this basis, and in view of sound science guidance, it would appear reasonable to develop further this approach with the consultation of appropriated specialists, i.e. plant physiologists and apidologists together with expertise of those bee experts involved in the existing guttation studies, before this approach is proposed and implemented. In other words, current knowledge at EFSA seems to be insufficient to propose an appropriated risk assessment. EFSA: Noted The lack of a robust risk scheme will only lead to inconclusive conclusions and identification of data gaps by risk assessors. This should not be the ultimate goal of a good guidance document. EFSA supporting publication 2013:EN

15 In principle, it has to be considered that the guttation droplets are not a regular exposure scenario. The demand of water of the honeybee colony differs depending on their condition and the circumstances. Guttation droplets are one out of several possible water sources in the vicinity of a bee colony. In addition, guttation liquid is only available at a limited time in the season and during the day. Therefore, the risk assessment should be adjusted considering the real exposure rather than theoretical risk assessment scheme. EFSA: Noted box: The lower tier of the scheme simply assumes that guttation fluid contains the active substance at a proportion of the water solubility. From appendix A it appears that the values proposed (e.g. 40%) are derived from data on four active substances. This may suggest a high uncertainty as regards other substances that may be systemic too but the metabolism [in plants] of which can differ. Default values to be used in a regulatory decision making scheme must be selected with a high level of certainty to fit with regulatory purposes. Further data are considered necessary - that would include a mechanistic analysis of residue transfers in plants - before a default value is selected. EFSA: The data are from substances which have systemic properties and for which concerns were raised. It is considered appropriate to focus on these substances. When more data will become available it will be possible to refine the first tier approach in future. 18. Pesticide Action Network Europe BEL % of the fields is excessive as in the worst cases, big fields near big apiaries in dry conditions could result in dramatic honeybee colony losses. Low percentages should never be considered negligible Please correct µg/larva and not /bee. EFSA: Noted Figure 1 is somehow misleading since it invites to evaluate granule application (even those applied with the seeds) together with spray applications. I now that this is further explained in the text (lines ). A way to make figure 1 and text more coherent would be to add Seed treatments and granule application (together with the seed) in the scheme of figure 1. EFSA: This is changed in the final version of the GD CARI BEL It is not clear to me how it is proposed to evaluate the guttation produced from a sprayed plant, the residues from which come from the direct absorption of the active ingredient by the plant (and not through the soil). (lines ) EFSA: Substances with systemic properties can be taken up via the plant surface and residues can be found in guttation droplets. Line 146 first paragraph: Please include in the summary the use of water by bees also for thermoregulation of the colony. It is afterwards mentioned in the text, but not in the summary. Thermoregulation is a very relevant activity of the colony. EFSA: The text in the box highlights only what is assessed and highlights the assumptions and uncertainties. Line These other plants are not covered in the scheme below as the risk for the treated crop will pose a EFSA supporting publication 2013:EN

16 greater risk than these other plants. Agree. However, this needs to be acknowledge in the uncertainty section, as other plants showing contaminated guttation droplets enable further chronic exposure or delayed exposure. Point 3. [...] the use of guttation fluid in royal jelly and other brood food [...] It is good to recognise the knowledge gaps, but the proposal as it is weakens this part of the EFSA Guidance document. Why not to measure residues in guttation in field or greenhouse tests and work on measured concentrations? Line 343 What does TWA mean? EFSA: Time Weighted Average Equations: Instead of using as toxicological endpoints as LD50 or LC50, NOEC values should be used, as they are better estimates of risk for effects to happen. EFSA: It would be an option to use NOEC values as a measure of toxicity in the risk assessment. The advantage would be that NOEC values are easier to communicate than EC50 or ECx values. From a scientific point of view ECx values are preferred because they give a more exact measure of toxicity. The NOEC is dependant on the study design (spacing of concentrations and statistical power to detect effects) and variability in control groups. Lines These sentences have a weird structure. It seems that they are not finished and information is missing. Could you please check this? EFSA: Sentence was checked and found correct. Lines There is not reference EFSA, 2012c. Please verify this. EFSA: this was amended in the final version. Lines Risk mitigation for exposure to guttation The proposed measures of providing alternative sources of water to honeybees to avoid them collecting could be possible in some cases, but not always. See for example the case of colonies subject to transhumance. Normally beekeepers transport the hives in the lorries to places where there is no source of water to fill, for example, containers. Furthermore, this would not solve the problems that wild pollinators could experience from the exposure to guttation droplets. EFSA supporting publication 2013:EN

17 20. European Beekeeping Coordination BEL We do not agree with the risk assessment scheme proposed for for various reasons: 1. Line 191: This proposal in our opinion has no sense in landscape/real terms. It needs to be reminded that risk assessment of a pesticide is done for one active ingredient/product applied to one crop. In the environment, following the authorisation of the active ingredient/product for a variety of crops and application methods, the exposure is likely to be higher or longer because of the possibility of contemporary-occurring contaminated guttation droplets in the area of influence of a colony. However, it is almost impossible to describe this exposure a priori for all the agricultural areas in the EU. Maybe we are misunderstanding the proposal. In this case, we propose to further clarify. 2. First tier assessment of the exposure is based on using 40% of water solubility of the acute assessment, 22% of the chronic PEC for adults and 29% for the chronic PEC for larvae. These figures are further explained in the annex A where we see that the 40% rule is only based on the data of neonicotinoids. However, this relationship is not applicable to other pesticide families: carbamates (methiocarb) or phenyl-pyrazols (fipronil). We''ve rechecked the residue values included in Table H1 of EFSA, 2012a, and we have seen that the residues of fipronil come from the application of the commercial formulation Regent. No information found for methiocarb application. Copolymers exist that enhance the systemicity of active ingredients when formulated together (Dieckmann et al., 2010). As a result, the reason for the awkward behaviour of residues in guttation of these substances could well be because of the presence in the formulation of these molecules instead of the unreliability of measurements as stated in the document. Therefore, little could be estimated from the solubility of the initial active ingredients. This is another reason for not finding the proposed approach adequate. 3. Half-life is used to estimate the PEC to be used in chronic terms. Despite of the fact that we understand the logic behind these calculations, we are concerned about the conclusions that might be extracted by people with no bee expertise. One could think that with a half-life of 3 days, the risk of the exposure to is reduced. However, the various studies shown in figures H1 to H7 of the Scientific Opinion show enormous values of residues initially (around 100 ppm or higher) going down to 10 ppb, high enough to trigger acute mortality or sublethal effects one month or even three months after emergence (for winter OSR even 8 months). As a result, we wonder about the toxicological relevance of the concept of half-life and its use in risk assessment. One who does not have the complete information about the evolution of the residues in /any other matrix might be tempted to say that there is no problem. We do risk assessment on the basis of more or less standardise parameters, without questioning the real environmental relevance in terms of exposure. In contrast, a more correct approach would be to continue measuring residues in whatever matrix under study, and use for exposure determination the information of residue amount and time until disappearance or non-toxicity. 4. We''d like to propose directly to run tests in controlled conditions (e.g. greenhouses) with the formulated product in the application form subject to authorisation. Based on these, guttation residues should be collected and their evolution registered in time. Not only both the applicant and the risk assessors would have a clear picture of the systemicity of the products under test, but also they would have interesting information from an efficacy perspective. EFSA: Residues found in guttation droplets are greater than in other sources of water. The proposed RA is considered as worst case and should cover exposure to other contaminated sources of water. The screening step is based on water solubility as the water solubility will limit the concentration of the active substance. This approach is sufficiently protective if compared to available residue data. The next step would be refinement based on measured residues. EFSA supporting publication 2013:EN

18 21. The Swedish Chemicals Agency SWE Page 11 line 345: We would appreciate if the criterion for when the use of TWA is justified is specified in the text. EFSA: Evidence of no long-term effects after short-term exposure including time to onset of effects and decline of compound in guttation fluid can be used to proof that the twa approach is appropriate. 22. The Swedish Chemicals Agency SWE Page 10 line 300: It would be useful to add a reference to how the characterizing of the exposure to is performed in the field. EFSA: This is not possible because the available measurements are from (Schenke et al., 2010, 2011) as described in the EFSA Opinion (EFSA Panel on Plant Protection Poducts and their Residues (PPR), 2012a) and these references are a poster and a oral presentation. 23. The Swedish Chemicals Agency SWE Page 10 line 292: Is it possible to simplify the scheme including the possibility to jump from box 3 to 8 without the semi field studies? Then this could be stated right here, after box 3. EFSA: It is possible to do that. The final text in the GD explains this better. 24. the Netherlands (NPPO, Ctgb, RIVM, Bijen@wur) NLD 145 Since presence or absence of guttation is not known for (most of 90% percentile) crops, it is the default to always assume guttation. This is a conservative approach, and stresses the need for studies actually assessing whether guttation takes place or not. As a starting point it is of course acceptable, but on the other hand superfluous higher tier testing should be avoided. The uncertainty is addressed by EFSA. EFSA also addresses the uncertainties that bees might or might not use guttation to collect (2) as well as the uncertainty that nurse bees might or might not feed to the larvae (3). For that reason conservative starting points have been chosen. Again this stresses the need to study water collection behaviour of bees on guttation as well as the extent and origin of water feeding by nurses to larvae. EFSA: Noted 149 Publication of Nicolson 2009 is not included in the reference list. EFSA: That reference is now included in the fianl version of the GD. 204 Please add that 11.4 ul/bee is the uptake of adult bees per day Please add that the PEC based on the 22% of the water solubility is a PECtwa over 10 days (this is explained in the appendix but it adds clarity to mention it here as well). EFSA: this has been made clearer in the final verison of the GD. 221 The word initial is confusing and should be replaced by 5-d twa (the PEC based on 29% water solubility is not an initial concentration but a 5-d PECtwa, right?) Please add examples of which information could justify the use of a 10d-twa PEC. Also it seems contradictory that in the first tier, a 10d-twa PEC can be used but not in the higher tier. What is the EFSA supporting publication 2013:EN