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REPORT DG5/PRPB/VVB/11045 Scientific opinion on the EFSA GD for the assessment of risks to bees (Apis mellifera, Bombus spp. and solitary bees) from the use of plant protection products
Prepared by: Dr. Tjeerd Blacquière Bijen@wur, Plant Research International, Wageningen Universiteit & Research, Wageningen [email protected] Prof. Dr. ir. Guy Smagghe Vakgroep Gewasbescherming, Faculteit Bio-ingenieurswetenschappen, Universiteit Gent [email protected]
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PREFACE
Version 5 of this document has been additionally supplied with some comments to statements or opinions that were made by CARI to version 3 of the document, and to which in the opinion of the authors no alteration of the original text nor a compromise was warranted. These places in the document are marked with *COMMENT by CARI* n
r. xx. At the end of the document these comments
are added in a list, and answered by the authors.
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1. LIST OF DOCUMENTS AND SCIENTIFIC LITERATURE AS FOUND AND USED FOR THIS REPORT
For this limited literature search we have been employing open access general literature databases, specialized literature databases, and also peer-reviewed scientific databases as MedLine and Web-of-Knowledge. During this tasks we took specific care to update with the recent documents. Most documents are from 2011 and 2012. The different documents are listed hereunder in alphabetic order. Here we notice that we have not tried to cover all literature extensively, which would not have been possible within the scope of our assignment, but we generally relied upon our general knowledge of the issue. We addressed some cases by making some more specific citations. Where conclusions have been drawn based on our knowledge, without addressing to references, these conclusions have been presented in italics, while recommendations have been presented in bold and Italics. AFSSA (Agence Française de Sécrurité Sanitaire et Aliments) (2008). Mortalité, effondrements et
affaiblissements des colonies d’abeilles . Composition of the working group on “Weakening, collapse and mortality of bee colonies”. 218p.
Alix, A. & Vergnet, C. (2007). Risk assessment to honey bees: a scheme developed in France for non-sprayed systemic compounds. Pest Manag Sci 63:1069-1080.
Andriessen, L. (2011) Hoe groot wordt een bijenvolk? Nieuwsbrief 22 Bijen@wur, http://enews.nieuwskiosk.nl/more.aspx?e=15018&b=127487&u=$uid$
Bernal J, Garrido-Bailon E, del Nozal MJ, Gonzalez-Porto AV, Martin-Hernandez R, Diego JC, Jimenez JJ, Bernal JL, Higes M. 2010. Overview of pesticide residues in stored pollen and their potential effect on bee colony (Apis mellifera) losses in Spain. Journal of Economic Entomology 103:1964-1971.
Bernal J, Martin-hernadez R, Diego JC, Nozal MJ, Gozalez-Porto AV, Bernal JL & Higes M, 2011. An exposure study to assess the potential impact of fipronil in treated sunflower seeds on honey bee colony losses in Spain. Pest Manag Sci on line, DOI10.1002/ps.2188
Blacquiere, T., Smagghe, G., Van Gestel, C.A.M. & Mommaerts, V. (2012). Neonicotinoids in bees: a review on concentrations, side-effects and risk-assessment. Ecotoxicology, 21, 973-992.
Blacquiere, T., Smagghe, G., Van Gestel, C.A.M. & Mommaerts, V. (2012). Neonicotinoïden en fipronil en strefte van bijen en bijenvolken–Overzicht van open beschikbare peer-reviewed laboratorium-, veld- en monitoringsstudies. Plant Research International, WUR, rapport 439, 73p.
Charvet R, Katouzian-Safadi M, Colin ME, Marchand PA, Bonmatin JM. (2004) Systemic insecticides: new risk for pollinator insects. Ann Pharm Fr 62:29-35.
Chauzat MP, Carpentier P, Martel AC, Bougeard S, Cougoule N, Porta P, Lachaize J, Madec F, Aubert M, Faucon JP. 2009. Influence of pesticide residues on honey bee (Hymenoptera: Apidae) colony health in France. Environmental Entomology 38:514-523.
Chauzat MP, Faucon JP, Martel AC, Lachaize J, Cougoule N, Aubert M. 2006. A survey of pesticide residues in pollen loads collected by honey bees in France. Journal of Economic Entomology 99:253-262.
Chauzat MP, Martel AC, Cougoule N, Porta P, Lachaize J, Zeggane S, Aubert M, Carpentier P, Faucon JP. 2011. An assessment of honeybee colony matrices, Apis mellifera (Hymenoptera Apidae) to monitor pesticide presences in continental France. Environmental Toxicology and Chemistry 30:103-111.
Chauzat, M. P., J. P. Faucon, A. C. Martel, J. Lachaize, N. Cougoule, and M. Aubert. 2006. A survey on pesticide residues in pollen loads collected by honey-bees (Apis mellifera) in France. J. Econ. Entomol. 99: 253-262.
Chauzat, MP, Carpentier P, Martel AM, Bougeard S, Cougoule N, Porta P, LaChaize J, Madec F, Aubert M & Faucon JP 2009. Influence of Pesticide Residues on Honey Bee (Hymenoptera: Apidae) Colony Health in France. Environ. Entomol. 38(3): 514-523Crane E (1975). Honey: a comprehensive survey. New York: Crane, Russak. Published in co-operation with the Bee Research Association.
Cresswell JE, Page CJ, Uygun MB, Holmbergh M, Li Y, Wheeler JG, Laycock I, Pook CJ, de Ibarra NH, Smirnoff N., Tyler C.R. (2012). Differential sensitivity of honey bees and bumble bees to a dietary insecticide (imidacloprid). Zoology 115(6), 365-71. doi: 10.1016/j.zool.2012.05.003.
Cresswell, J.E. & Thompson, H.M. (2012). Comment on “A common pesticide decreases foraging success and survival in honey bees”. Science, 337, 1453-b.
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DEFRA (2012). Neonicotinoid insecticides and bees. - The state of the science and the regulatory response. 36p.
EFSA (2012). Panel on Plant Protection Products and their Residues (PPR); 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 Journal 2012; 10(5) 2668. [275 pp.] doi:10.2903/j.efsa.2012.2668.
EFSA (2012). Statement on the findings in recent studies investigating sub-lethal effects in bees of some neonicotinoids in consideration of the uses currently authorised in Europe. EFSA Journal 2012;10(6):2752. [27 pp.] doi:10.2903/j.efsa.2012.2752.
EPA-USA (2012) White Paper in Support of the Proposed Risk Assessment Process for Bees. Submitted to the FIFRA Scientific Advisory Panel for Review and Comment, September 11-14, 2012, 275 p.
European Food Safety Authority; EFSA Guidance Document on the Risk Assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal 20YY;volume(issue):NNNN. [202 pp.] doi:10.2903/j.efsa.20YY.NNNN. Available online: www.efsa.europa.eu/efsajournal
Genersch E, Von der Ohe W, Kaatz H, Schroeder A, Otten C, Büchler R, Berg S,Ritter W, Mühlen W, Gisder S, Meixner M, Liebig G, Rosenkranz P 2010. The German bee monitoring project: a long term study to understand periodically high winter losses of honey bee colonies. Apidologie 41, 332–352Henry, M., Béguin, M., Requier, F., Rollin, O., Odoux, J.-F., Aupinel, P., Aptel, J., Tchamitchian, J. & Decourtye, A. (2012). A Common Pesticide Decreases Foraging Success and Survival in Honey Bees. Science 336, 348-350.
Henry, M., Béguin, M., Requier, F., Rollin, O., Odoux, J.-F., Aupinel, P., Aptel, J., Tchamitchian, J. & Decourtye, A. (2012). Response to comment on “A Common Pesticide Decreases Foraging Success and Survival in Honey Bees”. Science 337, 1453-c.
ICPBR (2009). Proceedings of the 10th International Symposium of the ICP-BR Bee Protection Group.
Julius-Kühn-Archives 423, 1-161. ICPBR (2012). Proceedings of the 11
th International Symposium of the ICP-BR Bee Protection Group.
Julius-Kühn-Archives 437, 1-222. Kubik M, Nowacki J, Pidek A, Warakomska Z, Michalczuk L and Goszczynski W, 1999. Pesticide
residues in bee products collected from cherry trees protected during blooming period with contact and systemic fungicides. Apidologie, 30, 521-532.
Kubik M, Nowacki J, Pidek A, Warakomska Z, Michalczuk L, Goszczyñski W and Dwuznik B, 2000. Residues of Captan (contact) and difenoconazole (systemic) fungicides in bee products from an apple orchard. Apidologie, 314, 531-541.Mommaerts, V. & Smagghe, G. (2011). Side-effects of pesticides on the pollinator Bombus: an overview. In: "Pesticides in the Modern World – Pests Control and Pesticides Exposure and Toxicity Assessment" (Stoytcheva, M., ed.). InTech Publishing, Croatia, 507-552. ISBN 978-953-307-457-3.
Mommaerts, V., Renders, S., Boulet, J., Besard, L., Sterk, G. & Smagghe, G. (2010). Risk assessment for side-effects of neonicotinoids against bumblebees with and without impairing foraging behaviour. Ecotoxicology, 19, 207-215.
Mullin CA, Frazier M, Frazier JL, Ashcroft S, Simonds R, vanEngelsdorp, D & Pettis JS 2010. High levels of miticides and agrochemicals in North American apiaries: implications for honey bee health. PlosOne 5(3), e9754. doi:10.1371
OEPP/EPPO (2010). Environmental risk assessment scheme for plant protection products. Système pour l’évaluation du risque des produits phytosanitaires pour l’environnement. Chapter 10: honeybees. Bulletin OEPP/EPPO Bulletin 40, 323-331.
OEPP/EPPO (2010). Environmental risk assessment scheme for plant protection products. Système pour l’évaluation du risque des produits phytosanitaires pour l’environnement. Side-effects on noneybees. Bulletin OEPP/EPPO Bulletin 40, 313-319.
Oomen P.A., De Ruijter A. & Van der Steen J. (1992). Method for honeybee brood feeding tests with insect growth-regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.
OPERA (2011). Bee health in Europe - Facts & figures. Compendium of the latest information on bee health in Europe. 52 p.
Schmuck R, Schoning R, Stork A, Schramel O. (2001) Risk posed to honeybees (Apis mellifera L. Hymenoptera) by an imidacloprid seed dressing of sunflowers. Pest Manag Sci 57:225-238.
Schneider CW, Tautz J, Grünewald B, Fuchs S (2012) RFID Tracking of Sublethal Effects of Two Neonicotinoid Insecticides on the Foraging Behavior of Apis mellifera. PLoS ONE 7(1): e30023. doi:10.1371/journal.pone.0030023
SETAC (2011). Pesticide Risk Assessment for Pollinators - Summary of a SETAC Pellston Workshop,
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15–21 January 2011, Pensacola, Florida, USA. 45p. Simon, N. “Environmental Risk assessment – State of play and future proposals for honeybees”.
European Beekeeping Coordination, 38 p. (http://bee-life.eu/medias/position_coeur/era-ebc-v12.pdf)
Smagghe G, Mommaerts V, Blacquière, T. 2012. Effect of neonicotinoids on pollinators: global adequate risks assessment crucial. Comment for "Field Research on Bees Raises Concern About Low-Dose Pesticides". Science online http://comments.sciencemag.org/content/10.1126/science.335.6076.1555
Steen, J.J.M. van der; Cornelissen, B.; Donders, J.N.L.C.; Blacquière, T.; Dooremalen, C. van (2012). How honey bees of successive age classes are distributed over a one storey, ten frames hive. Journal of Apicultural Research, vol.51, nr.2 - p. 174 - 178.
Stoner, K.A. & Eitzer, B.D.(2012) Movement of Soil-Applied Imidacloprid and Thiamethoxam into Nectar and Pollen of Squash (Cucurbita pepo). PLoS ONE 7(6): e39114. doi:10.1371/journal.pone.0039114.
Suchail, S., Guez, D., & Belzunces, L. (2001). Discrepancy between acute and chronic toxicity induced by imidacloprid and its metabolites in Apis mellifera. Environmental Toxicology and Chemistry , 20 (11), 2482-2486.
Tapparo A, Giorio C, Marzaro M, Marton D, Solda` L, Girolami V. (2011) Rapid analysis of neonicotinoid insecticides in guttation drops of corn seedlings obtained from coated seeds. Journal of Environmental Monitoring 13:1564-1568
Thompson, H.M. (2012). Interaction between pesticides and other factors in effects on bees. Supporting Publications 2012:EN-340. [204 pp.]. Available online: www.efsa.europa.eu/publications
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2. BRIEF OVERVIEW OF OTHER SCHEMES/PROPOSALS 2.1. Risk assessment schemes by EPPO and ICPBR The different risk assessment schemes/scenarios as developed by the EPPO and ICPBR have been published in different documents, as listed hereunder. We refer to these and also provide the information on the respective specific scope and the approval and amendment. The internet link is also given for easy consulting.
OEPP/EPPO (2010). Environmental risk assessment scheme for plant protection products. Système pour l’évaluation du risque des produits phytosanitaires pour l’environnement. Side-effects on honeybees. Bulletin OEPP/EPPO Bulletin 40, 313-319. (http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2338.2010.02418.x/full)
Specific scope: This standard describes the conduct of trials for the evaluation of side-effects of plant protection products on honeybees.
Specific approval and amendment: First approved in 1991-09. Aligned with revised standard text in 1998.
Revision (updated with ICPBR-recommendations) approved in 2000-09 and 2010-09.
OEPP/EPPO (2010). Environmental risk assessment scheme for plant protection products. Système pour l’évaluation du risque des produits phytosanitaires pour l’environnement. Chapter 10: honeybees. Bulletin OEPP/EPPO Bulletin 40, 323-331. (http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2338.2010.02419.x/full)
Specific scope: This standard provides an assessment of the risks presented by plant protection products to
honeybees. It was revised to include the risk presented by systemic plant protection products.
Specific approval and amendment: First approved in 1992-09. Edited as an EPPO Standard in 1998. Revised in 2002-09 and 2010-09 (updated with ICPBR recommendations).
ICPBR (2009). Proceedings of the 10th International Symposium of the ICP-BR Bee Protection
Group. Julius-Kühn-Archives 423, 1-161. (http://pub.jki.bund.de/index.php/JKA/issue/view/17)
ICPBR (2012). Proceedings of the 11th International Symposium of the ICP-BR Bee Protection
Group. Julius-Kühn-Archives 437, 1-222. (http://pub.jki.bund.de/index.php/JKA/issue/view/801) *COMMENT by CARI no 1* 2.2. Risk assessment proposal by EBC The risk assessment scheme as proposed by the European Beekeeping Coordination (EBC), has been summarized based on the document as written by Noa Simon “Environmental Risk assessment – State of play and future proposals for honeybees”. (http://bee-life.eu/medias/position_coeur/era-ebc-v12.pdf) The proposed risk assessment scheme by EBC is merely inspired by the felt need to use a different or at least a more stringent approach for systemic pesticides, since these may easily show up as residues in the food (nectar and pollen) of bees, and therefore may lead to chronic (lethal and non-lethal) exposures. In comparison and contrast to the operative scheme of EPPO/OECD, the following main points of approach are proposed as follows hereunder.
Tier 1
1. Determination of potential exposure of honeybees:
a. Not consider plant attractiveness in the decision whether a possible exposure is realistic. The rationale is that systemic insecticides will eventually anyhow be transmitted to the environment and end up in other forage crops, as well as may be exposing bees through guttation, including by non-attractive plants
b. They propose for systemic insecticides, independent of the way of application (both sprays, seed coating, soil drenching) to always carry out extra testing in comparison to non-systemic chemicals:
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b.i. For sprayed products they propose to use the octanol/air or octanol/water partition coefficient as an indication how probably pollen and nectar would be contaminated with residues upon spray application
b.ii. Test for residues after spraying as well as the other application methods, to be determined in pollen, honeydew and nectar, as well as possible guttation, up to the ppb level and with LOD<<LOQ
2. Acute LD50 testing
a. Any effect should imply further testing
b. Also a LD15 is proposed (but not worked out)
c. For spray applications: use HQ (= application rate/LD50) or use the TER (toxicity /exposure ratio; LD50/PEC (PEC = probable exposure concentration)
c.i.
c.ii.
3. Chronic oral exposure test (lab tests)
a. Should be done always with systemic PPPs
b. Chronic mortality test: HQ2 calculated from PEC (probable exposure rate) and PNEC (predicted no effect concentration; is between NOEC and LOEC)
c. If HQ2
4. Larval exposure test (lab test (Aupinel, in vitro reared, or Oomen brood test)
a. Should be done always with systemic PPPs
b. Larval mortality test: HQ2 calculated from PEC (probable exposure rate) and PNEC (predicted no effect concentration; is between NOEC and LOEC)
c. If HQ3
Tier 2 colony level
Always consider behaviour, immunology and social behaviour of bees.
a. Calculate PEC/PNEC = HQ4
b. If HQ4 < 1: safe
Higher Tier
This has not been worked out.
Further suggestions for improvements:
In oral chronic toxicity testing: o Use three temperatures: 15˚C, 25˚C, 35˚C o Always use young adult bees. However: collect them from the frames without brood,
or from the hive entrance. These two demands are contradictory (see also M . Checklists for Evaluating Laboratory Studies, comment at lines 4486 vv.)
o Use as a positive control for systemic PPPs not dimethoate but imidacloprid (of which they suggest an LC50 of 12 pg/bee (Suchail et al, 2001)
If no toxic standard is used: increase number of replications, and check the chemical beforehand and afterwards
o Dosing: 1/10 every day, or: concentration range with free feeding (ad libitum). The latter needs daily checking of the amount consumed!
Determine as a result the LC50 (from chronic tox study) / LD50 (from acute tox test):
If LC50/LD50 > 2: extra safety margin should be applied to TER calculation, as the PPP shows higher chronic activity
PER test for behavioural/learning abilities
It is suggested to use this as a measure
It was not worked out, no protocols suggested as yet Sublethal effects of pesticides on immune response of bees and bee colonies EBC considers reduced immune competence of colonies as one of the threats of chronic exposure to systemic insecticides. Although the fear is justifiable, the amount of literature for drawing a causal relationship between pesticides and immune competence is small. The issue is not addressed in the draft EFSA GD, but EFSA did discuss the available literature in the Scientific Opinion (May 2012), and stressed the ‘’difficulty to extrapolate to field conditions…’’ (page 114). Moreover, as Smagghe et al. (2012) stated, even in laboratory studies interactions can only be studied when all interacting factors are applied in a realistic way. Such studies so far hardly exist. EFSA did also commission a study on the “Interaction between pesticides and other factors in effects on bees” (Thompson, 2012). This
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study includes the interactions with diseases and effects on immune competence. This information should find its way into future test guidances. For instance, upon validation, the health status and specific observations trying to determine the immune competence of exposed colonies can be useful in the risk assessment scheme.
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3. OVERVIEW OF THE STRONG, WEAK/UNCLEAR AND NEUTRAL POINTS ON THE EFSA GD -- A CRITICAL AND SCIENTIFICALLY-BASED ANALYSIS Hereunder we have listed the detailed comments on the EFSA GD with strong and weak/unclear points, listed per chapter, section and line. We want to remark that the different points were analysed based on our current scientific knowledge and experience, and this was done independently and with the only concern related to an adequate risk assessment of pesticides on bees. Where possible we provided extra information and/or proposed an alternative based on the scientific literature and the experiences of working groups in the domain of risk assessment with bees. These recommendations are given in blue and bold. Per chapter/section/line: 2. Protection goals as agreed with risk managers from member states
240- Two remarks on “the magnitude of effects on colonies should not exceed 7%”: -The magnitude and timeline are not clearly defined. It is not clear how this percentage has to be calculated. -We believe that the use of a factor of 7% will be virtually impossible to be applied given the level of uncertainty in estimates of colony size. Indeed it is unlikely that frame coverage can be accurately reported to better than 10% at the efficiency needed to not adversely affect the colony during the assessment. Also it is not clear how the rigour of colony assessments will be determined? We recommend to validate the colony estimation by frame coverage method, and use the outcome discrimination strength as the input for the lowest discrimination level between control and affected colonies.
243- We can agree that the level of honey production can provide useful information to risk assessors, but we feel that honey production is not the “best” relevant for risk assessments. The reason for this reason is that honey production depends also on other factors in the colony and the environment. Moreover, if a PPS would affect the rate of nectar foraging by bees, either through repellence, reduced reward (sugar concentration) or through behavioural adaptations to the changes, this may affect honey production, but does not pose a risk to the colonies. A grower of a crop cannot be held responsible for the nectar supply of foraging bees. We also want to notice here that surrogate parameters are currently available through colony health and development, which imply an appropriate honey collection potential. We recommend to use these surrogate parameters as measurement endpoints instead of honey production in order to meet this protection goal. As surrogate parameters, we propose parameters that are linked to colony health and development: good examples are numbers of adult bees, surface area of (capped) brood cells. * COMMENT by CARI no 2* Honey production can of course be one of the parameters that are provided by the studies as part of the total pool of information; but care has to be taken with interpretation of this parameter.
3. Exposure assessment for bees 3.1.2. Specification of the exposure assessment goal
306-312
This paragraph states that incidents are not avoided with the current scheme. This cannot be the intention of the risk managers. Furthermore, we wonder if the statement is correct, since HQ values are calculated with triggers <<50 and the currently used HQ trigger of >50 has been shown in the past to be a good predictor of incidents.
337- 338
The list of plants visited by bees for honeydew based on data from Italy is not very relevant for Belgium. For example, in Belgium honeydew is found on Fagus and Rosa, but also on
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potato and cereal crops. No data from literature are available. As already stated in the guidance, honeydew-producing insect populations are usually controlled in crops. Many crops in Belgium show guttation. This phenomenon mainly occurs when there is a surplus of water in the environment. Bees will not forage exclusively on guttation water since they have alternatives. Note: guttation and surface water (including puddles) are treated in the newly added Feb 2013 chapters. We propose to draw lists of possible honeydew-producing crops for specific regions. These regions have to be much narrower than the proposed zonal classification. If this is in conflict with each other, we propose to omit such a listing at all. COMMENT of CARI 3
3.1.3. Selection of the eco-toxicologically relevant types of concentration
327 Our view on the importance of the exposure to honeydew and guttation is as follows:
Honeydew is an important source of forage during periods of nectar shortage, mortality incidents have been reported in the Netherlands and Germany on potatoes due to honeydew (see Proceedings of the ICPBR Avignon meeting 1999 (INRA Les Colloques 98).
Guttation water has so far been identified as less of a risk than originally proposed: there is a working group of the ICPPR Bees and Pesticides group evaluating exactly this issue and they are developing proposals for its evaluation and risk assessment (see Julius-Kühn-Archives 437: http://pub.jki.bund.de/index.php/JKA/article/view/1982/2358).
We propose to collect data at national level or where necessary to perform a preliminary study for residue monitoring in surface water. We recommend to follow up with the results and conclusions of the ICPBR working group or to follow the reasoning in the ‘White paper’.
Note: guttation and surface water (including puddles) are treated in the newly added Feb 2013 chapters. Although very conservative, the reasoning of EFSA can be defended until more data are available (see at 2,1 of the newly added chapters)
473 It is unclear if the ‘metabolism adjustment factor’ is always required. Is it always a refinement or can this factor also increase the risk (in which case it should always be required)? How many semi-field studies are necessary to get a good idea of the metabolism adjustment factor? We recommend to EFSA for providing more details on this matter of the need and use of metabolism adjustment factor.
467-469
There is little metabolism within the foragers during transport as pollen is carried externally and honey in the honey stomach which has no significant metabolic potential. The level in the hive will depend on the stage of processing (so at what point is the sample taken in the semi-field study?); this needs to be representative of the whole colony and pollen is moved around during processing? We recommend the following. In many crops, the collection of pollen and nectar is very difficult, and so it is more practical to collect pollen in pollen traps at the hive entrance and nectar from honey stomachs as this is the highest level entering the hive. This prevents the need for a “metabolism factor”. This can be used to determine that all hives are exposed to the active substance rather than 90% of the hives.
482 Post-authorisation monitoring. This is a rather extensive requirement of the monitoring, with a lot a uncertainties. It is not clear who will oversee that this monitoring is taking place in the right way? In the UK post registration monitoring is supported by the government.
493 We question here whether it is realistic and relevant to set a circle around the hive with a radius of 3 km? How many farmers within the 2827 ha are concerned with this approach? In addition, we want to note here that the time of introduction of the PPP into the market plays a role. For instance, in case a newly adopted product is slowly entering the market, a number of years of monitoring is advisable. Indeed here the pesticide a.i./product might not be very much used during the first year of authorisation, and in turn exposure might be unrealistic With quickly adopted PPPs, one or two seasons should be sufficient. We recommend to perform monitoring over several years as this allows a better data gathering.
505 The period of guttation may be for most of the period of growth of the crop. We recommend to determine this period as the period at which residues in the fluid
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pose a potential risk to bees.
508 How can a representative sample be taken from the hive? See also 472. We propose to use the incoming pollen (pollen trap) and honey sacs from returning foragers as input samples. On this matter, we want to remark that Kubik et al. (1999, 2000) reported that the residue levels of fungicides were higher in bee bread than in pollen pellets, but the authors also stated that this cannot be true. These scientists attributed the difference due to fixation of the residues to carbohydrates in pollen, which compromised the recovery. So in the conclusion of these two papers the higher amounts in the beebread are due to an artefact. We can agree with the latter conclusion, as it is also common sense, that residue levels in beebread are lower than in pollen pellets. However, for testing purposes, testing the residues in beebread could be added in order to have a more adequate exposure assessment. If not, another approach could be considered. Knowing that variations in the evaluation of residues may happen in pollen pellets and beebread, risk assessors may prefer to apply an uncertainty factor whenever dealing with the residues found in pollen pellets.
3.2. Exposure Assessment for spray applications 3.2.2. Conservative default values for RUDs of pollen and nectar after spray applications
540 More explanation is needed why the default values should be based on 99th percentile value
for RUDs (Residue Unit Doses). Why was chosen for such conservative defaults?
3.3. Exposure Assessment for solids 3.3.1. Introduction 3.3.2. Exposure Assessment for seed treatments
944 Again metabolism factor should be replaced by measuring residues in pollen and nectar from bees returning directly to the hive to remove the “metabolism factor”.
3.3.2.1 The exposure assessments for the different types of nectar and pollen collected by the bees
954 The active substance of some pesticides is taken up and transported to the nectar and pollen. The extent of this uptake is strongly influenced by the type of active substance (insecticides versus fungicides, systemic vs not systemic) and the purpose of the pesticide (short versus long period of protection). In case there is proven transport in the nectar and pollen and this combined with a toxicity of the product, we agree with the new guidance document of EFSA that in the assessment of exposure, first it needs to be evaluated the capacity of any active substance/product to contaminate pollen and nectar: systemicity, application pattern, persistency. We agree that fungicides that are potential contaminator to pollen and nectar (and that are potentially toxic for bees) are to be tested in first tier.
COMMENT of CARI 4
3.3.2.3. Concentrations in pollen and nectar in succeeding annual crops
999- It is proposed to perform a risk assessment in the case of annual succeeding crops after a seed treatment. Although in principle an exposure may not be excluded, the intensity of exposure should be documented in order to define concerns as regards the relative risks to bees. See citations added at 9.2.2, line 3466. Based on literature, the residues in nectar and pollen in succeeding crops are more than 10 times lower than in the first crop. We recommend to do only risk assessment for annual succeeding crops if a risk is
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probable. The probability of the risk should be determined by the amount of residues remaining in the soil after application, taking into consideration the different agronomical practices linked to the treated crop.
3.3.2.4. Concentration in pollen and nectar in field margins General comments on seed treatments:
The document still includes two scenarios for seed treatment in relation to dust drift. We favour the second scenario: Describe class of sowing equipment for a certain seed treatment: exclude sowing machines that generate more dust emission. In the case of scenario 1, calculations are made with a worst-case drilling machine with a high rate of emission. This situation is not representative for Belgium and some neighbouring countries, and certainly not for all crops and treated seeds (see Appendix D and lines 3941-3947). At the same time the authorisation of seed treatment products is blocked due to alleged dust drift which does not take place in our situation. Scenario 2 is justified, because if necessary, risks are mitigated by prescribing certain seed drilling technique. See also line 3427. We want to note here that deflectors do not reduce dust production to a 100% as given by the APEnet experiences. The second scenario will also enhance the innovation of emission-low technology. Furthermore, countries which have invested in these techniques will not be disadvantaged.
It should also be noted that dust emissions are the subject of an ICPPR working group and their considerations are published in Julius-Kühn-Archives 437 http://pub.jki.bund.de/index.php/JKA/article/view/1981/2357. The latter ICPBR group continues its work and may be helpful to discuss approaches. In parallel, a working group or workshop could be organised by the EFSA to continue the development of the methodologies proposed in the GD document.
1057 Appendix G should be Appendix D.
1072 We can agree that dusts may cause higher toxicity than sprays, but it is not clear where this factor of 5 is derived from.
1076-1077
Comments:
It looks not clear to us which “other crops” are meant?, and how is this percentage derived? The percentage of 2.3% seems rather high. For example in the case of vegetable seeds with high quality film coating the percentage will be low, should be comparable to that of sugar beets.
Based on the principle of open policy, we agree to the recommendation for making the results of the Heubach tests of all treated seeds available to risk assessors.
The percentages differ from line 4366-4367 and Table K1 (line 4419-4420)
1106 We notice that the Heubach-test is still in development and not yet suitable for all crops. This should be a priority for research in the near future.
3.3.3. Exposure Assessment for granules 3.3.3.4. Concentrations in pollen and nectar in plants in field margins
1370 The default value of 11% dust drift is very high. It is appreciated that in cases that data are lacking, a conservative approach is chosen. But we think that for many granules there is no air-assisted application which makes this default percentage of 11% too conservative.
3.4. Recommendations for further work to improve or underpin the proposed exposure assessment guidance
1455-1550
A long list of recommendations is made here. However, it is not clear which of these are essential to be solved before the guidance document can be used. Some of these proposed further studies/analyses could be very time consuming. Furthermore the accuracy of the outcome of some of the analyses may be weak due to crop rotation cycles, introduction of new crops, etc. We want to note that the data should also include flowering weeds around crops as these are a significant source of bee forage and are actively encouraged to
13
enhance biodiversity. For example, in locations with large areas of flowering maize, a significant proportion (>50%) of the pollen returned to the hive is from non-maize sources.
4. Laboratory, semi-field and field studies
4.1. Acute laboratory (oral+ contact LD 50), 10-d laboratory adult (LC50), Aupinel larvae test
1566 It should be better defined whether the LD50 is expressed in mg of the active substance (a.s.) or of the formulation.
4.2 Semi-field and field studies
1688 This sentence is confusing as all options in the table lead to a semi-field study. Indeed this section never explicitly mentions a field study.
1690-/ table
Comments:
The table includes addressing when to carry out a semi-field or field study but is not very helpful. It seems unnecessarily repetitive. For example, the first two options could be combined: “When the risk quotient for adult acute oral and/or contact LD50 is breached concern is related to acute effects…”). The outcome will be the same i.e. short-term higher tier testing according to EPPO 170.
There exists confusion and contradiction in the table. For instance, in both the chronic oral risk quotient and the bioaccumulative risk assessment, it refers to the need to extend the study sufficiently to ensure that long-term effects on adult bees and the colony can be assessed. However, in the proposed study design it states that as the effects are short-term studies according to OECD 75 can be conducted.
The decision making scheme as presented is too prescriptive and does not address a risk based approach to the decision making process for higher tier testing i.e. what test to conduct and how to design it. Thus, there are a number of paths that may lead to higher tier testing e.g. an acute risk as a result of direct/indirect exposure, a longer term risk as a result of chronic effects or chronic exposure (as a result of systemic activity and/or environmental persistence) or brood effects as a result of IGR activity. The nature of the initial risk profile will determine if a cage and/or field trial is appropriate and how each should be designed.
Third and fourth line: the second cell talks about long-term effects but the third cell about short-term effects; please check whether this is correct.
1696: In the EPPO honey bee RA scheme there is a flow diagram that lays out clearly the various paths that can be followed, including at the higher tier, together with the decision criteria that are needed to move between the various stages. In particular, there should be an option to decide on whether to conduct a semi-field (cage) study or proceed directly to a full field study (which in part will be determined by the requirements of the identified risk).
1710: Deciding between a semi-field and a (higher-tiered) field test will be to some extent on a case-by-case basis. Both have value depending on the nature of the risk and the level of the information required, for example as part of a sequential testing scheme. Basically, semi-field testing is a suitable option before field testing unless specific questions are being asked. The advantage of semi-field tests is that potential mortality is easier to assess and that exposure is ensured and can be easily proven. In semi-field tests, bee colonies are exposed in tunnels to a treated crop. Bees cannot avoid exposure to treated plants, while in field tests, where bee colonies are exposed in plots to the treated crops and are thus free of movements between the crop and surrounding areas. Field trials are more realistic in terms of exposure and with free-flying colonies under normal beekeeping conditions allow longer-term effects to be considered (including, if necessary, over-winter survival). It is evident that this results in a higher level of variability as the colonies may be exposed to a number of factors that are outside the control of the specific study. This has to be taken into account when assessing the results from cage and field studies.
1712 The importance of demonstrating that adequate exposure has been achieved in semi-field and field studies is clear. What is not clear is the proposed method for demonstrating appropriate exposure using residue levels measured in the treated crop and hive. There are many factors that will affect the levels of residues that may be found inside the hive. For example, for an active substance with a high level of acute toxicity there may be high levels
14
of mortality amongst foraging workers in the field so reducing hive exposure although overall the colony is impacted. Conversely, pyrethroids are known to repel foragers such that they avoid foraging on treated crop so that they avoid lethal exposure levels (again resulting in lower hives residues) and this is an inherent property of the compound that lowers its risk. There are also factors inside the hive that will affect residue levels e.g. the amount of food stores initially present, the rate of consumption of the food stores by the colony etc. The guidance indicates that the in-hive concentration of pollen and nectar in field studies should be higher than that measured under semi-field conditions. Given the additional dilution that is experienced under field conditions (if from other foraging sources), the only way that this could be achieved would be to apply higher rates in the field study (the whole point of the field study is that it is supposed to reflect more realistic exposure). Has the approach proposed been tested with real data to see if it is actually workable? We recommend that in practice a number of factors can be useful in assessing exposure, to be sure this has been sufficient in a specific study. In this respect it can also be useful to use a toxic standard, although this is not usually appropriate in the case of field trials. Parameters such as flight intensity and observation of the activity on flowers of the treated crop can provide useful information for that purpose, while pollen collection and residue analysis can provide useful supporting information. A quantified assessment of the exposure may be particularly important in the case of systemic products, as reference substances for systemic products are difficult to define, being also dependent on crop properties.
1725-1743
Comments:
We believe there appears to be an error in the approach. The proposed adjustment factor A should be defined as P hive / P flower instead of P flower / P hive as proposed in the EFSA guideline. In case the chemical (in-hive residue of PPP) is totally degraded (P hive = 0) and with A = P flower / P hive, this adjustment factor of A would reach infinity and not A = 0 as stated on line 1738.
It is highly unlikely that the residues in the hive in a field study will be greater than those in a semi-field study due to the fact that the bees forage on a variety of sources of pollen and nectar within the crop and field margins. Indeed, in semi-field studies bees do not have a choice to forage elsewhere, while in field studies at least some of the foragers will always find food outside of the treated field. In addition, it should be noted that pollen and nectar are mixed within the comb so dilution will occur within the colony.
1748 The EFSA guideline is proposing that a homing study should be carried out. We confirm that such is useful in risk assessment. However, we have no information on the availability of a validated protocol for homing studies yet. In addition, there is lack of a validated model to analyse homing study data, as recently discussed by Henry et al. (2012). The proposed homing test has not been validated and no protocol is as yet available. Several other homing experiments might be considered alike as examples for a homing test protocol. See also with Appendix O. We recommend to test and validate homing experiments, and also include other homing experiments (for example Schneider et al., 2012) as input. It is also important to make clear which role and place in the risk assessment scheme are dedicated to homing experiments (before semi-field testing, or coupled to field testing?)
5.Trigger values
1792- Comments on the redefinition of the HQ values and this also in different bees:
We believe that the usage of the lowest background mortality will lead to a conservative and unrealistic assessment.
We recommend that a realistic background mortality should be used, not the lowest. One could discard the whole experiment when the background mortality is (too) high (lower tier). In higher tier studies the mortality of a control group can also be used. Again the whole experiment should be discarded if the control colony forager mortality is very high. Here we want to note that there exists no definition for a “realistic background mortality rate” in the EFSA GD. Based on own experiences, the measurement of foragers mortality in the field is very difficult. Moreover, it may be very variable, for instance in relation to showers etc. Mortality should be evaluated as a comparison between the control versus the tested group. COMMENT by CARI 5
15
As given in Appendix U, it is noted that the first tier triggers for honeybees are more stringent than before. Currently, the HQ trigger is set at 33 for lowest observed mortality (compared to 50 before). Because of lack of data, a conservative approach has been taken. For bumblebees the HQ was set at 27.5 and for solitary bees (Osmia) at 31.5.
We want to highlight that there is no supporting evidence for decreasing the HQ to <33 for oral and <11 for contact. It is very unclear how this links to the mortality rate of foragers. The previous HQ-value of 50 had a significant evidence base (see Julius-Kühn-Archives 423). We recommend to use the HQ of 50 as trigger value in the RA of acute toxicity. We propose that these should also be expressed per gram of bee. We confirm the use of the HQ trigger value of 50 in the first tier approach for acute toxicity. COMMENT of CARI 6
As the HQ is expressed per bee, the HQ is already reduced by the factor of 2.1.This is based on the fact that a worker honeybee is weighing 100 mg and a Bombus terrestris worker 210 mg on average. These data so far suggest that the acute toxicity of bee species on a per weight basis is similar. Therefore as the LD50 varies widely depending on the weight of the bees used (EFSA 2012 Scientific Opinion), we suggest here to express the LD50 per gram of bee and then based on this value to calculate the HQ, taking into account the additional level of protection required. This should be done for honeybees, bumblebees and solitary bees. We suggest that the chronic toxicity data should be discussed in the same manner as the acute toxicity data; these should also be expressed per gram of bee.
1849 Bumblebee larvae are fed pollen and nectar unprocessed so the assessment factor of 10 from honeybees is appropriate due to lack of data. However, we believe that the proposed factor of 100-fold (2 times additional assessment factor of 10) is not appropriate.
We recommend that stakeholders provide data to address these uncertainties related to lab and field extrapolations. There are data available in regulatory reports on the levels of control mortality in field and semi-field studies.
6. Introduction to the risk assessment scheme for honey bees 6.1. Acute and chronic risk assessment
1926 The brood testing methods by Aupinel et al. and Oomen et al. are not yet validated guidelines. Currently, an OECD expert group is working on a test guideline on Honey Bee Brood Tests based on Aupinel et al. methodology. We propose, when finalised, to adopt this guideline in this EFSA GD.
6.2. Semi-field studies
1957 We agree with the statement: ‘ensure that the crop is highly attractive’, as is the case with Phacelia to guarantee flower visiting and exposure; this setup represents a worst case scenario.
6.3. Field studies
1984-1988
This paragraph can be deleted
6.4. Exposure assessment in the risk assessment scheme
Define the xth percentile.
6.5. Risk assessment for bumble bees and solitary bees
16
2007-2010
Study protocols on bumblebees should still be developed. It is not clear what should happen with the risk assessment in the meantime?
2015- We refer to the EPPO document in regard the use of a default value for residues in pollen and nectar, which were discussed together with biology and crop residue experts.
7. Risk assessment schemes Four general comments with unclear/weak points:
In all the schemes, a conclusion after higher tier and uncertainty analysis is missing (i.e. risk acceptable/unacceptable/acceptable only with the following risk mitigation:…).
It is not clear how multiple applications are taken into account?
This risk assessment scheme is not practical. Formula’s with input parameters are required. Even with the corresponding appendix S, it is difficult to find out how the risk should be calculated exactly.
Shortcut values are not appreciated, it is much easier if the separate values are shown (especially since these are not many) so that it is understood what exactly is calculated and so that refined parameters can be easily incorporated. For instance, we recommend that a table/calculator sheet/etc should be provided by EFSA; this would be a very useful addition.
7.1. Risk assessment scheme for honey bees 7.1.1. Risk assessment scheme for honey bees for spray applications
2153 Note 1: Examples of when exposure of bees is negligible: could wound sealing and healing treatments with systemic substances not lead to exposure of bees?
2195 ‘pending the validation of … a new risk assessment scheme’: it is not clear whether that this means that the proposed new scheme is to be revised soon?
7.1.2. Risk assessment scheme for honey bees for solid applications
2282 -How can an HQ from a solid application be used to generate an HQ which results in the same trigger as a directly sprayed application? -There is no note 6.
2320 Note 1: same as for 7.1.1.
7.2. Risk assessment scheme for bumble bees 7.2.1. Risk assessment scheme for bumble bees for spray applications
2320 Note 1: same as for 7.1.1.
2488- 2498
Note 2: -The need for bumblebee risk assessment is defined quite vaguely. This lack of clear guidance can lead to differences in risk assessment between member states, which is not in the interest of harmonisation. -A compound has to be assessed for bumblebees in case it was necessary in the honeybee scheme to revise the default exposure values or when an assessment of higher tier studies had to be carried out. -It could be highlighted in this paragraph that it should be checked whether risk mitigation measures taken for honeybees are adequate to protect bumblebees as well.
2500-
Note 3: A practical way forward could be to ask for a bumblebee product study only if the honeybee product study shows significantly higher toxicity. A definition of ‘significantly higher’ is then required; proposal: endpoint factor of >2 lower than that predicted based on the individual active substance.
2535-
Note 4: If it is agreed that there is a need for a separate risk assessment for bumblebees,
17
unnecessary data requirement should be avoided. We recommend that where possible, and especially in the first tier, data requirement should be derived from existing data requirements for honeybees. Extrapolation from honeybee data should be taken into account. For the higher tier testing, the structure, behaviour and life cycles of different bees are very different, which suggests that separate testing is warranted but more research is required.
2550- Note 6: It would be much better and easy to work with if all input parameters for bumblebees are shown in the risk assessment scheme for bumble bees, instead of referrals to different sections of the document and to multiplication factors.
2555- Note 7: This note gives two choices, but only one should end up in the final guidance document. Cresswell et al. (2012) described the differential sensitivity of honeybees and bumblebees to a dietary insecticide (imidacloprid) and reported on differences in accumulation and metabolism. For instance honeybees are better pre-adapted than bumblebees to feed on nectar containing insecticide residues? However, these experiments only included one member of one insecticide group (imidacloprid/neonicotinoids) and should therefore be taken with caution. It is plausible that the statement of Cresswell et al. (2012) cannot be generalized for all PPPs. Our recommendation is: Considering that the bio-accumulative study is a new approach, it is proposed that until more experience is available with this study with honeybees, it is assumed that honeybees are an adequate surrogate for bio-accumulative toxicity in bumblebees.
7.2.2. Risk assessment scheme for bumble bees for solid applications
2635 ‘go to 5’: 5 does not exist (is probably missing above the uncertainty analysis?).
2320 Note 1: same as for 7.1.1.
2681- Note 2: same as for 7.2.1.
2693- Note 3: same as for 7.2.1.
2729- Note 4: same as for 7.2.1.
2744- Note 6: same as for 7.2.1.
2751- Note 7: same as for 7.2.1.
7.3. Risk assessment scheme for solitary bees 7.3.1. Risk assessment scheme for solitary bees for spray applications
2869 Note 1: same as for 7.1.1.
2872- 2882
Note 2: -The need for solitary bee risk assessment is defined quite vaguely. This lack of clear guidance can lead to differences in risk assessment between member states, which is not in the interest of harmonisation. -A compound has to be assessed for solitary bees in case it was necessary in the honeybee scheme to revise the default exposure values or when an assessment of higher tier studies had to be carried out. -It could be highlighted in this paragraph that it should be checked whether risk mitigation measures taken for honeybees are adequate to protect solitary bees as well.
2884- 2888
Note 3: A practical way forward could be to ask for a solitary bee product study only if the honeybee product study shows significantly higher toxicity. A definition of ‘significantly higher’ is then required; proposal: endpoint factor of >2 lower than that predicted based on the individual active substance.
2921-2931
Note 4: If it is agreed that there is a need for a separate risk assessment for solitary bees, unnecessary data requirement should be avoided. We recommend that where possible, and especially in the first tier, data requirement
18
should be derived from existing data requirements for honeybees. Extrapolation from honeybee data should be taken into account. For the higher tier testing, the structure, behaviour and life cycles of different bees are very different, which suggests that separate testing is warranted but more research is required.
2744-2749
Note 6: It would be much better and easy to work with if all input parameters for solitary bees are shown in the risk assessment scheme for solitary bees, instead of referrals to different sections of the document and to multiplication factors.
Note 7: This note gives two choices, but only one should end up in the final guidance document. Same concerns as with bumblebees: see 7.2.1 and 7.2.2. Our recommendation is: Considering that the bio-accumulative study is a new approach, it is proposed that until more experience is available with this study with honeybees, it is assumed that honeybees are an adequate surrogate for bio-accumulative toxicity in solitary bees.
7.3.2. Risk assessment scheme for solitary bees for solid applications
2869 Note 1: same as for 7.1.1.
3067- Note 2: same as for 7.3.1.
3079- Note 3: same as for 7.3.1.
3113- Note 4: same as for 7.3.1.
9. Risk mitigation options 9.1. Risk mitigation for honeybees The proposed definition for flowering crops reads “when more than 2 plants (crop and/or weed plants) per square meter are flowering”. We propose that more explanation and feedback should be given here as many member states recommend not to apply during flowering in order to limit exposure, among other countries through the use of the SPe8 sentence: “do not apply on flowering crops” as it seems that the two proposals are not compatible anymore. 9.2. Risk mitigation options for honeybees 9.2.1. Spray treatment
3390 Part of the GAP is usually to suppress weeds in the fields. In an economically grown crop the presence of flowering weeds is not likely to occur on a large scale. Exceptions in Belgium are orchards. The possible limited adverse effect of reduced foraging area could be overcome by flowering field margins in agricultural areas etc.
9.2.2. Seed/soil treatment
3409 Reference should be Appendix D instead of K.
3466- In our opinion, it is not realistic to avoid flowering weeds off-field, and/or formation of honeydew in succeeding crops. Examples from literature:
Flowering weeds off-field may contain residues of systemic PPPs applied to the in-field crop. We agree that this may pose a risk as the residue levels can be high enough posing detrimental effects. Off-field weeds around a crop grown from seeds that were coated with clothianidin (this PPP being a member of the neonicotinoid insecticide class, can be seen as a worst case) did contain at most 30 µg/kg clothianidin in guttation droplets, which is 1000 times below the concentration in guttation in-field (Tapparo et al., 2011). Assuming a similar dilution in nectar and pollen, there will be no risk at all
19
COMMENT by CARI 7: concentrations in pollen / nectar in-field are ~5 µg/kg at most, 1/1000
th would result in 5 ng/kg.
Succeeding crops on fields with treated sunflower and maize, treated with imidacloprid (this PPP being a member of the neonicotinoid insecticide class, can be seen as a worst case), did show only very low residue levels (under the detection limits of 1 and 1.5 µg/kg in pollen and nectar, respectively), although the soil still contained imidacloprid between 2-18 µg/kg soil (Schmuck et al., 2001; Charvet et al., 2004).
COMMENT by CARI 8
10. Uncertainty analysis
3485- This chapter on uncertainty analysis is not written yet (now there is a draft: see Chapter 5 for comments). EFSA organized a second commenting round before the EFSA GD will be adopted (which we did recommend in an earlier version).
Appendices A. Nomenclature for Effect Sizes
3730 The practicality of defining negligible effect compared to a control at 3.5% should be illustrated by data in order to provide guidance on how to implement it in experiments. This should be discussed considering the level of effect that may actually be demonstrated in current studies. See also comments with Section 2.
3746 The model of Khoury et al. (2011) is proposed to derive protection goals. Considering the importance of the topic, we propose that a review of the models available should be provided together with an analysis of the output compared to real data sets. It seems simplistic to rely on this model only, considering it was not developed for that primary purpose. See also comments with Appendice O. We propose to use as guidance here “the white paper” to EPA, Sept 2012’, that is listing several other models to consider.
3758 Evidence lacks whether it is justified to convert the effects on bees to bumblebees, as described in the table. There are ecotoxicological data available for bumblebees (Bombus terrestris);
3771 It is noted that there is a response from Henry et al (2012) to Cresswell & Thompson (2012). In this response, yet other input values are chosen which do lead to spring collapse. The general idea from all this seems to be that there is still a lot of debate on relevant input parameters and that this type of modelling is not yet in such a stage that it can be used in risk assessment. This again leads to the question whether the model can be used to determine trigger values, as is done in this guidance document. We propose to use only models to derive trigger values after these models have been validated.
3785 The figure seems to be accidentally included twice.
F. Guttation and proposed risk assessment for guttation water
4046 We recommend to complete this table by evidence of decreasing concentrations in droplets with plant/crop age, which limits the occurrence of effects. Data are available to support this statement, which should be considered when addressing the guttation issue.
We note that guttation is not included in the RA scheme at the moment. It is also noted that field studies have shown guttation to pose only low (no) risks to honeybees in practice. We can therefore agree that this route is considered to be less relevant. Nonetheless more scientific data have to be provided to evaluate the possible exposure to contaminated guttation droplets. COMMENT by CARI 9
20
H. Landscape-level exposure assessment of the average concentration entering the hive This landscape-level approach is currently not included in the RA and therefore less relevant at the moment. The factor is under debate.
3850 We highly question the usefulness of the ‘attractiveness factor’ as it is expected to be highly variable. It will depend on many parameters (e.g. crops in the landscape; application of other pesticides on certain crops influencing the attractiveness; exact time of flowering of all crops and other flower in the landscape; needs of a colony at a certain time). It would be possible to determine the relative attractiveness factor between two flowering crops at a certain time/area/weather/etc but extrapolation of this to all other circumstances is probably not acceptable. We can agree that it may indeed be a better approach to measure directly environmental concentrations after application.
I. Pesticide residue levels in nectar and pollen and the residue unite doses (RUDs)
3965- RUDs (residue unit doses) from greenhouse trials were not included. RUDs from field trials are not considered relevant for greenhouse situations. How should a RA for greenhouse application be performed?
3991-3993
Regarding seed dressing. The theoretical seed dressing rate of 1 mg a.s./seed and the theoretical application rate of 1 kg a.s./hectare seem to be conservative and not representing the reality as well. Is it possible to calculate the RUD-value based on the realistic application rate as described in the GAP as stated by the applicant? For instance in Belgium in maize the dosage of thiamethoxam (this compound can be seen as a relatively worst-case situation) on basis of the GAP can be calculated as being 63 g a.s./ha. This is much lower than the theoretical rate of 1 kg a.s./ha. We recommend to calculate the RUD value on the realistic application rate as described in the GAP.
J. Protocol for performing field studies to assess a certain percentile of the concentration in pollen and nectar in a certain type of plants in the area of use of the substance
4089-4094
The residue definition for monitoring in plants and animal products covers all relevant substances (a.s.+metabolites) that are considered relevant for human toxicology. We recommend to add a sentence in this part in the EFSA GD that the applicant should show that all bee-relevant metabolites are covered with the residue definition for monitoring in plants and animal products.
M. Checklists for evaluating Laboratory studies General comment and suggestion.
We suggest that the proposed adaptations of study protocols should also be kept flexible so that study designs allow addressing concerns that are raised for each compound based on a compound (class of compounds) specific way and/or based on a mode of action-specific way. Examples may be neonicotinoids, fipronil and unknown insecticides. In our believe, some of the proposals are not sufficiently addressed on a scientific point to be considered as applicable to every single case. Clear links between some parameters as homing behaviour or proboscis extension reflex (PER) and protection goals need to be established in first place, in order to limit uncertainties in the risk assessment.
According to Section 6 (Introduction to the risk assessment scheme for honey bees), the chronic adult LC50 should also be included in µg a.s./bee/day. Therefore, this appendix should include guidance on how to calculate this value.
The recommendations for the Aupinel test should take the requirements as made in the OECD framework into account. As soon as a draft or official OECD test guideline is available this will supersede the requirements made here; please add a sentence to ensure that the policy makers are aware of the OECD developments.
21
4486- Three comments:
There exists no wide scientific evidence to assume that single and mixed strains of subspecies of bees react differently. Suchail et al. (2000) reported on this matter, but to the best of our knowledge we cannot evaluate these results on their value to make general conclusions. We recommend that it is much more important to use bees from different colonies as repetitions or use pooled bees from different colonies, in order to exclude differences due to differences in strains / colonies. It only makes sense to use a certain strain when there is evidence of a specific susceptible strain, but this evidence does not exist.
We recommend that the nutritional status of the colonies should be defined; for instance, not starving and having received diversified pollen sources.
The EFSA document does not indicate from where the bees should be sampled: forager or bees from the comb. Only the age of the bees is asked to be documented. This is however not possible unless bees had been marked upon hatching, or bees just hatched are used. We propose to use bees from a broodless comb inside the hive. These bees will be a mixture from all ages as reported by Van der Steen et al. (2012)
4490 The test runs for 96 h, but the 48h-LD50 is calculated?
4504 Recommendations as regards published testing methods should be accompanied of an analysis of the robustness of the protocols as well as repeatability and reproducibility criteria, in order to ensure that the risk assessment relies on a sufficient level of certainty. For example, working with newly/young-emerged bees is fundamentally wrong. Newly emerged bees should be supplied with ‘bee-bread’ or another protein containing diet.
4513 Question: Why are there three replicates proposed of the LC50 test during the season, because there is no evidence to suggest that it changes. If there is evidence, we agree with three testing repeats.
4529 Validity of the test when the control mortality is below 15%. This may for the chronic test protocol become difficult because a test duration of 10 days will be long for foragers, sampled from the hive entrance (their mean age will be between 2 and 4 weeks at the start). We recommend here not to use foragers for chronic testing.
4636- It looks that the feeding method is not as described in Oomen et al. (1992) where there is feeding for 9 days. The method is to provide 1 litre which is consumed over at least 3 days and to allow the colony to store this for feeding to the larvae. The use of a toxic reference and residue analysis of larvae can be used to demonstrate exposure. If the solution is fed per day, then the actual amount within the colony is not recorded.
4649 Question: What is the basis for the increased numbers of cells marked (at least 200 eggs, young larvae, old larvae)? Is there a statistical basis for this? We recommend that it is better to increase the number of replicates rather than the number of cells marked per colony.
N. Checklists for evaluating semi-field studies
4667 The EPPO 170 guideline has been used effectively for over 20 years to generate data for use in regulatory RAs. It has been reviewed and modified on a number of occasions, taking into account the experience obtained with its use and as new information has become available. There are a number of differences in the checklists for semi-field and field studies and it would seem appropriate that these should be justified. We refer here to the EFSA Opinion of May 2012.
4686 We comment on the “recommendation to use bigger colonies of at least 6000 adult bees (EPPO 170: 3-5000)”. It is known that the colony size is an important factor in cage studies, and it is even so that the confinement can result in experimental artefacts if the colonies are too large (for example in brood production). It is not evident that bigger colonies are better. We recommend to adjust the confinement area in balance with the colony size; keep the available forage in balance with the standing population of foragers and brood. We refer for this part to the OECD 75 that provides specific recommendations for colony size
22
in order to be able to investigate effects on the brood. Reference is made to extending studies to cover more than one brood cycle if appropriate but it should be recognised that cage studies may ultimately be limited in such circumstances.
4691 As an effective foraging area >60 m2, preferably 80 m
2 are recommended. EPPO 170 refers
to a minimal crop area of 40 m2, although it makes it clear that the area should be related to
the objectives of the study e.g. smaller cages may be sufficient for the assessment of short-term mortality on aged residues (where more replicates may be useful).
4692- The use of an attractive crop such as winter oilseed rape or Phacelia is recommended, even where the intended use is on a less attractive crop for instance strawberries, or zucchini. In contrast, EPPO 170 suggests that the use of crops on which a particular product is to be used (where this does not include attractive crops) may be useful for risk assessment purposes. We suggest that if effects are seen in a study with Phacelia, then it is difficult to assess if this risk would be significant in the context of the actual exposure that would be experienced in use (in an actual crop). In our opinion, it seems highly unrealistic to use a highly attractive crop (as Phacelia) in a (semi-)field study to assess the risk of an unattractive crop. Its unattractiveness would be a main factor determining the actual risk.
4707-4709
We suggest that, although the screening for diseases at the beginning of the study is necessary, testing organisms subject to diseases is not a good ecotoxicological testing practice and should be avoided. For instance, it is useless and not recommendable to test for Varroa infection during a semi-field test. We recommend to determine the presence of infestation prior to the test and after the test (only if it is a long lasting test) with use of a standard bee sample of 200.
O. Higher tier effects studies
4888 In our view we can accept this proposal to rely only on a semi-field study when the only risk quotient to be breached is the HQ-contact.
4890-4903
The residue concentration in the hive should be as high in field studies as in semi-field studies. However, in semi-field studies bees do not have a choice to forage elsewhere, while in field studies at least some of the foragers will always find food outside the treated field. Therefore we wonder whether it is really possible, and necessary, to meet this demand. It should only be relevant for cases with huge areas of treated monocultures (where dilution with other food sources would hardly occur). Statement by CARI 10
4953 How many studies would be required to prove that bees ‘normally collect only small proportions from the target crop’?
4979 Why is the Specific Protection Goal (SPG) set at a 7% detrimental effect on colony size? Has this been considered in the context of the actual natural variability e.g. between colony, between field, seasonal etc. This level of effect seems unachievable from a practical point of view and probably unnecessary from a risk point of view. The acceptability of effects in the field is the subject of an ICPPR working group and their considerations are published in Julius-Kühn-Archives 437 http://pub.jki.bund.de/index.php/JKA/issue/current: It is recommended that the ICPBR group and experts from EFSA continue to work and organise workshops and working groups to continue developing adequate RA methodologies.
4986 It is noted that EFSA is currently unable to prescribe a precise number of colonies in a field trial.
We recommend that the number of colonies has to be adapted to the size of the treated field as well as the statistical robustness. Putting too many colonies on a field will result in insufficient forage.
Besides, it is unlikely that even an ideal field study will be capable of detecting a 7% effect given the influence of other factors such as weather. A significant issue is measurement of the exact number of bees in a colony which will vary by time of day and foraging conditions, for example, when cool/wet the foragers will be within the colony, when warm/dry they will be foraging. The longer the colony assessment takes, the greater the effect it has on the colony, for example, the shaking all the bees
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off the combs to take photographs of brood area will have a significant effect on adult mortality.
5048 The statistics is impressive but appears to have lost touch with reality. A field study with 14 pairs of fields (98 pairs of hives) would be extremely difficult to perform and is an unnecessary use of resources that could be better used to understand the risk. This is on the basis of 7 hives per field but putting too many colonies on each field could result in insufficient forage being available i.e. more bees are likely to forage elsewhere so reducing the exposure achieved in the study. Taking into account that pairs of fields 4 km apart and as isolated as possible are needed indicates that this has not been based on any practical understanding of conducting these studies.
5063 It is not clear why the treated and control fields should be at least 2 ha? In the EPPO 170 is was set at 1 ha or less. It is known that 1 ha of an attractive crop (for example winter-oil seed rape) will easily support 7 colonies (Crane, 1975).
5066 It is rightly pointed out that even if large isolated fields are used, foragers will bring pollen and nectar from untreated plants back to the hive e.g. from flowering weeds. This highlights the issue with the proposed exposure criteria i.e. greater than the expected 90
th
percentile and greater than in the semi-field.
5089- Comments:
This use of large colonies of 60,000 is not realistic for Belgium. Colonies of 60,000 bees are extra-ordinary and in our regions (Belgium, the Netherlands, Luxembourg, Germany, UK) colonies reach about 30,000 at peak. This is actually the more ‘general’ maximum according to literature. Indeed Andriessen (2011) reported in a literature review that it is a true exception that a colony measures more than 50,000 bees. Measurements over different years confirmed that the average peak number of bees per colony is about 30,000. As a consequence, the size of a normal colony of bees ranges maximally between 25,000 and 40,000.
We propose to have a minimum colony size of about 10,000 bees for higher tier effects studies. On the real size of a mature colony to assess higher tier effects, we confirm the use a minimum colony size of 10,000 honeybees. Numbers of 30,000 are at peak size in Belgium.
In our opinion, a colony size of 60,000 is too large and is likely not to be as sensitive in detecting effects as smaller ones. Also, if the colony size is variable according to the season it will make comparison between studies more difficult.
We suggest for a better standardization and replication to use colonies that are smaller and actively growing. COMMENTs by CARI no 11
5127 One brood cycle is sufficient unless there are specific concerns about effects on brood (unless there is evidence to show that one brood cycle is not normally sufficient to detect any effects).
5202 The text proposes to measure honey production in a semi-field study, but we feel this as not being practical at all.
5378-5404
It is not clear what the proposed homing study would provide in terms of the overall risk assessment that current testing (at the higher tier) is doing in relation to the protection goals at the colony level. The homing study is taken straight from Henry et al. (2012) without addressing the concerns published in the EFSA 2012 review of this paper. While the paper of Henry et al. (2012) provides some interesting developments in terms of the use of a relatively new technology (the use of RFID tagging on honey bees), this is very much at the research stage. The methodology clearly has not been validated and in particular how the information generated would be used in a risk assessment is not clear. Concerns have been raised (for example by EFSA) as to the estimation of dietary exposure used and also to the application of the daily intake in a single oral dose. Reference is made to the model of Khoury et al. (2010), however no guidance is given as to how this would be interpreted in the context of any other higher tier studies that have been conducted. For example, what level of effect on the hive population would be considered significant (taking into account all the other factors that can influence this) and what would happen if the model is to predict effects that were not seen at the colony level in semi-field and/or field studies? Again, the model does not appear to have been validated and concerns have been raised about the parameters used, particularly in relation to colony growth and the impact this has on the use of the model for regulatory purposes.
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List of unclear points on the methodology for the homing study:
The foragers should be young. How is this defined?
The foragers should be exposed over a 4 h-period as in the LD50 study but to which concentration: potential in 1 foraging trip (only 10-20 µl in the OECD study), in foraging over 4 h or in 1 day?
The foragers are taken to an unfamiliar place. How representative is this of a bee foraging all day on a familiar crop?
Would it be more realistic to take foragers returning from the treated crop and release these 1 km away? This would be a realistic exposure profile within the day.
Over what time scale is the returning measured? We propose here to use the ‘White paper’ submitted Sept 2012 to FIFRA, that is providing a list of possible model approaches. This should also be done by EFSA before making a choice and posing recommendations.
P. Test protocols for bumblebees (Bombus terrestris) General comment:
We suggest that the proposed adaptations of study protocols should also be kept flexible so that study designs allow addressing concerns that are raised for each compound based on a compound (class of compounds) specific way and/or based on a mode of action-specific way. Examples may be neonicotinoids, fipronil and unknown insecticides. In our believe, some of the proposals are not sufficiently addressed on a scientific point to be considered as applicable to every single case. Clear links between some parameters as nest reproduction (i.e. numbers of drones per microcolony consisting of 5 bumblebee workers, i.e. one dominant worker and four workers) and foraging behaviour and protection goals need to be established in first place, in order to limit uncertainties in the risk assessment.
5472 The test described is not a bumblebee LC% but a micro-colony study with an egg-laying worker (pseudo-queen). Therefore, the risk assessment should take this into account.
5489 The exposure period is 11 weeks, but there is no crop that flowers for that long period. The test proposed is beyond standard laboratory studies and needs to be validated with control and toxic reference criteria before it can be recommended for risk assessment.
5511 The test proposed only supplies treated food for 24 h (this is a single exposure) and needs to be validated with control and toxic reference criteria, before it can be recommended for risk assessment.
Remarks and useful literature and methodologies for the risk assessment with bumblebees:
There are data available on risks of a diverse group of PPPs (covering different classes of insecticides, acaricides, fungicides of chemical and microbiological origin) against bumblebees of Bombus terrestris (as reviewed in Mommaerts and Smagghe, 2011). This methodology under standard conditions is making use of microcolonies consisting of five bumblebee workers (i.e. one dominant worker =pseudoqueen, and four workers). There is a determination of the risk for lethal (survival workers) and sublethal effects (nest reproduction as the number of drones) by three routes of exposure (dermal contact, oral feeding via supplemented sugar water, representing nectar, and/or supplemented pollen).
As an extension of the abovementioned tests with microcolonies of Bombus terrestris, Mommaerts et al. (2010) also reported on a behaviour bioassay under standard conditions. With this behaviour bioassay, Mommaerts et al. (2010) were able to predict the risks of imidacloprid and other neonicotinoids including their effects on foraging. Interestingly, the data of the behaviour test under standard conditions in the laboratory were validated with free-flying bumblebees and queen-right bumblebee nests under greenhouse conditions.
We propose that these behaviour bioassays with microcolonies of bumblebees can be useful and proposed in the assessment of the risks, especially to assess the risks for sublethal effects on reproduction and behaviour of bees.
Q. Test protocols solitary bees (Osmia cornuta and Osmia bicornis = O. rufa)
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5639 Remark/suggestion: The specification to feed bees with the “flower method” seems not necessary; the essence is to make sure that a solitary individual bee has sufficient uptake of a.s. within a certain time period.
26
4. THE EFSA GD AND THE CURRENT REGULATION 1107/2009/EC As a general comment, the EFSA guidance document remains (very) vague in many of the proposed schemes and bioassays, and many of these are not validated. Comment by CARI 12 Following discrepancies have been found between the EFSA guidance document and the 1107/2009/EC.
In chapter 3.4 of the EFSA document there is a request for bioaccumulation data. In contrast, there is no data requirement for a bioaccumulation test in bees under 1107/2009/EC. Similarly, in the notes 7 in chapters 7.2.1 and 7.2.2. (bumblebees) and 7.3.1. and 7.3.2. (solitary bees) of the EFSA document, the same question arises. Besides, the EFSA document leaves it open how to provide these data for bumblebees and solitary bees, and so all stays confusing: “Either assume that honeybees are an adequate surrogate for bioaccumulative toxicity or replicate design of test but using bumblebees (7.2.) and solitary bees (7.3.)”. Comment by CARI 13
In chapter 9 on risk mitigation options it is suggested to “remove weeds before flowering”. This action of risk mitigation based on removing flowering weeds seems to be in contrast with the 1107/2009/EC recommendation to protect biodiversity.
In the checklists for evaluating laboratory studies (Appendice M), the following is written: “for each test product, five concentrations are selected so as to range from 10 to greater than 100% mortality with no more than 2 fold dilutions between doses”. In 1107/2009/EC, there is need for a value of NOEC and/or LC10 and therefore a mortality below 10% is needed. In addition, although it is a detail, but toxicities of >100% mortality do not exist. We propose that it should be <10% to 100% in the EFSA document.
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5. ADDITIONAL CHAPTERS TO THE EFSA GD, as made available per 15 February 2013 The additional chapters or parts of chapters are on:
Assessment of risk from exposure to contaminated water (including guttation, surface water and water in puddles)
Risk assessment scheme for metabolites
Uncertainty analysis 2.1. Risk from guttation water Since the presence or absence of guttation is not known for (most of 90% percentile) crops, it is the default to assume guttation always. 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. This uncertainty (1) is addressed by EFSA. Comment by CARI 14 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 guttation water 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. 2.2 Risk from surface water Here EFSA avoids to do superfluous testing, and relying on the risk assessment for water invertebrates. Moreover, concentrations in surface water will almost always be far lower than in guttation and in puddles. 2.3 Water in puddles Concentrations in puddles, especially after rain events shortly after sowing, or by spraying combined with rain shortly afterwards, may be high and therefore pose a risk. This is a complicated problem because bees are generally very conservative regarding their water collecting behaviour. The latter means that once a colony has started to use a specific source for water (for instance a pool), they remain faithful to that pool, even if a new one is made closer to the hive. So if puddles occur, water collectors generally will ignore these, and stick to their “own” pool. However, if newly placed colonies appear (for instance for pollination services) and contaminated puddles are in place, these may prefer these puddles and not choose the (clean) pool a little further away. >We recommend that it is important that permanent puddles or pools close to the apiary should be kept clean as a mitigation measure. EFSA still needs time to work out this risk assessment part. We recommend also extra studies should be done. Specific comments:
149 reference Nicolson 2009 is not included in the reference list
240-254
Happily refinements by real data are proposed. We would prefer to use real measurements instead of PEC pore water scenarios, as these have still many conceptual as well as data gaps
290-302 and 313vv
It is a not well funded assumption that guttation water and transpiration water are exchangeable. Many concentrations of chemicals (incl. the plant metabolites and ions taken up) are strongly dependent on the transpiration rate. Most likely concentrations will be higher in guttation.
3. Metabolites risk assessment scheme We have no comments on this chapter.
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4. Uncertainty analysis This chapter is very helpful in analysing the possible uncertainties in carried out studies. Of course the uncertainties are the higher the higher the tier is. The table-wise approach is welcomed very much, and will also help to make different studies better comparable. Some more specific comments:
Table C3 line 1107 vv
In this and the next table, it should be more straightforward when to put a + or a – into the boxes. For instance: in table C4, the fact that only one study was done results in a + in ‘potential to make the true risk lower’. However, we expect that it allows the potential that in the real world (true risk) the risk is higher than deduced from this study. At least this is confusing.
1476 vv
TWA is not listed in the abbreviations glossary
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5. SUMMARY
We confirm that we did this task to analyse the Guidance Document (GD) of EFSA for strong, weak/unclear and neutral points with use of the best of our current scientific knowledge and experience and this in an independent manner and our concern was related only to an adequate and practical RA of pesticides on bees. The summary consists of the following 6 points; our recommendations are given in bold and blue. 1. We can appreciate very much the ambitions of EFSA to coordinate all RA work with bees. In
addition, we confirm that the GD is done with the ambition for a scientific basis, independently and it brings up most of the concerns that existed to RA of pesticides on bees. It is a very much appreciated work. We recommend that the document can open the development of adequate new RA schemes in guarding the health of bees in our agro-ecosystem where PPPs are present. We agree that the development and introduction of new PPPs with novel mechanisms of action demand new RA methods.
2. We appreciate the efforts of EFSA and the support for further work as listed in Section 3.4 (Recommendations for further work to improve or underpin the proposed exposure assessment guidance). But, in continuation of these efforts, we hope that these data are first generated in order to identify the actual gaps of the RA. These can then provide the data that may or may not justify the need for the development of these new scenarios. We recommend that, first, the level of protection by the current RA can be established and the need for further improvements should be derived of such an analysis. Second, the data that are necessary for this improvement can then be identified. We agree with EFSA that in the assessment of exposure, first it needs to be evaluated the capacity of any active substance/product to contaminate pollen and nectar: systemicity, application pattern, persistency. Afterwards, depending on the type of exposure that could eventually exist, relevant toxicity testing should be done, and irrelevant or superfluous testing avoided.
3. This GD document lists a number of agronomical scenarios (succeeding crops, adjacent crops, presence of flowering weeds in non-attractive crops) for which a risk may not fully be excluded, although examples of occurrence of these risks are not reported. In the absence of supportive data or related examples, we should remark that these scenarios rely on a series of assumptions, which result in RA hypotheses, containing a number of identified uncertainties as regards potential over-conservatism. Where possible, we provided data and related examples from the scientific literature and/or our experiences in the text: for instance validation of the colony estimation by frame coverage method; the collection of pollen in pollen traps at the hive entrance and nectar from honey stomachs; the number of colonies has to be adapted to the size of the treated field as well as the statistical robustness; usage of a minimum colony size of about 10,000 bees for higher tier studies COMMENT by CARI 15 ; usage of colonies that are smaller and actively growing for a better standardization and replication; usage of a realistic background mortality and not of lowest mortality.
4. The GD suggests some new studies in the RA scheme i.e. laboratory chronic toxicity study on adult bees, laboratory study on honeybee larvae and semi-field and field studies. We appreciate this but must remark that some are not yet available as ring tests or guidelines, and so these remain below a the required level of confidence and certainty. We propose to give priority in the ring-testing of the new studies as proposed for the new RA scheme. Here, we believe that the behaviour bioassay with microcolonies of bumblebees can be a useful tool in the RA scheme for sublethal effects against reproduction and behaviour of bees in general.
5. The GD proposes modifications of some testing protocols. We agree with the principle to revise
and update the RA schemes, but at several points it is done on the basis of a theoretical analysis of testing sensitivity. We underline that we did not perceive this as negative per se, but on the contrary, we feel it can help to revise and improve current RA schemes.
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We recommend that a sensitivity analysis is necessary, which should check the ability of these test protocols to actually detect effects. We propose that the amendments are discussed with the stakeholders as RA bee specialists and bee keepers in order to ensure their implementation in an experimental and practical design.
6. Finally, within the context of a general RA for bees, we want to underline on the essence of an
adequate strategy for the monitoring and control against bee diseases. Indeed, scientific papers have reported on a correlation between disease and collapsing colonies. In addition, a bee-friendly environment, providing habitat and food foraging abilities for bees, is also of crucial essence in guaranteeing the health and successful overwintering of bee colonies. We recommend that the EFSA, although it plays no role itself in monitoring, stimulates further support in these monitoring programs to obtain better insights in the multi-factorial problem of collapsing colonies and finally to guard the health of our bees. COMMENT by CARI 16
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6. NEDERLANDSE SAMENVATTING Het Guidance Document (GD) van de EFSA voor de risico-analyse (RA) van gewasbeschermings-producten voor bijen werd bestudeerd en geanalyseerd op sterke, zwakke, onduidelijke en neutrale punten. Dit werd gedaan op basis van onze huidige wetenschappelijke kennis en ervaring, op een onafhankelijke en open wijze, waarbij ons uitgangspunt een zo goed mogelijke en zo praktisch mogelijke risico vaststelling en beoordeling van pesticiden op bijen is. Deze samenvatting bestaat uit zes hoofdpunten, waarbij onze aanbevelingen vetgedrukt in blauw worden weergegeven. 1. Wij waarderen ten zeerste de ambitie van EFSA om alle RA werk met bijen te coördineren.
Bovendien bevestigen we dat het GD gemaakt is met de ambitie dit te doen op wetenschappelijke basis en onafhankelijk. Het GD haalt de meeste zorgen die bestonden over de RA voor bijen naar voren. Dit is belangrijk en zeer gewaardeerd werk, en dito document. We bevelen aan en verwachten dat het document de ontwikkeling van nieuwe en adequate RA schema’s ter bescherming van de gezondheid en veiligheid van bijen in onze agro-ecosystemen waarin gewasbeschermingsproducten voorkomen, op gang zal brengen. We zijn het met EFSA eens dat de ontwikkeling en introductie van nieuwe producten met nieuwe werkingsmechanismen ook nieuwe RA-methoden nodig maken.
2. We waarderen de pogingen van EFSA en de ondersteuning van verder werk zoals opgesomd in
Sectie 3.4 (Aanbevelingen voor verder werk om de voorgestelde guidance over de blootstellingsvaststelling te verbeteren of te onderbouwen). Maar voortbordurend op deze inspanningen hopen we dat deze data eerst gegenereerd worden, om de actuele gaten in de RA vast te stellen. Dergelijk onderzoek kan de gegevens leveren die het al dan niet nodig maken om nieuwe scenario’s te ontwikkelen. We bevelen aan om, ten eerste, de mate van bescherming door de huidige gebruikte schema’s vast te stellen. De noodzaak van verdere verbeteringen zouden moeten blijken uit deze analyse. Ten tweede, kunnen de benodigde aanvullingen in de data op grond van deze analyse worden vastgesteld. We zijn het met EFSA eens dat bij het vaststellen van blootstelling allereerst de mogelijkheid van elke stof of product om stuifmeel en nectar te contamineren moet worden geëvalueerd: systemiciteit, wijze van toediening, persistentie. Vervolgens moeten, afhankelijk van de soort blootstelling, relevante toxiciteitstesten worden gedaan, maar irrelevante of overbodige testen moet worden vermeden.
3. Het GD somt een aantal agronomische scenario’s op (opvolgingsteelten, naburige gewassen, aanwezigheid van bloeiende onkruiden in niet aantrekkelijke gewassen) waarvoor risico’s niet volledig uit te sluiten zijn, hoewel voorbeelden van deze risico’s niet beschreven zijn. In de afwezigheid van ondersteunende gegevens of verwante voorbeelden, moet worden opgemerkt dat dergelijke scenario’s die gebaseerd zijn op een reeks aannames, die weer resulteren in RA hypothesen en aanleiding geven tot over-conservatisme. Waar mogelijk hebben we data en verwante voorbeelden uit de wetenschappelijke literatuur en/of uit onze ervaring in de tekst aangebracht: bijvoorbeeld validatie van de bijenvolkengroottemetingen door de ‘raambezettingsmethode’; de bemonstering van inkomend stuifmeel en nectar via pollenvallen en verzamelde honingmagen; het aantal bijenvolken moet zowel zijn aangepast aan de veldgrootte als aan de statistische robuustheid; gebruik van een minimale bijenvolkengrootte van 10.000 bijen voor de higher tier studies COMMENTAAR door CARI 15; gebruik van bijenvolken die kleiner zijn en actief groeien om een betere standaardisering en replicatie te verkrijgen; gebruik van de realistische achtergrond mortaliteit en niet de laagste mortaliteit.
4. Het GD suggereert een paar nieuwe studies op te nemen in het RA schema, nl. een laboratorium-test voor chronische toxiciteit op volwassen bijen, een laboratorium test voor bijenlarven en semi-veld en veldstudies. We stellen dat op prijs maar moeten wel opmerken dat sommige van deze testen nog niet beschikbaar zijn in ringtesten of als richtlijn zodat ze zonder een bepaald niveau van zekerheid en betrouwbaarheid blijven. We bevelen aan prioriteit te geven aan het uitvoeren van ringtesten van de nieuwe studies zoals voorgesteld in het nieuwe RA schema. Wij denken dat hier de gedragsbiotoetsen met microvolkjes van hommels een waardevolle methode kan zijn in het RA schema om
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subletale effecten op reproductie en gedrag van bijen in het algemeen vast te stellen. 5. Het GD stelt veranderingen in sommige protocollen voor. We staan achter het principe om
protocollen te herzien en aan te passen in de RA schema’s, maar op verschillende plaatsten is dit gedaan op basis van een theoretische analyse van de testgevoeligheid. We onderstrepen dat we dat niet per se als negatief ervaren, integendeel we denken dat het kan helpen om de huidige RA schema’s te herzien en te verbeteren. Een gevoeligheidsanalyse is essentieel en deze moet uitwijzen of de protocollen voldoen om ook werkelijk effecten vast te stellen. We stellen voor de aanpassingen van de protocollen met de ‘stakeholders’ zoals de RA-bijenspecialisten en bijenhouders door te nemen teneinde opname in een experimentele en praktische opzet te bewerkstelligen.
6. Tenslotte willen we binnen de context van een algemeen RA voor bijen, het belang benadrukken
van een adequate strategie voor het monitoren en bestrijden van bijenziekten. Wetenschappelijke publicaties hebben correlaties tussen ziekten en instorten van bijenvolken gerapporteerd. Bovendien is een bijenvriendelijke omgeving die habitat en voedselfoerageermogelijkheden biedt voor bijen van cruciaal belang om de gezondheid en succesvolle overwintering van bijenvolken te garanderen. We bevelen aan dat de EFSA, hoewel ze zelf geen rol speelt in monitoring, verdere ondersteuning van monitoringsprogramma’s stimuleert teneinde een beter inzicht te verkrijgen in het multifactoriële probleem van instortende bijenvolken en teneinde de gezondheid van onze bijen te waarborgen. COMMENTAAR door CARI 16
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7. Résumé en français Le document d'orientation (Guidance Document ou GD) de l'EFSA relatif à l'analyse de risque (AR) des produits phytosanitaires pour abeilles a été examiné et les points forts, les points faibles, les points neutres et les zones d'ombre ont été analysés, ce de manière indépendante et ouverte, sur base de nos connaissances et expériences scientifiques actuelles, avec comme point de départ une définition et une évaluation la plus précise et la plus pratique possible des risques liés à l'utilisation de pesticides sur les abeilles. Le présent résumé comprend six points principaux et nos recommandations sont mentionnées en bleu et en gras. 1. Nous nous réjouissons de l'ambition de l'EFSA de coordonner l'ensemble des travaux d’AR
afférents aux abeilles. Nous confirmons en outre que le GD a été rédigé avec l'ambition de réaliser ce travail sur une base scientifique et en toute indépendance. Le GD évoque la plupart des préoccupations qui existaient au sujet de l'AR pour les abeilles. Le travail réalisé et le document d'orientation sont importants et très appréciés. Nous espérons que le document suscitera le développement de nouveaux systèmes d'analyse de risque adéquats visant à protéger la santé et la sécurité des abeilles dans les systèmes agro-écologiques qui utilisent des produits phytosanitaires. Nous sommes d'accord avec l'EFSA pour dire que le développement et l'introduction de nouveaux produits dotés de nouveaux mécanismes de fonctionnement rendent nécessaire la mise en place de nouvelles méthodes d’AR.
2. Nous apprécions les tentatives de l'EFSA et le soutien des travaux futurs énumérés à la Section
3.4 du document (Recommandations relatives à la suite des travaux d'amélioration et de fondement de la guidance proposée pour l'évaluation de l'exposition). Dans le prolongement de ces efforts, nous espérons néanmoins que ces données seront d'abord générées dans le but d'identifier les lacunes actuelles de l'analyse de risque. Ces recherches pourront fournir les données qui nécessiteront ou pas l'élaboration de nouveaux scénarios. Nous recommandons de commencer par déterminer le niveau de protection qu'offrent les systèmes d’AR actuels. Cette analyse devrait déterminer si des améliorations sont indispensables. Dans un second temps, les données nécessaires à ces améliorations pourront être identifiées sur base de cette analyse. Nous sommes d'accord avec l'EFSA pour dire que dans le cadre de l'évaluation de l'exposition, il y a avant tout lieu d'évaluer la capacité de chaque substance ou produit à contaminer le pollen et le nectar : systémicité, modalités d'application, persistance. Par la suite, en fonction du type d'exposition, des tests de toxicité pertinents devront être effectués, en évitant les tests inutiles ou superflus.
3. Le GD dresse la liste d'une série de scénarios agronomiques (cultures subséquentes, cultures adjacentes, présence de mauvaises herbes en fleur dans des cultures non attractives) pour lesquels des risques ne sont pas à exclure, malgré l'absence d'exemples rapportés. En l'absence de données probantes et d'exemples pertinents, il faut remarquer que ces scénarios reposent sur une série de suppositions qui, à leur tour, donnent lieu à des hypothèses d’AR ainsi qu'à un risque de surprotection.
Nous avons, dans la mesure du possible, apporté dans le texte des données et exemples issus de la littérature scientifique et/ou de notre expérience : p. ex. validation des estimations de colonies d'abeilles au moyen de la méthode d'observation des cadres de ruches ; la collecte de pollen dans des pièges à pollen à l'entrée de la ruche, et de nectar ramené dans le jabot ; le nombre de colonies d'abeilles doit être adapté à la taille du champ et à la robustesse statistique ; utilisation d'une taille de colonie d'au moins 10 000 abeilles pour des études de niveau supérieur COMMENTAIRE du CARI 15; usage de colonies plus petites qui connaissent une croissance rapide pour une meilleure standardisation et réplication ; recours à une mortalité de base réaliste et non à la mortalité la plus basse.
4. Le GD suggère d'intégrer de nouvelles études dans le système d’AR, à savoir un test de toxicité chronique sur des abeilles adultes en laboratoire, un test en laboratoire sur des larves d'abeilles, et des études en conditions naturelles et semi-naturelles. Si nous apprécions l'idée, il nous faut toutefois faire remarquer que certains de ces tests ne sont pas encore disponibles pour des tests en boucle ou comme directive et qu’ils ne disposent donc pas de la fiabilité nécessaire.
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Nous recommandons de donner la priorité à la réalisation de tests en boucle pour les nouvelles études proposées pour le nouveau système d’AR. Nous pensons que les tests biologiques comportementaux sur des microcolonies de bourdons peuvent être très utiles au système d’AR pour définir les effets sublétaux sur la reproduction et le comportement des abeilles en général.
5. Le GD propose des modifications dans certains protocoles de test. Nous sommes favorables au
principe de revoir et d'adapter des protocoles dans les systèmes d’ AR, mais à plusieurs endroits, des modifications ont été apportées sur base d'une analyse théorique de la sensibilité du test. Nous tenons à souligner que nous ne considérons pas cela en soi comme quelque chose de négatif. Au contraire, nous pensons que cela peut aider à revoir et améliorer les systèmes d’AR actuels.
Une analyse de sensibilité est indispensable et doit déterminer si les protocoles sont capables d'identifier des effets de manière effective. Nous proposons d'examiner les modifications des protocoles avec les « parties prenantes » (comme les spécialistes d’AR pour abeilles et les apiculteurs), de sorte à pouvoir les intégrer dans un concept expérimental et pratique.
6. Enfin, dans le contexte d'une AR générale pour abeilles, nous voulons souligner l'importance
d'une stratégie adéquate de monitoring et de lutte en matière de maladies des abeilles. Des publications scientifiques ont fait état de corrélations entre maladies et effondrement de colonies. De plus, un environnement respectueux des abeilles, qui offre à ces dernières un habitat et des possibilités de fourrage alimentaire, est crucial pour garantir la santé et un bon hivernage des colonies.
Nous recommandons que l'EFSA, bien qu'elle ne joue aucun rôle dans le monitoring, continue à encourager le soutien aux programmes de monitoring afin de mieux comprendre le problème multifactoriel des effondrements de colonies et de garantir la santé de nos abeilles. COMMENTAIRE du CARI 16
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COMMENTS to CARI
Com nr Comment CARI Answer by authors
1 In general, I continue disagreeing with the high importance that the report gives to a group for which the Conflict of Interest (COI) has been proved. I acknowledge the work ICPBR is doing, but it has to be clear that ICPBR, if it continues as it is, cannot be considered and independent bee expert anymore. As a result, the outcome coming from its working groups should be cautiously considered. Besides, in order the proposals to be considered, they should be submitted to peer review with a clear and transparent material and methods, public database, results, conclusions and source of financing. Conference proceedings are not enough as no peer review exists. Otherwise, we continue feeding the dynamic that pesticide industry has had so far: “according to my studies, this and this and this is possible, this and this and this is very unlikely”. In order to be able to analyse and trust these statements, I would like the data used for concluding these statements to be published in peer reviewed journals. Otherwise, for me this information does not exist, and should not be considered.
This is a statement of Noa / Cari. We cannot
accept and apply this. ICPBR is independent
BECAUSE all affiliations are included
2 On the collection of harvest information, my question is: What does it harm to take into account this source of information, easy to measure, objective and that provides an indication of the potential degree of exposure and the strength of the colony? Same as the authors, we are not saying that honey production has to be THE endpoint to evaluate if the colony has been affected or not, but only that it should be part of the pool of information that the tester should gather. Of course considering what is the testing crop, because as the authors say, if the crops is not interesting from a nutritional point of view, the production will affected. However, this fact will provide information about the level of exposure of the bees to this crop. Furthermore, colonies from the control group will help understanding if other parameters as weather, crop, etc. played a role in the honey production. In case repellence by a PPP exist, it can be predicted from other tests carried out in the risk assessment on other insects, or there are specific methodologies that can be used to test this effect. As a result, it is
Added by the authors: Honey production can of course be one of the parameters that are provided by the studies as part of the total pool of information; but care has to be taken with interpretation of this parameter.
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very easy to include into the test report a sentence like: “due to the repellency effect of the active ingredient in question, the data on honey production should be carefully considered.” or something alike. CONCLUSION: we agree that honey harvest as such do not have to be THE parameter to determine if protection goals are met, but it has to be part in the pool of measurements that are carried out during the testing. Comparison with control groups + consideration of characteristics of the pesticide will help understanding the relevance of this parameter in a case by case basis.
3 A more constructive proposal would be to recommend to cautiously consider the proposed list because of the lack of relevance at EU level, at the same time that an evolutive list is proposed. Or better, what the EFSA could do is to define a list of insects that can produce honeydew and the list of host plants linked to these species. This list should be
evolutive.
The Authors leave the choice to EFSA
4 The EFSA is going to carry out first an exposure evaluation, not only for fungicides, but for any active ingredient (a.i.). So there is no need to make assumptions, data will be available as it is stated in the second paragraph. If based on these data risk assessors evaluate that the a.i. Will not reach flowers, then this way of exposure will not be taken into account for risk assessment purposes.
5 Noa – I think I agree with this statement, but it is not easy to understand what exactly the recommendation is as the drafting is a little confusing. I understand that:
1. Realistic background mortality should be used, but there is no definition for it yet. (Noa's proposal for recommendation – monitor EU background mortality of healthy colonies in a harmonise way and feed with this information the methods proposed by EFSA?)
2. If overall background mortality of the test: in control and tested group, is too high, the whole test should be discarded.
3. If high mortality is observed in the control group, the test should be discarded
4. Mortality should be evaluated as a comparison between the control Vs the tested group.
The first point is the difficulty: a realistic
background mortality is not easy be given,
because it is very variable, depending on
forage, weather, etc. Therefore the control
mortality is the only realistic option, although it
is difficult to arrange really similar conditions in
the control group in field testing. However,
apart from incidences (heavy thunderstorm) it
should be between 10 and 20 (25?) % per day
in foragers.
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6 However, the value of 50 is an empirically obtained figure. It would be necessary to up-date it with the information of the active ingredients/products and bee accidents currently used in the market. The value of 50 is based on a study of 1975 if I am not mistaking.
Re-evaluated 2010 by Thompson. Recent
active ingredients have been included.
7 REFLECTION – Please consider (I put all units in ppb to allow comparison): (1) 30 µg/Kg (ppb) clothianidin in guttation droplets (nectar or pollen); (2) the LD50 of clothianidin is 0.0025 µg/bee (1 bee = 0.1 g, source: Agritox) – therefore: 0.025 ppm (25 ppb); (3) with NOEC (oral acute toxicity) = 0.001024 µg/bee (10.24 ppb); (4) bees are loyal to their water/food sources and go back repeatedly to the same site to harvest, therefore the exposure cannot be considered acute, but chronic or repeated (normally requiring lower doses to cause death in the long-run); CONCLUSION – how do the authors conclude that there will be no risk at all? Could they please provide their calculations? Even the content of clothianidin in guttation droplets is 1000 times below the concentration found in-field, the concentration is enough to cause acute problems on bees. Please consider that guttation droplets in field contain ENOROUSLY high concentrations.
This comment was actually only about the
realistically to expect residue concentrations in
pollen off field (flowering weeds). Tapparo
(2011) found that in guttation the concentration
was off field 1000 times lower than in field. If
this is similar in pollen (which is probable since
pollen is provided with residues through the
same xylem contents as is guttation), the
concentration in pollen would be off field 1000
times lower than in-field. That is what we
stated. The text and conclusion are not about
residues in guttation.
8 Succeeding crops on fields with treated sunflower and maize, treated with imidacloprid (this PPP being a member of the neonicotinoid insecticide class, can be seen as a worst case), did show only very low (under the detection limits) residue levels of 1 and 1.5 µg/kg in pollen and nectar, respectively (I think there is an error here, Schmuck et al, 2001 showed 3.3 µg/kg in pollen and 1.9 µg/kg in nectar, which goes very much in line with Bonmatin et al, 2003. Please verify). Although the soil still contained imidacloprid between 2-18 µg/kg soil (Schmuck et al., 2001; Charvet et al., 2004).
To be added to these data: A mean value of 12 µg/kg soil was found over a set of treated soils (n=33) at the end of the cultivation of imidacloprid-treated sunflower. 1 or 2 years after treatment residues of imidacloprid were still present
Our statement was correct, the data of CARI
concern a greenhouse study.
(To be added): this is correct
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in the soil: 19% of these soils gave values between 0.1 and 1 μg/kg; 78% of untreated soils still contain more than 1 μg/kg imidacloprid with an average value of 6 μg/ kg (after 1 year). Pollens obtained from plants of these soils (n=24) gave results; 25% of pollens was positive, with amounts of imidacloprid <1 μg/kg; 58% of pollens contained imidacloprid at levels from 1 to 11 μg/kg, with a mean value of 3 μg/kg. (Bonmatin et al., 2003)
But this is not correct: these residue data were the exposed plants, not the succeeding crop!
9 Actually, the problem is that data still lacks regarding guttation and the potential exposure of bees to this source of water in the wild. It is unacceptable to conclude as “less relevant” or “low (no) risk” to honeybees in practice, something that we practically do not know enough about. It would be like concluding that anything that we do not know cannot harm us/bees.
We already included: Nonetheless more scientific data have to be provided to evaluate the possible exposure to contaminated guttation droplets. Moreover, we added similar considerations in the later by EFSA added paragraph about guttation.
10 I see the reasoning of the authors and might have a point. However, it needs to be reminded that the risk assessment of an a.s. Or product is done in isolation, I mean, only the application on one crop in one field is done. However, in reality this a.s. Or product might be used for many different crops or applied in various fields surrounding the hive. Indeed, in areas of monoculture, it is very likely to observe this. As a result, a worse case could be observed, than that tested during the field test.
No comment by the authors
11 This use of large colonies of 60,000 is not realistic for Belgium. Colonies of 60,000 bees are extra-ordinary and in our regions (Belgium, the Netherlands, Luxembourg, Germany, UK) colonies reach about 30,000 at peak. This is not true according to CARI. This is actually the more ‘general’ maximum according to literature. Indeed Andriessen (2011) reported in a literature review that it is a true exception that a colony measures more than 50,000 bees. Measurements over different years confirmed that the average peak number of bees per colony is about 30,000. As a consequence, the size of a normal colony of bees ranges maximally between 25,000 and 40,000.
We propose to have a minimum colony size of about 10,000 bees for higher tier effects studies. Better to propose the use of a colony for testing that resembles
This is just a statement by CARI, for which they have no references provided. The Authors provided an overview with literature which can be consulted. We fully disagree with this vague statement. It
may seem better and sound better, but it will
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the size of the colonies in the area and season concerned, instead of an absolute figure. A strong colony is much more at risk than a small one because somehow it is at the maximum of its biological possibilities. As a result, any unbalance linked to a loss of foragers or brood problems, etc. will have a much larger impact than in small ones. If I remember well, this is somewhere mentioned into the EFSA Scientific opinion (EFSA, 2012).
In our opinion, a colony size of 60,000 is too large and is likely not to be as sensitive in detecting effects as smaller ones. Also, if the colony size is variable according to the season it will make comparison between studies more difficult.
We suggest for a better standardization and replication to use colonies that are smaller and actively growing. We disagree. This is not the worst case, since in the colony that is actively growing we can hardly see any effects unless they are very severe. The strength of the colony is too much and can compensate the deleterious effects. On the contrary, colonies that are stable would not behave in the same way: any effects can be better observed since they do not have such high compensating power.
be more difficult to produce reliable data.
We do not understand nor follow where CARI does get the ‘wisdom of the hive size’. Why has a big colony less compensation abilities? Our concern is that at peak, which is different for every colony, differences between colonies become big, and will prevent to reach data that can be used to draw conclusions
12 It must be said that in comparison with EPPO guidelines, the EFSA ones provide much more guidance and are much more complete.
No comment by the authors
13 It needs to be highlighted that no extra testing is required for the calculation of bioaccumulation tests. This tests only uses the information produced by other tests. Therefore, we obtain extra information for risk assessment, without increasing the costs of testing. So, why not to include in risk assessment, even if it is not a toxicological endpoint.
It is nice that no extra data need to be collected. But that does not imply that everything that is for free is also useful by definition
14 Please verify the comments previously done on guttation, as there is no coherence between the comments of different sections.
Yes, the first comment was made before EFSA
added the paragraph on guttation to the draft
Guidance. It has been addressed (need for
more data on exposure to guttation)
15 Instead of giving an absolute number of bees, why not to recommend the use of colonies for field testing that contain the amount of bees corresponding to the natural development of a colony at the area and season concerned?
We did comment on that (at comment nr. 12).
This introduces the need to know in every
area, what at that site and that moment the
actual sizes of bee colonies are. Very
unpractical. Moreover, every test will be done
with different size of colonies.
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16 The EFSA has no role on these monitoring programs, therefore it is not the EFSA to request for this. It is the Commission, the Member States and the EURLab, ideally keeping informed the EFSA experts, the ones to request the support and further development of the monitoring programes
We recommend that the EFSA, although it
plays no role itself in monitoring, stimulates
further support in these monitoring programs