EFSA Journal 20YY;volume(issue):NNNN 1 DRAFT SCIENTIFIC OPINION 2 Scientific Opinion addressing the state of the science on risk assessment 1 3 of plant protection products for in-soil organisms 4 EFSA Panel on Plant Protection Products and their Residues (PPR)2,3 5 European Food Safety Authority (EFSA), Parma, Italy 6 ABSTRACT 7 Following a request from the European Food Safety Authority, the Panel on Plant Protection Products 8 and their Residues developed an opinion on the science behind the risk assessment of plant protection 9 products for in-soil organisms. The current risk assessment scheme is reviewed, taking into account 10 new regulatory frameworks and scientific developments. Proposals are made for specific protection 11 goals for in-soil organisms being key drivers for relevant ecosystem services in agricultural 12 landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time- 13 scales and biological processes related to the dispersal of the majority of in-soil organisms compared 14 to terrestrial non-target arthropods living above soil, the Panel proposes that in-soil environmental risk 15 assessments are made at in- and off-field scale and field boundary levels. A new testing strategy 16 which takes into account the relevant exposure routes for in-soil organisms and the potential indirect 17 effects is proposed. In order to address species recovery and long-term impacts of PPPs, the use of 18 population models is proposed. 19 © European Food Safety Authority, 20YY 20 21 KEY WORDS 22 in soil-invertebrates, microorganisms, effects, pesticides, protection goals, risk assessment 23 1 On request from EFSA, Question No EFSA-Q-2011-00978, adopted on DD Month YYYY. 2Panel members: Paulien Adriaanse, Philippe Berny, Theodorus Brock, Sabine Duquesne, Sandro Grilli, Antonio F. Hernandez-Jerez, Susanne Hougaard, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Kyriaki Machera, Colin Ockleford, Olavi Pelkonen, Silvia Pieper, Rob Smith, Michael Stemmer, Ingvar Sundh, Ivana Teodorovic, Aaldrik Tiktak, Chris J. Topping, Gerrit Wolterink. Correspondence: [email protected] 3Acknowledgement: The Panel wishes to thank the members of the Working Group on Non-target arthropod and In-Soil risk assessment: Peter Craig, Frank de Jong, Michael Klein, Ryszard Laskowski, Ton van der Linden (until July 2015), Barbara Manachini, Silvia Pieper, Robert Smith, Paulo Sousa, Ingvar Sundh, Klaus Swarowsky, Aaldrik Tiktak and Christopher J. Topping for the preparatory work on this scientific opinion, and EFSA staff Maria Arena and Domenica Auteri for the support provided to this scientific opinion Suggested citation: EFSA ACRONYM Panel (EFSA Panel Name) [or] Scientific Committee, 20YY. Scientific Opinion on title of the opinion. EFSA Journal 20YY;volume(issue):NNNN, 248 pp. doi:10.2903/j.efsa.20YY.NNNN Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 20YY RA for in-soil organisms 24 SUMMARY 25 The new regulatory framework for plant protection products (PPPs) laid out in Commission 26 Regulation (EC) No 1107/2009 and Commission Regulation (EU) No 283/2013 and 284/2013 27 explicitly requires consideration of impacts on non-target species, on their ongoing behaviour and on 28 biodiversity and the ecosystem, including potential indirect effects via alteration of the food web. In 29 view of this new legislative background and the new scientific developments, the European Food 30 Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues (PPR) to 31 develop and update the guidance documents on terrestrial ecotoxicology (SANCO/ 10329/2002) 32 under mandate M-2009-0002. The assessment of effects on biodiversity is not explicitly addressed 33 under the existing guidance documents; appropriate risk-assessment methodology therefore needs to 34 be developed. This scientific opinion has been written as a precursor to the guidance document on the 35 risk assessment for in-soil organisms. Other terrestrial organisms as previously covered in the Sanco 36 Guidance 10329/2002 , such as birds and mammals, non-target arthropods, bees and non-target 37 terrestrial plants are covered in other EFSA scientific documents (EFSA, 2009c; EFSA PPR Panel, 38 2015a; EFSA, 2013; EFSA PPR Panel, 2014a). 39 In-soil organisms are species that dwell primarily in the soil and soil litter. In-soil organisms are 40 exposed to plant protection products (PPPs) from dermal and oral uptake routes of exposure in the 41 surrounding soil compartment. A ‘healthy’ soil supports a range of ecosystem functions or services 42 (such as nutrient cycling) that are essential for supporting the growth of crops as well as the organisms 43 that depend on those crops. The working group of the PPR Panel reviewed the current environmental 44 risk assessment, identified key drivers that sustain important in-soil, ecosystem services in agricultural 45 landscapes and developed proposals for specific protection goal (SPG) options for in-field and off- 46 field areas. The SPG options will then be discussed and agreed in consultation with Risk Managers. 47 The working group developed proposals for exposure assessment and testing of effects as well as a 48 method to calibrate the lower tier risk assessment steps. 49 50 The in-soil communities of invertebrates and microorganisms in and around crops are the most 51 diverse part of the ecosystem. Yet, the current risk assessment at the first tier only examines a small 52 selection of invertebrate species (e.g. Eisenia fetida/andrei, Folsomia candida/fimetaria, Hypoaspis 53 aculeifer) and one microorganism-mediated process (N transformation). The current tests were 54 reviewed in relation to the proposed in-soil SPG options and the available data. The Panel concludes 55 that the current test battery with the use of an appropriate assessment factor might cover the intra and 56 inter species variability in soil, with the exception of the toxicity of in-soil organisms when exposed 57 via food and via litter. Note that the current trigger values are not calibrated. The Panel recommends 58 adapting the test with Hypoaspis aculeifer to take the uptake of contaminated food into account, and 59 to develop a standardized test with isopods, to take exposure via the litter into account. For 60 microorganisms, the Panel proposed retaining and developing the N-transformation test, and adding a 61 test with mycorrhizal fungi. 62 63 In a tiered approach, considering the possibilities for intermediate tier testing, the Panel considers that 64 the Species Sensitivity Distribution (SSD) conceptual model is very useful, but that standard SSD 65 methodology cannot yet be applied to in-soil organisms until further guidance on how toxicity data 66 can be combined (e.g structural vs functional endpoints; toxicity data on different taxonomic groups 67 of in-soil organisms, etc.) will become available. At higher tiers, the Panel recommends assessment of 68 the response of communities of in-soil organisms to intended uses of PPPs, so that indirect effects on 69 populations of key drivers can also be detected. Natural assemblages of in-soil organisms should be 70 studied by using field tests or terrestrial model ecosystems (TMEs). 71 72 The Panel recommends that species recovery and other long-term impacts (including multiple 73 stressors) at population level are best investigated using a combination of experimental data and 74 population modelling, if these were including all relevant environmental and ecological parameters. 75 However, since long-term impacts and indirect effects at community level cannot be assessed using 76 population models, (semi)field studies with natural assembled communities are needed. It should be EFSA Journal 20YY;volume(issue):NNNN 2 RA for in-soil organisms 77 noted that species recovery after impact of PPP intended uses might be demonstrated only later in 78 time than suggested in the SPG options, especially for key drivers with longer generation time. 79 It is suggested that assessment factors be derived on the basis of statistical modelling of the 80 relationships between effects for different species in the various possible lower tier tests and higher 81 tier field studies and the surrogate reference tier. In particular, a Bayesian network model can exploit 82 information from both experimental data and expert judgement and provides a relatively transparent 83 method for deriving assessment factors in order to ensure a high probability of acceptable effects for 84 uses that pass the risk assessment. EFSA Journal 20YY;volume(issue):NNNN 3 RA for in-soil organisms 85 TABLE OF CONTENTS 86 Abstract .................................................................................................................................................... 1 87 Summary .................................................................................................................................................. 2 88 Table of contents ...................................................................................................................................... 4 89 1. Introduction ..................................................................................................................................... 7 90 1.1. Background and Terms of Reference as provided by requestor ............................................. 9 91 1.2. Legislative background..........................................................................................................