SCIENTIFIC OPINION ADOPTED: 15 December 2016 doi: 10.2903/j.efsa.2017.4690 Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in-soil organisms EFSA Panel on Plant Protection Products and their Residues (PPR), Colin Ockleford, Paulien Adriaanse, Philippe Berny, Theodorus Brock, Sabine Duquesne, Sandro Grilli, Antonio F Hernandez-Jerez, Susanne Hougaard Bennekou, Michael Klein, Thomas Kuhl, Ryszard Laskowski, Kyriaki Machera, Olavi Pelkonen, Silvia Pieper, Michael Stemmer, Ingvar Sundh, Ivana Teodorovic, Aaldrik Tiktak, Chris J. Topping, Gerrit Wolterink, Peter Craig, Frank de Jong, Barbara Manachini, Paulo Sousa, Klaus Swarowsky, Domenica Auteri, Maria Arena and Smith Rob Abstract Following a request from EFSA, the Panel on Plant Protection Products and their Residues developed an opinion on the science behind the risk assessment of plant protection products for in-soil organisms. The current risk assessment scheme is reviewed, taking into account new regulatory frameworks and scientific developments. Proposals are made for specific protection goals for in-soil organisms being key drivers for relevant ecosystem services in agricultural landscapes such as nutrient cycling, soil structure, pest control and biodiversity. Considering the time-scales and biological processes related to the dispersal of the majority of in-soil organisms compared to terrestrial non-target arthropods living above soil, the Panel proposes that in-soil environmental risk assessments are made at in- and off-field scale considering field boundary levels. A new testing strategy which takes into account the relevant exposure routes for in-soil organisms and the potential direct and indirect effects is proposed. In order to address species recovery and long-term impacts of PPPs, the use of population models is also proposed. © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: in-soil invertebrates, microorganisms, effects, pesticides, protection goals, risk assessment Requestor: EFSA Question number: EFSA-Q-2011-00978 Correspondence: [email protected] www.efsa.europa.eu/efsajournal EFSA Journal 2017;15(2):4690 RA for in-soil organisms Panel 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. Acknowledgements: 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 PPR Panel (EFSA Panel on Plant Protection Products and their Residues), Ockleford C, Adriaanse P, Berny P, Brock T, Duquesne S, Grilli S, Hernandez-Jerez AF, Bennekou SH, Klein M, Kuhl T, Laskowski R, Machera K, Pelkonen O, Pieper S, Stemmer M, Sundh I, Teodorovic I, Tiktak A, Topping CJ, Wolterink G, Craig P, de Jong F, Manachini B, Sousa P, Swarowsky K, Auteri D, Arena M and Rob S, 2017. Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in-soil organisms. EFSA Journal 2017;15(2):4690, 225 pp. doi:10.2903/j. efsa.2017.4690 ISSN: 1831-4732 © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. Reproduction of the following images is prohibited and permission must be sought directly from the individual copyright holders: Figures 1, 2, 3, 4, 5, 6, 7, 8, 16, 17, 18 and 19. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. www.efsa.europa.eu/efsajournal 2 EFSA Journal 2017;15(2):4690 RA for in-soil organisms Summary The new regulatory framework for plant protection products (PPPs) laid out in Commission Regulation (EC) No 1107/2009 and Commission Regulation (EU) No 283/2013 and 284/2013 explicitly requires consideration of impacts on non-target species, on their ongoing behaviour and on biodiversity and the ecosystem, including potential indirect effects via alteration of the food web. In view of this new legislative background and the new scientific developments, the European Food Safety Authority (EFSA) asked the Panel on Plant Protection Products and their Residues (PPR) to develop and update the guidance documents on terrestrial ecotoxicology (SANCO/10329/2002) under mandate M-2009-0002. The assessment of effects on biodiversity is not explicitly addressed under the existing guidance documents; appropriate risk assessment methodology therefore needs to be developed. This scientific opinion has been written as a precursor to the guidance document on the risk assessment for in-soil organisms. Other terrestrial organisms as previously covered in the SANCO Guidance 10329/2002, such as birds and mammals, non-target arthropods, bees and non-target terrestrial plants are covered in other EFSA scientific documents (EFSA, 2009a, 2013; EFSA PPR Panel, 2014a, 2015a). In-soil organisms are species that dwell primarily in the soil and soil litter. In-soil organisms are exposed to plant protection products (PPPs) from contact and oral uptake routes of exposure in the surrounding soil compartment. A ‘healthy’ soil supports a range of ecosystem functions or services (such as nutrient cycling) that are essential for supporting the growth of crops as well as the organisms that depend on those crops. The working group of the PPR Panel reviewed the current environmental risk assessment, identified key drivers that sustain important in-soil ecosystem services in agricultural landscapes and developed proposals for specific protection goal (SPG) options for in-field and off-field areas. The SPG options will then be discussed and agreed in consultation with Risk Managers. The working group developed proposals for testing of effects as well as suggestions to calibrate the lower tier risk assessment steps. The in-soil communities of invertebrates and microorganisms are the most diverse part inhabiting agricultural landscapes. Yet, the current risk assessment, at the first tier, examines a selection of invertebrate model species (e.g. Eisenia fetida/andrei, Folsomia candida/fimetaria, Hypoaspis aculeifer) and one microorganism-mediated process (N transformation). The currently requested tests were reviewed in relation to the proposed SPG options and the available data and the representativeness of the current standard species was discussed. The Panel suggests that the current test battery with the use of an appropriate (calibrated) assessment factor might cover the intra- and interspecies variability in toxicological sensitivity in soil, with the exception of some in-soil organisms when exposed via food and via litter. Note that the current trigger values as included in the Regulation 546/2011 have not been properly calibrated at the time of their inclusion in the Regulation. The Panel recommends adapting the test with H. aculeifer to take the uptake of contaminated food into account, and to develop a standardised test with isopods, to take exposure via the litter into account. For microorganisms, the Panel proposed retaining and advancing the N-transformation test, and adding a test with mycorrhizal fungi to the data requirements and risk assessment. In a tiered approach, considering the possibilities for intermediate tier testing, the Panel acknowledges the usefulness of the Species Sensitivity Distribution (SSD) conceptual model (in intermediate tier A); however, standard SSD methodology cannot yet be applied to in-soil organisms until further guidance on how toxicity data can be combined (e.g. toxicity data for different taxonomic groups of in-soil organisms, etc.) will become available. Another option of intermediate tier can also be a microcosm study assessing effects on natural assemblages of in-soil communities (intermediate tier B), although further experience is necessary to apply this methodology in risk assessment. At higher tiers, the Panel recommends assessment of the response of communities of in-soil organisms to intended uses of PPPs, so that indirect effects on populations of key drivers can also be detected. Natural communities of in-soil organisms should be studied using field tests or semifield test like terrestrial model ecosystems (TMEs), pending on the context triggering the need for higher tiers. The Panel recommends that species recovery and other long-term impacts (including multiple stressors) at the population level are best investigated using a combination of experimental data and population modelling, if these were including all relevant environmental and ecological parameters. However, since long-term impacts and indirect effects at the community level cannot