Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in‐soil organisms
2017; Wiley; Volume: 15; Issue: 2 Linguagem: Inglês
10.2903/j.efsa.2017.4690
ISSN1831-4732
AutoresColin Ockleford, Paulien Adriaanse, Philippe Berny, T.C.M. Brock, Sabine Duquesne, Sandro Grilli, Antonio F. Hernández, Susanne Hougaard Bennekou, Michael Klein, Thomas Kühl, Ryszard Laskowski, Kyriaki Machera, Olavi Pelkonen, Silvia Pieper, Michael Stemmer, Ingvar Sundh, Ivana Teodorović, A. Tiktak, Christopher John Topping, Gerrit Wolterink, Peter Craig, Frank de Jong, Barbara Manachini, Paulo Sousa, Klaus Swarowsky, Domenica Auteri, Maria Arena, Rob Smith,
Tópico(s)Agricultural safety and regulations
ResumoEFSA JournalVolume 15, Issue 2 e04690 Scientific OpinionOpen Access 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), EFSA Panel on Plant Protection Products and their Residues (PPR)Search for more papers by this authorColin Ockleford, Colin OcklefordSearch for more papers by this authorPaulien Adriaanse, Paulien AdriaanseSearch for more papers by this authorPhilippe Berny, Philippe BernySearch for more papers by this authorTheodorus Brock, Theodorus BrockSearch for more papers by this authorSabine Duquesne, Sabine DuquesneSearch for more papers by this authorSandro Grilli, Sandro GrilliSearch for more papers by this authorAntonio F Hernandez-Jerez, Antonio F Hernandez-JerezSearch for more papers by this authorSusanne Hougaard Bennekou, Susanne Hougaard BennekouSearch for more papers by this authorMichael Klein, Michael KleinSearch for more papers by this authorThomas Kuhl, Thomas KuhlSearch for more papers by this authorRyszard Laskowski, Ryszard LaskowskiSearch for more papers by this authorKyriaki Machera, Kyriaki MacheraSearch for more papers by this authorOlavi Pelkonen, Olavi PelkonenSearch for more papers by this authorSilvia Pieper, Silvia PieperSearch for more papers by this authorMichael Stemmer, Michael StemmerSearch for more papers by this authorIngvar Sundh, Ingvar SundhSearch for more papers by this authorIvana Teodorovic, Ivana TeodorovicSearch for more papers by this authorAaldrik Tiktak, Aaldrik TiktakSearch for more papers by this authorChris J. Topping, Chris J. ToppingSearch for more papers by this authorGerrit Wolterink, Gerrit WolterinkSearch for more papers by this authorPeter Craig, Peter CraigSearch for more papers by this authorFrank de Jong, Frank de JongSearch for more papers by this authorBarbara Manachini, Barbara ManachiniSearch for more papers by this authorPaulo Sousa, Paulo SousaSearch for more papers by this authorKlaus Swarowsky, Klaus SwarowskySearch for more papers by this authorDomenica Auteri, Domenica AuteriSearch for more papers by this authorMaria Arena, Maria ArenaSearch for more papers by this authorSmith Rob, Smith RobSearch for more papers by this author EFSA Panel on Plant Protection Products and their Residues (PPR), EFSA Panel on Plant Protection Products and their Residues (PPR)Search for more papers by this authorColin Ockleford, Colin OcklefordSearch for more papers by this authorPaulien Adriaanse, Paulien AdriaanseSearch for more papers by this authorPhilippe Berny, Philippe BernySearch for more papers by this authorTheodorus Brock, Theodorus BrockSearch for more papers by this authorSabine Duquesne, Sabine DuquesneSearch for more papers by this authorSandro Grilli, Sandro GrilliSearch for more papers by this authorAntonio F Hernandez-Jerez, Antonio F Hernandez-JerezSearch for more papers by this authorSusanne Hougaard Bennekou, Susanne Hougaard BennekouSearch for more papers by this authorMichael Klein, Michael KleinSearch for more papers by this authorThomas Kuhl, Thomas KuhlSearch for more papers by this authorRyszard Laskowski, Ryszard LaskowskiSearch for more papers by this authorKyriaki Machera, Kyriaki MacheraSearch for more papers by this authorOlavi Pelkonen, Olavi PelkonenSearch for more papers by this authorSilvia Pieper, Silvia PieperSearch for more papers by this authorMichael Stemmer, Michael StemmerSearch for more papers by this authorIngvar Sundh, Ingvar SundhSearch for more papers by this authorIvana Teodorovic, Ivana TeodorovicSearch for more papers by this authorAaldrik Tiktak, Aaldrik TiktakSearch for more papers by this authorChris J. Topping, Chris J. ToppingSearch for more papers by this authorGerrit Wolterink, Gerrit WolterinkSearch for more papers by this authorPeter Craig, Peter CraigSearch for more papers by this authorFrank de Jong, Frank de JongSearch for more papers by this authorBarbara Manachini, Barbara ManachiniSearch for more papers by this authorPaulo Sousa, Paulo SousaSearch for more papers by this authorKlaus Swarowsky, Klaus SwarowskySearch for more papers by this authorDomenica Auteri, Domenica AuteriSearch for more papers by this authorMaria Arena, Maria ArenaSearch for more papers by this authorSmith Rob, Smith RobSearch for more papers by this author First published: 22 February 2017 https://doi.org/10.2903/j.efsa.2017.4690Citations: 38 Correspondence: pesticides.ppr@efsa.europa.eu Requestor: EFSA Question number: EFSA-Q-2011-00978 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. Adopted: 15 December 2016 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. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2017.EN-1164/full AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat 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. 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 be assessed using population models, (semi)field studies with natural assembled communities are needed. It should be noted that recovery of populations of soil organisms and soil processes after impact of PPP intended uses might be demonstrated only later than the proposed time scale of tolerable effects in the SPG options. For example, if effects should not persist for more than 6 months, key drivers may need to be monitored for a longer time period depending on their generation time to exclude effects on reproduction and indirect effects persisting more than 6 months. It is suggested that assessment factors be derived on the basis of statistical modelling of the relationships between effects for different species in the various possible lower tier tests and higher tier field studies and the surrogate reference tier. In particular, a Bayesian network model can exploit information from experimental data and from expert judgement in the absence of suitable data. Such a model provides a relatively transparent method for deriving assessment factors in order to ensure a high probability of acceptable effects for uses that pass the risk assessment. Further research needs such as standardisation of additional testing protocols, development of a range of representative scenarios and models of relevant taxa for population modelling, use of toxicokinetic/toxicodynamic (TK/TD) for in-soil organisms, etc. have been identified. 1 Introduction In 2008, the PPR Panel was tasked by the European Food Safety Authority (EFSA) to revise the guidance document (GD) on Terrestrial Ecotoxicology (SANCO/10329/2002 rev. 2 final) (European Commission, 2002), which is currently used in the routine environmental risk assessment for terrestrial non-target organisms (except for birds and mammals and non-target arthropods) exposed to active substances in plant protection products (PPPs). The replacement of Directive 91/414/EEC1 by Regulation (EC) No 1107/20092 (hereafter referred to as 'the Regulation') in June 2011 called for revision of the existing GD in order to include new elements in environmental risk assessment (ERA), e.g. cut-off criteria and protection goals. It was decided to split the task and to address separately the risk for different groups of organisms, i.e. in-soil organisms, non-target arthropods (NTAs), amphibians and reptiles, and non-target terrestrial plants (NTTPs). For each group of organisms, the PPR Panel first summarises the science behind the respective risk assessment in a scientific opinion and, in a second step, EFSA will develop practical guidance on how to perform the risk assessment. The present Opinion is focussed mainly on in-soil invertebrates and soil microorganisms. Vertebrates such as moles are dealt with in the Guidance for birds and mammals (EFSA, 2009a). Rooted plants are dealt with in the Opinion on non-target terrestrial plants (EFSA PPR Panel, 2014a). Algae are also not covered in the present Opinion because they do not seem to play a key role in the majority of the agricultural soils. For the purpose of this Scientific Opinion and for consistency with the definitions as given in the recent Opinion of the PPR Panel on NTAs (EFSA PPR Panel, 2015a), in-soil organisms are defined as species that dwell primarily in the soil and soil litter layer. In-soil organisms may become exposed to PPPs from contact and oral uptake routes taking place in the surrounding soil compartment (EFSA PPR Panel, 2015a). The opinion is concerned with all non-target in-soil organisms, meaning all those in-soil organisms that are not indicated as the target pest species an active substance and PPP are effective against. According to ISO 11074:2005, soil is defined as the upper layer of the earth's crust transformed by weathering and physical/chemical and biological processes. It is composed of mineral particles, organic matter, water, air, and living organisms organised in generic soil horizons. Soil performs a multitude of key environmental, economic, social and cultural functions, and could be regarded as the most complex biological environment directly affected by PPPs. Soil, for example, provides food, biomass and raw materials and plays a central role as a habitat and gene pool (biodiversity). In-soil organisms, including macro-, meso-, microfauna and microorganisms, are extremely diverse and contribute to a wide range of ecosystem services, such as nutrient cycling, pest and disease control, natural attenuation of pollutants, soil formation and stabilisation, etc. All these important ecosystem services could potentially be impacted by the intentional release of PPPs in the environment if the key drivers of the services were to be adversely affected by exposure to pesticides. General protection goals are stated in the European legislation but are not precisely defined. A precise definition is however crucial for designing appropriate risk assessment schemes. Therefore, specific protection goal (SPG) options are presented, to be used in consultation processes with risk managers and stakeholders. It is the responsibility of risk managers to select the final SPG options that should be addressed in decision schemes of guidance documents. According to the PPR Panel Opinion (EFSA PPR Panel, 2010a), different groups of in-soil organisms (earthworms, microarthropods, macroarthropods, nematodes, gastropods, mycorrhizae and other fungi, bacteria, etc.) have been identified as providers of important ecosystem services in the soil ecosystem. SPGs have been developed considering six dimensions, namely ecological entity, attribute, magnitude of effects, temporal scale of effect, spatial scale of effect and degree of certainty. Proposals for SPGs have been defined both for in-field and off-field as in-soil organisms also occur and are potentially exposed to PPPs outside the treated field. However, dispersal ability and biological characteristics need to be considered in the context of the pesticide risk assessment for these organisms. Some organisms move between fields and across field boundaries, so that recolonisation processes from the off- to the in-field might take place in relevant time frames. Others move only a limited distance within a field and might predominantly recover from PPP effects by processes that govern internal recovery. 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 local scale, considering processes at the field boundary scale. Unlike NTA, 'action at a distance' is not expected to be important for most in-soil organisms. Recovery by recolonisation would be important at very long temporal scale, and thus the landscape-level assessment is not needed. In contrast to human toxicology, where individual health is protected by studies on several surrogate species, ecotoxicology is based on testing a limited number of species to make inferences about a much larger number of species. ERA for in-soil organisms is at the extreme end of the RA spectrum, because the diversity of in-soil species is much greater than for any other group of organisms in an environment directly affected by PPPs, while the tests and test data available are few. This Opinion is structured to address key scientific aspects behind ERA for in-soil organisms, with a focus on in-soil invertebrates and microorganisms, including the major points resulting from the EFSA public consultation on the SANCO Guidance Document on Terrestrial Ecotoxicology. After a brief explanation on how the risk assessment for in-soil organisms is currently done, a section on the further elaboration of the proposed SPGs option is presented. Also, a general framework with an overview on the key aspects on the possible future risk assessment scheme for in-soil organisms is presented, followed by discussion on aspects of both exposure and effects assessment. For exposure of in-soil organisms, the focus is on the work developed by EFSA for spray application to annual crops under conventional or reduced tillage (development of exposure assessment for permanent crop is on-going and an update of the EFSA GD 2015 is foreseen by the end of 2017). On the effects-assessment side, existing and promising testing approaches are presented including tests for intermediate and higher tiers, how to deal with persistency and how to tackle recovery. These approaches may possibly be adopted in the future ERA scheme. 1.1 Background and Terms of Reference as provided by the requestor In view of the revision of the current risk assessment for terrestrial organisms, in 2008, EFSA launched a public consultation on the SANCO Guidance Document on Terrestrial Ecotoxicology (EFSA, 2009b). The aim of the public consultation was to collect issues and gaps identified by different stakeholders to be used as inputs in the revision of the terrestrial guidance. A total of 33 comments were received from different stakeholders on the chapter about in-soil organisms (Chapter 6 of the SANCO guidance). The main comments concerned the following: Development of specific protection goals for in-soil organisms More clarity on the level of assessment (structure vs function) More guidance on persistent substances More guidance on how to consider bioavailability when interpreting effect test results and need for more standardised test design (% peat, addition of feed, application of the test item, correction factor) Earthworm field studies: more guidance on the evaluation of effects and acceptability criteria (% effects based on total earthworm numbers, biomass, safety factor, etc.). The use of the guidance on how to summarise earthworm field studies was suggested. Introduction of semifield tests (e.g. terrestrial model ecosystem (TME)) More guidance on the interpretation of effects on soil microorganisms More guidance on the exposure assessment (measurement of the concentration in the test, selection of the appropriate predicted environmental concentration (PEC), persistence, etc.). 1.2 Terms of Reference as provided by EFSA EFSA tasked the Pesticides Unit and the PPR Panel on the following activity, taking into consideration the legislative background, stakeholder comments as reported in Section 1.1 and the recommendations and priorities identified by Member States. Development of Guidance on risk assessment for in-soil organisms, with the following deliverables: Opinion addressing the state of the science to be delivered by the PPR Panel by April 2017; Public consultation on the draft Opinion of the PPR Panel to be issued by the 1st quarter of 2016; Guidance of EFSA to be delivered within 2 years after the agreement with risk managers on the specific protection goals; Public consultation on the draft Guidance of EFSA. 1.3 Legislative Background Active substances used in plant protection products (PPPs) are approved in the European Union (EU) under Regulation (EC) No 1107/2009. The Regulation requires that 'substances or products produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment'. With respect to the environment, this includes, in particular, considerations of the impact on non-target species, including the ongoing behaviour of those species, and the impact on biodiversity and the ecosystem. New Commission regulations laying down the data requirements for the dossier to be submitted for the approval of active substances contained in PPPs and the authorisation of PPPs (Commission Regulation (EU) No 283/20133 and 284/20134) were published in 2013. Those documents provide information on the core data needed to assess active substances and PPPs. As a general requirement for substance approval, it is stated in Commission Regulation (EU) No 283/2013 that 'the potential impact of the active substance on biodiversity and the ecosystem, including potential indirect effects via alteration of the food web, shall be considered'. Active agents as well as formulated products containing active agents (microbial PPPs) have specific data requirements and they are not specifically addressed in this opinion. 2 Current risk assessment 2.1 Current risk assessment for in-soil organisms and other background documents The state of the art regarding the risk assessment of pesticides to in-soil organisms is presented in this chapter. In particular, an overview is given on the 1) current risk assessment approaches according to the SANCO/10329/2002 Terrestrial Guidance Document (European Commission, 2002); 2) background documents, such as workshop on semifield methods for the environmental risk assessment of pesticides in soil (PERAS workshop, Coimbra, 2007; Schäffer et al., 2008, 2010) and guidance for summarising earthworm field studies (De Jong et al., 2006). 2.1.1 Terrestrial Guidance Document SANCO/10329/2002 The current risk assessment for in-soil organisms is carried out according to the SANCO/10329/2002 Terrestrial Guidance Document developed under the Council Directive 91/414/EEC. This Directive was repealed in 2009 by the (EC) Regulation 1107/2009, while the Commission Regulations (EU) No 283/2013 and 284/2013 laid down the new data requirements for active substances and plant protection products (PPPs), respectively. Therefore, only the parts of the Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) covered by the regulations will be considered in the following paragraphs. The risk assessment for in-soil organisms follows the principle of the risk assessment paradigm: 1) hazard identification, 2) hazard characterisation, 3) exposure assessment and 4) risk characterisation. A tiered approach is used. The concept of the tiered approach is to start with a simple, conservative assessment and to go towards more complex evaluations (higher tiers), when necessary. 2.1.2 Exposure assessment The exposure characterisation is represented by a comprehensive evaluation of fate and behaviour of the active substance and transformation products in soil of the treated area, including the estimation of PECs. The initial PECs values after single or multiple applications and PECs plateau are calculated according to FOCUS (FOCUS, 1997). The choice of the relevant PECs to be used for risk assessment will depend on the characteristic of the active substance (e.g. persistence in soil) and on the intended uses. 2.1.3 Effect assessment The effect assessment is represented by a comprehensive investigation of the dose–response relationships, in order to derive toxicity endpoints (e.g. LC50, NOEC), which can be compared with the predicted environmental concentrations. According to the new data requirements, the studies listed below should be conducted and reported unless it is proven that the contamination of soil is unlikely. It is highlighted that the acute toxicity study on earthworms is no longer a data requirement. Test for sublethal effects on earthworms (Eisenia fetida or Eisenia andrei). The test is conducted according to the OECD guideline 222 (OECD, 2004) and information on the effects on growth, reproduction and behaviour of the earthworms should be reported. The relevant endpoint might be either EC10 or EC20 to be presented together with a NOEC. Test on springtail Folsomia candida (OECD, 2009) and mite Hypoaspis aculeifer (OECD, 2008) for PPPs applied directly to soil as soil treatments. For PPPs applied as a foliar spray, data on soil invertebrates other than earthworms may be required in case concerns have been identified in the risk assessment of non-target arthropods, as data on both the hymenopteran parasitoid Aphidius rhopalosiphi and predatory mite Typhlodromus pyri may be used in an initial risk assessment. The relevant endpoint might be either EC10 or EC20 to be presented together with a NOEC. Test on the impact of active substances and PPPs on soil microbial activity in terms of nitrogen transformation (OECD, 2000). The test is done at two concentrations, the PEC (= maximum predicted concentration in soil) and a multiple of the PEC as the worst case. The results are reported as the ratio of the nitrate-formation rates at the PEC relative to the control, expressed as a percentage of the control rate. In case further refinements of the risk are triggered, field studies reflecting the intended uses of the PPP, the environmental conditions likely to arise and species that will be exposed, should be conducted, as indicated in the Uniform Principles (Commission Regulation (EU) No 546/2011). Field studies evaluate the effects on abundance and biodiversity, taking into consideration the likely level of effects, the species/groups affected, population recovery (within 1 year) as well as information on the application and fate of the PPP (EPPO, 2003). However, at present, there are few standardised higher tier protocols. The litter bag test is one example mentioned in the terrestrial SANCO guidance document but this is more concerned with functional rather than structural endpoints. The risk to in-soil organisms other than earthworms can be further refined using a more realistic test substrate or exposure regime. 2.1.4 Risk assessment Th
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