Statement on the FERA guidance proposal: ‘Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments’ (FERA, 2012)

Residues, EFSA Panel on Plant Protection Products and their

doi:10.2903/j.efsa.2015.4175

Cited by 3 publications

(1 citation statement)

References 81 publications

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“…Instead of the currently used harsh solvent extraction to determine the total extractable mass, a mild organic solvent would be preferable because this fraction generally correlates better with ecologically relevant endpoints like uptake in organisms (see Appendix 1 in EFSA, 2009c for an overview). However, no standard protocol is currently available for mild chemical extractions in relation to bioavailability testing (see also EFSA, 2009c;EFSA PPR Panel, 2015c). Furthermore, there is no commonly agreed exposure assessment methodology to determine the fraction that is available for oral uptake by organisms.…”

Section: Measuring Exposure In Test Systemsmentioning

confidence: 99%

Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in‐soil organisms

Ockleford

Adriaanse²,

Berny³

et al. 2017

EFS2

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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.

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Section: Measuring Exposure In Test Systemsmentioning

confidence: 99%

Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in‐soil organisms

Ockleford

Adriaanse²,

Berny³

et al. 2017

EFS2

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Scientific Opinion on the effect assessment for pesticides on sediment organisms in edge‐of‐field surface water

2015

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The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) was tasked to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev. 4 (final), 17 October 2002. This scientific opinion of the PPR Panel is the second of three requested deliverables within this mandate. The scientific background for the risk assessment on sediment organisms in edge-of-field surface waters is provided, with reference to benthic ecology and ecotoxicology, available test protocols and current knowledge on exposure and effects of sediment-bound plant protection products (PPPs). The scientific opinion provides approaches on how to derive regulatory acceptable concentrations (RACs) for sediment organisms and exposure to active substances of PPPs and transformation products of these substances, and how to link them in a tiered approach to predicted environmental concentrations (PECs) for the sediment compartment. A list of uncertainties in relation to such approaches is given. SUMMARYSediment Environmental Risk Assessment (ERA) is a combination of exposure and effect assessment. Proposals for these assessments are provided. The opinion describes specific protection goals (SPGs) for sediment-inhabiting organisms based on two options (1) the ecological threshold option (ETO), accepting negligible population effects only, and (2) if applicable, the ecological recovery option (ERO), accepting some population-level effects if ecological recovery takes place within an acceptable time period.Triggers for sediment ecotoxicity testing are proposed together with a decision scheme for when additional testing may be required. The ecotoxicologically relevant concentrations (ERCs) for sediment organisms are proposed, as this will be influenced by the choice of sediment layer, exposure metric and test duration.The current Forum for the co-ordination of pesticide fate models and their use (FOCUS) methodology for surface water does not consider the effect of multi-year applications, which could possibly lead to accumulation of pesticides in sediment. To account for this deficit, a proposed methodology for introducing an accumulation factor that can be used until an updated FOCUS methodology becomes available is presented in this opinion. The accumulation factor can be considered a conservative approach, since it does not include any possible transport processes, such as leaching or volatilisation, which may reduce the accumulation in sediment in the real field situation.A tiered effect assessment approach is proposed for different sediment organisms and how to link regulatory acceptable concentrations (RACs) to predicted environmental concentration (PECs). The assessment of bioaccumulation, biomagnification and secondary poisoning is discussed, as well as the prospect of improving ERA for sediment microorganisms.Transformation products from active substances also may need to be assessed, as well as mixture toxicity of formulations of plant protection products (PPPs). The op...

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Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Residues¹,

Ockleford²,

Hernandez-Jerez³

et al. 2018

EFS2

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The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quality of the data provided, the proposed fitting procedure of aged sorption experiments and the proposed method for combining results obtained from aged sorption studies and lower-tier studies on degradation and adsorption. Aged sorption was a relevant process in all cases studied. The test revealed that the guidance could generally be well applied and resulted in robust and plausible results. The Panel considers the guidance suitable for use in the groundwater leaching assessment after the recommendations in this Scientific Opinion have been implemented, with the exception of the use of field data to derive aged sorption parameters. The Panel noted that the draft guidance could only be used by experienced users because there is no software tool that fully supports the work flow in the guidance document. It is therefore recommended that a user-friendly software tool be developed. Aged sorption lowered the predicted concentration in groundwater. However, because aged sorption experiments may be conducted in different soils than lower-tier degradation and adsorption experiments, it cannot be guaranteed that the higher tier predicts lower concentrations than the lower tier, while lower tiers should be more conservative than higher tiers. To mitigate this problem, the Panel recommends using all available higher-and lower-tier data in the leaching assessment. The Panel further recommends that aged sorption parameters for metabolites be derived only from metabolite-dosed studies. The formation fraction can be derived from parentdosed degradation studies, provided that the parent and metabolite are fitted with the best-fit model, which is the double first-order in parallel model in the case of aged sorption.

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Statement on the FERA guidance proposal: ‘Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments’ (FERA, 2012)

Cited by 3 publications

References 81 publications

Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in‐soil organisms

Scientific Opinion addressing the state of the science on risk assessment of plant protection products for in‐soil organisms

Scientific Opinion on the effect assessment for pesticides on sediment organisms in edge‐of‐field surface water

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

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