Irish National Requirements (PPP)
Environmental fate and behaviour
The national soil exposure assessment is in line with the current EU assessment approach.
The national groundwater exposure assessment is in line with the current EU assessment. However, Applicants should note that only two of the FOCUS groundwater scenarios are relevant for Ireland. In order to demonstrate safe use conditions with respect to Irish groundwater, the (FOCUS PEARL and FOCUS PELMO) 80th percentile annual average leaching concentration corresponding to the realistic worst case GAP (i.e. maximum application rate, minimum interval between applications, minimum crop interception) at 1 m soil depth over a period of 20 years has to be ≤ 0.1 μg/L for the active substances and relevant metabolites for the two FOCUS scenarios representative of Irish pedo-climatic conditions (i.e. the Hamburg and Okehampton scenarios). Sanco/221/2000 – rev.11 21 October 2021 is used to assess the relevance of any metabolites arising in groundwater. If a crop is not covered by a FOCUS scenario a suitable surrogate crop should be used. Model calculations using reasonable worst-case substance properties with respect to leaching have to be provided for each of the two FOCUS groundwater scenarios in situations where substance properties depend on soil properties other than organic carbon.
Higher Tier assessments will be considered if they are in line with the recommendations given in EU guidance, SANCO/13144/2010 (version 3, 2014). This may include refinement of substance properties, refinement of the FOCUS scenarios or creation of new scenarios tailored to a certain crop area applying spatial modelling techniques. Data from non-targeted groundwater monitoring studies (conducted in Ireland or in other Member States) are generally not accepted for authorisation purposes unless it can be scientifically demonstrated the data is relevant and reliable for Ireland and the intended use. However, adverse data from non-targeted public groundwater monitoring conducted in Ireland (e.g. monitoring performed as part of the Water Framework Directive) will be taken into account on a case by case basis. Targeted groundwater monitoring studies conducted either in Ireland or in other Member States, will be considered provided the data is set into context with the FOCUS groundwater scenarios.
At EU level, the FOCUS surface water working group defined 10 realistic worst-case surface water scenarios for the aquatic exposure assessment (FOCUS, 2001), which assess the likelihood and level of pesticide exposure arising in a water body at the edge of the treated field from diffuse processes that occur either during or shortly after the application (i.e. spray/dust drift, runoff/erosion and drainflow). In addition, deposition onto water following volatilisation from soil and/or foliage is considered for certain substances depending on their vapour pressure. The FOCUS surface water scenarios are intended to represent realistic worst-case conditions (90th percentile vulnerability). If a crop is not covered by a FOCUS scenario a suitable surrogate crop should be used. Applicants should ensure that the choice of the application window results in an application date that is relevant and representative of the realistic worst-case GAP (i.e. lowest interception, highest rainfall period. More than one simulation may be necessary).
At the EU level, risk mitigation with respect to the aquatic exposure assessment may be applied by decreasing the direct input via spray drift using non-spray buffer zones and/or by introducing vegetated buffer zones between the treated field and the water course thereby reducing input via surface runoff and erosion (FOCUS, 2007). These (STEP 4) calculations should follow FOCUS (2007) guidance. Spray drift cannot be mitigated by more than 95% and runoff cannot be mitigated by more than 90% (i.e. not reducing solute flux in run‐off by more than 80% and erosion runoff of mass adsorbed to soil by more than 95%). The latest version of the SWAN tool should be appropriately used to implement these mitigation measures in the simulations. The FOCUS (2007) report acknowledges that for substances with KFoc < 2,000 L/kg the general applicability and effectiveness of run‐off mitigation measures had been less clearly demonstrated in the available scientific literature, than for more strongly adsorbed compounds. Where relevant, Applicants should justify the applicability of the runoff mitigation measure to their substance.
The national surface water exposure assessment is in line with the current EU assessment. However, Applicants should note that only a limited number of the FOCUS scenarios are relevant for the Irish surface water risk assessment. Based on a review of the pedo-climatic conditions associated with the FOCUS surface water scenarios, the D4 drainage FOCUS scenario was identified as the most applicable scenario to Irish conditions. In situations where the D4 scenario is not defined for a particular crop, the results from the D2 scenario, which is considered to be very conservative for Irish conditions, will be used instead. In any case, the national FOCUS surface water scenario accounting for drainage (i.e. D4/D2) has to demonstrate no unacceptable effects to aquatic organisms. In addition at least one of the FOCUS runoff scenarios relevant for the EU Central zone (R1, R3, R4), which are considered overly conservative for Ireland must demonstrate no unacceptable effects to aquatic organisms.
Available monitoring data from the EU Central zone concerning the fate and behaviour of the active substance and relevant metabolites, degradation and reaction products should be reported. Adverse data from non-targeted public surface water monitoring conducted in Ireland (e.g. within the Water Framework Directive) will also be taken into account.
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