3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)
Appropriate endpoints from the EU review were used to calculate PECs for 2,4-D and its metabolites in soil, surface water, ground water and air for the intended use patterns. The following was mentioned by zRMS in the Core dossier: The active substance Dicamba is not yet renewed. As EU (interzonally) agreed, the substance related sections are not reviewed by the zRMS. The review will be performed once the active is renewed. Therefore, in the Core dossier and NL Addendum, only the substance 2.4-D and its metabolites have been taken into account. PECs values for active substance dicamba have been included in the risk assessment with regards to the ecotoxicological aspect.
3.1.5.1 Predicted Environmental Concentration in Soil (PEC
soil) (Part B, Section 5, Points 9.4 and 9.5)
The PEC of UKS 118A, 2,4-D, dicamba and their metabolites in soil has been assessed with the FOCUS model and the FOCUS groundwater interception values and the DT50 values established in the EU review.
Based on the recommended use rate of 200 kg product/ha, the maximum initial predicted environmental concentration in soil (PECs) of 2,4-D and dicamba will be 0.533 mg/kg and 0.080 mg/kg, respectively.
For the metabolites 2,4-DCP, 2,4-DCA and DCSA, the proposed use pattern will lead to maximum initial PECs of 0.0342 mg/kg, 0.0641 mg/kg and 0.0562 mg/kg, respectively, which is acceptable according to the uniform principles.
The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PEC
GW) (Part B, Section 5, Point 9.6)
The PEC of 2,4-D and its metabolites in ground water has been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS PELMO, FOCUS PEARL and FOCUS MACRO models and the Koc
values established in the EU review, including the for NL relevant Kremsmünster scenario.
The predicted environmental concentrations (PECGW) at 1m depth for active substances following 26 years use on grass/alfalfa at 200 kg product/ha with 75 % foliar interception, were less than 0.01 µg/L in the Kremsmünster scenario using FOCUS PEARL 4.4.4. The potential for the metabolites 2,4-DCP and 2,4-DCA to leach to groundwater has been assessed in the same way. As the assessment is requested for non-professional use, the dose rate should have been corrected to match a maximum acreage of 500 m2. However the full dose rate was applied in the PECgw calculations as a conservative approach.
The models predict that the active substance and its metabolites will not be found in ground water at concentrations greater than 0.1 μg/L. Based on the assessment, the use of UKS 118A is not expected to lead to leaching into groundwater at levels that would be unacceptable when applied according to the recommended use pattern.
Monitoring data groundwater
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Active substance 2,4-D
The active substance 2,4-D was observed in the groundwater [RIVM Report 607310001/2007].
Regarding the presence of metabolite 2,4-DCA no monitoring data are available.
Monitoring data were collected in 2006 in the framework of groundwater monitoring for the WFD starting situation (so-called nulmeting) in the Dutch provinces Drenthe, Flevoland, Friesland, Gelderland, Groningen, Noord-Holland, Overijssel, Utrecht and Zeeland.
In Table 3.1.5.2-1 observed concentrations in groundwater are presented.
Table 3.1.5.2-1 Monitoring data for 2,4-D in Dutch groundwater (2006) Location/year Detection
limit [µg/L]
a/n* Filter depth Maximum conc.
[µg/L]
* Number of observations above detection limit (a)/total number observations (n).
It must be noted that (page 19 of the report, translated by Ctgb) “no check was performed on the
measurements as is required for use of the data in registration assessment, as this was not included in the current project remit. Presented values can therefore not be used as such in registration procedures.”
3.1.5.3 Predicted Environmental Concentration in Surface Water (PEC
SW) (Part B, Section 5, Points 9.7 and 9.8)
As the application concerns granular application, no drift will occur, and therefore no PECsw/sed values have been calculated.
Monitoring data surface water
In 2015, version 3 of the Pesticide Atlas was launched, which includes a statistical correlation analysis between concentrations, threshold exceedance and land use, which may indicate probable relationships. In this version also the correlation analysis of land use with the environmental quality standards (EQS) of the Water Framework Directive (WFD) is included.
Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold and environmental quality standards (MKN in Dutch, data source http://www.rivm.nl/rvs/Normen). These environmental quality standards consist either of the harmonised WFD thresholds derived according to the Fraunhofer methodology1 (AA-EQS and MAC-EQS) or of an MPC value (which is usually derived on the basis of outdated guidance). When EQS values according to the Water Framework Directive are available, the MPC value is not used further in the analysis of monitoring data for the purpose of the registration.
2,4-D
1 P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’. RIVM report 601782001.
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The active substance 2,4-D was observed in the surface water (most recent data from 2015). In Table 9.8.7.2-1 the number of observations in the surface water are presented.
The authorisation threshold equals 29 µg a.s./L (consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.05*EC50 Lemna gibba).
The relevant MPC for this substance equals 26 µg/L.
The currently available MPC value is reported here for information purposes when no EQS values are available.
Table 3.1.5.3-1 Monitoring data in Dutch surface water for 2,4-D (from www.pesticidesatlas.nl, version 3)
Total no of locations (2015)
* the number of observations at each location varies between 1 and 30, total number of measurements is 1530 in 2015.
n.a. not available
As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed use of the product.
Drinking water criterion
It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’.
The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 16352.
Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).
- For new substances, a pre-registration calculation is performed.
- For existing substances, the assessment is based on monitoring data of Vewin (drinking water board).
o If for an existing substance based on monitoring data no problems are expected by Vewin, Ctgb follows this Vewin assessment.
o If for an existing substance based on monitoring data a potential problem is identified by Vewin, Ctgb assesses whether the 90th percentile of the monitoring data meet the
drinking water criterion at each individual drinking water abstraction point.
2,4-D
2 Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use of plant
protection products for drinking water production from surface waters - A proposal for the registration procedure in the Netherlands. Alterra-Report 1635
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2,4-D has been on the Dutch market for > 3 years (authorised since 29-10-1989). This period is sufficiently large to consider the market share to be established. The existing active substance 2,4-D is included in the list of substances of concern due to its presence in surface water at drinking water abstraction points as established by Vewin/Ctgb. Therefore, an adequate risk assessment is needed based on the highest tier data. There are monitoring data concerning the presence of 2,4-D at drinking water abstraction points. See Table 3.1.5.3-2.
Table 3.1.5.3-2 Monitoring data for 2,4-D at drinking water abstraction points from surface water in the period 2011 – 2015
Abstraction point Number of
measurements above
** Please note that from the raw data, this value is way below 0.1 µg/L (90 P concentration = 0.05 µg/L), but due to rounding the value is reported in the table as 0.1µg/L , as some (raw) measurements were reported only containing 1 decimal behind the comma.
The relevant monitoring data (data set Vewin, 2011-2015) indicate that the overall 90-percentile at individual drinking water abstraction points is ≤ 0.1 μg/L.
Therefore, the application of UKS 118A is not expected to exceed the drinking water criterion.
3.1.5.4 Predicted Environmental Concentration in Air (PEC
Air) (Part B, Section 5, Point 9.9)
The fate and behaviour in air of 2,4-D and dicamba were evaluated during the Annex I Inclusion. No additional studies have been performed.
Implications for labelling resulting from environmental fate assessment: None.
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Date : April 2019