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EUROPE: New PELMO and PEARL Versions Released

New versions of the models PELMO (i.e. v.6.6.4) and PEARL (i.e. v.5.5.5) used for Predicted Environmental Concentrations in Groundwater (PECgw) calculations, accompanied by a new version of the Generic Guidance for Tier 1 FOCUS GroundWater Assessments (i.e. v.2.3) were released by the FOrum for Co-ordination of pesticide fate models and their USe (FOCUS DG SANTE).

The FOCUS DG SANTE recommends that the previous versions of the generic guidance (v.2.2), of PELMO (v.5.5.3) and of PEARL (v.4.4.4) should no longer be used in submissions made after 1 January 2022.

Updates of version 2.3 of the generic guidance are:

  • Update of the equations for converting pH measured in CaCl2 and KCl to pH measured in H2O, and,
  • Irrigation water in PELMO and PEARL is now applied at the soil surface for the crops apples, citrus and vines,

both to reflect the EFSA guidance on PECsoil calculation (EFSA Journal 2017;15(10):4982);

  • Update on guidance on pesticide property parameter derivation in case of pH dependence, to reflect the EFSA report on the ‘repair action’ on the FOCUS surface water scenarios (EFSA Journal 2020;18(5):6119);
  • Reference to the OECD 106 evaluators checklist in relation to equilibrium sorption parameters added (EFSA supporting publication 2017:EN-1326);
  • New options for defining transformation product formation fractions in PELMO;
  • Correction to periods to crop factors (Kc) for the crop onions at the Porto and Thiva scenarios;
  • Reference added to the new endorsed guidance determining aged (non equilibrium) sorption parameters (SANTE/12586/2020-REV 0).

The new versions of PELMO and PEARL were also developed to work in combination with the new PERSAM tool for PECsoil calculations. They will be used to generate higher tier (‘Tier 3A’) PECsoil (reference to our previous post on PERSAM).

 

To download: 

Generic Guidance for Tier 1 FOCUS GroundWater Assessments (version 2.3) (June 2021)

FOCUS PELMO 6.6.4 (GW) 6.6.1 (soil)

FOCUS PEARL 5.5.5

 

See also our previous articles: 

EUROPE – EFSA: New version of PERSAM tool for PECsoil calculations

EUROPE – EFSA: Revision of Surface Water FOCUS Scenarios

EUROPE: Guidance on Aged Sorption Studies Adopted

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE–EFSA: New version of PERSAM tool for PECsoil calculations

A new version (v3.0.5) of the PERSAM tool to conduct PECsoil calculations in agreement with the new EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (EFSA Journal 2017;15(10):4982) was recently released.

The list of the issues solved in versions v3.0.1 to v3.0.5 can be found in Section 1.2.2 (p. 8-9) of the updated PERSAM user manual, that comes with the tool (it can also be downloaded further below). PERSAM 3.0.5 can be downloaded via the ESDAC website (a request form should be fulfilled to receive a download link).

Further details on the issues can be found in the Bug fixing & update report recently released by EFSA (to be downloaded below).

 

To download: 

Update of PERSAM software models for predicting environmental concentrations in soil in permanent crops and annual crops: User manual PERSAM 3.0.5. EFSA Supporting publication 2021:EN-1756.

Software tool for calculating the predicted environmental concentrations (PEC) of plant protection products (PPP) in soil for permanent and annual crops: Bug fixing & update report. EFSA Supporting publication 2021:EN-6484.

 

See also our previous articles: 

EUROPE – EFSA: New version of PERSAM tool for PECsoil calculations

EFSA : Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE: Guidance on Aged Sorption Studies Adopted

The final version of the guidance document on aged sorption studies of plant protection products in soil was endorsed at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF meeting) of 25-26 January 2021.

The final version integrates the revisions suggested by the EFSA PPR panel (EFSA Journal 2015;13(7):4175 and EFSA Journal 2018; 16(8);5382). Additional comments from Member States made at SCoPAFF meetings between May 2019 and January 2021 will be considered in a later revision of the document.

The guidance document was drafted in order to provide a framework on how to conduct and interpret experimental studies aiming to demonstrate an increase in pesticide sorption with time and how to integrate the results in regulatory higher tier risk assessments. This framework was built on the basis of a literature review, experimental work and extensive modelling.

Only aged sorption as investigated in laboratory studies is under the scope of this document. Field studies being much more complex, further development and tests with real world data would be needed.

The guidance document addresses the following topics:

  • Modelling of aged sorption and conceptual definition of equilibrium sorption;
  • Experiments to derive aged sorption parameters;
  • Fitting of kinetic models to data from aged sorption studies;
  • Aged sorption in the tiered pesticide leaching assessment;
  • Special consideration for metabolite.

This new guidance document will apply from 1 April 2021 (date of dossier submission).

 

To download: 

Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments – SANTE/12586/2020–REV 0 – 26 January 2021

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EUROPE – EFSA: New version of PERSAM tool for PECsoil calculations

EFSA recently released a new version (v3.0.0) of the PERSAM tool to conduct PECsoil calculations in agreement with the new EFSA Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (EFSA Journal 2017;15(10):4982).

This new version of PERSAM includes, among other improvements, the updates of the latest version of the EFSA guidance document (2017 release which replaced the initial guidance document published in 2015 – EFSA Journal 2015;13(4):4093).

PERSAM v3.0.0 now covers field crops grown on ridges and permanent crops in addition to the annual field crops. It also allows to conduct initial PECs calculations for microbial active substances.

PERSAM tool will be used directly for Tier 1 (pre-defined scenarios based on total area of annual crops and permanent crops) and Tier 2 calculations (crop specific) to generate PECs. For Tier 3A (more realistic approach), the tool will be used for the generation of a transfer file (initial parametrisation) that will then be used to feed updated versions of PELMO and PEARL. Hence, in Tier 3A, PECs will be generated via PELMO and PEARL models. PERSAM v3.0.0 allows to conduct calculations either at the zonal level or at the country level at Tier 2 and Tier 3A.

As a reminder, a Tier 3B using spatially distributed numerical models was also mentioned in EFSA (2017). PERSAM would not be involved in such cases. However no agreed software tools/guidance are currently available for such refinement.

Complete details of new features of PERSAM v3.0.0 can be found in section 1.2 (p. 7) of the updated PERSAM user manual, that comes with the tool (it can also be downloaded further below). PERSAM 3.0.0 can be downloaded via the ESDAC website (a request form should be fulfilled to receive a download link).

 

To download: 

Update of PERSAM software models for predicting environmental concentrations in soil in permanent crops and annual crops: User manual PERSAM 3.0.0. EFSA Supporting publication 2019:EN-1756.
(The user manual includes the description of input screens and the Tier-1 and Tier-2 calculations of the PERSAM v3.0.0.)

Software tool for calculating the predicted environmental concentrations (PEC) of plant protection products (PPP) in soil: Documented review. EFSA Supporting publication 2019:EN-1763.
(This report describes the validation of the calculation results produced by PERSAM compared to independent results.)

Update of PERSAM software models for predicting environmental concentrations in soil in permanent crops and annual crops: Software architecture. EFSA Supporting publication 2019:EN-1762.
(This report describes the software architecture of the PERsistence in Soil Analytical Model (PERSAM) software tool version 3.0.0.)

Software tool for calculating the predicted environmental concentrations (PEC) of plant protection products (PPP) in soil for permanent and annual crops: External scientific report (Final report). EFSA Supporting publication 2019:EN-1761.
(This report describes the implementation phases of PERSAM version 3.0.0.)

 

See also our previous articles: 

EFSA : Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil

 

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! http://lynxee.consulting/en/contact/

 

EFSA : Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil

Further to the publication of the new EFSA guidance document (EFSA Journal 2015;13(4):4093), Lynxee consulting focuses on the new tiered approach for the exposure assessment of soil organisms to pesticides. Five tiers are defined with a same protection goal, i.e. the 90th percentile concentration within the area of intended use of a PPP. Both concentrations in total soil and in pore water are estimated over various depths and time windows. The assessments are based on average/mean active substance properties (e.g. half-live, Kom).

In first tiers (Tiers 1, 2B and 2C), PECs are calculated with the new software tool PERSAM (to be downloaded from European Commission Joint Research Centre (JRC) Website). In Tier 2A and higher tiers, PECs are calculated with updated versions of PEARL and PELMO. Crop interception and subsequent dissipation at the crop canopy may be included in higher tiers of the exposure assessment. In addition, an easy-to-use table has been developed for the estimation of the fraction of the dose reaching the soil (Appendix K of the guidance).

The recommended methodology does not consider dissipation processes such as leaching and plant uptake. This procedure works well for parent compound and most of the soil metabolites. However, the scenario selection procedure that forms the basis of Tiers 2A, 3A and 3B is not completely appropriate for certain metabolites (i.e. metabolites that do leach significantly from the top 20 cm of soil and metabolites that do not accumulate over the years). Despite this, it is advised to use the exposure assessment scheme for all soil metabolites until a commonly agreed alternative becomes available.

Note that this EFSA guidance covers only spray applications to annual crops under conventional and reduced tillage and also, with specific adaptations, granular products and row treatments. For permanent crops, crops grown on ridges and no-tillage systems, until new guidance is available, current methods still apply.