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EUROPE-EFSA: Latest Progress in the Revision of the 2013 Bee Guidance

In March 2019, the European Commission mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295). In this context, EFSA released two reports this summer.

The first report is the outcome of the EFSA collection of evidence on background bee mortality rates and in particular considering realistic beekeeping management and natural background mortality. A systematic literature review was supplemented with a survey sent to European bee keepers. The collection, which covers the tree bee groups (honey bees, bumble bees and solitary bees), provides solid grounds on background mortalities and will serve as a base for the revision of the EFSA guidance (2013).

The EFSA working group also published a supporting document addressed to risk managers about possible approaches to defining the specific protection goals (SPGs) that will be used in the EFSA guidance (2013) review. The document proposes 4 alternative approaches:

  1. Establish acceptable effect based on long-term colony survival, or,
  2. Derive threshold of acceptable effect on colony size based on their natural variability, or,
  3. Define acceptable levels on colony/population size (approach currently considered in the EFSA guidance 2013), or,
  4. Define levels of acceptable impact on the provision of the ecosystem services.

More details on approaches and associated pros and cons are available in the report (see the link below).

For the next step, risk managers will have to decide which of the approaches EFSA should use for the revision of the guidance. It is noted that the initial schedule is slightly delayed as this step was initially expected to be done by end of May 2020.

As a reminder, the publication of the revised EFSA guidance on bees is scheduled for Q1 2021.

 

To download: 

EFSA’s review of the evidence on bee background mortality – EFSA Supporting publication 2020:EN-1880.

Supporting document for risk managers on specific protection goals for bees – 22 June 2020.

 

See also our previous articles:

EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published   

 

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

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

 

EUROPE – EFSA: Revision of Surface Water FOCUS Scenarios

Further to a public consultation conducted from 24 September to 5 November 2018, EFSA published a scientific report as regards the ‘repair action’ undertaken on the FOCUS surface water scenarios commissioned by the European Commission.

The major revisions made by the working group are summarised below.

Assessment period over 20 years

The current 12- or 16-months assessment periods for the estimation of predicted environmental concentrations in surface water (PECsw) were replaced by a 20-year assessment period by use of additional weather data.

In addition, the following miscellaneous revisions were conducted:

  • A warming-up period of 6 years was added also for the run-off scenarios to account for the potential accumulation in sediment of more persistent substances;
  • Irrigation routines were revised to be based on water balances calculated internally by FOCUS models;
  • A revision of how crop interceptions are estimated in FOCUS MACRO and PRZM was made to ensure consistency with the other exposure models (i.e. for groundwaters and soil);
  • A revision of the cumulative drift probability was made in case of multiple applications (90th percentile drift values considered at the last application). In this way, modelling of PECsw following single application is no more necessary in case of multiple applications;
  • Adaptations were made to the calculation of the correction factor for metabolite formation in the upstream catchment.
Application date selection approach

A revision of the application date selection approach was needed because of the implementation of the new 20-year assessment period. The new approach is based on the link between the BBCH stage as intended in GAP and the calendar date at which this BBCH stage is actually reached over the years at each scenario location.

For single application, an application window was set to ±3 days around the intended application date (corresponding to intended BBCH). For multiple applications, an application window of 3 days prior to 1st application and 3 days after last application was set.

The modification of the application date selection approach allows to reduce the variability of input parameter selections related to application timing and therefore increases user confidence in PECsw calculations.

Besides, it is noted that the maximum number of applications that can be modelled, currently limited to 8, was increased to 50. The use of irregular application interval was also implemented.

Active substance parameter correlated with soil properties

In case of significant change in substance properties within a soil pH range from 5.1 to 8.0, the working group recommended to run individual modellings with substance properties representative for soil pH of 5.1 and of 8.0.

No recommendation was made as regards the soil clay content as this property is already part of the FOCUS scenario definition.

Description of wash-off from crops

Modifications were made in PRZM to ensure more consistency between PRZM and MACRO as regards foliar wash-off. The working group also proposed a revision of the wash-off coefficient used in surface water exposure scenarios to ensure a complete harmonisation with the coefficient used in groundwater and soil exposure scenarios.

PECsw processing times

An improvement was made in the computational approach of TOXSWA which should shorten the project run-time.

The working group underlined that the option of automatically running MACRO and PRZM within SWASH is of interest but could not be addressed within the present mandate.

Drift scenarios
  • The ‘vines early’ drift scenario was removed from the exposure assessment as the drift values were derived from application techniques that are not standard farming practices;
  • BBCH stages were set to discriminate the ‘pome/stone fruits, early’ and ‘pome/stone fruits, late’ drift scenarios: the less conservative ‘pome/stone fruits, late’ drift values will apply from BBCH 71 to 95. The more conservative ‘pome/stone fruits, early’ drift values will apply to other BBCH stages.
  • A downward spraying scenario to tall permanent crops (e.g. orchards, vineyards) was introduced to cover for example an herbicide use. It combines the drift of low arable crops with the default distance to water bodies of tall permanent crops.
Use and presentation of results

PECsw are estimated for each year of the new 20-year assessment period. Without setting a definitive temporal percentile for deriving the overall PECsw, the working group recommended to apply a temporal percentile between the 50th and the 90th percentile, the 90th percentile being more in line with the original intentions of the FOCUS working group. The working group highlighted that the temporal percentile may also be selected by integrating effect modelling on aquatic organisms and the overall exposure pattern rather than to use a fixed temporal percentile.

The working group noted that the revised FOCUS step 3 surface water scenarios do not necessarily cover the current FOCUS step 2 PECsw calculations. A revision of FOCUS step 1-2 is therefore recommended.

For sediment, exposure scenarios were revised in such a way that:

  • PECsed can be estimated in total content on organic matter (OM) basis (µg/kg OM), in total content on dry sediment mass basis (µg/kg dry sediment mass) and in pore water basis (µg/L), and
  • concentrations are averaged over the top 1 and 5 cm for the risk assessments for benthic invertebrates and macrophytes, respectively.

The working group however noted that the approach for PECsed calculation, even after revisions, is not conservative enough. Sediment-dedicated worst-case scenarios would be needed.

Dealing with rotational crops

The working group concluded that crop rotation was already implicitly included in the FOCUS exposure scenarios and it did not necessitate further revision.

Other miscellaneous modifications
  • New data available indicate that a complete and well-established vegetation cover within and between tall permanent crop rows is no more representative of current agricultural practices. A more realistic vegetation cover is now considered for the surface run-off route in tall permanent crop;
  • A revision of the procedure for the drainage route in the run-off scenarios was made;
  • The estimation water temperature in the exposure scenarios was improved.

 

The working group concluded that the revised FOCUS exposure scenarios for surface water delivers PECsw that are in the range of those delivered by the current FOCUS approach. However, the new exposure scenarios are considered to be less dependent on the application timing and thus, more robust.

 

To download: 

Revision of Surface Water FOCUS scenarios: EFSA report and Outcome of the Public Consultation

 

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

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

 

EUROPE – EFSA – Public consultation: Draft Guidance for Photo Transformation Compounds in PECgroundwater Modelllings

EFSA has launched a public consultation on a draft guidance for consideration and parameterisation of photo transformation compounds in groundwater simulations in the exposure assessment of plant protection products. The guidance document was drafted by the German Environment Agency (Umweltbundesamt, UBA).

The document gives recommendations on how to consider transformation products formed by soil photolysis when calculating predicted environmental concentrations in groundwater (PECgroundwater) using PELMO and PEARL models. It describes possible parameterisations of the photolytic pathway in a tiered approach. For PEARL, only the Tier 1 approach is currently possible. Further developments of the PEARL model would be needed to use the more complex photolysis scheme proposed in higher tiers.

The public consultation will be closed on 1 July 2020.

 

To download: 

Guidance for consideration and parameterisation of photo transformation compounds in groundwater simulations in the exposure assessment of plant protection products – Draft version 0.4, December 2018.

 

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

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

 

EUROPE – EFSA: Recurring issues in mammalian toxicology

During the EFSA peer review of pesticide active substances under Regulation (EC) No. 1107/2009, several aspects in the area of mammalian toxicology were identified by EFSA that needed discussion with experts from National Authorities in order to enhance the harmonisation of the risk assessment of active substances.

A new discussion was held at the Pesticide Peer Review Meeting 17 of October 2019. The following topics were addressed:

  • Experience gained and feedback on the assessment of endocrine disrupting (ED) properties with the EFSA/ECHA guidance (2018) – Points for a potential update of the guidance,
  • Possibility to apply to pesticides the new ECHA guidance on impurities in biocides (to be published),
  • Issues related to the assessment of isomers (EFSA guidance 2019),
  • Issues related to the assessment of relevant metabolite in groundwater as regards genotoxicity,
  • Assessment of genotoxicity in chemical mixtures,
  • Use of in silico method for predicting genotoxicity endpoints,
  • Toxicological assessment of metabolites found as residues (EFSA guidance 2016),
  • Possibility to use Benchmark Dose (BMD) when a NOAEL cannot be set in toxicological studies,
  • Top dose selection in (chronic) toxicology studies.

EFSA also presented an update on the following ongoing projects:

  • Use of in vitro interspecies comparative metabolism studies,
  • Update of the OECD guidance notes on dermal absorption (ENV/JM/MONO(2011)36),
  • Development of integrated approaches to testing and assessment (IATA) case studies on developmental neurotoxicity (DNT) risk assessment,
  • Development of adverse Outcome Pathway (AOP) for substances having ED properties.

Other issues (such as the use of historical control data in toxicology studies) were raised by experts and are reported for consideration in future discussions.

 

To download: 

EFSA Technical Report – Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology (26 March 2020)

 

See also our previous articles: 

EUROPE – EFSA: Recurring issues in mammalian toxicology (2018)

EUROPE – EFSA: Recurring issues in mammalian toxicology (2016)

 

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/

 

EUROPE – EFSA: Guidance on risk assessments for substances, impurities and transformation products that may have stereoisomers

EFSA has published a guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities. The document also proposes guidance to be used for active substances that, without containing any stereogenic element, may generate transformation products or metabolites  that do contain them. As a general principle, stereoisomers need to be treated as different chemical components for the risk assessment.

The draft version was proposed to public consultation in April – May 2019. A report presenting the  comments received and how they have been considered by EFSA has been made available.

In this guidance, Regulation (EU) 283/2013 on the data requirements for the plant protection active  substances is analysed, and recommendations are given on how to best address and assess the data requirements for active substances containing stereoisomers. Furthermore, the guidance gives recommendations on how to make the best  use of the available information to perform the risk assessment of these substances, particularly in situations when the information on individual isomers is not available or difficult to obtain, with the primary objective to reduce the need to repeat vertebrate animal testing.

One special situation is when active substances, that without containing any stereogenic element, may generate transformation products that do contain them. In these cases, it is appropriate to refer to metabolites containing stereoisomers. For these substances, the guidance should not be applied to the active substance but should be applied to assess metabolites that contain a stereogenic element.

 

To download: 

Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

Outcome of the public consultation on the draft guidance on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers

 

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

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

EUROPE-EFSA: Recurring Issues in Ecotoxicology

EFSA published a technical report on the outcome of expert’s discussions in Ecotoxicology that took place during Pesticide Peer Review Meeting 185 in October 2018.

Numerous general and specific issues are addressed. The specific issues discussed are related to risk assessment for terrestrial vertebrates, aquatic organisms, non-target arthropods, soil organisms and non-target terrestrial plants.

 

To download: 

Outcome of the Pesticides Peer Review Meeting on general recurring issues in ecotoxicology – EFSA Supporting publication 2019:EN-1673.

 

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

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

 

EUROPE-EFSA: Workplan for the Revision of the 2013 Bee Guidance Published

In March 2019, the European Commission mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295). In this context, EFSA just released the timelines for the guidance review (available to download below).

The first consultation will begin in a few weeks. Stakeholder and Member State representatives will be invited to give their views on the current guidance document. As announced in May 2019, the stakeholder feedback will be provided by a consultation group which has been selected by EFSA. The details of the consultation group members has also been released by EFSA (available to download below).

After a full public consultation to be held during summer 2020, the publication of the final revised guidance should be published in March 2021.

 

To download: 

Outline of the revision of the guidance on the risk assessment of plant protection products and bees

Meeting of the Selection Board for EFSA’s Stakeholder Consultation Group for the review of the Bee Guidance Document

 

See also our previous articles:

EUROPE-EFSA: Consultative Group for the Review of the Bee Guidance Document 2013

 

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

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

 

EUROPE-EFSA: Consultative Group for the Review of the Bee Guidance Document 2013

In March 2019, the European Commission (EC) mandated EFSA for a review of its guidance on the Risk Assessment of Plant Protection Products on Bees (EFSA Journal 2013;11(7):3295) which has still not been adopted at EU level. The scope of the mandate is to revise several areas of the current guidance document as asked by Member States and stakeholders and by considering new scientific evidence that has become available since its publication in 2013.

In particular, the EC asked for a review focused on:

  • Bee background mortality,
  • Exposure routes,
  • The list of bee-attractive crops,
  • The methodology with regard to higher tier testing.

For the purpose of the revision of the guidance, EFSA is setting up a stakeholder consultative group which will be consulted at various stages during the review and provide input to the EFSA scientific working group charged with revising the document. A call for stakeholder expert representatives was started by EFSA on 8 May 2019 with a deadline for application on 21 May 2019 (Please refer to Call to EFSA stakeholder organisations below). EFSA will select for the consultative group a maximum of 14 stakeholder  expert representatives from the nomination received.

Besides, Member State’ experts will also be consulted during the revision process and a public consultation and workshop will be held once a draft of the revised document is available.

Further details including timelines about how EFSA plans to address the mandate will be published by July 2019. According to EFSA, the revised guidance is to expected in 2021.

 

To download:

Call to EFSA stakeholder organisations for nominating stakeholder experts to the ad hoc EFSA Bee Guidance Stakeholder Consultation Group

 

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

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

 

EUROPE – EFSA: Issues in Physical and Chemical Properties and Analytical Methods

EFSA published a technical report on the outcome of expert’s discussions in the area of physical and chemical properties and analytical methods that took place during a Pesticide Peer Review Meeting in November 2018.

The main issues identified are related to (i) the quality and level of details of the renewal assessment reports and (ii) the adherence to the new data requirements, in particular regarding analytical methods and general issues regarding the assessment of the impurity profiles and specifications of the technical material. Discussions which focused mainly on national authorisation of Plant Protection Products (PPP) were not included in this EFSA technical report.

The main topics addressed are:

  • CRD guidance on physical and chemical properties
  • Physical-chemical properties of active substances and PPP
  • Revision of some guidance documents
  • Methods used for the generation of pre-approval data
  • Monitoring methods for body fluids and tissues
  • Evaluation of extraction efficiency in residue analytical methods
  • Guidance of isomers
  • Impurities
  • Five representative batches
  • Confirmation of analyte identification (active substance, relevant and significant impurities)
  • LOQ for relevant and significant impurities (5 batch analysis)
  • Detected but not quantified impurities (5 batch analysis)
  • Specifications
  • Microorganisms
  • Equivalence assessment issues for PPP authorisation at MS level

For each issue addressed in the document, a background is presented followed by the outcome of discussions reflecting the opinion of the majority of the participating experts and the associated EFSA proposals.

 

To download:

Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods – EFSA Supporting publication 2019:EN-1623

 

See also our previous articles:

EFSA: Issues in physical-chemical properties and analytical methods

 

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

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