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EUROPE–EFSA: Public Consultation on Updated Bird and Mammals Risk Assessment

EFSA has launched the public consultation on the draft updated guidance document on Risk Assessment for Birds and Mammals (Access to the consultation). The document is an update of the current EFSA’s guidance document (EFSA Journal 2009; 7(12):1438).

Comments will be welcomed until 10.11.2021.

 

To download: 

Draft EFSA guidance-document – Risk assessment for birds and mammals – Version of 29.09.2021 for Public Consultation.

Draft Annex B – Deposition values – Version of 29.09.2021 for Public Consultation.

Draft Annex C – HTET Residue Studies – Version of 29.09.2021 for Public Consultation.

Draft Annex D – HTET Ecological Field Studies – Version of 29.09.2021 for Public Consultation.

Draft Annex E – HTET Field Effect Studies – Version of 29.09.2021 for Public Consultation.

Draft Appendix F – Summary of Generic Model Species Parameters – Version of 29.09.2021 for Public Consultation.

 

See also our previous articles: 

EUROPE – EFSA: Database of Ecological and Residue Data Used in Assessments for Birds and Mammals

 

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

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

 

FRANCE: Public Consultation on New Measures to Protect Pollinators

The Ministries of Agriculture and Environment have launched the public consultation on the draft National Plan for Pollinators (Access to consultation) and the draft “bee” Order to replace the Order of 2003 as regards the Conditions of Use of Insecticides and Acaricides to Protect Bees and Other Pollinating Insects (Access to consultation). The consultation is open until 20 July 2021.

Draft National Plan for Pollinators

The draft National plan contains various actions to be carried out over the period 2021-2026 to “act in favour of pollinating insects, wild and domestic, and of pollination”. It is articulated around six axes:

  1. Improving scientific knowledge (including on wild pollinator populations, and stressors affecting domestic and wild pollinator populations),
  2. Economic levers and supports for farmers, beekeepers and foresters,
  3. Supports for other activity sectors (urban development, linear infrastructure, industrial sites, sites with large land rights, protected areas),
  4. Preservation of bee health (e.g. strengthening of bee health monitoring),
  5. Regulation of plant protection products (PPPs) to protect pollinators (it includes the strengthening of the provisions of the “bee” Order of 2003 – detailed below),
  6. Sharing of pollinator-friendly farming practices.
Draft “Bee” Order

In order to reduce the impact of PPPs on pollinators when applied during flowering, two main evolutions were retained in the draft “Bee” Order on the basis of Anses recommendations (see our previous articles):

  • Extension of the flowering-period specific assessment to all PPPs, i.e., inclusion of fungicides and herbicides:
    PPP applications on attractive flowering crops and on “bee foraging areas” would only be possible “if there is no unacceptable effect on bees (acute or chronic), nor on colony survival and development”. Anses would specify the data required for the evaluation.
  • Limitation of the PPP application period when used on flowering crops and on “bee foraging areas”:
    Applications would have to be carried out within 2 hours before sunset and 3 hours after sunset. This restriction period could be adapted or waived if measures providing an equivalent level of protection to pollinators are implemented (such measures are still to be defined with the support of Anses). Exemptions would also be possible in the case of technical deadlock.

As regards attractive plant covers under perennial crops, covers would have to be rendered unattractive to pollinators prior to any insecticide or acaricide application on crops. The other types of PPPs would not be concerned by this measure.

Transitory measures are planned for the entry into force of the new “bee” Order:

  1. Limitation of the PPP application period when used on flowering crops and on “bee foraging areas” would be immediately applicable to insecticides and acaricides for which an authorisation of application during flowering and/or exudate production period is already granted (current “Bee Claim” procedure), AND for PPPs other than insecticides and fungicides.
  2. For PPPs other than insecticides and fungicides whose authorisation renewal will be in less than 30 months after the entry into force of the new “bee” Order:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses risk assessment conclusions and provided that the required additional data are submitted within 30 months after the entry into force of the “bee” Order.
  3. For PPPs other than insecticides and fungicides whose authorisation renewal will be in more than 30 months after the entry into force of the new “bee” Order AND in the case of major uses in France:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses risk assessment conclusions and provided that the required additional data are submitted within 48 months after the entry into force of the “bee” Order.
  4. If the required additional data are not submitted within the deadlines (30 or 48 months), PPP application on flowering crops and on “foraging bee areas” would no longer be possible.
  5. A notification of the submission of the required additional data and of the uses concerned would have to be made 18 months before the submission.
  6. For PPPs other than insecticides and fungicides whose authorisation renewal will be in more than 30 months after the entry into force of the new “bee” Order AND in the case of minor uses in France:
    PPP application on flowering crops and on “foraging bee areas” would remain possible pending Anses conclusions on the renewal dossier. The required additional data would have to be submitted with the renewal dossier with no specific notification needed.

Given the current timeline, the new “bee” Order could be released by the end of 2021.

European context

The strengthening projet of the French measures for pollinators happens in a context of evolution of the pollinator protection policy at European level, with the current revision of the EFSA guidance document (EFSA Journal 2013;11(7):3295; see our previous articles) and with the revision of the uniform principles for evaluation and authorisation of PPPs as regards pollinators (Regulation (EU) No. 546/2011).

On 28 June 2021, a majority of Member States voted in favour of the European Commission’s proposal for a protection goal of 10% as a maximum permitted level of honeybee colony size reduction. This threshold will now be integrated into the draft updated EFSA guidance document for finalisation. The final version could be released by the end of 2021.

As regards uniform principles, their revision could take place in the first half of 2022.

 

To download (in French): 

Draft National Plan in Favour of bees and other pollinating insects – Version of 28.06.2021 for Public Consultation.

Draft Order as Regards the Protection of Bees and Other Pollinating Insects and the Maintenance of Pollination Service when Using Plant Protection Products – Version of 28.06.2021 for Public Consultation.

 

See also our previous articles: 

FRANCE – Anses: Recommendations for the Risk Assessment for Bees and Other Pollinators   

FRANCE – ANSES: recommendations to strengthen the protection of bees

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

 

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

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

 

EUROPE–EFSA: Environmental exposure and risk assessments for transition metals

Transition metals can be used as active substances in plant protection products (PPPs). Due to their specific behaviour in the environment, they are not fully covered by existing risk assessment guidances.

EFSA was thus asked by the European Commission to prepare a statement that provides a framework for conducting the environmental exposure, hazard characterisation and risk assessment for transition metals when used as active substances according to Regulation (EC) No 1107/2009.

The statement and the outcome of the public consultation performed form 3 August to 21 September 2020 were published on 29 March 2021.

In this statement, the EFSA’s PPR panel proposes to start with a preliminary phase in which monitoring data of transition metals in environmental compartments are compiled. Then a first assessment step is performed considering metal natural background and anthropogenic residue levels and assuming fully bioavailable residues. If higher assessment steps are performed, reduced bioavailability of residues from past applications could be considered. However, for freshly added transition metals such as PPP, equilibrium cannot be assumed.

For addressing speciation and bioavailability issues, models and scenarios including environmental processes and parameters relevant to the fate and behaviour of transition metals in water, sediment and soils would need to be adapted or developed. Care should be taken to avoid unnecessary complexity. All developments should follow current EFSA guidance documents.

If refined approaches have been used in the risk assessment of PPPs containing metals, post-registration monitoring and controlled long-term studies should be conducted and assessed.

Lastly, the statement highlights that the prospective risk assessment of metal-containing PPPs can only cover a defined period as there are limitations in the long-term hazard assessment due to issues of non-degradability. It is therefore recommended to consider these aspects in any risk management decisions and to align the environmental risk assessment with the goals of other overarching legislative frameworks.

 

To download: 

Statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP)

 

Outcome of the Public Consultation on the draft statement of the PPR Panel on a framework for conducting the environmental exposure and risk assessment for transition metals when used as active substances in plant protection products (PPP)

 

 

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 – EFSA: Guidance document on active substance applications for approval and renewal and on MRL applications

EFSA published on 03 March 2021 a technical report describing the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment or the renewal of approval of an active substance, and for applications for setting of maximum residue levels (MRLs). This guidance document is applicable for all applications submitted as of 27 March 2021.

This document describes the procedures and the timelines for handling these applications and also includes the new requirements related to the implementation of the Transparency Regulation (Regulation (EU) 2019/1381). The different support initiatives available and the interaction between the applicant, EFSA members and RMS/Co-RMS from the preparation of the application (pre-submission phase) to the adoption and publication of the EFSA’s conclusions or reasoned opinions are presented.

Eventually, a practical guidance for applicants and Member States also describes the key technical points for preparing dossiers and assessment reports under Regulation (EC) No 1107/2009 with the aim to enhance their quality.

 

To download: 

EFSA Supporting publication 2021:EN-6464: Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances and on the maximum residue level (MRL) application procedure

 

See also our previous articles: 

EUROPE-EFSA: Guidance on active substance applications for approbation and renewal

 

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

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

 

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/