Posts

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

In 2018, the Ministries of Agriculture and Ecological Transition asked Anses to make recommendations aimed at strengthening the regulatory framework for the protection of bees and other pollinators in France. Following this request and the first issued recommendations (Referral No. 2018-SA-0147in French), Anses began working on an update of the risk assessment procedure for bees and other pollinators in the context of Plant Protection Products authorisations (PPPs). On 28 October 2019, Anses published the conclusions of this work and its recommendations (Referral No. 2019-SA-0097in French).

Anses recommends replacing the current bee risk assessment scheme (based on SANCO/10329, 2002 and EPPO, 2010), by an approach based on the current version of the EFSA Bee guidance document (version of 4 July 2014, EFSA Journal 2013;11(7):3295), pending an harmonised approach is validated at European level. It is noted that the EFSA guidance document (2013) has not been adopted at EU level and is currently under revision by EFSA subsequent to a mandate from the European Commission (see our previous articles on this topic).

Anses recommendations concerning the new risk assessment scheme for bees and other pollinators are detailed below.

Effect assessment

Studies conducted with PPPs are recommended regardless of the type of PPP and regardless of the number of active substances they contain. Studies on honey bees and bumble bees are currently recommended.

Recommended laboratory toxicity studies

* on 14 June 2019

** Study required for all PPPs as soon as a chronic exposure to PPP cannot be excluded for any of the EFSA exposure scenario.

Recommended semi-field (tunnel) and field studies

Honey bees

When an acceptable risk cannot be demonstrated with laboratory studies, the recommended higher tier studies are those referred to in the European Commission documents in relation to Regulations (EU) No. 283/2013 and 284/2013:

Anses also refers to recommendations for tunnel and field studies from the EPPO Standard PP1/170 (4) (EPPO, 2010).

Tunnel and field studies are assessed in light of the protection goal for bees: it must be demonstrated that “under  field conditions  there are no unacceptable  effects on honeybee larvae,  honeybee behaviour, or colony  survival and development after use  of the plant protection product in accordance  with the proposed conditions of use” (Reg. (EU) No. 546/2011).

Other pollinators

Given the lack of validated standard protocol, no particular test is recommended by Anses. Anses however indicates that the studies should allow the assessment of an expected effect on the colony survival and on the colony ability to produce new fertile individuals that will perpetuate the cycle the following year.

Considered routes of exposure and risk assessments

With some exceptions, Anses recommends that exposure assessments be based on the EFSA Guidance Document (2013) for sprayed PPPs or for PPPs used for granular application or for seed treatment.

Initial risk assessments

For honey bees, it is noted that the scenario of oral exposure via guttation water is currently not recommended by Anses because the EFSA’s assessment method is deemed to be affected by too important uncertainties. In addition, guttation water is not regarded as a major exposure route. Exposure via guttation water may be considered once the methodology has been updated by EFSA.

A risk assessment for effects on the hypopharyngeal glands or for cumulative effects is also not recommended at this time due to the lack of validated experimental protocols available.

For bumble bees, only the acute risk for adults is considered. No further evaluation is recommended at this time due to the lack of validated experimental protocols available.

Regarding solitary bees, no assessment is recommended at this time due to the lack of validated experimental protocols available.

Risk quotients (“HQ”, “ETR”) should be compared to the threshold values defined in Regulation (EU) No. 546/2011. It is noted that a revision of this Regulation is ongoing and is expected to be adopted soon (SANTE/10094/2015). In the absence of regulatory threshold values ​​(e.g. acute risk – bumble bees, chronic risk and risk for larvae – honey bees and bumble bees), Anses indicates that the risk quotients should be compared to the threshold values ​​defined in the current EFSA guidance document (2013).

Refined risk assessments

When an acceptable risk cannot be demonstrated with laboratory studies, several options may be proposed:

  • Mitigation measures for problematic scenario (i.e. different variants of the SPe 8 phrase and mitigation measures as reported in EFSA guidance document (2013)).
  • Specific studies supporting the non relevance of certain exposure scenario or studies allowing to refine default exposure levels (residue studies conducted in pollen/nectar, residue dissipation studies, determination of the nectar sugar content of crops, etc.).
  • Higher tier studies (e.g. tunnel or field studies, studies assessing the ability of foragers to return to the hive).
Assessments for microorganism-based PPPs

For microorganism-based PPPs, the same methodology as for chemical-based PPPs is recommended. Adaptations of available experimental protocols are however recommended to justify the lack of pathogenicity/infectivity of microorganisms.

Perspective of the recommended risk assessment scheme

Anses indicates that the recommendations are made on the basis of the current version of the EFSA guidance document (2013) and on the basis of validated experimental guidelines currently available. Therefore, Anses call for:

  • An update of these recommendations after the revision of the EFSA guidance document (expected for March 2021).
  • An update of these recommendations as soon as a new experimental protocol is validated (e.g. acute toxicity assay on adults – solitary bees, chronic toxicity assay on adults and toxicity assay on larvae – bumble and solitary bees).
  • The development of new standardised assays for assessing the effects of microorganism-based PPPs.
  • The determination of regulatory threshold values for the chronic risk assessment for adults and for the risk assessment for larvae.

 

To download (in French): 

AVIS de l’Anses relatif à l’Evolution de la méthodologie d’évaluation du risque vis-à-vis des abeilles domestiques et des insectes pollinisateurs sauvages dans le cadre des dossiers de demande d’AMM des produits phytopharmaceutiques (Saisine n° 2019-SA-0097)

 

See also our previous articles: 

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

FRANCE – ANSES: recommendations to strengthen the protection of bees

 

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

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

 

EUROPE – EFSA: Public consultation on cumulative risk assessment (CRA) of pesticides in food

EFSA is carrying out a public consultation on its pilot assessments of the risks posed to humans by residues of multiple pesticides in food.

Interested parties have until 15 November 2019 to submit comments on two assessments: one considers chronic effects on the thyroid system and the other looks at acute effects on the nervous system.

These pilot assessments were conducted as a sequential process:

 

The first step was the establishment of cumulative assessment groups (CAGs) of pesticides for their effects on the nervous system and the thyroid. The methodology rests on the assumption that pesticides causing the same specific effects can produce cumulative toxicity.

Establishment of cumulative assessment groups of pesticides for their effects on the nervous system

All effects of pesticides on the nervous system were reviewed and five were found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA. 

Two CAGs (for brain and/or erythrocyte AChE inhibition and for functional alterations of the motor division) were considered sufficient to cover the cumulative risks associated to all five specific effects.

Establishment of cumulative assessment groups of pesticides for their effects on the thyroid

All effects of pesticides on the thyroid were reviewed and two were found to meet the criteria established by the PPR Panel and to be specific for consideration in CRA (hypothyroidism and C-cell hypertrophy, hyperplasia and neoplasia).

 

For the second step, cumulative exposure assessments were conducted using probabilistic modelling with two different software tools (MCRA and SAS®). The two tools produced nearly identical results and any observed differences are mainly attributed to the random effect of probabilistic modelling. These minor differences do not impact on the outcome of the exposure assessment.

Monte Carlo Risk Assessment (MCRA) software:

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using MCRA software

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using MCRA software

SAS® software:

Cumulative dietary exposure assessment of pesticides that have chronic effects on the thyroid using SAS® software

Cumulative dietary exposure assessment of pesticides that have acute effects on the nervous system using SAS® software

 

The third step was a cumulative risk characterisation which was based on the outcome of the first two steps and included an uncertainty analysis.

The draft assessments are the culmination of a multi-year collaboration between EFSA and the National Institute for Public Health and the Environment for the Netherlands (RIVM):

EFSA Scientific report – DRAFT Cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system

Overall, taking account of the available data and the uncertainties involved, it is concluded that cumulative exposure to pesticides that have acute effects on the nervous system does not exceed the threshold for regulatory consideration established by risk managers.

EFSA Scientific report – DRAFT Cumulative dietary risk characterisation of pesticides that have chronic effects on the thyroid

Overall, taking account of the available data and the uncertainties involved, it is concluded that cumulative exposure to pesticides that have chronic effects on the thyroid does not exceed the threshold for regulatory consideration established by risk managers.

 

The overall draft conclusion for both assessments is that consumer risk from dietary cumulative exposure is below the threshold that triggers regulatory action for all the population groups covered.

The EU regulation on maximum levels of pesticides in food (MRLs) stipulates that decisions on MRLs should take into account cumulative effects of pesticides as and when the methods to assess such effects become available. In addition, the regulation covering the placing of pesticides on the market stipulates that pesticides should have no harmful effects – including cumulative effects – on humans.

 

For more information: 

Public consultation on the draft EFSA scientific reports on a cumulative dietary risk characterisation of pesticides that have acute effects on the nervous system and chronic effects on the thyroid

 

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 : Statement on the coverage of bats by current risk assessment

EFSA has published a scientific statement that considers whether the current risk assessment performed for birds and ground dwelling mammals exposed to pesticides is also protective of bats.

Bats are not specifically mentioned under the current risk assessment for pesticides methodology however they are an important group of mammals, frequently foraging in farmland and potentially exposed to pesticides. Bats help to regulate arthropod populations.

EFSA PPR Panel addressed three main issues:

– whether bats are toxicologically more or less sensitive than the most sensitive birds and mammals;

– whether oral exposure of bats to pesticides is greater or lower than in ground dwelling mammals and birds;

– whether there are other important exposure routes relevant to bats.

Based on the evidence compiled, the PPR Panel concludes that bats are not adequately covered by the current risk assessment approach, and that there is a need to develop a bat-specific risk assessment scheme. Based on the current assessment, this should include a focus on:

(a) oral exposure via residues in insects and grooming,

(b) dermal exposure and

(c) exposure of pups via milk.

It is important to highlight that any risk assessment scheme should consider the total body burden from all exposure routes as bats foraging in the field will be exposed to residues in insects, and via dermal and inhalation routes.

In general, there was scarcity of data to assess the risks for bats exposed to pesticides. Recommendations for research are made, including identification of alternatives to laboratory testing of bats to assess toxicological effects.

 

To download: 

Scientific statement on the coverage of bats by the current pesticide risk assessment for birds and mammals (EFSA Journal 2019;17(7):5758)

 

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

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

EUROPE: Combined template to be used for assessment reports and proposals for classification

A revised template to be used for Assessment Reports according to Regulation (EC) No 1107/2009 and Proposals for Harmonised Classification and Labelling according to Regulation (EC) No 1272/2008 has been published by the Commission (SANCO/12592/2012 rev. 1.2).

This revised template was agreed by the PAFF Standing Committee on 6 October 2017. It should be used for combined assessment and CLH reports prepared for active substances covered by Commission Regulation (EU) No 844/2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 and for active substances for which an application for the approval has been submitted as from 6 October 2017.

To download: template to be used for for assessment reports and Proposals for classification

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

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

EUROPE: MCRA 8.1, EFSA new tool for consumer cumulative risk assessment

EFSA has developped MCRA sofware tool that allows cumulative risk assessment for consumers.
http://www.efsa.europa.eu/en/press/news/160127

 

In 2013, EFSA’s Panel on Plant Protection Products and their Residues published a general methodology for classifying pesticides into cumulative assessment groups (CAGs). http://www.efsa.europa.eu/en/press/news/130712

 

In 2015, the software – known as the Monte Carlo Risk Assessment (MCRA) tool – has been developed to process CAGs containing up to 100 active substances.

 

Luc Mohimont, from EFSA’s Pesticides Unit, said:

“This is an exciting and significant development. Progress has been made in developing an approach for carrying out reliable exposure assessments of multiple pesticides, which takes us a step closer to our ultimate goal: to carry out comprehensive risk assessments of the combined effects on humans of pesticides, rather than just individual chemicals.”

 

In a pilot study, consumer exposure assessments are now being performed with MCRA tool on groups of pesticides that may affect the thyroid and nervous systems. The results of these assessments will be published by the end of 2016, and will be considered by EFSA when it produces two scientific reports on cumulative risk assessments for the thyroid and the nervous systems in 2017.

Over the coming years, CAGs will be defined for other organs, tissues and systems. Data is already being collected to define groups of pesticides that affect the liver, kidneys, eyes, and the reproductive and developmental systems.

Experience gained in the initial assessments will be used to optimise the tool to ensure its fitness for purpose in the context of regulatory decisions on applications concerning maximum residue levels (MRLs) of pesticides in food.

 

Useful link:

EFSA Report (2016): MCRA made scalable for large cumulative assessment groups