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FRANCE: Order as regards the experimental use of pilotless aircrafts for pesticides spraying

The French Order regarding the implementation of the experimental use of pilotless aircrafts  for pesticides spraying was published on 08th October 2019 pursuant to Article 82 of the Agriculture and Food law, also called EGalim.

This Order sets the conditions of implementation of the trials performed as part of this experiment planned for maximum 3 years.

 

To download: 

Order regarding the experimental use of pilotless aircrafts for pesticides spraying (In French)

 

Our previous articles: 

FRANCE: Experimental use of pilotless aircrafts for pesticides spraying

 

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

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

FRANCE: Experimental use of pilotless aircrafts for pesticides spraying

The agriculture and food law, also called EGalim law authorises the experimental use of pilotless aircrafts, for a 3-year period (October 2018 – October 2021), for aerial spraying of plant protection products authorised in organic farming or within in certified farms, authorised for aerial spraying,and limited to crop areas with a slope equal to or higher than 30% (article 82).

This experiment aims at assessing the benefits of the use of pilotless aircrafts for the limitation of work-related accident  and for the application of pesticides.

It should be implemented in accordance with the French regulation as regards pilotless aircrafts, in particular Orders dated 18 May 2018 and 17 December 2015.

The EGAlim law sets that the experiment should be assessed by Anses. The law also sets that the conditions and modalities of this experiment should be defined by a joint order signed by the ministers of environment, agriculture and health, to ensure that there is no unacceptable risk for the Health and for the Environment.

 

The draft Order was proposed for public consultation from 26 June to 17 July 2019. The public comments (in French), the synthesis of the consultation (in French) and the reasons for decision (in French) have just been published.

 

At the same time, after being seized on 23 May 2019 by the Managing Director for food, the Managing Director for Health and the Managing Director for the prevention of risks, Anses has published a scientific and technical support note as regards « the implementation of experimental use of pilotless aircrafts for plant protection products spraying » (in French).

In this note, Anses indicates which guidelines should be considered and also which key data should be collected so that the experiment could achieve its goals:

A – Work-related accident Risk assessment when using pilotless aircrafts for spraying.

B – Operator and other actors exposure assessment during the mixing, loading, spraying and cleaning phases.

C – Spray drift assessment with the material used and assessment of the environmental exposure.

D – Other relevant criteria in the framework of the experiment and its goals, such as spray quality and efficacy.

 

References :

Public consultation: Draft Order as regards the implementation of experimental use of pilotless aircrafts for pesticide spraying (in French)

 

Order of 18 May 2018 as regards the requirements applicable to pilots using pilotless aircrafts for purposes other than leisure (in French)

Order of 17 December 2015 as regards the use of airspace by pilotless aircrafts (in French)

Order of 17 December 2015 as regards the pilotless aircarft design, conditions of use and abilities of people who use them (in French)

 

Our previous articles:

FRANCE: New Agriculture and Food law published

 

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

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

LYNXEE launch a Newsletter: Regulatory News on Plant Protection Products!

Many of you appreciate our posts on regulatory news and we are delighted of it. Therefore we decided to go even further by publishing a monthly newsletter compiling all our posts.

The newsletter is in English but you can always find our articles in French on our blog.

So, if you want to:

  • keep up-to-date on French and European regulatory news,
  • easily inform your French- and English-speaking colleagues and partners,

Have a look at the 2 Newsletters already published:

AND SUSCRIBE: http://lynxee.consulting/en/newsletters/

FRANCE: UIPP launches a new website against stereotypes!

The UIPP (Union of Plant Protection Companies) has launched a new website entitled “ABC of crop protection” : http://protectiondescultures.info/

It aims to fight against stereotypes and misperceptions concerning plant protection products.

The UIPP proposes a complete and accessible primer and numerous articles which raise the main issues of plant protection products: environment, consumers, farmers, sectors…

A nice website!

 

EUROPE: PPPAMS, a new system to apply for authorisation of a PPP

Applicants who wish to have a PPP authorised in the EU must now submit their applications to Member States via the Plant Protection Products Application Management System (PPPAMS). 

This online system manages the workflow of applications and will populate an EU wide public database of authorised PPPs.

Dossiers are NOT submitted via the PPPAMS. The system does not replace other manual processes in Member States; it works alongside the other electronic and manual processes that Member States operate. Fees are also still paid at MS level.

The PPPAMS manages the workflow of applications, enabling applicants and Member States to communicate with each other through the application process, primarily by changing the status of the application.

The system can also send notifications for information and action based upon status changes through the application process.

For now, PPPAMS is only enabled for first authorisation of products and mutual recognitions.

 

Useful link: PPPAMS 

 

Lynxee consulting’s team, as a consultant, can take care of your applications on PPPAMS.

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

 

EFSA: Data collection on exposure assessment scenarios for operator exposed to pesticides

EFSA issued in October 2014 a Guidance Document on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products (EFSA Journal 2014;12(10):3874). In this Guidance, new approaches are proposed to be used to calculate the exposure to PPPs. In addition, a way to assess resident exposure has been proposed according to the new requirements in the legislation. However, even though considering the most up to date available data for the assessment of non-dietary exposure to pesticides, many uncertainties still remain due to the complexity of this type of assessment and the scarcity of data. Therefore, it will be helpful for EFSA and the Member States to have available a comprehensive database of the non-dietary exposure assessments performed so far at EU level for the substances peer reviewed by EFSA, including all the key parameters, in order to: 1) identify critical issues not covered by the Guidance (e.g. use scenarios), 2) test the Guidance, and 3) identify the need of further research.

A compilation of a comprehensive MS Excel database with technical data from non-dietary exposure assessments performed at EU level for operators of PPPs was thus performed. The database as compiled contains information for 179 substances. The scientific report and the Excel database were published by EFSA on 24 July 2015.]

In the current project the work was focused on operator exposure assessments. However, due to the nature and structure of the database, the database can be easily adapted and expanded to also include worker and resident/bystander exposure assessments.

With regard to possible data gaps and needs for future research, the scientific report gives an overview of intended used labelled as ‘unusual’ with regard to their application method and/or application equipment for which NO exposure assessment was made based on one or more of the exposure models. Future research could focus on gathering exposure data/studies for these methods and or new model developments. The most frequent listed ‘unusual’ application methods concern seed treatment, soil injection/incorporation, gassing and fumigation.

Lynxee consulting’s team can adapt and develop exposure models for your intended uses not covered by standard models.

Contact us!

 

Sanco 12184 (14 July 2015) on emissions of PPP from protected crops to environment

On 14 July 2015, the Standing Committee on Plants, Animals, Food and Feed agreed to postpone the application date of Guidance Document on clustering and ranking of emissions of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments from (initially) 1 May to 1 December 2015 (Sanco/12184/2014 rev 5.1).

The full guidance, published in March 2014  (EFSA Journal 2014;12(3):3615), can be downloaded directly on EFSA website.

Moreover the new Greenhouse Emission Model (GEM) has been made available at www.pesticidemodels.eu.

Lynxee consulting’s team is at your disposal to conduct the risk assessments of your products intended for protected crops.

Contact us!

 

EFSA: Statement on the FERA guidance proposal (2012) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

The European Food Safety Authority (EFSA) Panel on Plant Protection Products (PPR) prepared a scientific opinion on the Food and Environment Research Agency (FERA) guidance proposal ‘Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments’ (2012).

The potential for the strength of soil sorption of a substance to increase over time (‘aged sorption’) is one of the phenomenon considered by applicants and notifiers when developing higher-tier approaches for leaching risk assessment. However, the procedures used to derive parameters to allow the inclusion of aged sorption as a higher-tier refinement for regulatory submissions are currently very uncertain, as demonstrated by the variety of different approaches employed for different substances.

FERA draft guidance was drafted in that context, based on the FOCUS (2009) guidance.

The review of the draft guidance by the Panel revealed that the experimental and modelling approaches described are reasonable compromises between the required effort and what is desirable from a theoretical point of view. However, the Panel has concerns about the interpretation of the experiments and how the results of the experiments should be used in the leaching assessment. The Panel investigated options for improvement, but could not complete its evaluation on these two topics because underlying data to test these options were not made available to the Panel. For this reason, the Panel prepared a statement instead of a scientific opinion. Therefore, the Panel cannot recommend the use of the guidance for the time being.

The Panel recommends an update of the current FERA draft guidance document, taking into account the conclusions and recommendations provided in its statement.

The Panel noted that the draft guidance document did not systematically review uncertainties arising from the use of aged sorption data in regulatory leaching assessments. Uncertainties may result from, for example, the experimental procedure (extraction procedures), the conceptual model and the quality of the fitted parameters. It is recommended that a systematic review of uncertainties is carried out when updating the draft guidance document.

This updated guidance document could be resubmitted to the Panel, together with supporting data, so that the Panel can finalise its review.

EFSA: Scientific Opinion on the effect assessment for pesticides on sediment organisms in edge-of-field surface water

The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) has published the second of three requested deliverables within  his mandate to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev. 4 (final), 17 October 2002). Further to the publication in July 2013 of the Guidance Document on tiered risk assessment for aquatic organisms in edge-of-field surface waters (EFSA Journal 2013;11(7):3290) , this new scientific opinion deals with the effect assessment for sediment organisms (EFSA Journal 2015;13(7):4176) and in particular with:

  • the benthic ecology of edge-of-field surface water

    • physical, chemical and biological diversity of sediment habitats;

    • benthic communities (microorganisms, microphytobenthos, rooted macrophytes, meiobenthos such as nematodes and macrobenthos such as larvae of insects, macro-crustaceans…);

    • exposure routes (via contact, food).

  • the identification of standard test species and standardised test systems

    • internationally accepted protocols on a limited number of taxa (insects with Chironomus spp., crustacean with Hyalella azteca, oligochaete with Lumbriculus variegatus and rooted macrophyte with Myriophyllum spp.): development needed;

    • differences between OECD and US EPA protocols (nature of sediment, spiking procedure): need for comparative studies to identify consequences on toxicity estimates.

  • the identification of specific protection goals (SPGs)

    • ecological threshold option (ETO) considered as the best option to provide adequate protection of benthic organisms, in comparison to  ecological recovery option (ERO).

  • the proposition of trigger for sediment testing

    • (1) if more than 10 % of the radio-labelled test material found in the sediment at or 14 days after application in the standard water–sediment fate study (OECD Guideline 308), or more than 10 % of the total annual dose of the active substance in sediment at the time of maximum PECsed as assessed by FOCUS modelling;

    • and (2) if the chronic NOEC/EC10 of Daphnia or another relevant pelagic animal species is less than 0.1 mg/L, or the EC50 of the standard test alga or vascular plant is less than 0.1 mg/L.

  • the definition of regulatory acceptable concentrations (RACs)

    • RACs expressed in terms of (1) total sediment concentration (dry weight) normalised to either the OC content in the dry sediment or to standard OECD sediment with an OC content of 5 %, and of (2) the freely dissolved fraction in pore water;

    • use of the 0–1 cm sediment layer for PECsed derivation for benthic fauna and microorganisms;

    • use of the 0–5 cm sediment layer for rooted macrophytes;

    • RACs derivation based on chronic toxicity data using sediment-spiked tests and benthic organisms (NB: semi-chronic toxicity data can also be used with an appropriate additional extrapolation factor).

  • the use of  a tiered approach for the exposure assessment

    • FOCUS methodology in 4 steps;

    • proposal for the inclusion of an accumulation factor to account for the effect of multi-year applications, not considered in the current FOCUS approach;

    • need for new sediment scenarios for total content and pore water concentrations to improve FOCUS assessment.

  • the use of a tiered approach for the effect assessment

    • a screening step based on chronic toxicity data for pelagic organisms and the equilibrium partitioning (EqP) approach, with an extrapolation factor of 10 for benthic fauna to cover the possibility of exposure due to sediment ingestion;

    • a first tier based on chronic standard tests with a decision scheme to select the appropriate benthic test species;

    • a second tier based (1) on chronic standard tests on additional test species with the use of the Weight of Evidence (WoE) approach (geomean approach not advised), and (2) on the use of Species Sensitivity Distribution (SSD) approach if sufficient number of benthic species (at least 8 species of the potentially sensitive taxonomic group (most likely benthic arthropods for insecticides; rooted macrophytes for herbicides), or 8 toxicity data for at least 5 different taxonomic/feeding groups if no specific potential sensitive taxonomic identified);

    • a third tier based on micro/mesocosms studies using preferably field-collected sediment and combined exposure routes (both water and sediment spiking), monitoring of exposure concentrations, observations of long-term benthic population and community-level effects;

    • To be highlighted: no consolidated ERA scheme available at this stage; need for more research and analysis of data to identify the most relevant exposure routes, depending on aquatic vertebrate species and substances.

  • the risk characterisation for active substances of PPP and their metabolites (ratio between effects and  exposure levels)

    • RACsed expressed in terms of initial exposure concentrations vs. PECsed, max as realistic worst-case;

    • PECsed, twa only used when field exposure concentrations being sufficiently variable during a time frame smaller than the duration of the sediment-spiked toxicity test that drives the RACsed;

    • two senarios advised: one with low OC (worst-case pore water scenario) and one with high OC (worst-case total content scenario);

    • need for the development of  environmental scenarios for ponds, ditches and streams;

    • relative contribution of the older (e.g. > 1 year) and recent fractions (e.g. latest growing season) in the PECsed,tot to be considered in a higher tier.

A later PPR Panel scientific opinion will deal with possible mechanistic effect models that can be used in the aquatic risk assessment for sediment-dwelling organisms. The adoption is foreseen for end 2017.

France : New responsabilities for Anses from 1 July 2015

From 1 July 2015, in accordance with French legislation for agriculture, food and forestry of 13 October 2014, Anses is in charge of granting  approvals for plant protection products and adjuvants. The Ministry of Agriculture was previously in charge of it.

The décret No.2015-791 of 30 June 2015 on the conditions for the exercise by the Agency of these new missions  specifies the technical conditions of the transfer of the approval granting from the French Minister of Agriculture to Anses Managing Director.

Indeed, since 1 july 2015, Anses Managing Director has authority for approval granting and for  trial permit approval and parallel trade. It has to be noted that the French Ministry of Agriculture keeps the responsibility for the 120-day derogations as defined  in Article 53 of Regulation (EC) No.1107/2009.

The Decree also institutes a declaratory system replacing the prior approval system for some administrative changes of authorisations, to simplify procedures that do not require any assessment by the Agency.

In addition, the decree removes the separate deadlines for the evaluation by Anses and the approval management by the Ministry of Agriculture. Now, the overall timelines given in Regulation No.1107/2009 will apply. The allocation of time between evaluation and approval management now depends on the internal organisation of the Agency.

Finally, the text sets up a shorter procedure for the evaluation and authorisation of biocontrol products.

To ensure the functional separation between scientific assessment and approval granting, two distinct and independent  departments were created. The Department for approval (DAMM) and the Department for the assessment of regulatory products (DEPR, ex-DPR).

The newly formed DAMM consists of two units:

– the Administrative Unit, unique contact point for notifiers for contractual and administrative aspects with Anses, in charge of the dossier completeness check and the processing of administrative dossiers;

– the Approval Decision Unit, in charge of the preparation, follow-up and renewal of approval decisions.

All assessment conclusions and decisions will be published in the Register of authorisations and assessment conclusions.

For transparency, Anses decided to develop guidelines to clarify the principles adopted by the DAMM for the issue of approval decisions.

The draft guidelines were submitted electronically to public consultation from 12 May 2015 to 5 June 2015. The comments received during the public consultation have not challenged the principle of these guidelines. A note summarising the comments received and those taken into account was published by Anses on 1 July 2015.

The DAMM will also contribute to the implementation of the comparative assessment of products available on the market under the new provisions of EU regulation to come into force on 1 August 2015.

Furthermore, in accordance with the law, a Committee of Approvals monitoring will also be formed in autumn 2015. This advisory structure will provide to Anses management further insight to the scientific evaluation to ensure in particular that the risk management measures imposed as part of the authorisations are practicable and effective in a real situation, given the constraints of field practices.

Note, to preserve the independence of the Agency, a Charter on relations with the stakeholders is being developed.

Finally, since 1 July 2015, ANSES is also entrusted with the implementation of a monitoring system called ‘phytopharmacovigilance’ (PPV) of the effects of these products on human health, fauna, flora and environment. This system will strengthen current arrangements for post-authorisation monitoring.

If you have questions about the new missions of ANSES, please do not hesitate to contact us: +33 9 72 50 40 29.

We are also at your disposal for all your questions about the status of Anses opinions or informal appeals not solved by DGAl on 30 June 2015.