ANSES Policy Orientations
In the field of Plant Health and Protection for 2016
presented to the Scientific Board on 22 September 2015, to the Board of Administrators
on 24 September 2015, and to the Thematic Steering Committee on 15 October 2015
France’s agricultural and forest landscape is constantly changing under the pressures of increased
frequency and volume of global trade, together with global climate change, changes in crop
management techniques (particularly in the context of the new agricultural policy, which
incorporates the concept of agro-ecology), and regulatory changes aiming to promote the use of
biocontrol products and reduce the use of other pesticides, both in number and quantity. Some of
these factors may increase the risk of introduction of new pathogens and pests in France, while
others may potentially lead to the emergence of new plant health issues. France also has
considerable overseas territories, which are ecologically fragile and particularly vulnerable.
As in the area of animal health, ANSES has expert appraisal structures for risk assessment, and
reference and research laboratories to perform analysis and monitoring, which it is able to mobilise
rapidly to respond to emerging plant health issues. Several entities work on expert appraisal for the
Agency in the field of plant health and protection:
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The Plant Health Laboratory (LSV), which, in its role as national reference and research
laboratory, performs missions in the field of plant health, on plant pathogens and quarantine
pests as well as on invasive plants and the detection of GMOs.
The Lyon Laboratory, through its Resistance to Plant Protection Products (RPPP) unit.
The Regulated Products Assessment Department (DEPR), which conducts risk
assessments for plant protection substances and products, fertilisers and growing media, in
accordance with European and French regulations.
The Risk Assessment Department (DER), whose scope encompasses the work of the
Expert Committee (CES) on Biological risks for plant health, with scientific support from the
LSV and work by the Phytopharmacovigilance Methodology and Observation unit.
Since 1 July 2015, new missions have been entrusted to the Agency: management of marketing
authorisations for plant protection products, fertilisers and growing media, as well as the
establishment of a surveillance scheme, known as phytopharmacovigilance, to monitor the effects
of these products on human health, flora and fauna, and the environment.
In order to maintain a functional separation between the scientific assessment of applications and
the issuing of authorisations, a new body entitled the Market Authorisations Department (DAMM)
has been created, separate from and independent of the Regulated Products Assessment
Department (DEPR). The phytopharmacovigilance scheme, meanwhile, has been assigned to the
Risk Assessment Department (DER).
Moreover, one of the aspects of the context which will guide our work programme for 2016, is the
Order on surveillance provided for by the Act on the Future of Agriculture of 2014, which
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French Agency for Food, Environmental and Occupational Health & Safety
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establishes a new framework for biological and health surveillance in France. ANSES will work
closely with the ministries and the professions and will make its scientific expertise available in
support of efforts to structure the necessary schemes and networks.
The different entities involved in plant health regularly discuss their work and collaborate with each
other. This overall approach to plant health and protection, which involves studying pathogen
interactions with the plant and its environment, helps maintain the Agency firmly within its health
and economic context, while taking into account the demands of society and the needs of risk
assessment.
Key points from 2015 and the 2016 programme
a. Reference activities for detecting and identifying pests and invasive plants,
and detecting GMOs
The year 2014-2015 was marked by the establishment of the surveillance plan on Xylella
fastidiosa, which the LSV had anticipated with the development of a specific tool with which to
detect it. Anticipation of the need for analytical tools for surveillance also led, in the field of
entomology, to the finalisation of the characterisation of a molecular identification tool for Ceratitis
capitata. To facilitate the transfer of technical knowledge for a better diagnosis in plant health, a
scientific seminar was organised at the LSV in partnership with the RFSV and the RMT Vegediag.
As a reference laboratory, the challenge in 2015 for the LSV has been to continue to promote the
key factors that ensure efficient health surveillance and improved responsiveness to crises and
emerging problems in mainland France and its overseas territories, namely:
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developing detection and identification methods, particularly for emerging and potentially
emerging plant pest organisms, by using innovative tools such as high-throughput
sequencing approaches;
acquiring and mastering these innovative tools through projects implemented in
collaboration with ANSES’s research and technology platforms;
exploring and developing new approaches, such as characterising the diversity of species
complexes (insect pests, Fusarium fungus, bacteria such as Pseudomonas syringae pv.
actinidiae, Ralstonia solanacearum, etc.), improving screening of GMOs via highthroughput sequencing and the addition of new valences, etc.;
improving vigilance and its contribution to surveillance, in conjunction with the Laboratory
Affairs Department's unit for Coordination and Support for Surveillance;
capitalising on its skills and knowledge by participating in research projects within national
and international networks.
The year 2016 will also be one of new challenges for the LSV, such as:
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harmonising the orientation of its activities with the future categorisation of pests drawn up
at the end of 2014 as part of the new health regulations;
the progressive integration of innovative techniques for diagnosis (barcoding in entomology,
NGS and digital PCR in phytopathology and in GMO detection);
the expansion of its influence through national, European and international networks and
partnerships, especially via a future consortium for setting up an EURL with the
Netherlands and the UK;
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active involvement in implementing cross-cutting actions within ANSES itself in terms of
reference missions (e.g. method validation processes, organisation of proficiency tests) and
expert appraisal tasks;
its contribution to the organisation of the epidemiological surveillance platform or platforms
for plant health;
its involvement in surveillance networks in France and Europe to improve advance warning
of plant health risks, an action consistent with deliberations at ANSES on how to best
organise scientific monitoring and early warning activities;
its research activity, in particular through thesis projects.
b. Resistance to plant protection products
The general missions are to i) design and validate methods for characterising resistance for "PestSubstance-Host" trios according to conditions of use; this mission is mainly accomplished through
the implementation of surveillance plans developed by the health authorities that help monitor the
development of known cases of resistance and demonstrate the emergence of new phenomena, ii)
contribute to assessing epidemiological situations by studying the selection and adaptation
conditions of pests of interest, according to the mechanisms of resistance and their genetic
expression.
In the course of the past year, monitoring and studies revealed the following:
- the alarming development in the resistance of apple scab to 14α-demethylase inhibitors
(fungicides targeting the biosynthesis of sterols). Laboratory analyses showed an increase in this
resistance, threatening the effectiveness of this type of fungicide against apple scab in many
orchards,
- confirmation of the emergence of resistance by Sclerotinia sclerotiorum on oilseed rape to
fungicides of the class of Succinate Dehydrogenase Inhibitors (SDHI), in certain fields sampled in
the Lorraine and Picardie regions.
The scientific orientations for 2016 are two-fold:
- To pursue the Agency's reference activity by continuing to:
1) formalise methods,
2) seek the baseline sensitivity of various pests with regard to new classes of active
substances.
- To pursue research activities in three areas of interest:
a) Myzus persicae, the green peach aphid: publication of the results of the current study
on the dispersion of resistance alleles and continuation of the search for resistance
mechanisms regarding neonicotinoids,
b) Mycosphaerella graminicola, the causal agent of septoria leaf blotch in wheat:
evaluation of the risk of multi-drug resistance and development of a method for
detection of such resistance,
c) Plasmopara viticola, the causal agent of grapevine downy mildew: the search for
resistance mechanisms regarding new modes of fungicidal action, including the
classes of Quinone inside Inhibitors (QiI) and Quinone outside Inhibitors-Distal (QoID).
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c. Continual improvement in assessment methodologies for plant protection
products and fertilisers 1
ANSES scientists involved in the assessment of plant protection products (PPPs) and fertilisers
have worked hard to develop or improve assessment methodologies. These studies were most
often undertaken in partnership with other organisations or in the framework of national, European
or international working groups. Their purpose is not only to enhance the interpretation of assays
used to determine chemical hazards, but also to construct detailed exposure scenarios and models
used in assessing hypothetical risks and agricultural benefits. ANSES also funds specific studies to
stimulate the production of new knowledge needed for its expertise.
During the past year, the DEPR coordinated the following actions:
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In the area of fertilisers and growing media:
The DEPR commissioned the CNRS-ISA in Lyon to conduct work on assessment methods for
determining the environmental impact of synthetic polymers that are incorporated in PPPs,
fertilisers and growing media, and that eventually end up in agricultural soils. The research carried
out in 2015 focused on characterising wetting agents and water-retaining agents, as well as
validating analytical methods.
With regard to ecotoxicological assessment, an agreement with INERIS was signed with a view to
developing a battery of ecotoxicity tests devoted to risk assessment of fertilisers and growing
media.
The DEPR participated in the French Fertilisation and Environment Joint Technology Network
(RMT F&E) in connection with work to characterise organic waste products and their fertilising
value.
In addition, the VALDIPRO programme (an acronym for VALorisation of DIgestate from agricultural
methanisation as fertiliser PROducts), funded by the CAS-DAR to move forward on the issue of
marketing digestate produced from agricultural methanisation and to which the DEPR contributed,
was finalised in 2015.
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In the area of plant protection products:
The DEPR coordinated and actively contributed to the revision of the presentation format for
assessing the efficacy of PPPs as part of zonal assessments. In addition, a workshop was
organised by the DEPR to promote cooperation with scientists from the other Member States of the
southern zone involved in this field.
The DEPR also participated at the European level in the drafting and updating of two guidance
documents, the first on plant-based substances and the second on chemical mediators
(pheromones) used as plant protection products. The purpose of this work was to adapt the
assessments in proportion to the levels of hazard and risk.
1
Only work involving the efficacy of plant protection products and their environmental impact is presented here.
Work on public health risks is detailed in the "Food Safety" and "Occupational Health" documents. The issue of the
transfer of MA decisions on plant protection products and fertilisers/growing media is also addressed elsewhere.
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In a partnership with the IRSTEA (Lyon) laboratory, the DEPR participated in research and
development for the project entitled "Monitoring the presence of plant protection substances in
surface water".
As regards bees, the DEPR is currently working on a response to a formal request from the
Agency's supervisory ministries on the issue of the review of neonicotinoids and to contribute, at
European level, to the development of risk assessment methods for bees and other pollinators.
In addition, and via the working groups of the Biological Trials Committee of the French
Association for Plant Protection (AFPP), the DEPR is coordinating the drafting of:
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an experimental method especially devoted to plant defence stimulators that can be used
in biocontrol,
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a method defining the recommendations for monitoring resistance of grapevine diseases to
fungicides.
Work planned for 2016, some of which will be based on studies that the Agency commissions on
its own initiative, aims to:
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continue monitoring work on the fate in the environment of certain polymers used in
agriculture;
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improve methods for assessing environmental risks related to the use of fertilisers and
growing media;
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continue the development of proposed exposure scenarios that are better adapted to
assessing environmental risks, concerning uses of PPPs in tropical environments;
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terminate its support for the project for monitoring pesticides in surface water.
d. Risk assessment concerning plant health
Risk assessment is the principal mission assigned to ANSES. Work to prioritise plant pests was
started in 2014. This enabled the DGAL to categorise an initial group of pests. The work was
continued in 2015 with the design of an automated method for identifying the necessary
information within databases, websites and scientific documents, gathering it all in a database and
analysing it using a multicriteria approach in order to prioritise them. This tool and the associated
data will provide a new prioritised list of pests for metropolitan France in the autumn of 2015. A
variant of this tool is currently in development for the overseas territories which, once applied, will
assist with the prioritisation of risks for the various overseas territories.
This database should serve as a resource for analysing future plant health risks, anticipating
unforeseen events and modelling invasions.
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To establish effective public health recommendations, ANSES carries out independent,
multidisciplinary, collective and adversarial scientific expertise through its Expert Committees
(CESs). The CES on Biological risks to plant health, created at the start of 2012, renewed its
members in 2015. The most frequent formal requests concern pest risk assessments (PRAs)
carried out according to the International Standards for Phytosanitary Measures (ISPMs), as
stipulated by the International Plant Protection Convention (IPPC). This CES is also involved in
environmental protection and public health issues in collaboration with CESs specialising in other
areas. ANSES issued an internal request in 2015 focusing on the risks to sunflower and Jerusalem
artichoke crops of the emergence of an insect pest of the common ragweed. The work will continue
in 2016 with a study of the potential benefits and risks associated with the use of this insect to
combat ragweed, in response to a request from four ministries (DGS, DGAL, DGALN and DGITM).
Two urgent requests on Xylella fastidiosa were received in 2015, one on the Commission's
proposed decision and the other on the efficiency of treatment with hot water. The Agency can
expect to receive further requests following its detection in Corsica on Polygala myrtifolia. In
addition, we have been selected by EFSA following the call for contributions on the collection of
data and information on the biology and the fight against vectors of Xylella fastidiosa.
e. Programme of phytopharmacovigilance (PPV) activities in 2015-2016
i.
General orientations for the deployment of PPV in 2015-2016
The purpose of the PPV scheme is to detect and analyse the signals concerning adverse effects of
plant protection products on humans, fauna, flora and the environment. This was provided for in
the Act for the Future of Agriculture passed in September 2014. A consultation phase involving all
the ministries and organisations concerned, as well as stakeholders, was carried out in 2014 by
ANSES to conduct a detailed review and make recommendations in view of the deployment of
PPV. This phase was completed in March 2015 with the publication of the Consultation Report
indicating, in particular, the existing public schemes contributing information to PPV. PPV is
currently being deployed according to three main components:
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drafting of the Enforcement Decree of the Act for the Future of Agriculture regarding PPV
and the Order designating the agencies participating in PPV; the draft Decree and Order
must be transmitted to the Council of State in the autumn for publication at the end of 2015;
preparation of the installation of the bodies planned for its governance: ministerial steering
committee (May and June 2015), operational committee with the participating organisations
(July 2015), PPV-ORP unit (February 2015), and PPV Working Group composed of
external scientific experts (October 2015);
gradual commencement of the study projects (January to December 2015).
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The deployment of PPV is based on a very regular flow of information from the ministries and
organisations concerned, as well as on collaboration with the Ecophyto plan. Finally, calls for
applications have been issued for the PPV Working Group of external experts set up to assist with
the orientation of studies and the drafting of the annual report. The launch of the WG is planned for
October. The ANSES COTs will ensure that stakeholders are consulted and informed. A brief
overview of the status of PPV deployment was published in early July when stakeholders were
informed about the transfer of PPP marketing authorisations.
ii.
Actions carried out with the agencies participating in PPV
Two main actions have been taken on this subject:
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on the one hand, there have been bilateral discussions with each agency likely to
participate, to determine the conditions for collaboration and the needs for investment to
improve or accelerate the transmission of information. Special attention is paid to health
effects reported as part of toxicovigilance; this should result in bilateral agreements being
signed between ANSES and each of the agencies concerned.
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on the other hand, a study is under way in the framework of the formal request on the
potential effects of glyphosate, following the publication of the findings of the reassessment
of its carcinogenicity by the IARC. This work, among others, will serve as a basis for the
work of the above-mentioned PPV Working Group.
iii. Progressive launch of the study projects for 2015-2016
In the light of the identified needs, ANSES decided to give priority to operational studies for direct
application to PPV or for risk assessment conducted in the context of examinations of applications
for product marketing authorisations.
The four study projects identified during the previous consultation phase are currently in start-up
phase: an inventory of alerts from poison control centres (the CAP-TVs of Nancy and Paris) and
those from the RNV3P (Inserm-ISPED), a feasibility study of the possible exploitation of treatment
registers to provide information about usages (INRA), and biomonitoring of exposure to plant
protection products authorised for sale to the general public (InVS). These projects will continue in
2016. Other study projects are in the consultation phase in the various PPV governance bodies:
steering committee, operational committee, scientific committees (the Phyto CES or the PPV WG,
depending on the type of project) and will be presented to the Thematic Steering Committee. They
focus mainly on resistance (support for surveillance plans and a project to upgrade the EcoACS
database), the monitoring of exposure in workers (workers in greenhouses, banana workers in the
French overseas territories) and nearby residents (biomonitoring project), the monitoring of acute
effects (modernisation of the toxicovigilance information system) and chronic effects (descriptive
study of the CCMSA's medico-administrative database), residues in water (validation of predictive
models for use in the French overseas territories), and effects on the environment (effects on
annelids).
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f. Programme of activities for the Market Authorisations Department (DAMM)
The DAMM was set up on 1 July 2015. Starting in 2014, and during 2015, consultations were held
with stakeholders within the various bodies of the Agency, including the COTs, to contribute to the
discussions on the organisation of this new entity. The result of these discussions is that the
DAMM is divided into two units:
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the administrative examination unit, responsible for verifying the admissibility of applications
relating to plant protection products, fertilisers and growing media, biocidal products, and
the handling of administrative decisions and contractual relations with applicants;
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the decisions unit, responsible for forming decisions relating to applications requiring a
scientific assessment by the DEPR, relations with the agricultural sectors, the scientific
secretariat of the committee for monitoring marketing authorisations, and inspection and
control missions.
The most noteworthy activities of the first half of 2015 were the recruitment of officers, a major
contribution to the drafting of texts for the enforcement of the Act for the Future for Food,
Agriculture and Forestry, the organisation of the transfer of activities and dossiers between the
DGAL and the Agency, and the drafting of key documents. As a result, the following documents
were produced, with the support of a working group set up specifically for this purpose and
including persons specialising in crop protection, the environment and human health:
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guidelines for issuing decisions relating to the placing on the market of plant protection
products, fertilisers, growing media and adjuvants (documents published on the Agency's
website on 1 July),
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a guidance document relating to the comparative assessment of plant protection products
in France (also published), and a draft decree concerning the information to be submitted to
ANSES in the framework of the implementation of comparative assessment.
The end of 2015 will be devoted to the establishment of the committee for monitoring marketing
authorisations and the deployment of the decision-making activity, which will be made public via
the future e-PHY website and the register of the Agency's acts, opinions and decisions. The work
of drafting procedures for examining the different requests will be continued with the objective of
obtaining ISO 9001 certification for these activities in 2016. A charter governing relations with
stakeholders will be finalised.
Two activities covering new areas will be set up in 2015-2016.
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The first concerns engineers specialising in the various sectors, who will build a network
with the actors of the agricultural sectors for which they are responsible, particularly in order
to contextualise MA applications examined by the DAMM and to assess the agronomic and
socio-economic benefits of the different plant protection solutions available;
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The second concerns inspection and control, with the recruitment of two accredited
inspectors whose mission will be to propose a targeted control process for plant protection
products, fertilisers and growing media, to develop a memorandum of understanding with
the other control bodies (DGAL and DGCCRF, and possibly Customs) and to determine
which testing laboratories meet the necessary criteria.
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g. Development of partnerships
Since the research issues that interest ANSES for building its expertise cannot rely solely on the
skills and resources available in its laboratories, the Agency forges operational partnerships on
three geographically and operationally coherent levels:
i.
Within ANSES
Concerning the activity of the NRL, the LSV will share with the Agency's other laboratories its
experience in implementing the ISO/IEC 17043 Standard for the organisation of interlaboratory
trials, and various processes such as the validation of analytical methods. Finally, advances in the
analytical techniques used at the LSV and the needs of research projects have led to technical
collaborations between the LSV and high-throughput technology platforms such as "Identipath",
"NGS" and "MaldiTof", located respectively in Maisons-Alfort, Ploufragan and Nancy. The RPPP
Unit in Lyon plays an active part in the collective expert appraisal set up by the DEPR for the
assessment of plant protection preparations. Through these intra-ANSES actions, shared between
the RPPP unit and the DEPR, recommendations for management measures are formulated and
then advocated in the opinions issued by the Agency. In addition, the RPPP unit has been asked
by the phytopharmacovigilance unit of the Risk Assessment Department to participate, in liaison
with the Laboratory Affairs Department, in the implementation of phytopharmacovigilance in the
field of resistance to plant protection products; furthermore, it will participate in organising the
Agency's internal multi-disciplinary "Resistances" initiative, which will enable it to benefit from the
experience of units that have been working on antimicrobial resistance for several decades.
ii.
National level
The LSV units are partners in various research projects, in particular those carried out in
conjunction with INRA and CIRAD as part of calls for proposals issued by the ANR, CASDAR
(Special Funds for Agricultural and Rural Development), etc. The framework agreements with
GEVES and the FN3PT have given rise to collaborative projects. A framework agreement with
Fredon France was signed in 2015.
In the context of scientific co-operation with other organisations, in 2016 the RPPP unit will be
aiming to:
- continue and reinforce collaboration with INRA research groups working on resistance, in
the context of the R4P (Pesticide Resistance Forum and Research) network. Thus,
following the acceptance of the MDRisque project, within the framework of the MEDDE's
"Pesticides" programme, close collaboration with one of INRA's R4P units (the BIOGER
unit of INRA Grignon) will be organised at the end of 2015.
In addition, the participation of all units in the R4P network in Phytopharmacovigilance
(PPV) activities is likely to help consolidate this partnership between INRA and ANSES in
2016. In this context, seven specific study projects, carried out in partnership, have been
drawn up and proposed to the bodies responsible for implementing PPV;
- continue the work undertaken with INRA in Rennes and the CEFE (Centre for Evolutionary
and Functional Ecology at the University of Montpellier) on the green peach aphid (Myzus
persicae) beyond the current study, which is being funded by France Agri Mer until March
2015.
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Finally, the LSV and the RPPP unit will respond to ACTA's desire to develop scientific relations
with technical institutes, particularly through the choice of topics for theses of importance to the
different production sectors.
iii.
European and international level
The European partnerships will continue being developed as part of the Euphresco ERANET
project for developing analytical methods, and the European network of quarantine stations will
continue to be enhanced.
The LSV units are also stakeholders in the FP7-KBBE projects either in progress (PlantfoodSec,
Q-collect) or in preparation (H2020).
A draft consortium between the United Kingdom, the Netherlands and France is being assembled
in the framework of a future call for applications for an EURL in plant health.
In addition, most of the assessment work conducted by the DEPR on plant protection products and
substances involves close collaboration with European and international bodies (EFSA, OECD,
EPPO, and assessment agencies in other Member States).
ANSES, through its DEPR, is contractually bound to the Central Africa Inter-State Pesticides
Committee and contributes by offering training on pesticide approval in the CEMAC zone
(Cameroon, Central African Republic, Congo, Gabon, Equatorial Guinea and Chad). Through its
LSV, ANSES also contributes to training actions through twinning programmes (e.g. Ukraine and
Egypt) funded by the EU or expert appraisal agreements.
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