EFSA development of guidance documents

Luc Mohimont Pesticides Unit

Brussels Regulatory Conference12 & 13 March 2014

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Quick introduction to the Pesticides Unit : 5 major areas of activities :

1.Peer review of active substances: Regulation (EC) No 1107/2009 (Conclusions on the peer review of ASs)

2.Maximum Residue Level (MRL) related work: Regulation (EC) No 396/2009 (Reasoned opinions, Annual report)

3.Support to the PPR Panel: Regulation (EC) No 178/2002 (Scientific opinions and guidance of the PPR Panel)

4.Outsourced projects (External Scientific Reports)

5.Development of Guidance Documents (EFSA guidance)

Experience of EFSA with GDs

List of adopted guidance documents :

2009: Risk assessment for birds and mammals (EFSA guidance)2012: Dermal absorption (PPR Panel guidance)2012: Use of probabilistic methodology for the assessment of dietary exposure (PPR Panel guidance)2013: Tiered risk assessment for edge-of-field surface water (PPR Panel guidance)2013: Risk assessment for bees (EFSA guidance)

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Experience of EFSA with GDs

Existing mandates for :

2014: Operator, bystander, worker and resident exposure (EFSA guidance)2014: Emissions from protected crops (EFSA guidance)2014: Determination of DegT50 in soil from laboratory and field dissipation studies (EFSA guidance)2014: Predicting environmental concentrations in soil (EFSA guidance)2015: Residue definition for dietary risk assessment (PPR Panel guidance) From 2015: RA in various areas of terrestrial ecotoxicology

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Development of a guidance document : typical sequence of events

• Identification of a need• Drafting of a mandate • Collection of data• Opinion of the PPR Panel• Establishment of a Working Group• Preparation, adoption (or approval) of the Guidance• Consultations • Entry into force

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Identification of a need / Initiation of a guidance

Commission : Direct request to EFSA (Art 29 of 178/2002)Ex. risk assessment for bees

EFSA: Capacity of initiating a mandate on its own initiative (Art 29 of 178/2002)Ex. Residue definition for dietary risk assessment

Pesticide Steering Committee (Network of MSs): in advisory capacity – Identification and agreement on priorities

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Drafting of a mandate (Concept paper)

• Background (Scientific and legal framework)• Terms of Reference (exact scope of the guidance)• Foreseen consultations• Deadline• Type of deliverable(s) : guidance of EFSA or guidance of the PPR Panel – Public consultation report – Case study

Link to Mandates:http://www.efsa.europa.eu/en/request/requests.htm?wtrl=01

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Mandate: An example (Extracts from the mandate of the PPR Panel to prepare a guidance on the residue definition for dietary risk assessment).

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TORs:This guidance should consist of a stepwise method helping the risk assessor, on the basis of factual information (derived from toxicological data, metabolism data) and non-testing methods, to, by weight of evidence:• conclude for which of the terminal residues of a pesticide on food and feed commodities a hazard identification and characterisation is needed;• perform such a hazard identification and characterisation• define the compounds present as terminal residues that should be included in the residue definition for risk assessment.

Consultations:A public consultation of stakeholders on a draft of the guidance will be launched before finalising the guidance.Any relevant opinions and guidance documents elaborated by the Scientific Committee of EFSA will be duly considered… In case needed, the European Commission and Member States will be consulted on particular risk management elements contained in the guidance.

Data collection

Very often the preparation of a guidance document requires a collection of information as a preliminary step.

• Qualitative information: State of the science in the scope of the mandate (Open scientific literature)• Quantitative data: Environmental data, use data, pesticide data

Data collected as a result of an outsourced activity (Grant agreement – Procurement – Service Level Agreement) are published as external scientific reportshttp://www.efsa.europa.eu/en/publications.htm?entity=praper&scdtype=reporte

Evaluating the environmental risk of microbial pesticidesCollection of information of crop interceptionVulnerability of non target arthropods communities…

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Opinion of the PPR Panel

An opinion of the PPR Panel is often requested before starting the drafting of the guidance document.

This is typically the case when new tools or new types of risk assessment are envisaged.

Examples:

Scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees)→ chronic effects on colony survival and development, inclusion of new routes of exposure…

Scientific Opinion on Evaluation of the Toxicological Relevance of Pesticide Metabolites for Dietary Risk Assessment→ applicability of TTC approach and of QSAR analysis…

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Establishment of a Working Group – EFSA Policies

Operations• Decision of the EFSA Management Board concerning the establishment and operations of the Scientific Committee, Scientific Panels and of their Working Groups.• Decision of the Executive Director concerning the selection of members of the Scientific Committee, Scientific Panels and external experts to assist EFSA with its scientific work.

Independency• Policy on Independence and Scientific Decision-Making Processes of the European Food Safety Authority and implementing rules.• Decision of the Executive Director implementing EFSA’s policy on independence and scientific decision-making process regarding declarations of interests.

http://www.efsa.europa.eu/en/aboutefsa/keydocs.htm?wtrl=0111

Establishment of a Working Group - In practice

• Mapping of the needed expertise to address the mandate• Regulatory expertise is always present in the WG• Best use of the expertise present in the PPR Panel• Identification of missing expertise• Selection of external experts using of the EFSA Expert Databasehttp://www.efsa.europa.eu/en/networks/expertdb.htm• Screening of the declarations of interests• Allocation of roles (Chair, Vice-Chair, Rapporteur)

Chairs are Panel member (in case of PPR panel guidance) or EFSA staff (in case of EFSA guidance)

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Consultations

Risk Managers (Coherence between RA and RM)Consultation on Risk Management questions (Objectives of protection, regulatory assumptions):• Commission (official letters)• SCoFCAH (minuted meetings)• Pesticide Steering Committee (minuted meetings)

Stakeholders• Technical hearing on specific issues during Working Groups meetings (minuted meetings)• Public consultation on a (draft) guidance (Technical report)

On ad-hoc basis

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Preparation, Adoption and Approval of the guidance

Coordination of activities and deliberations take place during WG meetings • Members are acting in an independent and personal capacity.• Confidentiality of individual views.• Agendas, secretarial notes and published minutes.• Successive drafts are prepared and commented.• A rapporteur provides regular feedback to the PPR Panel in case of PPR panel guidance.• The final draft of the Guidance is either formally adopted by the PPR Panel (guidance of the PPR Panel) or formally approved by the EFSA Executive Director (guidance of EFSA).

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Entry into force

Requires a taking note and the setting of implementation dates by the SCoFCAH.

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About Uncertainties and Conservatism

Article 1.4 of 1107/2009The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory.

Uniform principles, Evaluation, general principlesIn interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of under-estimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product. This should be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different.

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Thank you for your attention

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