EFSA development of guidance
documents
Luc Mohimont
Pesticides Unit
Brussels Regulatory Conference
12 & 13 March 2014
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)
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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
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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).
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.
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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 reports
http://www.efsa.europa.eu/en/publications.htm?entity=praper&scdtype=reporte
Evaluating the environmental risk of microbial pesticides
Collection of information of crop interception
Vulnerability 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=01
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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 Database
http://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 1107/2009
The 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 principles
In 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 16
different.
Thank you for your attention
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