Workshop with Stakeholders on the "Use of Epidemiological findings in Regulatory Pesticide Risk Assessment"

Programme

Introduction

In recent years an abundance of epidemiological studies investigating possible associations between pesticide exposure and human health outcomes have become available in the open literature. In this context, EFSA, with the support of ANSES, is organising a stakeholder workshop in the area of pesticide epidemiology to collect views from civil society and the Authority’s institutional stakeholders. This event will examine the best way to make use of this scientific area and how to interpret and integrate epidemiological studies into pesticide risk assessment.

Background

In 2013, EFSA published an external scientific report summarising the association between any pesticide and 23 major categories of human health outcomes based on a systematic literature review, together with an on-line database of all the epidemiological studies analysed in the report

In 2014, ANSES (the French Agency for Food, Environmental and Occupational Health & Safety) published an opinion on a collective expert appraisal report by INSERM (the French National Institute for Health and Medical Research). The INSERM report was based on a scientific literature review of epidemiological and experimental studies of health effects (cancer, neurodegenerative diseases, cognitive or depressive disorders, effects on reproductive function and the impact on pregnancy, child development and paediatric cancers) potentially related to pesticides.

In both the EFSA report and the INSERM report, indications of positive associations were observed between pesticides, via different routes of exposure, and several health outcomes including Parkinson’s disease, childhood leukemia and other cancer risks. Also a number of methodological limitations of the epidemiological studies were highlighted in the EFSA report making it difficult to draw firm conclusions about the observed findings.

Until now, the available information from epidemiological studies on pesticide exposure and health effects has not been fully considered in the regulatory practices of pesticide risk assessment. In Regulation (EU) No 283/2013, the Commission states that applicants should submit relevant epidemiological studies, where available, when applying for approval of an active substance to be considered for plant protection products.

Objectives of the meeting

The overall aim of this workshop is to collect views from civil society and institutional stakeholders of EFSA on the use of epidemiological studies and how to interpret and integrate these studies into the regulatory practices of pesticide risk assessment. The meeting will include the following break-out sessions:

Break-out session 1

Epidemiological studies available in the literature are part of the data requirements for regulatory risk assessment of pesticides; participants in this session will discuss how the inclusion of epidemiological data in risk assessment can be used by risk assessors. Currently, epidemiological data rarely suit the purpose of a regulatory risk assessment, as either exposure or potential confounders might not be adequately considered in the process of establishing health based reference values. The following questions should be answered:

• How can risk assessors make best use of epidemiological data in their risk assessment?
• What do risk assessors need to make a better and consistent use of epidemiological findings and to integrate these into the risk assessment?

Main expertise helpful for this discussion would include regulatory risk assessors, epidemiologists, and statisticians.

Break-out session 2

A large number of epidemiological studies are available in the literature; participants to this session are expected to provide a list of factors that epidemiological researchers should take into account in the design of studies to allow their use for regulatory purposes. In particular, the following questions should be answered:

• Can researchers conduct epidemiological studies that meet the needs of regulators?
• How can researchers improve current tools to bridge the gap between risk assessment and epidemiological studies?

Main expertise helpful for this discussion would include epidemiologists and regulatory risk assessors.

Break-out session 3

Epidemiological studies are based on findings from a wide selection of pesticides and health effects in different populations; participants to this session are expected to provide criteria and priorities to direct the research efforts and the attention of regulators. In particular, the following question should be addressed:

• Where to focus our attention and give priority: which pesticides, effects and/or populations?

Main expertise helpful for this discussion would include exposure specialists and epidemiologists.

Structure of the meeting

The workshop will be organised in a way that enables an interactive exchange of expert views. Participants have the opportunity to comment on the use of epidemiological studies in regulatory risk assessment of pesticides and participate in the discussions on topics selected by EFSA and ANSES. EFSA will publish on its website an event report collecting and summarising the discussions of the workshop. 

Who should attend?

The workshop is intended for scientific experts in the field of pesticide epidemiology and regulatory risk assessment of pesticides. 

To ensure a thorough discussion, participation is limited to a maximum of 90 participants, including speakers and other experts already identified by EFSA and ANSES. 

Registration will close on 14^th January 2015.

On-line registrations

Interested experts are requested to register at http://registerofquestions.efsa.europa.eu/roqFrontend/meetingsub/meetingid/25 by 11^th January, indicating their area(s) of expertise to be considered for participation as well as and preferred discussion group.

Travel and accommodation

Selected participants will be asked to make their own travel arrangements at their own expense. Concerning accommodation, EFSA has made a block-booking for the night of 17th February. Selected participants will be requested to make their own reservation when participation is confirmed. There is no fee for participation.

Dates and venue

The workshop will be held in Paris, France. The meeting will start at 08:30 and end at 17:00 on 18th February. Further details on the venue and logistics will be communicated to participants upon confirmation of selection.

Language

English is the official language of the EFSA technical meeting. No translation is provided.

Contact

Do not hesitate to contact Federica Crivellente (scientific information) and Vanessa Descy (logistical matters) at events [at] efsa.europa.eu (events[at]efsa[dot]europa[dot]eu)