European Crop Protection Association Conference, Paris

Catherine Geslain-Lanéelle

Speaking Notes

The role of EFSA in assessing risk and ensuring safe foods

Dear Chairman, distinguished guests, ladies and gentlemen,

Introduction
Thank you for the kind introduction. I am very pleased to be here with you today in Paris and for the opportunity to address the ECPA conference.

This conference provides an important platform for actors in the field of crop protection – food producers, the agrichemical industry, regulators and risk assessors – to discuss how we can all contribute to the sustainability of the food and feed supply in Europe.

Food security has jumped to the top of the global agenda and demand for food is expected to increase by 50% by 2030.

In the drive to increase food supply, we must not lose sight of the fact that there can be no food security without food safety. In addition, we must be mindful of the impact of our agricultural practices on the environment and of ensuring the sustainability of our food production systems.

EFSA’s work on pesticides
Plant protection products – pesticides – constitute an integral part of EFSA’s work and our activities in this field are concentrated in two of our Units. The Pesticide Risk Assessment Peer Review (PRAPeR) Unit is responsible for the EU peer review of active substances used in pesticides and the assessment of existing and proposed maximum residue levels (MRLs) for pesticides. The Panel on Plant Protection Products and their Residues (PPR) deals with the risk assessment of pesticides and their residues and publishes its results as EFSA scientific opinions in particular in relation with revised or new Guidance Documents. The Head of the PRAPeR Unit, Herman Fontier, will discuss the implications for EFSA of legislative changes in the field later this afternoon.

EFSA has been involved in the risk assessment of pesticide active substances since 2003.

With a total staff of 34, the PRAPeR Unit is now one of the largest Units within EFSA and, in 2008, ten new staff members joined the PRAPeR Unit – a demonstration of our commitment to this activity. Compared with 20 conclusions on active substances in 2007, this year’s output is expected to reach 62 conclusions. And this level of output is required if we are to manage the anticipated workload in 2009 and beyond.

2008 has also been an important year for the PRAPeR Unit because the MRL Regulation became fully applicable. This has led to an important increase in EFSA’s involvement in the procedures for establishing MRLs. Since September, the PRAPeR Unit has received Member State evaluations of applications for the setting of new or amended MRLs. EFSA has 3 months to issue a reasoned opinion on these evaluations. The first of these opinions are now published and our objective is to have completed 20 opinions by the end of the year. Hence, you will agree with me that this already represents tangible progress in a very short time.

The PPR Panel receives questions from the PRAPeR Unit to support their evaluations of specific substances or to give scientific advice on more generic issues. In addition, questions are received from the Commission.

Since 2003, the PPR Panel has adopted 38 opinions in the areas of fate and behaviour, ecotoxicology, toxicology and residues of pesticides. The revision of existing and elaboration of new Guidance Documents by the PPR Panel is crucial in providing notifiers and Member States with advice on conducting risk assessments for authorisation of pesticides. Currently the PPR Panel is working on 9 Guidance Documents. Some of this work is managed with the help of national scientific organisations that we are funding. Work on Guidance Documents is self-tasked by the Panel and it emphasises how crucial self-tasking is for EFSA in delivering its mandate. Currently, about 80% of our self-tasking activities in EFSA is devoted to risk assessment methodology.

How we work
EFSA is a science-based organisation and the quality and transparency of its science is critical. The new European food safety system has, above all else, delivered one crucial reform: the separation of risk assessment and risk management. As the EU’s risk assessor, EFSA supports the European Commission, European Parliament and Member States in taking effective, appropriate and timely risk management decisions by providing a scientific, evidence-based foundation for policies and legislation.
And in this respect I am in full agreement with the ECPA President that independent scientific advice is and will continue to be crucially important in the regulation of food and feed in order to protect consumer health.

The legislators rightly identified the importance of the excellence, independence and quality of the scientific advice underpinning food law, the openness and transparency of the organization developing this advice, and the need to communicate coherently, accurately and in a timely manner. These factors are the building blocks of EFSA which has now matured into an organisation employing over 380 people, 60% of whom have a scientific background. It has built networks comprising 1000 scientific experts, 30 national agencies and 250 scientific organisations.

Transparency
We leave no stone unturned in ensuring that the founding principles are adhered to; by way of example, in 2007 we reviewed the processes associated with the Declarations of Interest of EFSA’s scientific experts, Management Board and staff.

To ensure transparency in all its operations, EFSA makes extensive use of its website to provide open access to all its outputs: publications, mandates, opinions, and stakeholder activities. The meetings of our Management Board are webcast live and the Authority regularly consults the public on key issues such as cloning and nanotechnology.

In relation to pesticides, PRAPeR launches 40-day public consultations for all Draft Assessment Reports for existing and new active substances and the PPR Panel has launched 4 public consultations this year on Guidance Documents for pesticide persistence in soil, risk assessment for birds and mammals, emissions from protected crop systems, and aquatic and terrestrial ecotoxicology.

Integrated approach
EFSA has a broad and integrated remit covering the entire food chain from the field through to the safety and nutritional aspects of food on the plate. Clearly, what happens in the field, on the farm, in the animal, in the plant or in the environment can affect the wholesomeness of what ends up on our plates. This is especially true of modern production methods like those we have in Europe, which use a lot of inputs. EFSA’s mandate reflects that approach, and we owe the European legislator a debt of gratitude for it.

The drivers of change in the field of food safety are constantly evolving and foremost among them is globalisation, one of the defining influences of our time. The European food supply has become globalised and, as a result, food products, animals and plants are travelling greater distances and are crossing more and more national boundaries. As the largest importer of food in the world, the potential for new or re-emerging risks to the European food supply is great and we must remain vigilant to ensure that the public is protected from these new risks as well as preventing established threats from re-entering.

Likewise, climate change is a growing threat and the extreme weather events associated with changes in climate – high rainfall, increased temperature and drought – can favour the occurrence of organisms such as fungi, the source of aflatoxins, which reduce crop quality and may threaten public health. It is also likely that milder winters in Northern Europe will favour the development of vector-borne viral diseases, and may increase the need for pesticide use to control the pests. With hotter summers other pests, currently contained to glasshouse crops, may affect open-field vegetables and even wild flora. EFSA will need to be prepared to assess the direct and indirect impact on health and the environment of climate change.

We will also need to be able to assess and compare risks in an integrated manner, taking into consideration any benefits to health or the environment of new products or technologies, so that risk managers have a comprehensive and accurate overview on which to take action. One of the key strengths of the Authority is that it brings together a wide range of European expertise that spans the entire length of the food chain. It is important that we continue to use the full range of expertise at our disposal in delivering our risk assessments. We will continue to build and develop this integrated approach to enable us to assess and respond to the challenges we face.

Increasing workload
Today in EFSA we see an ever increasing need for our scientific advice, with the number of questions rising from 229 in 2003 to over 620 so far in 2008 and our productivity increasing from 201 scientific outputs in 2007 to more than 400 this year. We allocate about 40% of our resources to providing advice related to authorisations and peer review.

We are striving to enhance our dialogue with risk managers and to streamline our procedures to ensure that they are efficient. That is why last year I mandated a working group to evaluate the efficiency of the pesticide peer review process.

Later today you will hear more about the outcome of this exercise and about the future implementation of the recommendations from Herman Fontier. Incidentally, I greatly appreciate the constructive comments ECPA provided to the report issued by the working group and I can assure you that your comments are being carefully considered.

And of course quantity on its own is not enough – our outputs must meet the usability criteria of risk managers. To this end we have put in place a system of quality review, the internal component of which we implemented this year with the external component scheduled for 2009.

Cooperation
It is increasingly important that we continue to build our relationship with Member States at all levels and this is very evident in the pesticides field. By sharing information and expertise, we can make effective use of synergies, benefit from the available pool of European expertise and avoid duplication of work and unnecessary divergence of opinion. Cooperation is emphasised in our Founding Regulation and the Strategy for Networking and Cooperation adopted by our Management Board in December 2006 provides the framework for our activities in this area.

To reflect the emphasis we place on cooperation, in 2008 we created a new Directorate – Scientific Cooperation & Assistance, which includes the PRAPeR Unit – with the remit of building cooperation and supporting our risk assessment activities. It specifically provides expertise in data collection, exposure assessment, emerging risk and assessment methodologies and more generally, enables us to respond promptly to requests for advice.

EFSA’s Advisory Forum, which brings together representatives of all 27 national food safety authorities and observers from Norway, Iceland, Switzerland and the European Commission, is central to our cooperation activities. It has developed into a crucial platform for dialogue and collaboration and it is playing an increasingly active role in our work. It facilitates information exchange, better coordination of work programmes, early identification and analysis of emerging risks, increased coherence in scientific risk assessment and communication, and avoidance of duplication of activities.

Several projects have been identified by the Forum and are now being developed, such as the harmonisation of risk assessment approaches, food consumption database, harmonization of chemical occurrence data collection, safety assessment of botanicals, and emerging risks.

Article 36 of EFSA’s Founding Regulation authorises competent organisations to assist the Authority in its work. In 2006, our Management Board adopted a list of public institutions that qualify for these grants. We issued 12 calls last year and this has been expanded in 2008 with 19 calls and a budget in the region of €2.2 m. The Article 36 programme is an important mechanism for us in managing our workload and we also contract-out scientific work under public procurement procedures where necessary. Compared with a budget for 2007 of approximately €0.5 m, we anticipate that we will have allocated €3 m to scientific cooperation projects by the end of 2008.

EFSA’s activities in the area of cooperation received added impetus by the creation of Focal Points over the past 12 months or more. These interfaces, nominated by Member States, form an important bridge between EFSA and the national food safety authorities, research institutes and national stakeholders. They are helping us to disseminate information on our activities in the Member States and also to seek the views and inputs of the Member States and all national stakeholders on our work.

Stakeholders
In relation to cooperation, we pay very special attention to our stakeholders, i.e. consumer groups, farmers, industry, retailers and NGOs, because their input is crucial to our mission and goals. Since its early days, EFSA has opened its doors to stakeholders and a milestone in the Authority’s stakeholder activities was reached with the establishment of the EFSA Stakeholder Consultative Platform in 2005, of which ECPA is an active member.

To ensure that our engagement is meaningful and effective, an external review of the Platform’s activities was carried out in 2007 and we are using the findings to guide our future policy. In our daily work, it is extremely important to be aware of and address the concerns and expectations of stakeholders and we attach great priority to meeting stakeholders to do so. We consult them through both web-based public consultations and dedicated meetings. For example, the PPR consultations on its Guidance Documents communicate the work of the Panel to all stakeholders and enable us to take their comments on board.

International and European cooperation
The challenges that risk assessors and managers face, today and in the future, focus our attention even further on the need for effective cooperation.

That is why our cooperation activities extend beyond Europe. In 2007, we signed a landmark confidentiality agreement with the US FDA on information sharing. In addition, EFSA works closely with relevant international organisations – such as the WHO, FAO, OIE and OECD – as well as other European agencies – such as EMEA, ECDC, and ECHA. Recently, we signed an agreement on cooperation with the Joint Research Centre of the European Commission which will help to keep EFSA’s risk assessment at the forefront of science.

Communication
EFSA is committed to providing clear communication grounded in the most up-to-date scientific information and knowledge which takes into consideration consumer concerns and perceptions. EFSA contributes to consumer confidence in the food chain by providing scientific advice in an open, balanced and impartial way. We work closely with the communications departments of the national food authorities to build a coherent EU-wide approach and to address different national perceptions. With the Commission, EFSA carried out a Eurobarometer survey in 2006 on the perception of risks in food and we have plans to do further work on this in 2009 and 2010.

Conclusion
In conclusion, I would like to reiterate that EFSA is committed to ensuring the safety of the European food and feed supply. We strive to work with all actors in the food chain towards the shared goal of consumer protection and sustainability of the food and feed production. I would like to thank the organisers once again for this opportunity to address you and I look forward to what I’m sure will be a very stimulating discussion.

Thank you for your kind attention.