Geoffrey Podger: Address to European Parliament, Agricultural Committee, Brussels

Geoffrey Podger

Thank you very much for the opportunity to appear for the first time before the Agriculture Committee. We very much appreciate your interest in the European Food Safety Authority’s work.

By way of introduction, I should perhaps stress at the outset that EFSA was established to be an independent scientific risk assessment body of the European Union. We have closeinternational contacts not least with OIE/FAO/WHO. We are not responsible for risk management measures nor for the operation of the food controls system: these remain the responsibility of the European Commission.

The Scientific activities are grouped around four major themes:

1. providing scientific opinions, guidance and advice in response to questions from the European Commission, the European parliament, the Member States or by EFSA itself (approximately 30%);

2. assessing the risk of specific groups of regulated substances and developing proposals for risk-related factors, following legally defined notification procedures and time-schedules. These include the assessment of pesticides, feed additives, GMOs and food additives (approximately 45%);

3. monitoring of specific risk factors and animal diseases and providing scientific opinions on test and other tools to control these risk factors and diseases. E.g. geographical BSE risk assessment, validation of BSE/TSE diagnostic test, the monitoring of zoonoses and other food-borne zoonotic agents, the scientific review of new tools for eradication of specific animal diseases (approximately 10%);

4. development, promotion and application of new and harmonised scientific approaches and methodologies for hazard and risk assessment of food and feed. This includes the development of a harmonized European food consumption data base and the organization of scientific colloquia on emerging issues. (approximately 15%).

It may be helpful if I give example of what EFSA has done in your area of competence:

1. The mandate for the BIOHAZ panel covers food microbiology, food hygiene, foodborne zoonoses and meat inspection. The Panel has recently assessed the age limit for the removal of Specific Risk Materials (SRM) in cattle. The panel concluded that raising the age – from over 12 months – as regards the removal of the SRMs (including the vertebral column) from cattle to 30 months would still be a
considerable but not an absolute safety margin. Alternatively, raising the age limit to 21 months would cover even the youngest animals detected with the disease since monitoring began in 2001 and would thus be a more cautious approach. However, it is up to the risk managers to take the risk management decision on which age limit to apply and in this decision use the precautionary principle. The
Panel has dealt with salmonella in poultry and focused on advantages and disadvantages of antimicrobials and vaccines to control Salmonella. Furthermore the Panel has answered a question from the Parliament as regards the safety of goat milk and goat milk products. This month the Panel will give a further opinion on BSE in goats.

2. The FEEDAP Panel has an extensive work programme on the assessment of feed additives, a programme laid down in Community legislation. The Panel has initiated self tasking projects such as the update of criteria in assessing bacteria for antibiotic resistance and also environmental risk assessment models for feed additives. A recent project is the assessment of herbal products for use in animal nutrition.

3. One large scientific project is the new task assigned to EFSA to take over the responsibility for the Community Summary Report on Zoonoses and linked to that the reporting system required in the legislation. The reporting system developed has improved the analyses of the data and also the harmonisation of the monitoring and reporting approaches. A specific priority is the development of a multi-disciplinary
reporting scheme for food-borne outbreaks, the launching of a new web-based electronic reporting system and the analysis of the results from the first salmonella baseline study conducted in the Community.

4. The AHAW Panel has issued opinions on the welfare of laying hens (together with the BIOHAZ Panel), animal transport, microclimate during transport and also piglet castration. The Panel will address several topics related to animal welfare of dairy cows, rabbits, pigs and also laboratory animals.

EFSA's role as regards vaccination

1. EFSA's remit includes risk assessment of animal health and welfare, primarily related to food producing animals. Prevention of spreading of a disease through vaccination or other means are included in these EFSA risk assessments, along with other elements such as disease epidemiology and animal welfare aspects.

2. Vaccination is one important component in the control and eradication of many animal diseases. However this commonly requires new marker vaccines as well as diagnostic tools for differentiation between vaccinated and infected animals.

3. Some diseases are currently dealt with through national eradication programmes. Whereas the eradication of such endemic diseases is very important, new diseases that were previously exotic, such as blue tongue, are now entering the EU. The current EFSA activities focus on the risk assessment related to the possible entry of such diseases in the EU. Current mandates include Avian influenza, Foot and
Mouth Disease, and Rift Valley Fever. The potential use of vaccines in the control  of those diseases in the EU or in third countries is included in these risk assessments.

4. The Community is an area which imports more and more commodities of animal origin and has seen its land borders change rapidly. Hence, risk for import of exotic diseases will remain a big preoccupation for the EU. A number of key threats have been defined as EFSA priorities. These will be submitted as selfmandates as soon as available resources allow so. Examples are Classical Swine Fever, Blue tongue, Newcastle disease, African swine fever and African horse Sickness.

5. There is a need for a long term commitment for successfully combating these new threats. This requires substantial EU research in the study and control of those diseases along with incentives for the animal health industry to invest in the development of vaccines against these exotic diseases

Genetically Modified Organisms

1. I know that your Committee has a particular interest in GMOs for very obvious reasons. Here again EFSA’s role is strictly limited to providing scientific advice and opinions in the field of food, feed and environmental safety - we are not responsible for the subsequent risk management process.

2. Similarly co-existence of GM crops with conventional and organic agriculture, and also thresholds for labelling the adventitious presence of GM traces/seeds in other seed lots is not within the responsibility of EFSA. Both issues relate to GM crops already risk – assessed and authorised on the market. The issue of co-existence is linked to the potential economic risks to agricultural systems. Again it falls to the
Commission, as they have done to issue recommendations on co-existence in support for Member States’ approaches in establishing national strategies.

3. Scrutinising GMO applications so as to give a scientific view on their safety is however very much EFSA’s business and a major task of the Biotechnology Panel. The requirements on the applicants made by EFSA are both comprehensive and stringent. The relevant Guidance Document was published in March 2005 and is, of course, publicly available. Whilst the responsibility for the data submitted rests with
the applicant, such applications are in no way “rubber stamped” by EFSA. On the contrary EFSA scrutinises the applicants’ dossiers very carefully and frequently requests clarifications and further information. The Panel is well able to scrutinise for any irregularities or inconsistence in the data presented by the applicant and it should be noted that much of the data may come from work done by private
laboratories rather than the applicant himself.

4. EFSA has until recently delivered opinions according to procedures which involve the Member States making the first risk assessment, followed by a Community procedure involving EFSA, if reasoned objections from the Member States were given towards the first assessment. The new procedure in the food and feed legislation stipulates that EFSA will make the first risk assessment - within six months - and thereafter followed by the risk management procedures by the Commission and the Member States. EFSA is however obliged to consult the
national competent authorities as regards applications with environmental safety requirements - as regards seeds EFSA shall ask a national competent authority to carry out the environmental risk assessment.

5. EFSA has though taken the initiative to consult all contact points which have been nominated by the Members States for the GMO applications and not only those involved in the environmental risk assessment. All the comments received from the Member States during the 3-month consultation period are distributed to the members of the GMO panel and are being considered in the development of the
Panel’s opinion. In all adopted opinions, the GMO Panel has included, listed and discussed the most relevant comments from Member States. In this way EFSA has taken the initiative to involve all Member States at an early stage in the risk assessment process and thus have the opportunity to raise concerns in this early process before the adoption of the formal opinion.

6. EFSA also has as its general position that information we hold should be made publicly available, unless genuinely commercially confidential or subject to some particular legal restraint. Our website shows clearly that we make every effort to achieve this. We apply exactly the same principle to GMOs but it does have to be stressed that normally it is not EFSA but a Member State or the Commission who is
the determining authority for the classification of confidentiality.

7. EFSA is of course well aware of the continuing opposition within the EU to GMOs. This cannot and does not affect our scientific advice – anymore than if GMOs were widely popular, EFSA would consider for a moment taking a more favourable scientific stance in consequence. Public reaction is of course a matter which risk managers rightly take account of. EFSA, for its part, is always ready to consider new scientific work and change its view on any point if there is scientific justification. We do not however intend to change our views by one iota when
groundless attacks are made on the integrity of our Panel members and it must be hoped that the current level of dialogue can be returned to a scientific one.

8. In conclusion, I would also like to praise the GMO Panel for being themselves prepared to break new ground. In addition to the Guidance Document on Risk Assessment, which was the subject of consultation with stakeholders from all sections of opinion, the Panel has also initiated a number of self tasking projects on risk assessment approaches (including allergenicity and animal studies) and the key
issue of post marketing environmental monitoring. EFSA will continue to pursue the difficult GMO questions and we will continue to act independently, objectively and on the basis of high quality science.

Given the important issues dealt with by this Committee. I have concentrated today on the scientific aspects of EFSA’s work. It would be wrong, however, not also to lay emphasis on our parallel activity on risk communication. Since our inception, EFSA has
been very keen not merely to produce good quality science but to communicate it. Our website now currently scores over 3 million hits per month. We have extensive dealings with the press and have issued over 60 press releases in our two years of life.

Our most important achievement in this field, in my view, is, however, the establishment of not only a scientific network but also a communications network with the national food authorities of the Member States. We have invested much effort in enabling national
food authorities to be able to communicate rapidly with EFSA and each other so as to ensure that core scientific messages can be transmitted quickly and consistently across the European Union – and in a manner which respects the linguistic and cultural
preferences of each country. This should help significantly in times of crisis or food scare to ensure that consumers get accurate and proportionate messages on risk. Crises of course do not merely involve risk assessors but also risk managers and we will be
working together with the Commission later this year to hold a joint crisis exercise with the Member States. Again we are breaking new ground but it seems to me that this is a major way EFSA can help the Agriculture Sector of the European Union by ensuring that everyone is better prepared for problems and that they are handled in a more effective and proportionate way than has always been achieved in the past.

I thank the Committee for your attention and for your continuing support of EFSA.