Transparency and harmonization: essential conditions for success

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Transparency and harmonization essential
conditions for success

• HERMAN B.W.M. KOËTER Deputy Executive Director
  and Director of Science

Committed to the safety of Europes food
Bratislava, 28 June 2007
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EFSA Mission and tasks

• Provision of scientific advice and scientific and
  technical support for the Communitys legislation
  and policies in all fields which have a direct or
  indirect impact on food and feed safety -
  including nutrition, plant health and animal
  health/welfare
• Provision of independent information on all
  matters within these fields
• High level of scientific excellence, independence
  and transparency
• Risk communication.

3
EFSA Science
SC / AF
Executive Directorate
External Relations
Science
Administration
Communications
Risk Assessment
Scientific Cooperation and Assistance
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Science Directorate

• Department of Risk Assessment (RA)
• comprising 9 Panel Support Units

• AFC
• AHAW
• BIOHAZ
• CONTAM
• FEEDAP

• GMO
• NDA
• PLH
• PPR

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Science Directorate

• Department of Scientific Cooperation and
  Assistance (SCA)
• comprising
• Data collection and exposure (DATEX) Unit
• Scientific cooperation (SCOOP) Unit
• Emerging risks (EMRISK) Unit
• Assessment methodology (ASMET) Unit
• Pesticides risk assessment (PRAPeR) Unit
• Zoonosis Unit.

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Scientific Panels

• Structure defined in the founding Regulation and
  copied from the Commission
• Together covering the whole food chain
• Expert members appointed by Management Board
  following a call to express interest
• Maximum of 21 members per panel selected on the
  basis of scientific excellence, area of
  expertise, gender and geographical balance.

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The 9 Scientific Panels

• Food additives, flavourings, processing aids,
  materials in contact with food (AFC)
• Animal Health and Welfare (AHAW)
• Biological hazards (BIOHAZ)
• Contaminants in the food chain (CONTAM)
• Additives and products in animal feed (FEEDAP)
• Plant Protection Products (PPR)
• Genetically modified organisms (GMO)
• Dietetic products, nutrition and allergies (NDA)
• Plant Health Panel (PLH)

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Scientific Committee

• Comprises the Chairs of all 9 Panels
• Additional 6 independent members
• Provides guidance to all Panels
• Manages projects involving several Panels
• Advises EFSA on emerging issues and priorities
  for scientific work.

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Scientific activities (work themes)

• Providing scientific opinions, guidance and
  advice in response to questions
• Assessing the risk of regulated substances and
  development of proposals for risk-related
  factors
• Monitoring of specific animal health risk factors
  and diseases
• Development, promotion and application of new and
  harmonized scientific approaches and
  methodologies for hazard and risk assessment of
  food and feed.

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Scientific activities (work themes)

• Providing scientific opinions, guidance and
  advice in response to questions
• Assessing the risk of regulated substances and
  development of proposals for risk-related
  factors
• Monitoring of specific animal health risk factors
  and diseases
• Development, promotion and application of new and
  harmonized scientific approaches and
  methodologies for hazard and risk assessment of
  food and feed.

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Investing in food science

• Focus areas
• Harmonization of detection methodology for
  chemical and microbiological contaminants in
  food/feed
• Improving the risk assessment process (e.g.,
  environment, transparency, animal health and
  welfare, specific substances)
• Methodologies to detect and recognise emerging
  risks
• Exposure assessment modelling (chemical and
  microbiological).

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Transparency and harmonization

• Harmonization means removing discrepancies
  between different approaches
• Transparency implies openness, communication and
  accountability
• Transparency is needed to achieve harmonization

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Transparency

• EFSA Transparency policy (1)
• Public meetings of the MB
• Making public the agendas and minutes of the MB,
  AF, SC, Panels and all WGs
• Publication of all scientific advice on EFSAs
  website
• Register of Questions is publicly available
• Transparent selection process of external
  experts.

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Transparency

• Best available, unbiased experts
• Best experts Major effort is made to select the
  best available (European) experts for the 9
  Expert Panels and Scientific Committee
• Independence No scientific expert is totally
  free of any bias Declaration of Interest
• Unbiased opinions The Panel as a whole develops
  opinions and advice which are unbiased as they
  are collectively agreed.

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An interest is not the same as a conflict of
interest

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Transparency

• EFSA Transparency policy (2)
• Publication of names, affiliations and DoIs of
  all experts
• Communicating advice pro-actively
• Arrange for discussions with stakeholders and
  critics
• Disseminating information, tailored to the needs
  of different audiences.
• Transparency in science most critical

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Transparency in science

• Scientific Committee is leading the work
• Opinion on a harmonised approach for risk
  assessment of substances which are both genotoxic
  and carcinogenic
• Opinion related to Uncertainties in Dietary
  Exposure Assessment
• Transparency in risk assessment carried out by
  EFSA guidance document on procedural aspects
• Transparency in risk assessment carried out by
  EFSA scientific considerations

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Transparency in science

• Scientific considerations
• Strengths, robustness and limitations of the data
  used for risk assessment
• Description of underlying assumptions and
  uncertainties which provide the reasoning for
  conclusions
• Criteria for inclusion or exclusion of available
  scientific information an selection of pivotal
  studies
• Science-based justification for the need for
  studies (stepwise risk asessment).

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Transparency what more?

• Developing a data base of national experts in MS
• Finalizing and updating, as needed, the SC
  opinion on transparency in risk assessment
• Describing all working procedures in SOPs
• Attach Explanatory Notes to most of EFSAs
  non-substance specific opinions.

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Harmonization

• EFSA Harmonization policy (1)
• Removing discrepancies (article 31)
• Intensifying contacts between EFSA and national
  food safety agencies (focal points)
• Exchanging a maximum of information
• Developing data collections for common use
  (occurrence, food consumption, etc)
• Developing Guidance Documents

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Harmonization

• EFSA Harmonization policy (2)
• Sharing draft opinions
• Organizing EFSA risk assessment courses involving
  leading experts from MS
• Developing strategies for the use of animals in
  risk assessment
• Developing procedures for internal and external
  reviews of EFSAs opinions
• Further improving the transparency in scientific
  work

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Harmonization

• EFSA Harmonization policy (3)
• Most importantly close cooperation with MS
  institutions and organizations through
• Exchange of ENDs
• Cooperation through Article 36 grants
• Outsourcing through procurement
• Real cooperation working together.

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Scientific Cooperation
Strategy for Cooperation and Networking with EU
Member States

• Establishment of a Steering Group of
  representatives of the AF, SC and EFSA experts
  (SGC)
• Setting priorities for cooperation projects (SGC
  proposals for AF and SC agreement)
• EFSA Scientific Cooperation working groups with
  participation of SC and AF experts
• Front-runner projects.

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Scientific Cooperation
Strategy for Cooperation and Networking with EU
Member States

• Establish Terms of Reference and a lead for
  agreed projects
• Project time schedule, milestones
• End product of scientific cooperation WGs
  submitted to the Executive Director of EFSA for
  consideration
• Next step in most cases request to SC or Panel
  to consider the end product and develop an
  opinion, statement, GD or other product.

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Scientific Cooperation

• Front-runner projects
• Data base of recognised experts in EU Member
  States (EFSA SCA lead)
• Risk / benefit of folic acid fortification of
  food (Ireland, UK, Germany)
• Identifying emerging food / feed safety risks
  (SC, UK)
• Harmonisation of data collections on chemical
  occurrence (EFSA SCA lead)
• European network of food consumption data base
  managers (EFSA SCA lead).

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Transparency and harmonization

• Harmonization what more can be done?
• Optimising the use of EFSA Extranet for exchange
  and sharing of information
• Organizing EFSA risk assessment courses and
  colloquiums with involvement of leading European
  experts
• Communicating more pro-actively EFSA opinions and
  other advice in a tailor made fashion to target
  audiences
• Increase consultation meetings with NGOs and
  other stakeholders, where feasible.

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Transparency and harmonization

• Overall goals
• Producing scientific advice of the highest
  achievable scientific quality and latest
  developments, acceptable by all Member States
• Producing scientific advice useful for the risk
  manager and all target audiences
• Communicating the scientific advice timely and in
  an understandable manner.
• EFSA needs you