SAFE FOODS

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SAFE FOODS
Dr. Harry A. Kuiper RIKILT - Institute of Food
Safety The Netherlands
Kick-off meeting SAFE FOODS 17-18 May 2004 WICC,
Wageningen, The Netherlands
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Promoting Food Safety through a New Integrated
Risk Analysis Approach for Foods
SAFE FOODS
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SAFE FOODS

• Type of Project Integrated Project
• Project title
• Promoting Food Safety through a New Integrated
  Risk Analysis
• Approach for Foods
• Coordinators Dr. H. A. Kuiper and Dr. H. Marvin
• Total budget 14,5
• EU contribution 11,4
• Number of partners 32
• Number of countries involved 18

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SAFE FOODS

• State of the Art
• Broad public concern about the safety of the
  European food supply
• BSE, dioxin, E.coli 0157, GM food crops
• Low public trust in how food crises were handled
• Low trust in the Regulatory System in Europe

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NEWS Frankenfears Andy Coghlan, David Concar,
Debora MacKenzie
POTATO DOCTOR SACKED
Editorial
Gag on food scientist is lifted as gene
modification row hots up
Stanley WB Ewen and Arpad Pusztai
Monster mash Take one transgenic potato and a
colony of lab rats
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The Food Debate!
ADMINISTRATORS
POLITICIANS
EXPERTS
MEDIA
SCIENTISTS
ACTION GROUPS
INDUSTRY
CONSUMERS
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Commission Wake Up to Consciousness

• EU White Paper on Food Safety (COM (1999), 719
  final)
• General Food Law (Regulation 178/2002)
• Establishment of the European Food Safety
  Authority (EFSA) in 2002, http//www.efsa.eu.int

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Tasks of EFSA

• Risk assessment
• Risk communication
• Not Risk management !

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The 4 Components of EFSA

• Management Board
• Advisory Forum
• Executive Director and staff
• Scientific Committee and 8 Panels

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The Advisory Forum

• 15 representatives of the members states
• From national bodies with similar role to EFSA
• ( e.g. AFSSA, FSA)
• chaired by the Executive Director

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The 8 EFSA Panels

• Panel on contaminants in the food chain
• Panel on food additives, flavourings, processing
  aids and materials in contact with food
• Panel on dietetic products, nutrition and
  allergies
• Panel on biological hazards
• Panel on additives and products or substances
  used in animal feed
• Panel on genetically modified organisms
• Panel on animal health and welfare
• Panel on plant health, plant protection products
  and their residues

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EFSA Objectives in Risk Assessment

• Taking forward the science of risk assessment
• Greater transparency of the Risk Assessment
  process including timeframes
• Authoritative views respected across Europe and
  beyond
• Increased stakeholder confidence in the Risk
  Assessment Process
• Risk assessment divorced from risk management
• EFSA not part of the Commission nor answerable to
  it

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EFSAs Role in Risk Communication

• Independent of political process
• Open and transparent
• Coordination with national authorities
• Support to Commission over food
  scares/emergencies

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New European Approach the Panacea for all Food
Evils?
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SAFE FOODS, A TOPICAL EVENT TO FURTHER SHAPE THE
NEW EUROPEAN APPROACH FOR RISK ANALYSIS OF FOODS
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SAFE FOODS
Early Detection of Emerging Risk Associated with
Food and Feed Production
Comparative Safety Evaluation of Breeding
Approaches and Production Practices Deploying
High - and Low- Input Systems
Quantitative Risk Assessment of Combined Exposure
to Food Contaminants and Natural Toxins
DESIGN OF A NEW INTEGRATED RISK ANALYSIS APPROACH
FOR FOODS
Consumer Confidence in Risk Analysis Practices
Regarding Novel and Conventional Foods
Investigation of the Role of Regulatory
Institutions in Risk Management
Management, Co-ordination and IPR
Dissemination and Training
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SAFE FOODS

• Strategic Objectives
• An effective European working-procedure for
  early identification of emerging risks in food
  production chains in an expanding European
  market.
• To develop comparative safety assessment
  approaches for foods produced by different
  breeding and production practices
• Quantitative risk assessment of complex food
  contamination patterns
• To investigate consumers concerns/preferences in
  risk analysis practices for foods.

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SAFE FOODS

• Strategic Objectives
• To investigate the new role of institutions
  across Europe involved in risk assessment and
  management taking a broader impact of food
  production on environment, animal welfare,
  sustainability, and socio-economic consequences
  into account.
• To design a new risk analysis approach for foods,
  integrating scientific principles, societal
  aspects and effective public participation.

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Nations of Partners and Subcontracting Parties
CHINA
SOUTH AFRICA
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SAFE FOODS
European Food Safety Network (EFSN) RIKILT /
RIVM 29 government-related research
institutes from 21 EU countries (including 7
pre-accession countries)

• European Thematic Network on Safety Assessment of
  Genetically Modified Food Crops
• Dr. H.A. Kuiper
• RIKILT, the Netherlands
• 65 Participants from 13 EU countries
• 5 RTD projects
• 4 Working Groups on Safety Evaluation and
  Assessment
• Project duration 01-01-2000 to 01-01-2003

Promoting Food Safety through a New Integrated
Risk Analysis Approach for Foods (SAFE FOODS)
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SAFE FOODS
Risk Analysis Framework

• Risk Assessment
• Hazard identification
• Hazard characterization
• Exposure assessment
• Risk characterization

• Risk Management
• Assess policy alternatives
• Select and implement appropriate options

Increased transparency increased
credibility? Incorporation of societal values
to create an integrated framework
Risk Communication and Stakeholder Involvement
Interactive exchange of information and
opinions
(after WHO, 1998)
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SAFE FOODS

• Characteristics of the New Risk Analysis Model
• Integration of assessment of human health aspects
  of foods with consumer preferences and values.
• Active consumer participation in the various
  stages of the risk analysis process.
• Improved functional and structural risk
  management procedures.
• Improved risk communication with consumers
  throughout the process of risk analysis.
• Pan European applicability.

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What is New in this IP?Challenges

• Large scale
• Multidisciplinary character
• Natural and social sciences together
• Integration of projects or no added value
• Integrated project and financial management

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SAFE FOODS
NEW RISKS IN EXPANDING MARKETS CAPACITY BUILDING
PROBABILISTIC/ DETERMINISTIC RISK
ASSESSMENT COMPARATIVE ASSESSMENT QUANTIFY
UNCERTAINTIES
COMPARATIVE PROFILING ANALYSIS HISTORY OF SAFE
USE
INTEGRATED SCIENCE-BASED SYSTEMIC RISK ANALYSIS
MODEL
CONSUMER CONFIDENCE/PREFERENCE VALUE
JUDGEMENT RISK ACCEPTABILITY PRECAUTION
NEW APPROACHES FOR SYSTEMIC RISK ANALYSIS NON-
STATIC PROCESS ADAPTATION
STAKEHOLDERS DIALOGUE COMMUNICATION TRAINING
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The New (?) Role of Science

• Science is a creative enterprise in which
  ethics and values of individuals and societies
  play an increasingly important role (ICSU 2004,
  New Genetics, Food Agriculture))
• Science must be active in alerting the public
  early on new developments and consequences for
  the society
• RISKS, UNCERTAINTIES, BENEFITS, CHOICES
• Spend public money on these issues first
  (Biotechnology the wrong example)
• Update regulatory approaches that keep abreast of
  new scientific developments

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Agricultural Biotechnology a Learning Case

• Insufficient information on the technology by
  independent laboratories and agencies
• Industry driven
• No clear benefits perceived by the consumer
• Playing God, threat for nature integrity
• Concerns regarding long term effects on human
  health and the environment
• No consumer choice

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THE FUTURE OF RISK ASSESSMENT IN THE EUROPEAN
UNION (Scientific Steering Committee)

• First and Second Report on the Harmonization of
  Risk Assessment Procedures, December 2000, April
  2003
• Final Report on Setting the Scientific Frame for
  the Inclusion of New Quality of Life Concerns in
  the Risk Assessment Process
• http//europe.eu.int/comm/food/fs/sc/ssc/outcome_e
  n.html

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New Issues in Risk Assessment

• Integrated Risk Assessment
• In silico Toxicology
• Low dose effect extrapolation (hormesis?)
• Exposure to mixtures and effect quantification
• Sensitive groups in the population
• Use of gene expression and metabolite profiling
  techniques
• Risk comparison/risk ranking?

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Uncertainty Analysis (UA)

• Difference between variability in measurements
  (errors) and lack of knowledge of assumptions
  (sensitivity humans-animals)
• Numerical/language description
• Quantification of uncertainties in assumptions
  difficult
• Clear expert judgement
• Application of the Precautionary Principle (PP)
• UA and PP complementary or separated?

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Inclusion of New Quality of Life Criteria in the
Risk Analysis Process

• Human physical and psychological health
• Animal welfare
• Environmental impact
• Cost- Benefit considerations
• Acceptability of risks, cultural attitudes
• Socio-economical impact
• Essential part of the risk assessment or in
  addition?

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Risk Analysis Process Further Developed

• Update the Risk Assessment Process, not too slow
  and not too fast
• Improve interplay between risk assessors and risk
  managers consequences of conclusions, options,
  responsibilities
• Risk communication throughout the process about
  what and by whom
• Role and involvement of stakeholders in the
  various steps of the risk analysis process
• Role of monitoring and surveillance science
  driven, by public concerns or ethical
  considerations?

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Major Deliverables

• First comparative databases for profiling of
  foods produced by different breeding approaches
  and production systems.
• Development of a working procedure for
  identification of new emerging chemical and
  microbial risks in food production chains.
• New approaches for risk modelling of food
  contaminants and natural toxins, and criteria
  development for comparative risk analysis.
• Analysis of food safety risk perceptions of
  experts, regulators, consumers and other
  stakeholders regarding novel and conventional
  foods.

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Major Deliverables

• Analysis of uncertainties in risk assessment and
  identification of best practice in communicating
  risk uncertainty with the public.
• Identification of consumers preference for risk
  analysis strategies for foods across Europe.
• Guidance for evaluation and governance of
  systemic food risks.
• Recommendations for improvement in risk
  management procedures and institutional
  structure.
• New Risk Analysis Approach for foods that
  integrates risk assessment, risk management,
  consumer preferences and values, as well as
  impact analysis of socio-economical aspects.

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Expectations from SAFE FOODS

• Successful co-operation between ?- and ?
  scientists
• Improved risk assessment of different types of
  foods and food contaminants
• Balanced science driven Framework for the Risk
  Assessment
• Transparent Risk Analysis Cycle, responsive to
  the societal and economical impact of the
  introduction of new foods
• New model with a high degree of interaction with
  the various stakeholders

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SAFE FOODS
New Integrated Risk Analysis Approach