Risk Analysis: the new paradigm in food safety assurance

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Risk Analysis the new paradigm in food safety
assurance

• A summary of international initiatives
• By F.K.Käferstein

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Uruguay Round on Multilateral Trade
Negotiations1986 -1994

• Considers trade agreements for products,
  including food. Two will later be known as
• Agreement on Sanitary and Phytosanitary Measures
  (SPS)
• Agreement on Technical Barriers to Trade (TBT)

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SPS Agreement (1)

• Recognizes right of governments to protect health
  of their people from hazards which may be
  introduced with imported food by imposing
  sanitary measures, even if this meant trade
  restrictions

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SPS Agreement (2)

• Obliges governments to base such sanitary
  measures on risk assessment to prevent disguised
  trade protection measures

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SPS Agreement (3)

• Sanitary measures need to be
• non-discriminatory
• not more trade-restrictive than necessary
• based on sufficient scientific evidence

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SPS Agreement (4)

• Governments should base their sanitary measures
  on international standards.
• Codex standards are explicitly recognized as
  those, compliance with which is consistent with
  SPS provisions.

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Joint FAO/WHO Conference on Food Standards,
Chemicals in Food and Food Trade (1991)convened
in collaboration with GATT

• Recommends to Codex to incorporate risk
  assessment principles into decision making

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Codex,19th (91) 20th (93) sessions

• Agreed on the incorporation of risk assessment
  principles in its procedures

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Executive Committee (1994)

• Urged FAO WHO to convene a consultation on
• risk analysis

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Joint FAO/WHO Expert Consultation on the
Application of Risk Analysis to Food Standard
Issues

• WHO-HQ, Geneva
• 13-17 March 1995

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Definition of term Risk analysis

• It is a process consisting of three components
• Risk assessment
• Risk management
• Risk communication

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Risk assessment

• A scientifically based process which consists of
  4 steps
• Hazard identification
• Hazard characterization
• Exposure assessment
• Risk characterization

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Current practices in Codex(Example vet.drug
residues)

• Hazard identification
• CCRVDF requests JECFA to assess a certain
  chemical
• Hazard characterization
• JECFAs toxicological evaluation - ADI

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Current practices in Codex(Example vet.drug
residues)

• Exposure assessment
• JECFA estimates intake of residue, based on
  residue and food consumption data
• Risk characterization
• comparison of estimated intake with ADI

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Codex, 1995

• All relevant Codex committees to examine the
  report so that risk analysis concept incorporated
  in CAC procedures
• FAO WHO requested to convene further
  consultations on risk management and risk
  communications

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Joint FAO/WHO Consultation on the Application of
Risk Management to Food Safety Matters

• FAO-HQ, Rome, 27-31 Jan.1997

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Risk management

• The process of weighing policy alternatives,
  considering risk assessment and other factors
  relevant for the health protection of consumers
  and for the promotion of fair trade practices,
  and, if needed, selecting appropriate prevention
  and control options

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Risk managementElements

• risk evaluation (initial risk management
  activities)
• risk management option assessment
• implementation and management of decisions
• monitoring and review

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Joint FAO/WHO Consultation on Application of Risk
Communication to Food Standards and Safety Matters

• FAO-HQ, Rome, 2-6 Feb.1998

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Risk communication

• An exchange of information and opinions
  throughout the risk analysis process concerning
  risk, risk-related factors and risk perception,
  among all interested parties, to explain risk
  assessment findings and the basis of risk
  management decisions

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Risk communicationElements

• Nature of risk
• Nature of benefit
• Uncertainties in risk assessment
• Risk management options

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Codex, 1997

• Decided to adopt
• key definitions of risk analysis terms
• related to food safety and to publish them in the
• Codex Procedural Manual

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Risk assessment of chemical vs. biological hazards

• Chemical hazards
• well advanced
• (JECFA, 1956 JMPR, 1963)

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Risk assessment of chemical vs. biological hazards

• Biological hazards
• new, developing science
• (1st FAO/WHO meeting of experts in 2000)

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Risk assessment of biological hazards

• CCFH has developed
• Principles and Guidelines for the Conduct of
  Microbiological Risk Assessment
• (to be adopted by 24th CAC, 2001)
• CCFH is developing
• Guidelines for Mirobiological Risk Management (at
  step 3)

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The information age

• Where is the wisdom we
• have lost in knowledge?
• Where is the knowledge we
• have lost in information ?
• T.S.Elliot
• (The Rock)

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Risk analysis(i.e. assessment, management,
communication)

• Framework for organizing data (information) in a
  rational, consistent way
• Framework of rules for different players along
  food chain will help to
• transform information into knowledge and
  knowledge into wisdom, needed for rational,
  transparent decisions.

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Risk analysisrelevant FAO/WHO documentation (1)

• Codex Procedural Manual, 11st edition, FAO WHO,
  1999
• Food Standards, Chemicals in Food and Food Trade,
  report of FAO/WHO Conference, FAO WHO, 1991
• Application of Risk Analysis to Food Standards
  Issues, report of FAO/WHO Consultation, WHO
  document WHO/FNU/FOS/95.3

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Risk analysisrelevant FAO/WHO documentation (2)

• Risk management and food safety, report of
  FAO/WHO Consultation, Food and Nutrition Paper
  65, FAO,1997
• The application of risk communication to food
  standards and safety matters, report of a FAO/WHO
  Consultation, Food and Nutrition Paper 40, FAO,
  1999
• Risk assessment of microbiological hazards in
  foods. Report of FAO/WHO Consultation, WHO
  document WHO/SDE/PHE/FOS/99.5

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Risk analysisrelevant FAO/WHO documentation (3)

• Food safety and globalization of trade in food. A
  challenge to the public health sector.
• WHO document WHO/FSF/FOS/97.8 Rev.1 (1998)
• Food safety in international trade. Miyagishima
  K. F.K.Käferstein, World Health Forum 19,
  407-411, 1998.

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JIFSAN SEMINAR SERIES 2000
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Food Safety Risk Analysisat JIFSAN

• Will Hueston, DVM, PhD
• Wendy Fineblum, DVM, PhD
• University of Maryland

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Background

• Joint Institute for Food Safety and Applied
  Nutrition (JIFSAN) - 1996
• FDA-UM collaboration to enhance risk analysis
• Presidents Food Safety Initiative - 1997
• Established intergovernmental Risk Analysis
  Consortium (RAC)
• Promised Food Safety Risk Analysis Clearinghouse

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JIFSAN Risk Analysis Goals

• Improve tools and techniques for food safety risk
  analysis
• Generate data to support risk analysis
• Offer risk analysis training and education
• Provide outreach to risk analysis communities

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Food Safety Risk Analysis Clearinghouse

• Major risk analysis outreach initiative for
  JIFSAN
• Supports use of risk analysis for safe food both
  nationally and internationally
• Make data and information available to all
  interested parties

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Creating the Clearinghouse

• Central repository for data and information
• Focus on Web-based internet site because
• links to other web sites
• universal access via internet
• speed of revision and data sharing
• unlimited volume potential

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Clearinghouse Users

• Government Risk Professionals (USDA, FDA, EPA,
  CDC)
• Industry
• Academics
• Consumers
• Non-governmental Organizations
• International Groups

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Food Safety Risk Analysis Clearinghouse

• www.foodriskclearinghouse.umd.edu

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Take home messages

• JIFSAN is alive and well
  ...AND GROWING!
• Risk analysis IS the new paradigm for food safety
  assurance
• Demand for food safety data and risk analysis
  tools is growing exponentially
• The Food Safety Risk Analysis Clearinghouse is
  working to meet this need

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Food Safety Risk Analysis Clearinghouse

• Come visit us at
• www.foodriskclearinghouse.umd.edu

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JIFSAN SEMINAR SERIES 2000