an international framework for the interaction between assessors and managers of microbiological...
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An International Framework for the Interaction Between Assessors and
Managers of Microbiological Hazards
Anna M. LammerdingHealth Canada
1st International Conference on
Microbiological Risk AssessmentJuly 24 – 26, 2003
University of Maryland
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BackgroundBackground
Generic frameworks for managing foodborne risks described by FAO/WHO documents:
– Risk Management and Food Safety, FAO Food and Nutrition Paper 65, FAO Rome (1997)
– The Interaction between Assessors and Managers of Microbiological Hazards in Food, Report of a WHO Expert Consultation (Kiel, 2000)
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BackgroundBackground
Generic frameworks for managing foodborne risks described by FAO/WHO documents:
– Principles and Guidelines for Incorporating Microbiological Risk Assessment in the Development of Food Safety Standards, Guidelines and Related Texts, Report of an FAO/WHO Expert Consultation (Kiel, 2002, in preparation)
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BackgroundBackground
WORK of FAO/WHO
Codex Committee on Food Hygiene (CCFH)
Identified Priority Pathogen/Foodsfor Risk Management
FAO/WHO Assembled & Coordinated Workof Drafting Groups for Risk Assessments
Organized Expert Consultationsto Review Work
Reports & Assessments presented to CCFH
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BackgroundBackground
Work on four Risk Assessments to-date:– Salmonella spp. in Broiler Chickens and
Salmonella Enteritidus in Eggs– Listeria monocytogenes in Ready-to-Eat Foods– Vibrio spp. in Shellfish– Campylobacter jejuni in Broiler Chickens
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BackgroundBackground
Lapses: Priority pathogens/foods identified, but the
purpose for doing the work not clearly defined, and not defined at the onset of the work
Lack of effective communications between Risk Assessors and Risk Managers (CCFH) during the progress of the work.
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BackgroundBackground
Additional Challenge
Long-distance relationship among the RA drafting group members …
… work carried out in addition to daily load!
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BackgroundBackground
Now, ad hoc CCFH Risk Management drafting groups identified to define RM questions, help “manage” the risk assessment process and activities, and to communicate with Risk Assessors during the course of the work
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Why the Need Why the Need for Guidance for Guidance on Interaction on Interaction Between Risk Between Risk Assessors & Assessors & Risk Risk Managers?Managers?
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Functional Separation of Risk Functional Separation of Risk Assessment and Risk ManagementAssessment and Risk Management
Individual(s) assessing the risk should not be the same individual(s) responsible for managing the risk
Essential in order to maintain the scientific integrity of the risk assessment process, avoid pre-concluded biases toward certain courses of action, avoid political pressures
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Functional Separation of Risk Functional Separation of Risk Assessment and Risk ManagementAssessment and Risk Management
Recognized in some situations, same person responsible for both functions
Recognized that the risk manager can also be most familiar with the “science” of the risk issue
Nevertheless: Risk assessment and risk management processes and activities must be distinct, transparent and documented
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Why the Need for Guidance on Why the Need for Guidance on Interaction?Interaction?
Risk Analysis: Interactive, iterative & dynamic
Common understanding of the risk issue and risk management goals is essential to producing useful risk assessments and outcomes
On-going interaction leads to a better understanding of the risk assessment parameters, benefits and limitations, ultimately more informed decision-making
Policy-related decisions and value judgments arising during the work – beyond the mandate of assessors
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Risk Management Framework Risk Management Framework (Kiel, 2000)(Kiel, 2000)
Risk Evaluation
Implementation
Option Assessment
Monitoring & Review
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Risk Management Framework Risk Management Framework (Kiel, 2000)(Kiel, 2000)
Risk Evaluation
Implementation
Option Assessment
Monitoring & Review
Risk Assessment
Cost-BenefitAnalysis
Use of risk model to help evaluate
Identify new issues
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Risk Evaluation(Preliminary Risk Management Activities)
Food Safety IssueIdentification
Risk Profile
Management Decision
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Risk Evaluation(Preliminary Risk Management Activities)
Food Safety IssueIdentification
Risk Profile
Management Decision
Do nothing
Urgent: Interim Action
Existing Regs
Limited Evaluation
Risk Assessment ?
Need more information
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Risk Evaluation(Preliminary Risk Management Activities)
Risk Assessment?
Scope & Purpose
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Defining Purpose & Scope of Defining Purpose & Scope of MRA & Need for Interaction!MRA & Need for Interaction!
Critical first step Often, managers themselves not clear about
purpose, AND/OR have not articulated goals
Understanding on both sides increases if clarify “Why, where, when, what, and how?”
Distinguish the risk management problem/goals from what questions the mRA is to answer
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Benefits From the Use of MRABenefits From the Use of MRA
Objective evaluation of RM options that are controversial and/or costly
More effective development of a range of food safety measures capable of achieving stated levels of consumer protection
Facilitating design of “production to consumption” food safety programs
Risk-based development of performance criteria
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Benefits From the Use of MRABenefits From the Use of MRA
Balancing competing risks Providing modular components that can be
adapted by other users (nations, regions) with different data inputs and food safety needs
Facilitating objective demonstration of the equivalence of alternative technologies and food safety measures
Scientific justification of import requirements that are more stringent than benchmark Codex standards
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Benefits From the Use of MRABenefits From the Use of MRA
Routine application where an mRA is mandated by law, regulation, or other policy
Identifying and focusing research and data collection needs
Communicating the scientific basis of risk management decisions to all interested parties
These Are examples of broad risk management goals, but not the specific questions the RA will answer
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When the manager doesn’t When the manager doesn’t know what he/she wants…know what he/she wants…
Q. Why do you want from the risk assessment? What will you (the manager) do with the information?
A.“Do the MRA first, then I will decide what I want to do with it”
A. “Risk assessment is “pure science” … the risk management issue/goal should have nothing to do with carrying out an assessment”
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Defining Purpose & Scope of Defining Purpose & Scope of MRAMRA
Determine if a risk assessment is the best strategy to answer the questions, or is it more appropriate to chose another means to acquire the information needed?
Determine the approach that is needed (degree of precision; direct, or production-to-consumption) … should be appropriate for the specific risk issue
Is the work feasible within constraints of time, resources, data availability, expertise, etc.?
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Types of Risk Assessments:Types of Risk Assessments: Increasing Precision & Detail Increasing Precision & Detail
Qualitative, descriptive, categorical, ranking
Quantitative, probabilistic
Generic numbers, simple model(s)
Specific data, sophisticated models
Quantitative point-estimates
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Risk Evaluation(Preliminary Risk Management Activities)
Risk Assessment?
Scope & Purpose
Appropriate & Feasible?NO
Alternate Management
Strategy
Establish Risk Assessment Policy
Yes
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Risk Assessment PolicyRisk Assessment Policy
Documented guidelines for judgements or policy choices during the work that are not dictated by scientific or analytical protocol
Intended to ensure RA is systematic, complete and transparent
Protect the scientific integrity of the process Depends on adequate definition of scope and purpose Responsibility of Risk Manager, but requires discussion
& input from risk assessor to identify & clarify policy issues, or if policies present inappropriate constraints/biases
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Risk Evaluation(Preliminary Risk Management Activities)
Commission the Risk Assessment
Establish Risk Assessment Policy
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Commission Risk AssessmentCommission Risk Assessment
Risk Manager assembles the risk assessment team
Definition and documentation of all background information relevant to the work, and expectations
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Risk Evaluation(Preliminary Risk Management Activities)
Commission the Risk Assessment
Establish Risk Assessment Policy
Conduct Risk Assessment
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Risk assessor/manager Risk assessor/manager interactioninteraction
“Discoveries” during the risk assessment work:
– Cannot anticipate all road-blocks until actually start the work– Critical data gaps– Non-critical data gaps– Modelling challenges– New knowledge, new insights about risk issue– Unexpected constraints, unexpected findings– Decision-making, judgement calls
PERIODIC REVIEW & IF NEEDED, RM goals, direction, RA scope, policies, resources may need to be refined or modified
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Risk Evaluation(Preliminary Risk Management Activities)
Commission the Risk Assessment
Establish Risk Assessment Policy
Conduct Risk Assessment
Presentation of Results
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Presentation of ResultsPresentation of Results
Appropriate for scientific and non-scientific audiences
Probabilistic analyses not intuitive – clearly translate assumptions, uncertainties and outcomes so that can be understood by managers, others
Communicate insights gained during information gathering, model building, importance analysis
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Risk Managers must recognize that Risk assessment does not in itself provide the answer to: “What is the right decision to make in this situation?”
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Consideration of ResultsConsideration of Results
Managers need to understand:
– Variability and Uncertainty in risk estimate and key inputs, and impacts of V & U
– What are the important assumptions and impacts– Influence of constraints on the work– To what extent could alternative, plausible
assumptions or models affect conclusions– Key controversies concerning data or assumptions
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Consideration of ResultsConsideration of Results
A Risk Assessment should be decision-focussed…(therefore) inappropriate to review it independently from the question(s) the assessment is addressing…
(David Vose, 2002)
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Consideration of ResultsConsideration of Results
Expectations sometimes exceed the work commissioned
Not scientific research, not a scientific manuscript … not intended to be a complete scientific review/evaluation of all data and all knowledge concerning the pathogen, the food, the host … only that which is relevant to the risk issue and the decision at hand.
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Risk Management Framework Risk Management Framework (Kiel, 2000)(Kiel, 2000)
Risk Evaluation
Implementation
Option Assessment
Monitoring & Review
Risk Assessment
Cost-BenefitAnalysis
Use of risk model to help evaluate
Identify new issues
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Identification of options is a risk management function in consultation with other stakeholders
Insights gained by risk assessors during RA work can contribute
Additional analysis with RA model to help define what reductions in exposure necessary to meet defined levels of risk
Potential effectiveness of various options can be “tested” and compared by using the risk assessment model
Risk assessment can contribute to cost-benefit analyses
Option Assessment
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Role of assessor generally limited in implementation activities
Risk assessors may be involved in evaluating results of monitoring the risk reduction measure using the risk model updated with the new data
Monitoring & ReviewImplementation
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Challenges at the International Challenges at the International LevelLevel
More Players: Decision-makers
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Challenges at the International Challenges at the International LevelLevel
More Players: Stakeholders
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Challenges at the International Challenges at the International LevelLevel
More Players Generally, broader scope in Risk Assessment
and Risk Management activities – more Variability and more Uncertainty
Different populations, cultures, political and regulatory infrastructures
Considerations for developing countries Broader audience to communicate with
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Challenges at the International Challenges at the International LevelLevel
More Players, but also Opportunities for Harmonization, Cooperation and Collaboration
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Future DirectionsFuture Directions
Education and experience in “risk-based thinking” & systematic decision-making processes will lead to better utilization of risk assessment methods and their benefits
Development of both simplified AND more complex risk assessment approaches – both based on increasingly better scientific knowledge and understanding –
Acknowledgment of microbial risk assessment benefits & limitations, and development of a range of analytical strategies appropriate for the diversity of food safety risk issues and risk management needs.