Anna M. Lammerding Health Canada

1. An International Framework for the Interaction Between Assessors and Managers of Microbiological Hazards Anna M. Lammerding Health Canada 1st International Conference on Microbiological Risk Assessment July 24 – 26, 2003 University of Maryland

2. Background 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)

3. Background 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)

4. Background WORK of FAO/WHO Codex Committee on Food Hygiene (CCFH) Identified Priority Pathogen/Foods for Risk Management FAO/WHO Assembled & Coordinated Work of Drafting Groups for Risk Assessments Organized Expert Consultations to Review Work Reports & Assessments presented to CCFH

5. Background • 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

6. Background 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.

7. Background Additional Challenge • Long-distance relationship among the RA drafting group members … • … work carried out in addition to daily load!

8. Background • 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

9. Why the Need for Guidance on Interaction Between Risk Assessors & Risk Managers?

10. Functional Separation of Risk Assessment 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

12. Functional Separation of Risk Assessment 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

13. Why the Need for Guidance on 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

14. Risk Management Framework (Kiel, 2000) Risk Evaluation Monitoring & Review Option Assessment Implementation

15. Risk Management Framework (Kiel, 2000) Identifynew issues Risk Assessment Use of risk model to help evaluate Risk Evaluation Monitoring & Review Option Assessment Implementation Cost-Benefit Analysis

16. Risk Evaluation (Preliminary Risk Management Activities) Food Safety Issue Identification Risk Profile Management Decision

17. Risk Evaluation (Preliminary Risk Management Activities) Food Safety Issue Identification Risk Profile LimitedEvaluation Do nothing Management Decision Existing Regs Need more information Urgent: Interim Action RiskAssessment ?

18. Risk Evaluation (Preliminary Risk Management Activities) Risk Assessment? Scope & Purpose

19. Defining Purpose & Scope of 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

20. Benefits 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

21. Benefits 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

22. Benefits 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

23. When the manager doesn’t 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”

24. Defining Purpose & Scope of MRA • 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.?

25. Qualitative, descriptive, categorical, ranking Types of Risk Assessments: Increasing Precision & Detail Generic numbers, simple model(s) Specific data, sophisticated models Quantitative point-estimates Quantitative, probabilistic

26. Risk Evaluation (Preliminary Risk Management Activities) Risk Assessment? Scope & Purpose Alternate Management Strategy Appropriate & Feasible? NO Yes Establish Risk Assessment Policy

27. Risk 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

28. Risk Evaluation (Preliminary Risk Management Activities) Establish Risk Assessment Policy Commission the Risk Assessment

29. Commission Risk Assessment • Risk Manager assembles the risk assessment team • Definition and documentation of all background information relevant to the work, and expectations

30. Risk Evaluation (Preliminary Risk Management Activities) Establish Risk Assessment Policy Commission the Risk Assessment Conduct Risk Assessment

31. Risk assessor/manager interaction “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

32. Risk Evaluation (Preliminary Risk Management Activities) Establish Risk Assessment Policy Commission the Risk Assessment Conduct Risk Assessment Presentation of Results

33. Presentation 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

34. 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?”

35. Consideration 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

36. Consideration 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)

37. Consideration 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.

38. Risk Management Framework (Kiel, 2000) Identifynew issues Risk Assessment Use of risk model to help evaluate Risk Evaluation Monitoring & Review Option Assessment Implementation Cost-Benefit Analysis

39. Option Assessment • 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

40. Monitoring & Review Implementation • 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

41. Challenges at the International Level • More Players: Decision-makers

42. Challenges at the International Level • More Players: Stakeholders

43. Challenges at the International Level • 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

44. Challenges at the International Level • More Players, but also Opportunities for Harmonization, Cooperation and Collaboration

45. Future 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.