An International Framework for the Interaction Between Assessors and Managers of Microbiological Hazards Anna M. Lammerding Health Canada 1 st International.

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

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)

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)

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

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

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.

BackgroundBackground

Additional Challenge

Long-distance relationship among the RA drafting group members …

… work carried out in addition to daily load!

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

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

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

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

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

Risk Management Framework Risk Management Framework (Kiel, 2000)(Kiel, 2000)

Risk Evaluation

Implementation

Option Assessment

Monitoring & Review

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

Risk Evaluation(Preliminary Risk Management Activities)

Food Safety IssueIdentification

Risk Profile

Management Decision

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

Risk Evaluation(Preliminary Risk Management Activities)

Risk Assessment?

Scope & Purpose

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

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

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

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

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”

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.?

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

Risk Evaluation(Preliminary Risk Management Activities)

Risk Assessment?

Scope & Purpose

Appropriate & Feasible?NO

Alternate Management

Strategy

Establish Risk Assessment Policy

Yes

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

Risk Evaluation(Preliminary Risk Management Activities)

Commission the Risk Assessment

Establish Risk Assessment Policy

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

Risk Evaluation(Preliminary Risk Management Activities)

Commission the Risk Assessment

Establish Risk Assessment Policy

Conduct Risk Assessment

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

Risk Evaluation(Preliminary Risk Management Activities)

Commission the Risk Assessment

Establish Risk Assessment Policy

Conduct Risk Assessment

Presentation of Results

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

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?”

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

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)

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.

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

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

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

Challenges at the International Challenges at the International LevelLevel

More Players: Decision-makers

Challenges at the International Challenges at the International LevelLevel

More Players: Stakeholders

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

Challenges at the International Challenges at the International LevelLevel

More Players, but also Opportunities for Harmonization, Cooperation and Collaboration

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.