Interactions Between Risk Assessors and Risk Managers Robert L. - - PowerPoint PPT Presentation

▶

Mar 27, 2023 32 likes •144 views

Interactions Between Risk Assessors and Risk Managers Robert L. Buchanan Richard C. Whiting Center for Food Safety and Applied Nutrition Food and Drug Administration Risk Analysis Traditionally described as being comprised of three

SLIDE 1

Interactions Between Risk Assessors and Risk Managers

Robert L. Buchanan Richard C. Whiting

Center for Food Safety and Applied Nutrition Food and Drug Administration

SLIDE 2

Risk Analysis

Traditionally described as being comprised of three components: Risk management Risk assessment Risk communication

Risk Management Risk Communication Risk Assessment

SLIDE 3

Framework for Risk Management

Engage Stakeholders Problem/ Context Decisions Evaluation Options/ Mitigations Actions Risks

SLIDE 4

A Four Phase Selection Process for Risk Assessment

Concept Generation Concept Generation Problem Formulation Problem Formulation Feasibility Determination Feasibility Determination

Risk Profile Risk Profile

Decision to proceed Decision to proceed

Under direction of Risk Managers

SLIDE 5

Risk Analysis Working Groups

Policy and risk management team Risk communication team Risk assessment team

Project leader Scientists (Microbiologist and food technologist/engineer Modelers & risk assessors

Risk manager

SLIDE 6

Risk Manager

Liaison between RA, RM and RC Schedules meetings, sets time lines Handles personnel, budget Oversees clerical, word processing Supervises auditors, proof readers Manages advisory groups, reviewers, public meetings, press releases, public availability of documents Provides time for RA team to work

SLIDE 7

Risk Management

Policy makers:

Responsible for setting the objectives of the risk assessment, overall scope, key parameters, questions to be answered by risk assessment Assign people, time, budget

SLIDE 8

Risk Assessors

Must be responsive to the needs of the risk management Describe how assumptions affect the assessment and uncertainty associated with the results Make technical decisions on data analysis, interpretation and modeling Explain limitations of the data on the results of the risk assessment to non-risk assessors

SLIDE 9

RM and RA Interactions

Example from Listeria Risk Assessment

RM—One population group should be elderly RA—Best data from CDC groups data at ≥ 60 yr. Is this OK? RM—We’d prefer elderly to be ≥ 65 yr RA—Someone will go to Atlanta for 2 weeks to work through CDC files, $, probably not great difference between 60 and 65 yr old. RM—Use 60 as the criteria for elderly.

SLIDE 10

RM and RA Interactions

Example from Listeria Risk Assessment

Heat-treated natural & Processed cheese Hard Cheese < 39% moisture Heat-treated natural & Processed cheese Semi-soft cheese 39-50% moisture Aged cheese Soft Ripened Cheese > 50% moisture Goat, sheep and feta cheese Soft Unripened Cheese > 50% moisture Soft mold-ripened & Blue-veined cheese Fresh Soft Cheese Fresh Soft Cheese

2003 Cheeses 2001

SLIDE 11

Conclusions

Need constant communication:

RA should go through each step with RM and describe data and how they will interpret and model the data RM make decisions on objectives and scope RA make decisions on data handling, modeling and output RM and RA must respect the line between them to have an unbiased risk assessment