Lessons Learned in Initiating Lessons Learned in Initiating and Conducting Risk Assessments and Conducting Risk Assessments within a Risk Analysis within a Risk Analysis Framework: A FDA/CFSAN Approach Framework: A FDA/CFSAN Approach Robert Buchanan DHHS Food and Drug Administration Center for Food Safety and Applied Nutrition
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Lessons Learned in Initiating and Conducting Risk Assessments within a Risk Analysis Framework: A FDA/CFSAN Approach Robert Buchanan DHHS Food and Drug.
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Lessons Learned in Initiating Lessons Learned in Initiating and Conducting Risk and Conducting Risk
Assessments within a Risk Assessments within a Risk Analysis Framework: A Analysis Framework: A FDA/CFSAN ApproachFDA/CFSAN Approach
Robert BuchananDHHS Food and Drug AdministrationCenter for Food Safety and Applied
Nutrition
PerspectivePerspective
Risk Assessor vs. Risk Manager
Risk Manager vs. Risk Assessor
The ParadoxThe Paradox
Codex Alimentarius “Principles and Guidelines for the Conduct of Microbial Risk Assessments” Principle #2: There should be a Principle #2: There should be a
functional separation between risk functional separation between risk assessment and risk managementassessment and risk management
Important principle that doesn’t work if you achieve it
Setting the StageSetting the Stage
Experience:Experience: conducted two large quantitative microbial risk assessments Vibrio parahaemolyticus Listeria monocytogenes
Learning:Learning: address the “bumps” encountered to discuss lessons learned to develop a risk analysis framework
for future major risk assessments
The BumpsThe Bumps Resource intensive Setting time frames and
establishing deadlines Establishing why risk assessment is
being done Establishing expectations
What a risk assessment can do? Establishing boundaries
Who is in charge? Who gets to decide? Who settles conflicts?
The BumpsThe Bumps Communicating with risk managers
Center’s resourcesCenter’s resources Data feasibilityData feasibility
Personal ObservationPersonal Observation
If science is complex, there is no consensus among stakeholders, and there are multiples ways of managing the risk – consider a quantitative risk assessment
If science is straight forward, there is general consensus among stakeholders, and there is only one risk management option – do not conduct a quantitative risk assessment
Where do risk Where do risk assessment ideas come assessment ideas come from?from?
Stakeholders (public)
Follow up to completed risk assessment
Regulatory staff Management Researchers Other agencies
A Four Phase A Four Phase Selection ProcessSelection Process
Phase 1:Phase 1: Concept Concept
GenerationGeneration
Phase 2:Phase 2: Problem Problem
FormulationFormulation
Phase 3:Phase 3: Feasibility Feasibility
DeterminationDetermination
Phase 4:Phase 4: Disposition Disposition
Selection ProcessSelection Process
Concept GenerationConcept Generation
Problem Formulation
Feasibility DeterminationDisposition (selection)
Identify and maintain list of potential RM questions for which a RA would assist with policy decisionsIdentify hazards/commodities State the RM question(s)State the RA question(s)
Selection ProcessSelection Process
Concept Generation
Problem FormulationProblem Formulation
Feasibility DeterminationDisposition (selection)
Management reviews list and approves specific RAs for further evaluation (feasibility determination)
Using the results of the feasibility determination as an aid, management selects RAs to be conducted based on technical merit, resource availability, and other factors and get commitment of resources
Conducting the Risk Conducting the Risk AssessmentAssessment
Conducting the Risk Conducting the Risk AssessmentAssessment
A four step process: Step 1: Plan
Step 2: Perform
Step 3: Review
Step 4: Publish
Conducting the Risk Conducting the Risk AssessmentAssessment
Organization of Risk Organization of Risk AnalysisAnalysis Risk analysis should be
conducted by teams: Risk Management TeamRisk Management Team Risk Assessment TeamRisk Assessment Team Risk Communication TeamRisk Communication Team
Meet regularly to discussion process and surface issues
Organization of Risk Organization of Risk AnalysisAnalysis Established three unique Established three unique
positions to help with positions to help with consistency, coordination, and consistency, coordination, and making decisions making decisions Science Advisor for Risk Analysis Risk Analysis Coordinator Risk Assessment Project Manager
Summary of Recommendations Summary of Recommendations ImplementedImplemented
Decision-based approach to identify and select all ‘major’ risk assessments
Procedure for the conduct of risk assessment within risk analysis framework
Established new organizational structure
Summary of Recommendations Summary of Recommendations ImplementedImplemented
Criteria to evaluate data quality Procedures for the approval and
release of risk assessments Formal peer review process Enhance capabilities to conduct
risk assessments and interaction between chemical and microbiological risk assessments
Report AvailableReport Available
“Initiation and Conduct of All ‘Major’ Risk Assessments within a Risk Analysis Framework”
Available on FDA website: http//:www.cfsan.fda.gov/~dms/http//:www.cfsan.fda.gov/~dms/
rafw-toc.htmlrafw-toc.html
New TwistsNew Twists
OMB Guidelines on Data Quality
Court decisions of status risk assessment when used as part of a regulatory activity
Security issues when risk assessment used for food security activities