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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
(Why can’t risk assessors speak English?) Modeling Explaining uncertainty vs. variability
Lack of understanding of risk assessment techniques (Why are risk managers so dense?)
Getting risk managers to pay attention early
The BumpsThe Bumps Presenting the results
Interpretation Transparency Plain language (Who rights the report?) Dealing with unexpected results
Review of risk assessments Impact on risk management programs Protecting the risk assessors against
outside pressure
Risk Analysis Working Risk Analysis Working GroupGroup Senior managers Risk managers Risk assessors
Scientists “Modelers” Project leaders
Risk Communicators Facilitator
Risk Analysis Working Risk Analysis Working GroupGroupOverall Goal:Overall Goal:
To improve the quality and consistency of “major” risk assessments conducted by the Center for Food Safety and Applied Nutrition
What Are ‘Major’ Risk What Are ‘Major’ Risk Assessments?Assessments?
Non-routine, complex, and/or quantitative
Involve multiple program offices and/or cross-cutting in nature
Require a commitment of significant resources to complete
Risk Analysis Working Risk Analysis Working GroupGroup
Specific Tasks:Specific Tasks:1) Identify boundaries and
responsibilities of key participants in the risk analysis process
2) Develop a process for identifying and selecting risk assessments conducted by CFSAN
3) Establish procedures for the conduct of risk assessment within a risk analysis framework
Risk Analysis – The TheoryRisk Analysis – The Theory
Traditional definition: risk analysis is composed of : Risk Risk
ManagementManagement Risk Risk
AssessmentAssessment Risk Risk
CommunicatioCommunicationn
Risk Management
Risk Communication
Risk Assessment
Risk Analysis – The Risk Analysis – The RealityReality In CFSAN risk
analysis is a “stew” of : Center
Management Risk
Management Risk Assessment Risk
Communication Research Etc
Risk
MgmtRisk
Communi-cation
Risk Assess- ment
Research
CFSAN
Mgmt
FDA
Mgnt
FDA
GC
Procedures to Initiate and Procedures to Initiate and Conduct Risk AssessmentsConduct Risk Assessments
INITIATE:INITIATE: A decision-based approach to identify and select all ‘major’ risk assessments Four phase process: concept
generation, problem identification, data feasibility evaluation, disposition
CONDUCT:CONDUCT: A systematic and iterative approach to conducting risk assessments Four step process: Plan, Perform,
Review, Publish
The Identification and The Identification and Selection ProcessSelection Process
Selection of Major Risk Selection of Major Risk AssessmentsAssessments
Select major risk assessments on basis of
Center’s risk management Center’s risk management needsneeds
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)
Selection ProcessSelection Process
Concept Generation
Problem Formulation
Feasibility Feasibility DeterminationDeterminationDisposition (selection)
Review literature to determine availability of data needed to conduct RA to answer RM questions
Recommend action:More research neededModify RM questionQualitative RA vs. Quantitative RA
Selection ProcessSelection Process
Concept Generation
Problem Formulation
Feasibility DeterminationDisposition (selection)Disposition (selection)
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
Step 1: PlanningStep 1: Planning Define scope Identify resource needs Assign teams Develop timelines
Conducting the Risk Conducting the Risk AssessmentAssessment
Step 2: PerformStep 2: Perform Answer risk management
questions
Receive Charge from Risk Managers
Receive Assumptions from RMRefine Assumptions for modeling
Assemble data/model inputsVerify data/model inputs
Develop modelAudit model
Run model/iterations
Review results
New data
Draft Report
Conduct sensitivity analysis
Conducting the Risk Conducting the Risk AssessmentAssessment
Step 3:Step 3:Review – ongoing process
Advisory CommitteesPeer Review SGE PanelsPublic Comment
ApproveClear
Technical and Scientific Reviews of Technical and Scientific Reviews of the Draft Risk Assessment the Draft Risk Assessment
DocumentsDocuments
Final D ocum ent
D raft D ocum ents for Public C om m entFederal R egister N otice
D ocum ents Available on FD A/C FSAN W ebsitePublic M eeting
Internal and External R eviewD ata and Assum ptions
D raft D ocum entM odel
Request for Data and In form ationFederal R egister N otice
Public M eetingsAdvisory C om m ittee (N AC M C F)
Conducting the Risk Conducting the Risk AssessmentAssessment
Step 4: PublishStep 4: PublishDevelop “roll out” strategyPublic release of documentsHandling commentsPublic comment
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