#### U. S. Food and Drug AdministrationCenter for Food Safety and Applied NutritionMarch 2002

# Initiation and Conduct ofAll 'Major' Risk Assessmentswithin a Risk Analysis Framework

## A Report by the CFSAN Risk Analysis Working Group

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### Table of Contents

- Recommendations
- Contributors
- Acknowledgments
- Abbreviations and Acronyms
- Glossary
- Table of Contents
- Background
- Part I: Overview of the CFSAN Risk Analysis Framework    - What is Risk Analysis?
  - Characteristics of CFSAN's Risk Assessments
  - Risk Analysis Teams
  - Risk Analysis Activities
- Part II. A Decision-Based Approach to Identify and Select RiskAssessments    - When is a Risk Assessment Needed?
  - What Type of Risk Assessment is Needed?
  - Who Coordinates the Identification and Selection Process?
  - How Are Candidate Risk Assessments Identified?
  - Four Phases of the Identification and Selection Process       - Phase 1. Concept Generation
    - Phase 2. Problem Identification
    - Phase 3. Data Feasibility Determination (Evaluation and Recommendation)
    - Phase 4. Disposition (Selection)  **Part III. Conducting Risk Assessment within the Risk Analysis Framework**- Step 1. Planning the Risk Assessment     - Identify Participants/Form Teams
  - Define Scope and Develop Charge
  - Allocate Resources
  - Develop Timeline and Milestones
  - Determine Communication Needs  
  - Step 2. Perform the Risk Assessment       - Clarify scope of the risk assessment
    - Collect/Assemble Data and Information
    - Develop and Validate Model
    - Prepare the Draft Document(s)  
    - Step 3. Reviewing the Risk Assessment Documents
    - Step 4. Issuing the Risk Assessment Documents         - Develop and Implement Roll-out Plan
      - Public Dockets
      - Issue Final Report
      - Follow up or Debriefing  **Part IV: Conclusions, Recommendations, and Next Steps**- Conclusions
- Recommendations and Next Steps  
- Appendix A: Components of a Risk Assessment
- Appendix B: Example Questions: Communication Between the Risk Managersand Risk Assessors
- Appendix C: Risk Communication Activities
- Appendix D: Criteria for Identifying Candidate RiskAssessments
- Appendix E: Criteria for Evaluating Technical Feasibility
Recommendations
The CFSAN Risk Analysis Working Group recommends the following:

**Risk analysis is a powerful tool** that should be used to enhance the scientific basis of regulatory decisions. Itshould be conducted within CFSAN through the efforts of risk assessment, risk management, and risk communication**teams**. Risk assessment should be conducted in an **iterative manner** that allows refinement of the riskassessment question(s), key assumptions, and data used in the model. The exchange of information (**communication**)within and between the risk analysis teams, with other agencies, and stakeholders (including industry, consumer groups,and other interested parties) should be encouraged by **active participation** in the process and collaboration, whenappropriate.

To support and promote the use of a risk analysis framework for initiating and conducting 'major' risk assessments, CFSANshould:
- Adopt a decision-based approach to identify and select risk assessments  conducted by CFSAN, particularly thosethat are 'major' (complex and impact or involve multiple offices). Available resources, regulatory needs, and publichealth concerns should be considered in the selection of risk assessments. This approach should be implemented formicrobial risk assessments now, and later expanded to include chemical and other non-microbial hazards. 
- Establish a procedure  for the conduct of risk assessment within a risk analysis framework. The procedureshould identify the boundaries and responsibilities of key participants in the risk analysis process. 
- Develop criteria to evaluate the quality of data  used for risk assessments and  specify what information isneeded  to scientifically evaluate the usefulness of a study or data set used for risk assessment. 
- Develop guidelines to evaluate  risk assessments and supporting data developed by stakeholders and submitted tothe Center. 
- Formalize a peer review process  that will encourage critical review and evaluation of CFSAN's riskassessments by government and non-government experts in a manner that improves the science and acceptance of complex riskassessments. 
- Build capacity  to conduct complex risk assessments by providing training opportunities for current staff,hiring new staff or using contractors (as needed), and acquiring additional resources such as computers, software, anddedicated workspace. 
Contributors
**CFSAN Risk Analysis Working Group Members**
**Co-Chairs**:- Robert Buchanan, Senior Science Advisor, Director Office of Science Janice F. Oliver, Deputy Director CFSAN
**Group Facilitator**:
- Susan Santos, FOCUS GROUP Risk Communication and Environmental Management Consultants  **Working Group Members**:    - Philip Bolger, OPDFB
  - Karen Carson, OPDFB
  - Marjorie Davidson, FSS
  - Sherri Dennis, OSci
  - Patricia Hansen, OSci
  - Kathy Gombas, OFP
  - Donald Kraemer, OS
  - John Kvenberg, OFP
  - Wesley Long, OSci
  - Marianne Miliotis, OARSA
  - Arthur Miller, OSci
  - Patricia Schwartz, OS
  - Philip Spiller, OS
  - Terry Troxell, OPDFB
  - Richard Whiting, OPDFB
  - Richard Williams, OSAS **Working Group Meeting Organizers**:    - Catherine DeRoever, OSci
  - Linda Hayden, OSci
  - Carloyn Jeletic, OSci      Acknowledgments  In the development of a risk analysis framework for the initiation and conduct of risk assessments, we evaluated andadopted concepts and processes that have been described by others. As appropriate, the principles of risk analysisdeveloped by other federal agencies and international organizations were adapted to be compatible  t to the specificrequirements for CFSAN. The CFSAN Risk Analysis Working Group thanks the following for their contributions to this effort:    - Catherine Bailey, EOS
  - Mary Bender, ONPLDS
  - John Bowers, OSAS
  - Donald Burr, OARSA
  - Richard Canady, OPDFB
  - Clark Carrington, OPDFB
  - Anthony Hitchins, OPDFB
  - Jennifer Cleveland, visiting scientist from Rutgers University
  - Ensook Jhon, visiting scientist from the Korea Food and Drug Administration
  - Clark Nardinelli, OSAS
  - Richard Raybourne, OARSA
  - Marianne Ross, OSAS
  - Mark Walderhaug, OPDFB  Special thanks to Dr. Ensook Jhon for her expertise in collecting and evaluating various approaches to identifyingpriority risk assessments and assisting in the development of the decision-based approach described in this document. We are especially grateful to the *Listeria monocytogenes* and *Vibrio parahaemolyticus* risk assessment teamsfor freely sharing their experiences in conducting risk assessments and for reviewing and commenting on early drafts ofthis document. The group also extends its appreciation to Susan Santos for her expertise in facilitating the working group meetings andhelping us find common ground needed to develop a framework and for her thoughtful comments and suggestions to improveearlier drafts of this document. This is a working document and it will be revised as needed, based on the continuing experience using these procedures forrisk assessment in a risk analysis framework.      Abbreviations and Acronyms  Abbreviation/ AcronymDefinitionCFSANFDA's Center for Food Safety and Applied NutritionCACCFSAN's Cancer Assessment CommitteeEOSExecutive Operations Staff, CFSANFDAUnited States Food and Drug AdministrationFSSFood Safety Staff, CFSANJIFSANJoint Institute of Food Safety and Applied NutritionNACMCFNational Advisory Committee on Microbiological Criteria for FoodsNOAELNo-Observed Adverse Effect LevelOARSAOffice of Applied Research and Safety Assessment, CFSAN/OSciOCOOffice of Constituent Operations, CFSANOFPOffice of Field Programs, CFSANONPLDSOffice of Nutritional Products, Labeling, and Dietary Supplements, CFSANOPDFBOffice of Plant, Dairy Foods, and Beverages, CFSANOMBOffice of Management and BudgetOSASOffice of Scientific Analysis and Support, CFSANOSciOffice of Science, CFSANOSOffice of Seafood, CFSANSGESpecial Government EmployeeSOPStandard Operating ProcedureQMRAQuantitative Microbial Risk AssessmentQRACCFSAN's Quantitative Risk Assessment CommitteeRACInteragency Risk Assessment ConsortiumUS DHHSUnited States Department of Health and Human Services        Glossary  TermDefinitionConceptual model:A visual presentation of the proposed structure of the risk assessment model showing data needs, model outputs, andlogical flow of the calculations.Distribution:A series of values or a mathematical equation describing a series of values.Dose:The amount of a toxic component or the number of a pathogen that is ingested or interacts with an organism(host).Dose-response assessment:The determination of the relationship between the magnitude of exposure and the magnitude and/or frequency of aneffect.Empirical distribution:A representation of observed values or data of a series or population.Exposure assessment:A component of a risk assessment that characterizes the source and magnitude of human exposure to the hazard.Foodborne pathogen:A microorganism (bacteria, virus, protozoa) that is capable of causing disease and is transmitted by food.Frequency distribution:A distribution describing the rate or frequency of occurrence of a value in a series or population arranged inascending or descending order.Hazard:Biological, chemical or physical agents with the potential to cause an adverse health effect.Hazard identification:The identification of known or potential health effects associated with a particular agent.Hazard characterization:The qualitative or quantitative evaluation of the nature of the adverse effects associated with biological, chemical,and physical agents.Iteration:One computational cycle of a set of instructions (e.g., formula, algorithm) that is repeated a specified number oftimes.Major risk assessment:A risk assessments that is non-routine and complex; that may be qualitative or quantitative; that involves multipleCFSAN program offices and is generally cross cutting in nature; and requires a commitment of significant resources tocomplete.Modeling (mathematical):A representation of aspects of the behavior of a system by creating an approximate (mathematical) description basedon theory or phenomenon that accounts for its known or inferred properties.Model validation:The process by which the model is evaluated by comparing a model prediction with empirical data.Monte-Carlo Simulation:A process for making repeated calculations with minor variations of the same mathematical equation, usually with theuse of a computer. May be used to integrate variability in the predicted results for a population or the uncertainty of apredicted result. A two-dimensional Monte Carlo simulation may be used to do both.Probability:The subjective assignment of likelihood of future events; or the frequency of occurrence of an experimental orobservations outcome. It refers to the uncertainty or partial knowledge associated with decision making.Risk:The likelihood of the occurrence and the magnitude of the consequences of exposure to a hazard on human health.Risk Analysis:The process consisting of three components: risk assessment, risk management, and risk communication.Risk Assessment:The scientific evaluation of known or potential adverse health effects resulting from human exposure to hazards. Theprocess consists of the following steps: hazard identification, exposure assessment, hazard characterization(dose-response), and risk characterization.Risk Assessor:Member of team of interdisciplinary group of professionals, responsible for conducting the risk assessment. Includesindividuals knowledgeable and experienced in the risk assessment process, provides specific technical expertise,mathematical modeler.Risk Characterization:Integration of hazard identification, hazard characterization and exposure assessment into an estimation of theadverse effects likely to occur in a given population, including attendant uncertainties.Risk Communication:The interactive exchange of information and opinions concerning risk and risk management among risk assessors,managers, consumers, industry, and other interested parties.Risk Manager:A decision maker; individuals or group responsible for taking actions to control, reduce, or mitigate an identifiedhazard.Risk Management:The process of weighing policy alternatives in light of results or risk assessment, and, if required, selecting andimplementing appropriate control options, including regulatory measures.Uncertainty:An expression of the lack of knowledge, usually given as a range or group of plausible alternatives.Variability:A description of differences among the individual members of a series or population.Validation:A process by which a simulation model is evaluated for its accuracy in representing a system.          Background  Charter: CFSAN's Risk Analysis Working Group . A working group was formed at the request of the Center for Food Safety and Applied Nutrition (CFSAN) senior management toexamine lessons learned from conducting quantitative risk assessments. Dr. Susan Santos, FOCUS GROUP Risk Communicationand Environmental Management Consultants, facilitated the work and direction of this group. The overall goal of the CFSAN Risk Analysis Working Group was to improve the quality and consistency of risk assessmentsconducted within the Center. Specific tasks of the working group were as follows.    - Identify boundaries and responsibilities of key participants in the risk analysis process.
  - Develop a process for identifying and selecting risk assessments conducted within the Center.
  - Establish procedures for the conduct of risk assessments within a risk analysis framework.  The CFSAN Risk Analysis Working Group discussed and developed proposals for each of these tasks. Most importantly, thegroup supported the concept that CFSAN's risk assessments should be conducted within a risk analysis framework anddeveloped a list of guiding principles (see below). Specific recommendations for implementing this framework were proposedincluding:  a decision-based approach for selecting risk assessments; a step-by-step procedure for conducting the riskassessment; development of criteria to evaluate the quality of data; development of guidelines to evaluate riskassessments; formalizing a process for review of assessments, and building capacity to conduct risk assessments. Theserecommendations are provided on page ii. This document provides a systematic overview of the procedures needed to initiate and conduct risk assessments within arisk analysis framework. Part I of this document is a description of the CFSAN risk analysis framework, including rolesand responsibilities of participants. In Part II, the proposed decision-based approach to identify and select riskassessments to be conducted by CFSAN is described in detail. Procedures and activities needed to plan, perform, review,and issue/ publish risk assessments within the risk analysis framework are described in Part III. The implementation ofthis framework is discussed in Part IV. The specific roles and responsibilities of risk managers and risk communicators as they relate to risk assessmentactivities are also described in this document. However, other risk analysis activities of the risk management and riskcommunication that are conducted independent of the risk assessment are not within the scope of this document. Forexample, it was not the intent of this document to explain how risk managers develop an action plan to evaluateand propose changes needed to implement or redirect the Center's current regulatory strategies. While the Risk Analysis Working Group specifically wanted to build on the lessons learned during the conduct of the*Listeria monocytogenes*, *Vibrio parahaemolyticus*, and methyl mercury risk assessments it was the group'sexpectation that the developed procedures should be used by the Center for all hazards, including chemical. However, itwas felt that this process was generally only necessary for 'major' risk assessments. **What are 'Major' Risk Assessments?** As defined by CFSAN's Risk Analysis Working Group, all 'major' risk assessments include those that are:    - non-routine and complex;
  - may be qualitative or quantitative;
  - involve multiple program offices and are cross-cutting in nature; and
  - require a commitment of significant resources to complete.  This definition of 'major' risk assessments would  not  include a variety of routine safety/risk assessments, suchas those currently conducted for food additives or botanicals because these are generally conducted within or for a singleCFSAN office. It would also  not  include activities the CFSAN Cancer Assessment Committee (CAC) and the QuantitativeRisk Assessment Committee (QRAC). The activities of these standing committees are described in their charter and standardoperating practices (SOP) documents. The following guiding principles were developed based on the discussions during the work group meetings.    **Guiding Principles--Risk Assessment within a Risk Analysis Framework**- Risk analysis is a valuable tool for CFSAN to use to **enhance the scientific basis** of regulatory decisions.All 'major' risk assessments conducted by CFSAN should be performed within the **risk analysis framework**. Using thisframework, project goals are accomplished through the efforts of risk assessment, risk management, and risk communicationteams.
- Risk assessment of complex topics should be **conducted in an iterative manner** that allows refinement of therisk assessment question(s), key assumptions, and data used in the model. An iterative process requires activeparticipation and collaboration among the various risk analysis teams and with other interested parties.
- **An open exchange of information and ideas (communication)** within and among the risk assessment, riskmanagement, and risk communication teams is critical for successful conduct of risk assessment projects. As such,stakeholders including consumer groups, industry, and other agencies should be identified early in the process andcommunication should occur frequently with them during the assessment.
- Risk assessments conducted by CFSAN should be **identified and selected using a decision-based approach** thatconsiders the appropriate use of the Center's resources to provide the best scientific analysis to solve high prioritypublic health problems.
- **Resources** needed to effectively and efficiently conduct risk assessments must be identified and allocatedprior to commissioning the assessment.
- Realistic **timeframes** with intermediate milestones must be established and agreed to by all participants whenthe risk assessment is commissioned. Timeframes must consider the iterative nature of risk assessments.
- The risk assessment should be as **simple** as possible while providing risk managers with the informationneeded to make decisions.
- The risk assessment process must be **transparent**. All assumptions, data, and decisions that impact the riskassessment conclusions and risk management actions must be clearly documented and shared with interestedparties.
- Draft risk assessment documents and models must undergo **peer review** by government and non-government expertsusing a process that allows for extensive evaluation and critical review of the assessment.
- The Center must continue to  build capacity  to conduct risk assessments through research, training, hiring, andother means such as using contractors.
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