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. It should 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 risk assessment 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, when appropriate.
To support and promote the use of a risk analysis framework for initiating and conducting 'major' risk assessments, CFSAN should:
CFSAN Risk Analysis Working Group Members
Co-Chairs:Group Facilitator:
Working Group Members:
Working Group Meeting Organizers:
The CFSAN Risk Analysis Working Group thanks the following for their contributions to this effort:
Special thanks to Dr. Ensook Jhon for her expertise in collecting and evaluating various approaches to identifying priority 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 teams for freely sharing their experiences in conducting risk assessments and for reviewing and commenting on early drafts of this document.
The group also extends its appreciation to Susan Santos for her expertise in facilitating the working group meetings and helping us find common ground needed to develop a framework and for her thoughtful comments and suggestions to improve earlier drafts of this document.
This is a working document and it will be revised as needed, based on the continuing experience using these procedures for risk assessment in a risk analysis framework.
| Abbreviation/ Acronym | Definition |
|---|---|
| CFSAN | FDA's Center for Food Safety and Applied Nutrition |
| CAC | CFSAN's Cancer Assessment Committee |
| EOS | Executive Operations Staff, CFSAN |
| FDA | United States Food and Drug Administration |
| FSS | Food Safety Staff, CFSAN |
| JIFSAN | Joint Institute of Food Safety and Applied Nutrition |
| NACMCF | National Advisory Committee on Microbiological Criteria for Foods |
| NOAEL | No-Observed Adverse Effect Level |
| OARSA | Office of Applied Research and Safety Assessment, CFSAN/OSci |
| OCO | Office of Constituent Operations, CFSAN |
| OFP | Office of Field Programs, CFSAN |
| ONPLDS | Office of Nutritional Products, Labeling, and Dietary Supplements, CFSAN |
| OPDFB | Office of Plant, Dairy Foods, and Beverages, CFSAN |
| OMB | Office of Management and Budget |
| OSAS | Office of Scientific Analysis and Support, CFSAN |
| OSci | Office of Science, CFSAN |
| OS | Office of Seafood, CFSAN |
| SGE | Special Government Employee |
| SOP | Standard Operating Procedure |
| QMRA | Quantitative Microbial Risk Assessment |
| QRAC | CFSAN's Quantitative Risk Assessment Committee |
| RAC | Interagency Risk Assessment Consortium |
| US DHHS | United States Department of Health and Human Services |
| Term | Definition |
|---|---|
| Conceptual model: | A visual presentation of the proposed structure of the risk assessment model showing data needs, model outputs, and logical 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 an effect. |
| 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 in ascending 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 of times. |
| Major risk assessment: | A risk assessments that is non-routine and complex; that may be qualitative or quantitative; that involves multiple CFSAN program offices and is generally cross cutting in nature; and requires a commitment of significant resources to complete. |
| Modeling (mathematical): | A representation of aspects of the behavior of a system by creating an approximate (mathematical) description based on 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 the use of a computer. May be used to integrate variability in the predicted results for a population or the uncertainty of a predicted 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 or observations 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. The process 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. Includes individuals 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 the adverse 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 identified hazard. |
| Risk Management: | The process of weighing policy alternatives in light of results or risk assessment, and, if required, selecting and implementing 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. |
A working group was formed at the request of the Center for Food Safety and Applied Nutrition (CFSAN) senior management to examine lessons learned from conducting quantitative risk assessments. Dr. Susan Santos, FOCUS GROUP Risk Communication and 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 assessments conducted 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.
The CFSAN Risk Analysis Working Group discussed and developed proposals for each of these tasks. Most importantly, the group supported the concept that CFSAN's risk assessments should be conducted within a risk analysis framework and developed a list of guiding principles (see below). Specific recommendations for implementing this framework were proposed including: a decision-based approach for selecting risk assessments; a step-by-step procedure for conducting the risk assessment; development of criteria to evaluate the quality of data; development of guidelines to evaluate risk assessments; formalizing a process for review of assessments, and building capacity to conduct risk assessments. These recommendations are provided on page ii.
This document provides a systematic overview of the procedures needed to initiate and conduct risk assessments within a risk analysis framework. Part I of this document is a description of the CFSAN risk analysis framework, including roles and responsibilities of participants. In Part II, the proposed decision-based approach to identify and select risk assessments 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 of this framework is discussed in Part IV.
The specific roles and responsibilities of risk managers and risk communicators as they relate to risk assessment activities are also described in this document. However, other risk analysis activities of the risk management and risk communication that are conducted independent of the risk assessment are not within the scope of this document. For example, it was not the intent of this document to explain how risk managers develop an action plan to evaluate and 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's expectation that the developed procedures should be used by the Center for all hazards, including chemical. However, it was 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
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 this framework, project goals are accomplished through the efforts of risk assessment, risk management, and risk communication teams.
Risk assessment of complex topics should be conducted in an iterative manner that allows refinement of the risk assessment question(s), key assumptions, and data used in the model. An iterative process requires active participation 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, risk management, 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 and communication should occur frequently with them during the assessment.
Risk assessments conducted by CFSAN should be identified and selected using a decision-based approach that considers the appropriate use of the Center's resources to provide the best scientific analysis to solve high priority public health problems.
Resources needed to effectively and efficiently conduct risk assessments must be identified and allocated prior to commissioning the assessment.
Realistic timeframes with intermediate milestones must be established and agreed to by all participants when the 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 information needed to make decisions.
The risk assessment process must be transparent. All assumptions, data, and decisions that impact the risk assessment conclusions and risk management actions must be clearly documented and shared with interested parties.
Draft risk assessment documents and models must undergo peer review by government and non-government experts using a process that allows for extensive evaluation and critical review of the assessment.