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3 Adopting a Risk-Based Decision-Making Approach to Food Safety
Pages 75-120

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From page 75...
... The former responsibility requires rapid decision making in cooperation with multiple regulatory partners, while the latter requires long-term strategic planning aimed at proactive activities that are based on data and risk-based prediction and prioritization. For example, the FDA's responsibility during a foodborne illness outbreak would focus on identification of the source of contamination (product trace-back)
From page 76...
... . Similarly, effective cooperation and communication with diverse stakeholders will require that all levels of the FDA embrace a proactive, risk-based approach to food safety management and facilitate its implementation (Chapter 9)
From page 77...
... 7) These previous documents go beyond the scope of traditional technical risk assessment by introducing such terms as "risk-based resource allocation" and "relative risk and benefit." In its deliberations, the committee recognized the need to address risk analysis in the broader context of regu 1 See http://www.rff.org/rff/Documents/RFF-IB-02-02.pdf (accessed January 25, 2010)
From page 78...
... The challenges and best practices for integrating science to support effective risk management decisions are widely recognized, as summarized by a recent NRC study (NRC, 2009a) : The most effective decision support efforts are organized around six prin ciples: begin with users' needs; give priority to processes over products; link information producers and users; build connections across disciplines and organizations; seek institutional stability; and design processes for learning.
From page 79...
... These attributes are further described in Box 3-1. A Conceptual Approach to Risk-Based Food Safety Management The risk-based system envisioned by the committee will entail analysis and prioritization at several distinct levels: • the formulation of a strategic plan that identifies outcomes/goals of the risk-based system, • broad-based risk ranking to identify the most important risks based exclusively on public health considerations, • the identification of additional data/information needs upon which prioritization of resources may be based, • the choice of intervention strategies and allocation of regulatory resources, and • the evaluation of outcomes.
From page 80...
... A risk-based system employs analytical methods to rank risks based on public health impact. A risk-based system systematically ranks risks even if those risks differ in complexity and uncertainty.
From page 81...
... These considerations should be formally communicated to stakeholders. A risk-based system employs measures to evaluate the efficacy of the risk management program on a continuous basis.
From page 82...
... Step 1: Strategic Planning Step 2: • Identify Public Health Step 6: Public Health Risk Ranking Objectives Monitoring and R eview • Establish a Risk Management Plan • Develop or Select Tools for • Collect and Analyze Data on Public Health Risk Ranking • Establish Metrics to Measure Evaluation Measures Performance • Rank Risks Based on Public • Inter pret Data and Evaluate Health Outcomes Intervention Results • Report Results and Solicit • Deter mine Whether Public Feedback Health Objectives Are Being Met • Communicate the Results to Stakeholders • Review and Refine the Process as Necessary to Step 3: Accomplish Inter mediate Target ed Informat ion Outcomes and Public Health Gathering and Consideration Objectives so as to Achieve of Ot her Fact ors Continuous Improvement • Identify and Cons ider Additio nal Criteria for Decision Making Step 4: • Conduct Targeted Analysis and Select ion of Information Gathering Intervention(s) Step 5: • Identify Priority Risks for Design of an Intervention (Instrument)
From page 83...
... for public health risk ranking in consultation with stakeholders.
From page 84...
... Further Description of the Proposed Approach to Risk-Based Food Safety Management Step : Strategic Planning Strategic planning, conducted at several different levels, is an essential element of a successful food safety program. The highest level of strategic planning involves the identification of long-term and broadly stated goals for protecting public health from the threats associated with food contaminants, sometimes referred to as public health objectives.
From page 85...
... Improve food-employee food prepara tion practices that directly relate to foodborne illnesses in retail food establishments. Objectives Retained but Modified from Healthy People 2010 FS HP2020–3: Reduce infections caused by key pathogens commonly transmitted through food.
From page 86...
... Step : Public Health Risk Ranking (Ranking of Hazards) The first step in support of the strategic plan is to identify which risks constitute the greatest threat to public health and hence should be a priority
From page 87...
... Public health risk ranking is a formalized process that involves comparing the relative risk of multiple hazards, including foods, with the purpose of aiding in the establishment of risk management priorities, the allocation of resources, and the identification of critical data and research needs (CAST, 2006; Havelaar et al., 2006; Mangen et al., 2009)
From page 88...
... Food Safety Systematic ranking of food Risk score calculated Ontario Universe safety risks in three dimensions: multiplicatively as Ministry of Database food, hazard, and location in a product of six Agriculture chain. Establishes two "axes" subscores.
From page 89...
... The overall role of foodborne illness attribution in a risk-based food safety management system is discussed further at the end of this chapter. The alternative or "bottom-up" approach to public health risk ranking adheres roughly to the standard microbial risk assessment paradigm and follows the agent through the food chain to produce a prediction of risk to human health relative to other agents and/or foods.
From page 90...
... Risk prioritization, an emerging approach in the food safety arena, uses the combined tools of risk assessment and decision analysis to determine the importance of one risk relative to another. Unlike risk ranking, which the committee has defined as a type of risk assessment exercise, risk prioritization is inherently a risk management tool.
From page 91...
... In economic and policy analysis, the term "instrument" is used to describe the means a government has at its disposal to achieve public policy outcomes -- to govern. Instrument types that are often used include laws, economic incentives, self-regulation, standards, contracts, and information and education, all of which establish relationships between the state and its citizens (Treasury Board of Canada Secretariat, 2007)
From page 92...
... The MCDA approach does not need to be highly sophisticated, but it does need to provide a road map to ensure that the same factors and trade-offs are considered across intervention alternatives for different risk situations. A template (Treasury Board of Canada Secretariat, 2007)
From page 93...
... , such as public health objectives and intermediate objectives, to the actual outcomes of an intervention. Direct metrics of public health might include cases of illness, hospitalizations, deaths, measurements of disease burden (e.g., disability-adjusted life years)
From page 94...
... , it does not meet the need for information for effective monitoring of the success of the HACCP/Pathogen Reduction regulations. The overall role of foodborne illness attribution in a risk-based food safety management system is discussed further at the end of this chapter.
From page 95...
... The risk- and evidence-based food safety management approach described above is meant to be comprehensive in that the general steps are applicable to virtually all FDA food-related decision making. Certainly, the approach is relevant to broad-based prioritization, as might be the case for strategic planning of how best to use agency resources associated with specific functions (e.g., research, inspection, communication, surveillance)
From page 96...
... , there would be a need for periodic reevaluation using risk ranking and prioritization (back to Steps 2 and 3) to ensure that resources would continue to be allocated appropriately.
From page 97...
... 5) The risk-based food safety management system presented here takes the concepts of risk analysis to an operational level by creating a process that uses analytical methodology to evaluate risk, and then facilitates decision making in light of the myriad factors that need to be considered in the risk management process.
From page 98...
... Risk-Based Activities of CFSAN Although CFSAN has a long history of conducting safety assessments for food additives and risk assessments for chemicals, it was not until 1999 that the center conducted more complex quantitative risk assessments for pathogens. In 2002, a CFSAN risk analysis working group produced an internal report Initiation and Conduct of All Major Risk Assessments Within a Risk Analysis Framework, which is based on the principles of risk analysis and describes how to prioritize and conduct risk assessments.4 Several offices within CFSAN have a role in developing and coordinating risk-based initiatives5: • The Risk Assessment Coordination Team (RACT)
From page 99...
... To date, five public meetings to gather stakeholder input have been conducted, and this group is apparently developing a framework document describing the major processes, guidance, regulations, and policy issues entailed in addressing feed safety. As of this writing, however, the significance of the AFSS as applied to risk-based food safety management is unclear (Hartogensis, 2009)
From page 100...
... Public Health Risk Ranking Under an FDA cooperative agreement, the Institute of Food Technologists convened a panel of experts to develop a risk-ranking prototype designed to analyze data on hazards (both chemical and biological) in food and return an estimate of the resulting health burden at a population level.
From page 101...
... . The model appears to utilize such information as the occurrence of multiple hazards, the potential for fatal illness outbreaks, consumption by all segments of the population, and conditions under which the hazard is likely to occur.
From page 102...
... . Food Safety Performance Measures The Healthy People food safety goals could theoretically serve as the basis for the identification of specific performance measures.
From page 103...
... . COMPARISON OF THE CURRENT FDA APPROACH TO RISK MANAGEMENT AGAINST THE VISION AND ATTRIBUTES OF A TRUE RISK-BASED DECISION-MAKING APPROACH TO FOOD SAFETY MANAGEMENT Based on the information presented in public meetings and conversations with FDA staff and other publicly available information, the committee concluded that the agency currently is not practicing some aspects of a systematic risk-based food safety management approach with the attributes identified in Box 3-1.
From page 104...
... . However, the production of risk assessments and profiles alone does not constitute a risk-based food safety management system.
From page 105...
... NOTE: "Output" and "Outcome" designations appear in the Budget Justification. The absence of a strategic vision to embrace and implement a risk-based food safety management system is apparent at almost every level.
From page 106...
... Most of the other attributes of a risk-based food safety management system (e.g., public health risk ranking, prioritization for resource allocation, transparency in risk management, effective and frequent communication with stakeholders) are all but absent from the FDA's current approach to food safety.
From page 107...
... It should be clear from the preceding discussion that this will be a substantial undertaking. Virtually all of the recommendations in this report can and perhaps should be adopted with the stated purpose of supporting a riskbased approach to food safety management.
From page 108...
... One option is to create a centralized risk-based analysis and data management center, which would provide a multiagency and multidisciplinary core of expertise in risk analysis for all agencies with responsibilities for food safety.
From page 109...
... Foodborne Disease Attribution Data and Models The IOM/NRC report Scientific Criteria to Ensure Safe Food states that "science-based food safety criteria must be clearly linked to the public health problem they are designed to address. To accomplish this, a cause/effect relationship needs to be established between contaminants in foods and human disease, that is, to allocate the burden of foodborne disease among foods and food groups" (IOM/NRC, 2003, p.
From page 110...
... Consequently, the system was designed to include ongoing case control studies to identify specific foods/food groups that might be consumed more commonly by ill persons infected with a specific resources will be needed for further characterization of foodborne disease attribution in support of risk-based food safety management. Simply knowing the proportion of the occurrence of a particular disease that is associated with a specified hazard is not enough.
From page 111...
... losis cases attributable to the consumption of contaminated leafy greens is associated with poor personal hygiene practices of food handlers versus preharvest contamination on the farm? Likewise, because agents can be transmitted by multiple routes, more defined data on transmission are needed -- for instance, what proportion of human norovirus infections is attributable to foodborne routes as compared with person-to-person transmission?
From page 112...
... for disease; calculation of ability to explore multiple establishment of temporality. food attribution persons with respect population-attributable exposures (specific foods, Many cases required for adequate are sparse (see to previous exposures; risk to estimate relative food preparation practices, statistical power.
From page 113...
... Quantitatie microbial Information on estimates Allows a high level of detail Serious data gaps. Substantial CFSAN/FSIS, risk assessment for parameters to use in with respect to specific food uncertainty (should be accompanied 2003 (Listeria Yields mathematically modeling and uncertainty commodities.
From page 114...
... In short, solid epidemiological attribution data form the cornerstone of riskbased prioritization, management, and evaluation. KEY CONCLUSIONS AND RECOMMENDATIONS The committee defined a risk-based food safety management system as "a systematic means by which to facilitate decision making to reduce public health risk in light of limited resources and additional factors that may be considered." The committee went on to define the key attributes of such a system and produced a stepwise approach to its design.
From page 115...
... Recommendation 3-2: The FDA should develop a comprehensive stra tegic plan for development and implementation of a risk-based food safety management system. The agency should also develop internal operating guidelines for the conduct of risk ranking, risk assessment, risk prioritization, intervention analysis, and the development of metrics with which to evaluate the performance of the system.
From page 116...
... Recommendation 3-4: The FDA should identify expertise needed to implement a risk-based approach. This includes training current and/or hiring new personnel in the areas of strategic planning; management of data; development of biomathematical models and other tools for risk ranking, prioritization, intervention analysis, and evaluation; and risk communication.
From page 117...
... 2006. Using Risk Analysis to Inform Microbial Food Safety Decisions.
From page 118...
... Paper pre-pre sented at Institute of Medicine/National Research Council Committee on Review of the FDA's Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Gueorguieva, V., J
From page 119...
... Paper presented at Institute of Medicine/ National Research Council Committee on Review of the FDA's Role in Ensuring Safe Food Meeting, Washington, DC, May 28, 2009. Mangen, M
From page 120...
... Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA's Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.


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