Society For Risk Analysis Annual Meeting 2012

Advancing Analysis

Session Schedule & Abstracts

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Common abbreviations

Symposium: Part I: Framework and Methods - Recent Efforts for Advancing the Risk-Informed Decision Making System in the FDA Foods Veterinary Medicine (FVM) Program

Room: Pacific Concourse K   3:30 - 4:50 PM

Chair(s): Kara Morgan, Yuhuan Chen

Sponsored by DARSG

Efforts to modernize food safety policy in the United States and through-out the world are looking to risk-informed decision making systems to accomplish this task. In June 2010, the IOM/NAS issued a ground-breaking report “Enhancing Food Safety,” that provided a normative view of how such a process could work at FDA. In 2011, FDA began work to align that vision with the current risk-informed decision making work already underway in the agency. This alignment included consideration of the requirements in FSMA and the objectives laid out in the FDA FVM Strategic Plan (2012). This work will develop a clear path forward that identifies FDA’s priorities and defines clear steps for making progress. During the same time, work was progressing on decision tools that were already in development to support risk-informed decision making, and on joint work with CDC and FSIS to improve attribution, one of the foundational pieces of information needed to drive an FDA risk-informed decision making system. This two-part symposium provides a review of the priorities identified for improving the risk-informed decision making system at FDA, as well as some updates on tools for risk-informed decision making and attribution-related projects.

M4-B.2  15:30  Leveraging Epidemiology and Risk Assessment Methods to Inform Risk-based Food Safety Decisions. Hoffmann SA*, InterAgency Risk Assessment Consortium , InterAgency Food Safety Analytics Collaborative ; USDA, Economic Research Service

Abstract: Efforts to modernize food safety policy in the U.S. are increasingly relying on risk-based decision systems. Where the risk is of a public health nature, like foodborne illness, epidemiology and risk assessment are looked to to inform these decisions. While there have been significant advances in each field, there has not been as much focused inquiry on how these fields could interact to better inform risk-based food safety decision making. This paper presents a proposal for integration of modeling and research in the two fields developed by the IRAC and IFSAC through a series of webinars and a 2-day workshop. These brought together leading government epidemiologists, risk assessors and risk researchers to explore ways in which epidemiology and risks assessment methods could be better integrated to address limitations of each method. The webinars familiarized participants with models and data collection efforts currently used to inform risk-based food safety decision analysis in the U.S. They focused on the strengths and limitations of each method. The workshop used a series of 4 case studies to explore ways in which more integrated analysis could strengthen the analytical basis for risk-based food safety decision making. Each case study focused on a question central to this decision process: what are leading foodborne illness risks; how can potential interventions be identified and evaluated; how can changes over time in food risks be estimated; what can be done to improve knowledge about the cause of unattributed foodborne illnesses. Workshop participants explore how methods in each discipline currently can address each question, where they confront limitations, and how greater integration of methods could help overcome these limitations. Based on the problem-centered discussions about these case studies, participants developed a preliminary framework for more integrated analysis that could better inform risk-based food safety decision making. They also developed a set of recommendations for research needed to support this integration process.

M4-B.3  15:50  Applying the IOM framework to FDA’s current FVM program. Hooberman B*, Morgan K, Pomeroy E, Kern J, Feldstein F, Anderson B, Schroeder J, Harms B, Mokhtari A, Pierson K; Food and Drug Administration

Abstract: The Food and Drug Administration’s (FDA’s) Foods and Veterinary Medicine (FVM) Program is implementing a risk-informed decision making system that will permeate through all levels of its food safety management program. The foundation for the system is contained in the IOM report Enhancing Food Safety: The Role of the Food and Drug Administration (2010). Providing additional impetus to the adoption of risk-informed decision making is the Food Safety Modernization Act of 2010 (FSMA), which is the first major overhaul of U.S. food safety law in over 70 years. FSMA provides new tools for ensuring the safety of the food supply and creates new public health mandates, many of which are directed in the legislation to be based on relative assessments of risk, and thus call for increased emphasis on risk-informed decision making. The first step in building on the FVM Program’s existing capabilities for risk-informed decision making was to develop a detailed gap analysis between FDA’s current state of risk-informed decision making and the needed risk-informed decision making system as envisioned by IOM. The gap analysis identified gaps associated with both specific, more tactical risk-informed decision areas and broader, more strategic cross-program areas. The gaps were then evaluated for their impact on risk-informed decision making in order to prioritize the efforts to develop a multi-year implementation plan that will improve the FVM Program’s ability to systematically make decisions in accordance with the vision the IOM report depicts.

M4-B.4  16:10  Economics-based Methodology for Ranking Foodborne Microbiological Contaminants . Lasher AB*, Minor* T, Brown B, Parish M; FDA-CFSAN

Abstract: On January 4, 2011, the FDA Food Safety Modernization Act (FSMA) (Public Law 111-353) was signed into law. Section 104 of FSMA, Performance Standards, requires the review and evaluation of health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices relating to food, and recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants. To rank the most significant microbiological pathogen contaminants and their associated food commodity, we utilize a number of steps and data sources. We start with percentages of illnesses attributed to specific pathogens within broad food categories. Multiplying these percentages by the total annual incidence of each foodborne agent, estimated by Scallan et al. (2011), yields the estimated number of illnesses, separable by agent, attributable to each food commodity. The total illnesses attributable to each agent-commodity pairing are then multiplied by an agent specific cost of illness. This cost of illness measure is comprised of the costs of diagnosis, medical treatment, lost Quality Adjusted Life Days (QALDs), and premature mortality. This valuation allows us to put a total dollar value on each agent-commodity pair that is comparable across all agents and commodities. With these values, we then can rank the agent-commodity pairs that we view as posing the most significant threat to public health.

M4-B.5  16:30  Developing a path forward to advancing risk informed decision making in the Food Veterinary Medicine Program (FVM) at FDA . Morgan K*, Hooberman B, Pomeroy E, Kern J, Feldstein F, Anderson B, Schroeder J, Harms B, Mokhtari A, Pierson K; US Food and Drug Administration

Abstract: The FDA’s Food Veterinary Medicine program (FVM) has limited resources to ensure that millions of FDA-regulated food import entries and hundreds of thousands of foreign and domestic food manufacturing facilities, food transporters, holders, and importers comply with the Food Drug and Cosmetic Act and provide safe and wholesome food for American consumers. There is broad interest in using those resources in a risk-informed way. Research, standards development, inspections, sample collection, sample analysis and communication are important foundational tasks to this work. The FVM program also works with state and local partners to collaboratively and efficiently protect public health with available resources. Determining the risk-informed set of resource requirements, informing decisions within those programs based on risk, and evaluating those decisions across different types of activities, facilities, and foods creates enormous challenges. This project was designed to develop an implementation plan for an integrated, risk-informed system making best use of data to inform decision making across all of FDA’s food safety activities. This implementation plan would build on the recommendations of the IOM, Enhancing Food Safety report, and also integrate the new tools and requirements of FSMA. The implementation plan will be designed to answer the following types of questions: (1) What are the steps to establish broad awareness of available risk information so that it is available to be used in different types of decisions in the Foods Program? (2) What is needed to develop a repository and resource of data, risk information and risk-based tools for decision-makers in the Foods program to utilize? (3) What approach should be taken to develop consistent, transparent processes for risk-informed decision making? (4) How can consistent use of evaluations for continuous improvement in risk-informed decision making be implemented?

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