The ORACBA Risk Forums provide an opportunity for discussion of a broad range of policy-related scientific, and methodological issues concerning risk assessment. Forums are open to all public and private risk assessors.
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FSIS Office of Public Health and Science
December 10, 2015
Process models that include the myriad pathways that pathogen-contaminated food may traverse before consumption and the dose-response function to relate exposure to likelihood of illness may represent a ‘‘gold standard’’ for quantitative microbial risk assessment. Nevertheless, simplifications that rely on measuring the change in contamination occurrence of a raw food at the end of production may provide reasonable approximations of the effects measured by a process model. In this study, we parameterized three process models representing different product-pathogen pairs (i.e., chicken-Salmonella, chicken- Campylobacter, and beef–E. coli O157:H7) to compare with predictions based on qualitative testing of the raw product before consideration of mixing, partitioning, growth, attenuation, or dose-response processes. The results reveal that reductions in prevalence generated from qualitative testing of raw finished product usually underestimate the reduction in likelihood of illness for a population of consumers. Qualitative microbial testing results depend on the test’s limit of detection. The negative bias is greater for limits of detection that are closer to the center of the contamination distribution and becomes less as the limit of detection is moved further into the right tail of the distribution. Nevertheless, a positive bias can result when the limit of detection refers to very high contamination levels. Changes in these high levels translate to larger consumed doses for which the slope of the dose-response function is smaller compared with the larger slope associated with smaller doses. Consequently, in these cases, a proportional reduction in prevalence of contamination results in a less than proportional reduction in probability of illness. The magnitudes of the biases are generally less for nonscalar (versus scalar) adjustments to the distribution.
September 17, 2015
Sponsored by: ORACBA and National Capital Area Chapter of the Society for Risk Analysis
Mark Powell, ORACBA Risk Scientist
Retrospective review is a key to designing effective food safety measures. The analysis examines trends in the reported incidence of U.S. foodborne illness using both a conventional generalized linear model and penalized B-spline regression. B-spline regression is a semi-parametric, locally-controlled method that makes no assumptions about the form of the trend. To address the sensitivity of B-spline regression to choices about the number and location of join-points called knots, penalized B-spline regression imposes a “roughness” penalty on differences among neighboring B-spline regression coefficients. The optimal degree of smoothing is determined based on statistical model selection criteria (e.g., generalized cross-validation). The result is a flexible, smooth curve that avoids over-fitting the data, while providing a statistical test for trend. The findings indicate a lack of evidence for continuous reduction in foodborne illnesses in the U.S. during 1996-2013.
September 15, 2015
Sponsored by: ORACBA and National Capital Area Chapter of the Society for Risk AnalysisDima Yazji Shamoun, co-author
Objectivity in the science of risk plays a monumental role in the projection of the benefits from health and safety regulations, which constitute the majority of total reported benefits of all federal regulations. Claims concerning the accuracy of regulatory risk assessments have been un-testable so far in that they focus on whether a risk assessment over- or underestimates the risk of exposure to certain hazards; yet such claims rely on an implication that the true level of risk can be known. This presentation proposes moving the debate from the realm of the un-testable to the realm of the testable "process objectivity" of the science of risk. Consistent adherence to a process should yield objective results. There is a sizable body of guidelines and recommendations on sound risk assessment practices produced by the federal government and by various scientific bodies. The proposed process incorporates these guidelines and recommendations and is testable, objective, and—if adhered to consistently—has the potential to shed light on the accuracy of the benefits calculus of major federal health and safety regulations.
Agencies can benefit from reviewing past regulatory actions to better understand if anticipated outcomes differ from observed outcomes and if there were any unintended consequences of the regulation. APHIS is developing a framework to conduct retrospective analyses of significant rules. Using regulations of avocado imports as a case study, we assess the accuracy of our economic projections concerning domestic production and prices, consumption, and trade. We revisit issues raised in public comments to the proposed rule to assess how we would respond to the issues today, given the additional data that is now available. We anticipate using this framework to look back at additional significant rules to incorporate lessons learned from prior actions for future analyses.
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July 23, 2014
David Oryang, Sherri Dennis and Yuhuan Chen, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Presents FDA’s multi-scale efforts to develop risk modeling tools for enhancing fresh produce safety. Two case studies that model the complex interface between the environment and fresh produce will be examined: an agent based produce risk assessment model; and a geospatial risk assessment model.
July 15, 2014
Clare Narrod, Research Scientist and Risk Analysis Program Manager and Kyle McKillop, IT Program Manager
Joint Institute for Food Safety and Applied Nutrition (JIFSAN)
Foodrisk.org is a comprehensive on-line resource for the food safety risk analysis community. The web site is home to a variety of risk assessment models, food safety risk tools and a library of completed risk assessments as well as some unique data sets. It is operated by the Joint Institute for Food Safety and Applied Nutrition in collaboration with FDA’s Center for Food Safety and Applied Nutrition and USDA’s Food Safety Inspection Service. JIFSAN has been working with a number of colleagues over the last couple of years to develop tools to assist the risk analysis community. Dr. Narrod and Kyle McKillop will discuss new risk assessment tools recently added to foodrisk.org as well as several that are in progress.
September 18, 2013
Mark Powell, ORACBA Risk Scientist
This paper is currently available in the early view on-line version of Risk Analysis (DOI: 10.1111/risa.12054)
June 18th, 2013
Analysis to Support Regulations and Metrics Development
Lettuce, enterohemorrhagic E. coli and irrigation water: Application of FDA's iRISK rool for rapid risk assessment to support proposed produce regulation
Yuhuan Chen, Division of Risk Assessment, Office ofAnalytics and Outreach, CFSAN/FDA
Interagency Risk Assessment for L. monocytogenes in Retail Delis
Janell Kause, Scientific Advisor for Risk Assessment, Office of Public Health Science, FSIS, USDA
Quantitative Assessment of the Risk of Listeriosis from Soft-ripened Cheese consumption in the United States and Canada
Régis Pouillot, Division of Risk Assessment, Office of Analytics and Outreach, CFSAN/FDA
Methods for Risk Informed Decision Making
Addressing Chemical Contaminants Without Established Regulatory Limits in Meat, Poultry and Egg Products: the De Minimis Level Approach
Alexander Domesle, Risk Analyst, Office of Public Health Science, FSIS, USDA
How do you model a "negligible" probability under the WTO Sanitary and Phytosanitary Agreement?
Mark Powell, Risk Acientist, Office of Risk Assessment and Cost-Benefit Analysis, OCE,USDA
Revising Analytical Methods in Response to New Data or Information
Using a systems approach to retrospective regulatory review: quantifying economic impact and potential risk reduction due to cumulative regulatory actions in an agricultural watershed in Washington
Linda Abbott, Director, Office of Risk Assessment and Cost-Benefit Analysis, OCE, USDA
EPA Dietary Exposure Assessment of Pesticides: Overview and Evaluation of Updated Consumption Data on Commodity Intake and Exposure
Aaron Niman, LT, U.S. Public Health Service, Office of Pesticide Programs, HED, EPA
|05/04/2013||Procedures for the Pesticide evaluation-assessment in the EU, role of EFSA, Dr. Jordi Serratosa, European Food Safety Authority (EFSA)|
Science, Policy and Risk Forum, Estimation of cancer risks and benefits associated with a potential increased consumption of fruits and vegetables, Rick Reiss, Principal Scientist, Exponent
Risk versus Hazard – Lessons from Europe, Ragnar Löfstedt, of King’s College of London