34,457 research outputs found

    Building the Science Foundation of a Modern Food Safety System: Lessons From Denmark, the Netherlands, and the United Kingdom on Creating a More Coordinated and Integrated Approach to Food Safety Information

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    Examines how food safety reforms in three countries and the European Union affected data collection and analysis, coordination and integrated approaches, and use of data for prevention. Makes recommendations for U.S. programs, policies, and activities

    Prioritizing Opportunities to Reduce the Risk of Foodborne Illness: A Conceptual Framework

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    Determining the best use of food safety resources is a difficult task faced by public policymakers, regulatory agencies, state and local food safety and health agencies, as well as private firms. The Food Safety Research Consortium (FSRC) has developed a conceptual framework for priority setting and resource allocation for food safety that takes full account of the food system’s complexity and available data but is simple enough to be workable and of practical value to decisionmakers. The conceptual framework addresses the question of how societal resources, both public and private, can be used most effectively to reduce the public health burden of foodborne illness by quantitatively ranking risks and considering the availability, effectiveness, and cost of interventions to address these risks. We identify two types of priority-setting decisions: Purpose 1 priority setting that guides risk-based allocation of food safety resources, primarily by government food safety agencies, across a wide range of opportunities to reduce the public health impact of foodborne illness; and Purpose 2 priority setting that guides the choice of risk management actions and strategies with respect to particular hazards and commodities. It is essential that such a framework be grounded in a systems approach, multi-disciplinary in approach and integration of data, practical, flexible, and dynamic by including ongoing evaluation and continuous updating of risk rankings and other elements. The conceptual framework is a synthesis of ideas and information generated in connection with and during the three FSRC workshops convened under a project funded by the Cooperative State Research, Education, and Extension Service of USDA. Workshop materials are available on the project website: http://www.card.iastate.edu/food_safety/.

    Numerical Relativity: A review

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    Computer simulations are enabling researchers to investigate systems which are extremely difficult to handle analytically. In the particular case of General Relativity, numerical models have proved extremely valuable for investigations of strong field scenarios and been crucial to reveal unexpected phenomena. Considerable efforts are being spent to simulate astrophysically relevant simulations, understand different aspects of the theory and even provide insights in the search for a quantum theory of gravity. In the present article I review the present status of the field of Numerical Relativity, describe the techniques most commonly used and discuss open problems and (some) future prospects.Comment: 2 References added; 1 corrected. 67 pages. To appear in Classical and Quantum Gravity. (uses iopart.cls

    Development of hazard analysis and critical control points (HACCP) procedures to control organic chemical hazards in the agricultural production of raw food commodities

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    Hazard Analysis by Critical Control Points (HACCP) is a systematic approach to the identification, assessment and control of hazards in the food chain. Effective HACCP requires the consideration of all possible hazards, i.e., chemical, microbiological and physical. However, current procedures focus primarily upon microbiological and physical hazards, and, to date, chemical aspects of HACCP have received relatively little attention. Consequently, this report discusses the application of HACCP to organic chemical contaminants and the particular problems that are likely to encounter within the agricultural sector. It also presents generic templates for the development of organic chemical contaminant HACCP procedures for selected raw food commodities, i.e., cereal crops, raw meats and milk

    Manufacturing Barriers to Biologics Competition and Innovation

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    As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA regulation, not only creates high barriers to entry of indefinite duration but also undermines efforts to advance fundamental knowledge. In sharp contrast, offering incentives for information disclosure to originator manufacturers would leverage the existing interaction of trade secrecy and the regulatory state in a positive direction. Although trade secrecy, particularly in complex areas like biologics manufacturing, often involves tacit knowledge that is difficult to codify and thus transfer, in this case regulatory requirements that originator manufacturers submit manufacturing details have already codified the relevant tacit knowledge. Incentivizing disclosure of these regulatory submissions would not only spur competition but it would provide a rich source of information upon which additional research, including fundamental research into the science of manufacturing, could build. In addition to provide fresh diagnosis and prescription in the specific area of biologics, the Article contributes to more general scholarship on trade secrecy and tacit knowledge. Prior scholarship has neglected the extent to which regulation can turn tacit knowledge not only into codified knowledge but into precisely the type of codified knowledge that is most likely to be useful and accurate. The Article also draws a link to the literature on adaptive regulation, arguing that greater regulatory flexibility is necessary and that more fundamental knowledge should spur flexibility. A vastly shortened version of the central argument that manufacturing trade secrecy hampers biosimilar development was published at 348 Science 188 (2015), available online

    Advanced Methods for Dose-Response Assessment: Bayesian Approaches—Final Report

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    Resources for the Future (RFF), in conjunction with the U.S. Environmental Protection Agency, the Society for Risk Analysis, and the Electric Power Research Institute, held a workshop September 18–20, 2000, at the RFF Conference Center in Washington, D.C. The intent was to discuss how Bayesian approaches could be useful in improving techniques for estimating exposure–response functions. Ten distinguished scholars from a range of fields (medical biostatistics, decision sciences, environmental engineering, and toxicology) served as faculty. Approximately 80 people attended the workshop. Bayesian methods have been applied to a variety of problems in biomedical research and environmental risk analysis, including design of clinical trials, estimation of exposures to humans and local environments, and, in a few cases, estimation of exposure–response functions. Bayesian methods offer two signal advantages: their use requires careful analysis of problem logic, which has intrinsic utility, and disparate data can be incorporated into calculations. Although application of formal Bayesian analysis can be computationally challenging, widely available computer programs now greatly reduce this burden. Participants identified several factors that may impede the dissemination of Bayesian approaches among practitioners of dose–response assessment and made some recommendations for overcoming these hurdles. EPA, other regulatory agencies that use dose–response assessment as part of their processes, and the private sector all should take steps to foster the use of Bayesian approaches. EPA and other agencies should work to persuade professional societies (for example, Society for Risk Analysis, Society of Toxicology) to seek out and recognize meritorious analyses that use Bayesian approaches. EPA and private-sector organizations should consider sponsoring research into using Bayesian approaches, demonstration analyses that use them, and using the results of this work to help educate peers in the risk analysis and toxicology professions. EPA should request all staff and contractor scientists who develop mathematical models to use Bayesian techniques to calibrate models. EPA should consider ways to inform its staff, contractors, and the research community as to the utility of Bayesian analyses. EPA should consider improving its research planning by making use of Bayesian techniques (including value-of-information analyses).Bayesian analysis, dose–response, regulation, risk assessment, arsenic

    Balancing Consumer Protection and Scientific Integrity in the Face of Uncertainty: The Example of Gluten-Free Foods

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    In 2009, gluten-free foods were not only hot in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term gluten-free. The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers
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