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The supply of food in the U.S. is dependent upon a highly complex system of interactions among government agencies, international and domestic food manufacturers, farmers, retailers, wholesalers, distributors, importers, transportation companies and consumers. There are a multitude of steps necessary to grow or import commodities and ingredients, to transport them to a processing facility, and to manufacture them into a safe, nutritious and wholesome food product that can withstand conditions of transportation and storage. Protection of foods from intentional and unintentional contamination with deleterious microorganisms, chemicals or radiological agents is a primary responsibility of government agencies which derive their authority from a variety of laws. Regulations and guidance documents promulgated under these laws provide the food industry with information necessary to pass formal inspections by FDA, USDA or other federal agencies and to market foods that are safe for consumption. Executive Order 12866 (Sept 30, 1993) requires agencies to use scientific data to assess risks and costs/benefits prior to proposing regulations. The study of risk in foods covers the three areas of communication, management and assessment and federal agencies now use risk assessment as a decision-making paradigm due to its basis in science. There are numerous methods for conducting a risk assessment depending upon the ultimate need. Assessments may be qualitative in nature, often involving ranking of risks associated with a specific situation, or quantitative in nature resulting in a number to describe an amount of risk associated with a specific situation. Risk assessments may address one microorganism in one food product (e.g., SE in shell eggs), a specific production process, points within the food chain, or a group of toxins/microorganisms in a general category such as produce or poultry. The objectives of this project are: 1) to assess and analyze risk-related information in federal and other food protection databases, 2) to investigate the role of risk assessment, risk management and risk communication in the regulatory process, and 3) to conduct studies on risks associated with existing or emerging issues, such as antibiotic resistance of pathogens or food nanotechnology.
Non-Technical Summary: Risk analysis has been adopted by numerous federal agencies as the paradigm used to make regulatory decisions related to food protection. For example, in the past 10 years or more, several different risk analyses have been conducted in relation to specific foods and specific microorganisms, e.g. Salmonella Enteritidis in shell eggs. The impact of federal food protection risk assessment, communication and management structures on regulatory activity and public health will be investigated. <P> Approach: Food protection risk assessment can be broadly defined as the use of scientific data to rank or measure hazards, assess exposure, and characterize risks associated with specific foods or food production practices (Parish, Congressional Research Service Report RS20310, 1999). Existing databases related to food protection, including but not limited to the FDA Class I, II and III recall list; the JIFSAN foodrisk.org; CDCs outbreak database; and WHO/FAO Codex websites, will be analyzed for relationships among factors such as regulatory decisions, outbreaks, and risk of illness associated with foods. Production practices related to those foods most involved in outbreaks will be studied to identify research gaps and risks along the farm-to-fork food chain using standard qualitative and quantitative assessment methods such as risk ranking, expert solicitations, non-numerical descriptors, and mathematical modeling based on probabilistic statistical analysis of the occurrence of adverse events. Those research gaps identified through risk ranking may be addressed with standard laboratory methods. For example, microbiological data gaps may lead to studies using appropriate experimental design and microbiological methods from standard authorities such as the FDA Bacteriological Analytical Manual or the Compendium of Methods for the Microbiological Examination of Foods.