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Enhancing Food Safety: The Role of the Food and Drug Administration Appendix H Glossary Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) Agreement concerning the application of food safety and animal and plant health regulations as established by the World Trade Organization in 1995. Under these agreements, countries can set their own standards for safety as long as they are based on science. Appropriate level of protection A way to express, on a population level, what level of risk a society is prepared to tolerate or considers to be achievable to protect human, animal, or plant life or health within its territory. Biologics/biological products A wide range of products including vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. These products are regulated by the U.S. Food and Drug Administration (FDA). Biomolecule Any molecule that is involved in the maintenance and metabolic processes of living organisms. Biomolecules include carbohydrate, lipid, protein, nucleic acid, and water molecules. Biosecurity A strategic and integrated approach that encompasses the policy and regulatory frameworks (including instruments and activities) used in analyzing and managing risks in the sectors of food safety, animal life and health, and plant life and health, including associated environmental risk. Biosecurity covers the introduction of plant pests, animal pests and diseases,
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Enhancing Food Safety: The Role of the Food and Drug Administration and zoonoses; the introduction and release of genetically modified organisms and their products; and the introduction and management of invasive alien species and genotypes. Bioterrorism The intentional release of viruses, bacteria, or other agents used to cause illness or death in people, animals, or plants. Bottom-up data Data that model the path of pathogens from their source through the food supply chain to health outcomes. CARVER+Shock A risk assessment tool that enables users to conduct assessments of the risks of, and vulnerabilities to, intentional contamination of a food production and distribution process. Its use by the food and agriculture sector and government agencies originates in its use by military special operations forces. The acronym stands for Criticality, Accessibility, Recuperability, Vulnerability, Effect, and Recognizability, which are the factors considered in assessing risk and vulnerability. Class I recall A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Classified information According to U.S. Code Title 18, any information or material that has been determined by the U.S. Government—pursuant to an executive order, statute, or regulation—to require protection against unauthorized disclosure for reasons of national security, and any restricted data, as defined in the Atomic Energy Act of 1954. Cooperative Extension System A network of nationwide offices staffed by one or more experts who provide useful, practical, and research-based information to agricultural producers, small business owners, youth, consumers, and others in rural areas and communities of all sizes. Decision analysis An applied branch of decision theory that offers individuals and organizations a methodology for making decisions; it also offers techniques for modeling decision problems mathematically and determining optimal decisions numerically. Decision models have the capacity for accepting and quantifying human subjective inputs, including judgments of experts and preferences of decision makers. Implementation of these models can take various forms ranging from simple paper-and-pencil procedures to sophisticated computer programs known as decision aids or decision systems.
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Enhancing Food Safety: The Role of the Food and Drug Administration Detention without physical examination (DWPE) An enforcement mechanism by which the FDA can detain shipments of imported products without having to actually analyze those shipments. Electronic Foodborne Outbreak Reporting System (eFORS) A web-based reporting system used by the U.S. Centers for Disease Control and Prevention (CDC) to collect basic summary data from states on all reported foodborne illness outbreaks. Electronic Laboratory Exchange Network (eLEXNET) A web-based information network that allows comparison of laboratory analysis findings and serves as a warning system for potentially hazardous foods. Embargo authority When referring to food, the authority to issue and enforce a stop sale, stop use, removal, or hold for a food or processing equipment when there is probable cause to believe that it is dangerous, unwholesome, fraudulent, or insanitary. Enterprise architecture A blueprint for organizational change and a foundation for information technology management, describing the current operation of an organization, how it intends to operate in the future, and how it plans to reach these goals. Entry line Each portion of an import shipment that is listed as a separate item on an entry document. Items in an import entry having different tariff descriptions must be listed separately. Epidemiology The study of the occurrence, distribution, and determining factors associated with the health and diseases of a population; the study of how often health events or diseases occur in different groups and why. Etiology The cause or origin of a disease. Food contaminant A substance that may be present in foods as a result of environmental contamination, cultivation practices, or production processes. If present above certain levels, these substances can pose a threat to human health. Some contaminants are formed naturally; carried over to food from water, air, or soil; or created as a by-product of the food production process itself. Food defense A collective term used by agencies including the FDA, the U.S. Department of Agriculture (USDA), and the U.S. Department of Homeland Security to denote activities associated with protecting the nation’s food
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Enhancing Food Safety: The Role of the Food and Drug Administration supply from deliberate or intentional acts of contamination or tampering. The term encompasses other similar verbiage, such as counterterrorism. Food Protection Plan A plan issued by the FDA in 2007 to lay out the agency’s integrated strategy for food safety and food defense. The three core elements of the plan are prevention, intervention, and response. Food safety risk The likelihood of harm to health resulting from exposure to hazardous agents in the food supply. Food Safety Working Group (FSWG) A group created by President Obama in 2009 to advise him on how to upgrade the U.S. food safety system. It is chaired by the Secretaries of the U.S. Department of Health and Human Services and USDA. Foodborne illness An illness, usually either infectious or toxic in nature, caused by an agent that enters the body through the ingestion of food. FoodNet A collaborative project of CDC, USDA, the FDA, and 10 Emerging Infections Program sites. It consists of active surveillance for foodborne illnesses and related epidemiologic studies designed to help public health officials better understand the epidemiology of foodborne illnesses in the United States. FoodSHIELD A web-based platform whose mission is to support federal, state, and local regulatory agencies and laboratories in defending the food supply through web-based tools that enhance threat prevention and response, risk management, communication and asset coordination, and public education. Functional genomics The study of genes, their resulting proteins, and the role played by the proteins in the body’s biochemical processes. Hazard A biological, chemical, or physical agent in or condition of food with the potential to cause an adverse health effect. Hazard Analysis and Critical Control Points (HACCP) A production control system for the food industry. It is a process that identifies where potential contamination can occur (the critical control points) and strictly manages and monitors these points as a way of ensuring that the process is under control and that the safest possible product is being produced. HACCP is designed to prevent rather than detect potential hazards.
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Enhancing Food Safety: The Role of the Food and Drug Administration Information science The collection, organization, storage, retrieval, exchange, interpretation, and use of information. iRISK A web-based risk-ranking prototype used to compare microbial and chemical hazards to support risk management decisions. Iterative approach The repetition of a numerical or non-numerical process whereby the results from one or more stages are used to form the input to the next stage. Generally the recycling of the process continues until some preset goal is achieved, or the process result is constantly repeated. Melamine A synthetic chemical with a variety of industrial uses, including the production of resins and foams, cleaning products, fertilizers, and pesticides. If ingested in sufficient amounts, melamine can result in kidney failure and death. Memorandum of understanding (MOU) A document outlining the terms and details of an agreement between parties, including each party’s requirements and responsibilities. Metabolomics The science of measurement and analysis of metabolites, such as sugars and fats, in the cells of organisms at specific times and under specific conditions. The field of metabolomics overlaps with biology, chemistry, mathematics, and computer science. Molecular surveillance Combines the methods of molecular biology with those of epidemiology in an effort to identify exposure to foodborne pathogens and subsequent disease. The use of molecular biology makes it possible to conduct pathogen surveillance at a genetic level and to determine the associations between contamination and disease when they are separated in space or time. PulseNet and VetNet are examples of molecular surveillance systems. Multiple criteria decision analysis (MCDA) An approach used to systematically structure and model decision problems in multiple dimensions, with the goal of achieving a well-considered and -justified decision, and to provide a transparent explanation of the decision’s basis. Operational risk management A management approach used by the Departments of Defense and Transportation to identify risks and reduce them to an appropriate level, ensuring that benefits outweigh any risks.
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Enhancing Food Safety: The Role of the Food and Drug Administration OutbreakNet A network of foodborne disease epidemiologists from all states and CDC that works to improve communication among these partners. Pathogen An agent causing disease or illness to its host, such as an organism or infectious particle capable of producing disease in another organism. Phototoxicology Assessment of the toxic and/or carcinogenic potential of chemicals and agents when exposed to light or when applied to photo-treated skin. Postmarket enforcement A process by which a regulatory agency determines the safety of a product only after it has entered into commerce. For example, manufacturers of foods and cosmetics in the United States generally do not have to submit evidence of safety to the FDA or obtain approval from the agency before putting their products on the market. If the FDA determines that a product is unsafe after it is on the market, the agency may take enforcement action against the product, but in any formal enforcement action, the burden is on the FDA to establish that the product in question is unsafe. PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting) A screening tool that will automate decisions currently made by import entry reviewers by utilizing intelligence information from numerous sources. PREDICT will target higher-risk shipments for examination and will expedite the clearance of lower-risk cargo if accurate and complete data are provided by importers and entry filers. Premarket Approval A process by which a regulatory agency determines whether a product is safe for the public before permitting it to enter into commerce. For example, manufacturers of food and color additives may put a product into commerce in the United States only if the FDA has already determined that the product in question is safe and has approved it for sale. In any formal enforcement action against an unapproved product, the FDA does not have to establish that the product in question is unsafe; rather, the agency will prevail simply by showing that the product has not received the requisite premarket approval. Prior notice A requirement of the Bioterrorism Act of 2002 that the FDA receive advance notice of food to be imported into the United States before the food arrives. Protected Critical Infrastructure Information (PCII) program A program established pursuant to the Critical Infrastructure Information Act of 2002 that provides a means for sharing private-sector information with the gov-
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Enhancing Food Safety: The Role of the Food and Drug Administration ernment while providing assurance that the information will be exempt from public disclosure and will be properly safeguarded. Proteomics The large-scale study of proteins, particularly their structures and functions. PulseNet A national network of federal, state, and local laboratories coordinated by CDC that uses standardized collection and sharing of pulsed-field gel electrophoresis (PFGE) molecular subtyping data to link isolates obtained from diverse sources. PulseNet allows scientists at public health laboratories throughout the country to rapidly compare the PFGE patterns of bacteria isolated from ill persons and determine whether those bacteria are similar. Risk The possibility or probability of loss, injury, disadvantage, or destruction. Risk analysis A transparent means by which to link the nature and extent of public health protection (risk reduction) achieved as a result of different risk management actions (or interventions). Risk analysis is composed of three activities: (1) risk assessment, (2) risk management, and (3) risk communication. Risk assessment A process that provides information on the extent and characteristics of the risk attributed to a hazard. Risk communication The exchange of information and opinions concerning risk and risk-related factors among risk assessors, risk managers, and other interested parties, stakeholders, and the public. In this report, risk communication is applicable when the message is directly related to specific risks (or benefits) of certain behaviors. Risk management The activities undertaken to control risk. Risk prioritization A multifactorial approach to ranking risks that considers a wide range of factors (in addition to public health) that might influence prioritization or decision making. Risk prioritization uses tools of both risk assessment and decision analysis to determine the importance of one risk over another, usually in relationship to mitigation. Risk prioritization is inherently used as a risk management tool. Risk ranking A special form of risk assessment whose purpose is to compare hazards, commodities, or hazard–commodity pairs with respect to their degree of risk relative to one another.
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Enhancing Food Safety: The Role of the Food and Drug Administration Risk-based food safety system 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. Sunshine laws State and federal statutes requiring that government meetings, decisions, and records be made available to the public. Surveillance A key component of epidemiology, it can be defined as the ongoing collection, analysis, interpretation, and dissemination of health-related data. Surveillance is one of a number of methods used by epidemiologists to gather information on a disease. Top-down data Surveillance-based data, such as epidemiological data on illnesses and deaths. Toxicoinformatics Analysis and integration of genomic, transcriptomic, proteomic, and metabolomic databases with the objective of knowledge discovery and the elucidation of mechanisms of toxicity. Traceability In the food arena, the ability to trace the history, application, or location of a food under consideration. Trace-back/trace-forward activities In the food arena, activities performed to determine the origin (trace-back) or distribution (trace-forward) of a product, usually to identify contaminated food. The activities are conducted jointly with local health departments and appropriate federal agencies. They entail the review and analysis of records such as harvesting dates, specific field and product locations, number of packages within a lot, and packing and shipping dates. User fee A charge for the use of a particular good or service, for example, an entrance fee to a state park or the rental of equipment at a pubic facility. Many government-operated facilities are financed by both tax revenues and user fees. Viral communications/marketing Use of social networking to rapidly diffuse ideas, marketing campaigns, or other messages. Zoonotic disease A disease of animals that may be transmitted to humans under natural conditions (e.g., brucellosis, rabies).