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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Appendix A Glossary Active pharmaceutical ingredient (API): Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body (Active Pharmaceutical Ingredient Committee, 1999). Aflatoxins: Toxins produced by mold that grows in nuts, seeds, and legumes. 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. Agrifood: The business of producing food agriculturally, as opposed to hunting and fishing. Audit: a systematic examination to determine whether what is actually happening complies with documented procedures. Biologics/biological products: A wide range of products including vaccines, blood and blood components, allergenics, somatic cells, gene therapy,
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad tissues, and recombinant therapeutic proteins. These products are regulated by the U.S. Food and Drug Administration (FDA). Codex Alimentarius Commission: The Codex Alimentarius Commission is a subsidiary body of the Food and Agriculture Organization of the United Nations and the World Health Organization. The Commission is entrusted with the elaboration of international standards of food to protect the health of consumers and to ensure fair practices in the food trade. Codex committees: These subsidiary bodies of the Codex Alimentarius Commission include 9 general subject committees, 15 specific commodity committees, 6 regional coordinating committees, and time-limited ad-hoc Intergovernmental Task Forces on specific subjects. Critical control point: A step at which control is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. Discriminatory strict liability: Holds those who import and sell foreign products in the United States legally liable for regulatory violations pertaining to goods. It mandates more severe penalties for violations related to imports than domestically produced goods. Under this form of liability importers and sellers may be found liable for issues with products even if they took appropriate safety precautions and were unaware that the product is unsafe (Bamberger and Guzman, 2008). Drug regulation: Encompasses a variety of functions, such as licensing, inspection of manufacturing facilities and distribution channels, import and export controls, product assessment and registration, pharmacovigilance, quality control, control of drug promotion, and advertising and control of drug clinical trials. Economies of scale: Factors that cause the average cost of producing a product to fall as the volume of its output increases. Enterprise risk management: Enterprise risk management is a discipline, by which an organization in any industry assesses, controls, exploits, finances, and monitors risks from all sources for the purpose of increasing the organization’s short- and long-term value to its stakeholders (Casualty Actuarial Society-Enterprise Risk Management Committee, 2003). Epidemiology: The study of 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.
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Equivalence: The process of recognition that enables the sanitary and phytosanitary measures employed in one country to be deemed equivalent to those of a second country trading in the same product although different control measures are being practiced. Excipient: A pharmacologically inactive substance used as a carrier for the active ingredients of a medication. Farm-to-Table: Includes all steps involved in the production, storage, handling, distribution, and preparation of a food product. Food contaminant: Any biological or chemical agent, foreign matter, or other substance not intentionally added to food that may compromise food safety or suitability. Food control: A mandatory regulatory activity of enforcement by national or local authorities to provide consumer protection and ensure that all foods during production, handling, storage, processing and distribution are safe, wholesome, and fit for human consumption; conform to quality and safety requirements; and are honestly and accurately labeled as prescribed by law. Food hygiene: All conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain. Food inspection: The examination, by an agency empowered to perform regulatory and/or enforcement functions, of food products or systems for the control of raw materials, processing, and distribution. This includes in-process and finished product testing to verify that they conform to regulatory requirements. Food Safety Modernization Act: Signed into law by President Obama on January 4, 2011. The Act aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. Food surveillance: The continuous monitoring of the food supply to ensure consumers are not exposed to components in foods, such as chemical contaminants or biological hazards, which pose a risk to health. Food safety risk: The likelihood of harm to health resulting from exposure to hazardous agents in the food supply.
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Foodborne illness: An illness, usually either infectious or toxic in nature, caused by an agent that enters the body through the ingestion of food. Good Agricultural Practices (GAP): Practices of primary food producers (such as farmers and fishermen) that are necessary to produce safe and wholesome agricultural food products conforming to food laws and regulations. Good Manufacturing Practices (GMPs): Conformance with codes of practice, industry standards, regulations and laws concerning production, processing, handling, labeling, and sale of foods decreed by industry, local, state, national, and international bodies with the intention of protecting the public from illness, product adulteration, and fraud. Hard-currency markets: Refers to globally traded currencies that are expected to serve as a reliable and stable store of value. Factors contributing to a currency’s hard status might include the long-term stability of its purchasing power, the associated country’s political and fiscal condition and outlook, and the policy posture of the issuing central bank. Hazard: A biological, chemical, or physical agent in, or condition of, food with the potential to cause harm. Hazard analysis: The process of collecting and interpreting information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan. Hazard analysis critical control point (HACCP) plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards that are significant for food safety in the segment of the food chain under consideration. Hazard analysis critical control point (HACCP) system: The HACCP system is a scientific and systematic way of enhancing the safety of foods from primary production to final consumption through the identification and evaluation of specific hazards and measures for their control to ensure the safety of food. HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing. High-value agriculture: Agricultural goods with a high economic value per kilogram, per hectare, or per calorie, including fruits, vegetables, meat, eggs, milk, and fish (Gulati et al., 2005).
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Import lines: Finance facilities for importers covering documentary credits, bills receivables, and import loans. Lot release of vaccines: The process of evaluating each individual lot of a licensed product before giving approval for its release into the market. This process is carried out for vaccines and other biologicals in most countries. A general practice of release involves the review of manufacturer’s production data and quality control test results (product summary protocol) by national regulatory authorities and national control laboratories. This may or may not be supplemented by laboratory testing by the national control laboratory, or by an agency or contracted laboratory performing tests for the national regulatory authority. Medical devices: Medical instruments, apparatus, or materials used on patients for surgery, treatment, or diagnosis (Mori et al., 2011). Medical products: A wide range of products that include pharmaceutical drugs and medical devices. 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. Monitoring: In a HACCP plan, the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a critical control point is under control. One Health Initiative: A global strategy for expanding interdisciplinary collaborations and communications in all aspects of health care for humans, animals, and the environment. Its goal is to advance health care by accelerating biomedical research discoveries, enhancing public health efficacy, expanding scientific knowledge, and improving medical education and clinical care. One-up, one-back: In the food arena, activities performed to determine the distribution (one-up) and origin (one-back) 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 packaging and shipping dates.
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Ontology: The structural frameworks for organizing information. It represents knowledge as a set of concepts within a domain, and the relationships between those concepts. Product safety: The reduction in the probability that use of a product will result in illness, injury, death or negative consequences to people, property or equipment. Use of a product refers to its consumption, physical implantation into the body, or placement into physical use (Marucheck et al., 2011). Product security: The delivery of a product that is uncompromised by intentional contamination, damage, or diversion within the supply chain (Marucheck et al., 2011). PulseNet: A national network of federal, state, and local laboratories coordinated by the Centers for Disease Control and Prevention (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. Regulations: Establish government agencies, such as the U.S. Consumer Products Safety Commission (CPSC) and the Food and Drug Administration (FDA) with the responsibility for performing critical duties, such as approving products as safe and effective prior to entering the market, inspecting manufacturing facilities, and pursuing recalls. These agencies assure that firms meet basic rules for safety, and they also possess the authority to impose sanctions or fines when they discover violations or non-compliance (Marucheck et al., 2011). Regulatory science: The science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all regulated products. It involves training in basic sciences that relate to the regulatory system; the development and validation of regulatory tests; screening and compliance testing; investigation of test results; and submission of dossiers for government or in-house review (FDA, 2012; Irwin et al., 1997). Risk: The possibility or probability of loss, injury, disadvantage, or destruction. Risk analysis: A process consisting of three components: risk assessment, risk management, and risk communication.
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Risk assessment: 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 characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization, and exposure assessment. Risk communication: The interactive exchange of information and opinions concerning risks among risk assessors, risk managers, consumers, and other interested parties. Risk management: The process of weighing policy alternatives in the light of results of risk assessment, and, if required, selecting and implementing appropriate control options, including regulatory measures. Standard setting: The establishment of a standard through the formulation of written rules and procedures. Standards: Established norms or codified requirements for a product, such as material specifications or technical standards for performance. Standards may be developed by regulatory agencies, public organizations or industry associations (Marucheck et al., 2011). Stringent regulatory authority: A national drug regulatory authority participating in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use or the Pharmaceutical Inspection Co-operation Scheme. Countries with stringent regulatory agencies include the United States, European Union member states, and Japan, but for its purposes the committee also included Australia, New Zealand, Norway, Iceland, Switzerland, and Canada in this group. Supply chain: A system of organizations, people, technology, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chain activities transform natural resources, raw materials, and components into a finished product that is delivered to the end customer. Surveillance: A key component of epidemiology, it can be defined as the ongoing collection, analysis, interpretation, and dissemination of health-related
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad data. Surveillance is one of a number of methods used by epidemiologists to gather information on a disease. Surveillance system: A group of integrated and quality-assured, cost-effective, and legally and professionally acceptable processes, designed for the purpose of identifying in an ongoing, flexible, standardized, timely, simple, sensitive, and predictive manner the emergence of meaningful epidemiologic phenomena and their specific associations. These processes include human, laboratory, and informatics activities to skillfully manage information derived from an entire defined community (or subgroup thereof that is sufficiently representative and large) and to disseminate that information in a timely and useful manner to those able to implement appropriate public health interventions. Third party certification: An independent assessment declaring that specified requirements pertaining to a product, person, process, or management system have been met. Trace: The ability to know the historical locations, the time spent at each location, record of ownership, packaging configurations, and environmental storage conditions for a particular drug (Koh et al., 2003). Track: Involves knowing the physical location of a particular drug within the supply chain at all times (Koh et al., 2003). Track and trace: The foundation for improved patient safety by giving manufacturers, distributors, and pharmacies a systemic method to detect and control counterfeiting, drug diversions, and mishandling (Koh et al., 2003). Verification: In HACCP, the use of methods, procedures, or tests in addition to those used in monitoring to determine compliance with the HACCP plan, and/or whether the HACCP plan needs modification in order to enhance food safety. REFERENCES Active Pharmaceutical Ingredient Committee. 1999. Good manufacturing practices in active pharmaceutical ingredients development. Brussels, Belgium: APIC. Bamberger, K. A., and A. T. Guzman. 2008. Keeping imports safe: A proposal for discriminatory regulation of international trade. California Law Review 96(6):1405-1447. Casualty Actuarial Society-Enterprise Risk Management Committee. 2003. Overview of enterprise risk management. Fairfax, VA: Casualty Actuarial Society.
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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad FDA (Food and Drug Administration). 2012. The promise of regulatory science. http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228206.htm (accessed January 24, 2012). Gulati, A., N. Minot, C. Delgado, and S. Bora. 2005. Growth in high-value agriculture in Asia and the emergence of vertical links with farmers. Paper read at Workshop on Linking Small-Scale Producers to Markets: Old and New Challenges, December 15, 2005. Irwin, A., H. Rothstein, S. Yearley, and E. McCarthy. 1997. Regulatory science—towards a sociological framework. Futures 29(1):17-31. Koh, R., E. W. Schuster, I. Chackrabarti, and A. Bellman. 2003. White paper: Securing the pharmaceutical supply chain. Cambridge, MA: Auto-ID Center, Massachusetts Institute of Technology. Marucheck, A., N. Greis, C. Mena, and L. Cai. 2011. Product safety and security in the global supply chain: Issues, challenges and research opportunities. Journal of Operations Management 29(7-8):707-720. Mori, M., R. Ravinetto, and J. Jacobs. 2011. Quality of medical devices and in vitro diagnostics in resource-limited settings. Tropical Medicine and International Health 16(11):1439-1449.
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