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Appendix A Current and Proposed Definitions of Key Food Safety Terms One of the important tasks of the committee was to establish the definitions of food safety terms to be used throughout this report. Definitions of key food safety terms from a variety of agencies and organizations were thoroughly reviewed and are listed in Table A.1. To assure uniformity and consistency, the committee decided to adopt most of the definitions published by the International Commission on Microbiological Criteria for Foods (ICMSF, 2002), which are widely accepted throughout the global food safety community. There are a few terms that were specifically defined by the committee, one that was modified from the ICMSF definition, one that was adopted from the Codex Alimentarius Commission, and one that was used in a presentation to the committee (Personal communication, R. Buchanan, Food and Drug Administration, February 5, 2002~. These definitions are explained below. A microbiological criterion defines the acceptability of a product or a food lot, based on the absence or presence or number of microorganisms, including parasites, and/or the quantity of their toxins/metabolites, per unit of mass, vol- ume, area, or lot (CAC, 1997~. Microbiological criteria usually fall into three categories and include microbiological standards, guidelines, and specifications. Microbiological standards are used to determine the acceptability of a food with regard to a regulation or policy. These standards are established by regula- tory authorities and define the microbiological content that foods must meet to be in compliance with a regulation or policy. Foods not meeting the standard are in violation of the regulation or policy and are subject to removal from the market (ICMSF, 2002~. 273

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274 TABLE A-1 Definition of Terms APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSIS~ Appropriate level of protection Control point Criterion The level of protection deemed appropriate by the country establishing a sanitary or phytosanitary measure to protect human, animal, or plant life or health within its territory Any step at which biological, chemical, or physical factors can be controlled A requirement on which a judgment or . . . decision can be made Critical control A step at which A point, step, or A point, s point (CCP) control can be procedure in a procedure applied and is food process at food prod essential to which a control which cor prevent or measure can be can be ap: eliminate a food applied and at and, as a: safety hazard or which control is a food sat reduce it to an essential to hazard cat acceptable level reduce an prevented identified food eliminates hazard to an reduced to acceptable level acceptable levels

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 2 75 FSIS~ NACMCFe Codexf WTOg ECh The level of protection deemed appropriate by the country establishing a sanitary or phytosanitary measure to protect human, animal, or plant life or health within its territory Any step at which biological, chemical, or physical factors can be controlled t, step, or are in a ocess at control e can be . and at control is al to an ed food to an able level A point, step, or procedure in a food process at which control can be applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels A requirement on which a judgment or . . . decision can be made A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level continued

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276 TABLE A-1 Continued APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSIS~ Defect action Maximum level level of natural or unavoidable defect in foods for human use that presents no health hazard Food safety A statement of A statement of objective the maximum the maximum (FSO) frequency frequency and/or and/or concentration concentration of a hazard in a of a food at the time microbiologica of consumption hazard in a foo that is at the time of considered consumption tolerable for that provides consumers the appropriate Maximum levels of natural or unavoidable defects in foods for human use that present no health hazard

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 2 77 FSIS~ NACMCFe Codexf WTOg ECh urn levels rat or fable in foods can use sent no hazard A statement of the frequency or concentration of a microbiological hazard in a food appropriate for consumer protection continued

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278 TABLE A-1 Continued APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSISd Microbiological A criterion that criterion defines the acceptability of a product or food lot, based on the absence or presence or number of . . microorganisms, including parasites, and/or the quantity of their toxins/ metabolites, per unit of mass volume, area, or lot A microbiological criterion defines the acceptability of a product or food lot, based on the absence or presence or number of A yardstick on which a judgment or decision can be made: a microbiological criterion will stipulate that a type of . . microorganism, microorganisms, including group of parasites, and/or microorganisms quantity of their or toxin toxins/ produced by a metabolites, per unit(s) of mass, volume, area or lot Microbiol criteria ar regulatory standards, are bench: for evalua test result . . microorganism must either not be present at all, be present in only a limited number of samples, or be present as less than specified number or amount in a given quantity of a food or food ingredient

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 2 79 FSIS~ NACMCFe Codexf WTOg ECh Microbiological criteria are not regulatory standards, but are benchmarks for evaluating test results A microbiological criterion for food-stuffs defines the acceptability of a process, product or food lot based on the absence or presence, or number of microorganisms and/or quantity of their toxins/ metabolites, per unit(s) of mass, volume or area continued

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280 TABLE A-1 Continued APPENDIX A Term Committee Consensus ICMSFa NRCb FDAC FSISd Microbiological An advisory An advisory guideline microbiological criterion used to inform food operators of the microbiological content that can be expected in food when best practices are applied Microbiological Part of a specification purchasing agreement between a buyer and a supplier of a food; such criteria may be mandatory or advisory according to use criterion used to inform food operators of the microbiological content that can be expected in a food when best practices are applied Part of a purchasing agreement A criterion that often is used by the food industry or a regulatory agency to monitor a manufacturing process. Guidelines function as alert mechanisms to signal whether microbiological conditions prevailing at critical control points or in the finished product are within the normal range A microbiological criterion that is between a buyer used as a and a supplier purchase of a food; such requirement criteria may be whereby mandatory or advisory according to use conformance with it becomes a condition of purchase between a buyer and vendor of a food or ingredient; such criteria may be either mandatory or advisory

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 281 FSIS~ NACMCFe Codexf WTOg ECh Criteria included in legislation or regulations which are intended to guide the manufacturer and help to ensure good hygienic practice continued

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282 TABLE A-1 Continued APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSIS~ Microbiological A mandatory A mandatory A A criteria standard microbiological criterion that is microbiological is part of criterion that is incorporated criterion that is regulation incorporated into a law or a part of a law, is a legal into a law, ordinance ordinance or requireme regulation, or administrative ordinance regulation. A standard is a mandatory criterion. Failure to comply with it constitutes a violation of the law, ordinance, or regulation and will be subject to the enforcement policy of the regulatory agency having jurisdiction Monitor The act of The act of To conduct a Monitorin conducting a conducting a planned consists o planned planned sequence of observatic sequence of sequence of observations or measured observations or observations or measurement to taken to a measurements measurements assess whether whether a of control of control a process, point, is within parameters to parameters to or procedure is establishe assess whether assess whether under control critical lit a CCP is under a CCP is under and to produce control control an accurate record for use in verification

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 283 FSIS~ NACMCFe Codexf WTOg Ech A criterion that Criteria included is part of a in legislation or regulation; regulations is a legal where failure to requirement comply with them can result in rejection of the food duct a Monitoring To conduct a The act of 1 consists of planned conducting a ce of observations or sequence of planned actions or measurements observations or sequence of ement to taken to assess measurements observations or whether whether a CCP to assess measurements ss, point, is within the whether a CCP of control edure is established is under control parameters to ontrol critical limit and to produce assess whether produce an accurate a CCP is under Irate record for control for use future use in ication verification continued

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284 TABLE A-1 Continued APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSIS~ Performance The required The required A public health criterion outcome of a outcome of a goal that is step, or step, or based on relating combination of combination of the level of steps, that steps, that stringency with contributes to contribute to achieving some assuring a food assuring a food level of control safety objective safety objective over the public is met is met health impact of the hazard; it requires being able to qualitatively or quantitatively relate the level of hazard in a food with its public health impact Performance The degree to The degree to Performar standard which a step or which a step or standards combination of combination of prescribe steps in the steps in the objectives production, production, levels of processing, processing, performer distribution, distribution, (such as and/or and/or pathogen preparation of preparation of reduction a food must a food MUST standards operate to operate to raw prods achieve the achieve the establishn required level desired level must achi~ of control over of control over a hazard a hazard

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 285 FSIS~ NACMCFe Codexf WTOg ECh ic health at is in relating e1 of Icy with ng some f control e public impact of arc; it s being Lively or atively he level of in a food , public impact gree to ~ step or ration of ~ the Lion, sing, action, rtion of MUST to the level rot over d Performance standards prescribe the objectives or levels of performance (such as pathogen reduction standards for raw product) establishments must achieve Defines the expected level of control at one or more steps in a process: establishing and meeting performance standards can be a means of reaching public health goals to reduce foodborne illness; the stringency of a performance standard should be proportional to the risk and stated public health goals continued

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286 TABLE A-1 Continued APPENDIX A Term Committee Consensus ICMSFa NRCb FDAC FSISd Process criteria The control parameters of a step, or combination of steps, that can be applied to achieve a performance criterion Processing The FSO minus safety objective projected pathogen growth Product criterion Public health goal Public health objective A parameter of a food that can be used to assess the acceptability of a lot or consignment The desired outcome associated with reducing the burden of . . alsease In society A measurable population-based target for maintaining or improving health The control parameters of a step, or combination of steps, that can be applied to achieve a performance criterion The FSO minus projected pathogen growth A parameter of a food that can be used to assess the acceptability of a lot or consignment

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 287 FSIS~ NACMCFe Codexf WTOg ECh continued

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288 TABLE A-1 Continued APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSISd Tolerable level The level of of risk risk proposed following consideration of the public health impact, technological feasibility, economic implications, and that which society regards as reasonable in the context of, and in The level of risk proposed following consideration of public health impact, technological feasibility, economic implications, and that which society regards as reasonable in the context of, and in comparison with, comparison with, other risks in other risks in everyday life everyday life Validation Obtaining evidence that the elements of the Hazard Analysis and Critical Control Point (HACCP) plan are effective Obtaining evidence that the elements of the HACCP plan are effective Element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP plan, when properly implemented, will effectively control the identified food hazards The scion and techn: process fc determinist that the C and assoc: critical lit are adequ and suffix: to control likely haz

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 289 FSIS~ NACMCFe Codexf WTOg ECh at of action 1 on ng and sing Be. arc and al Action to one r the P plan, Properly rented, ectively the ed food The scientific and technical process for determining that the CCPs and associated critical limits are adequate and sufficient to control likely hazards The element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards Obtaining evidence that the elements of the HACCP plan are effective continued

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290 TABLE A-1 Continued APPENDIX A Committee Term Consensus ICMSFa NRCb FDAC FSIS~ The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan Zero tolerance Lay audience perception of the absence of a hazard that cannot be scientifically assured, but is operationally defined as the absence of a hazard in a specified amount of food as determined by a specific method The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan Those activities, other than monitoring, that establish the validity of the HACCP plan and that the system is operating according to the plan a ICMSF = International Commission on Microbiological Criteria for Foods (ICMSF, 1997, 1998, 2002). b NRC = National Research Council (NRC, 1985). c FDA = Food and Drug Administration (FDA, 1995, 2001). d USDA = U.S. Department of Agriculture (USDA, 1996). e NACMCF = National Advisory Committee on Microbiological Criteria for Foods (NACMCF, 1997, 2002). f Codex = Codex Alimentarius Commission (CAC, 1997). g WTO = World Trade Organization (WTO, 1995). h EC = European Commission (EC, 1999).

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 291 FSIS~ NACMCFe Codexf WTOg ECh activities, Ian ring, ;ablish City of .CCP id that Em iS :lg ng to Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine compliance with the HACCP plan 997, 1998, NACMCF,

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292 APPENDIX A Microbiological guidelines are usually established by a regulatory authority, industry trade association, or a company to indicate the expected microbial content of a food when best practices are applied. Food companies use microbiological guidelines as a basis to design their control systems. These guidelines are advi- sory in nature and may not lead to rejection of a food (ICMSF, 2002~. Microbiological specifications are used by buyers of a food or ingredient to reduce the likelihood of purchasing a product that may be of unacceptable safety or quality. Microbiological specifications can define the microbiological limits for an ingredient so that when it is used, the final product will meet all the requirements for safety and quality. Buyers throughout the food system establish microbiological specifications for materials they purchase. In most cases, specifi- cations are advisory and the materials are sampled periodically. When microbio- logically sensitive ingredients are purchased, each incoming lot may be sampled and tested (ICMSF, 2002~. A performance standard is the degree to which a step or combination of steps in the production, processing, distribution, and/or preparation of a food must operate to achieve the desired level of control over a hazard (Personal communi- cation, R. Buchanan, Food and Drug Administration, February 5, 2002~. The term performance standard does not appear anywhere in the U.S. Department of Agriculture Pathogen Reduction/Hazard Analysis and Critical Control Point Final Rule (USDA, 1996), but was incorporated from regulations used in other industries. It should be noted that the committee defined a food safety objective as a statement of the maximum frequency and/or hazard in a food at the time of consumption that is considered tolerable for consumer protection. This is broader and less restrictive than the ICMSF definition of the term because it includes microbiological, chemical, and physical hazards. It should also be noted that the committee changed the word "acceptable" to "tolerable" because contamination of food is seldom acceptable; it cannot be deemed "appropriate" either. A public health objective is a measurable population-based target for main- taining or improving health, while a public health goal is the desired outcome associated with reducing the burden of disease in society. The committee defined the term zero tolerance as the lay audience percep- tion of the absence of a hazard that cannot be scientifically assured but is opera- tionally defined as the absence of a hazard in a specified amount of food as determined by a specific method. REFERENCES CAC (Codex Alimentarius Commission). 1997. Hazard Analysis and Critical Control Point System and Guidelines for its Application. Annex to CAC/RCP 1-1969, Rev. 3-1997. Rome: CAC.

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CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 293 EC (European Commission). 1999. The Evaluation of Microbiological Criteria for Food Products of Animal Origin for Human Consumption. Online. Available at http://europa.eu.int/comm/food/ fs/sc/scv/out26_en.pdf. Accessed March 14, 2003. FDA (Food and Drug Administration). 1995. Procedures for the safe and sanitary processing and importing of fish and fishery products; Final rule. Fed Regist 60:65095-65202. FDA. 2001. HACCP procedures for the safe and sanitary processing and importing of juice: Final rule. Fed Regist 66:6137-6202. FSIS (Food Safety and Inspection Service). 1996. Pathogen reduction; Hazard analysis and critical control point (HACCP) systems; Final rule. Fed Regist 61:38805-38855. ICMSF (International Commission on Microbiological Specification for Foods). 1997. Establish- ment of microbiological safety criteria for foods in international trade. World Health Stat Q 50:119-123 . ICMSF. 1998. Potential Application of Risk Assessment Techniques to Microbiological Issues Re- lated to International Trade in Food and Food Products. J Food Prot 61: 1075-1086. ICMSF. 2002. Microorganisms in Foods 7. Microbiological Testing in Food Safety Management. New York: Klewer Academic/Plenum Publishers. NACMCF (National Advisory Committee on Microbiological Criteria for Foods). 1997. Hazard analysis and critical control point principles and application guidelines. J Food Prot 61: 1246- 1259. NACMCF. 2002. Final. Response to the Questions Posed by FSIS Regarding Performance Standards with Particular Reference to Ground Beef Products. Online. FSIS, U.S. Department of Agricul- ture. Available at http://www.fsis.usda.gov/OPHS/nacmcf/2002/rep_stand2.pdf. Accessed March 12, 2003. NRC (National Research Council). 1985. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. Washington, DC: National Academy Press. USDA (U.S. Department of Agriculture). 1996. Pathogen reduction; Hazard analysis and critical control point (HACC) systems; Final rule. Fed Regist 61:38805-38989. WTO (World Trade Organization). 1995. Agreement on the Application of Sanitary and Phytosanitary Measures (SPS). Geneva: WTO.