APPENDIX D
Glossary

Abeyance Temporary inactivity, cessation, or suspension.

Adulterant Any substance that lessens the purity or effectiveness of another substance.

ALLRTE Food Safety and Inspection Service (FSIS) testing program for Listeria monocytogenes in which inspectors sample products at random.

AssuranceNet FSIS web-based system that monitors field activities and helps ensure that its enforcement actions are consistent nationwide.

Enforcement action Measure of an establishment’s ability to implement and maintain corrective action once a noncompliance is observed and documented. FSIS can take a variety of enforcement actions (e.g., notice of intended enforcement [NOIE], suspension, and inspection under consent order) against establishments that fail to comply sufficiently with applicable requirements.



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74 APPENDIX D Escherichia coli O157:H7 An enterohemorrhagic strain of E. coli that produces large quantities of toxins that cause severe damage to the lining of the intestine. It is the most commonly identified Shiga toxin- producing E. coli (STEC) in North America. As a bacterial pathogen, E. coli O157:H7 is capable of causing foodborne infections in humans. Food Safety Assessment Assessment conducted by FSIS to analyze an establishment’s control of its food safety systems. FSAs assess all aspects of an establishment’s food safety system in accordance with FSIS Directive 5100.1. While performing an FSA, Enforcement, Investigations, and Analysis Officers (EIAOs) assess whether meat and poultry establish- ments have designed their food safety systems to control, and thereby mini- mize, the presence of Salmonella, E. coli O157:H7, and L. monocy-togenes. Foodborne disease Disease caused by the consumption of contaminated foods or beverages. Many different disease-causing pathogens can contaminate foods, resulting in many different foodborne infections. The most commonly recognized foodborne infections are those caused by the bacteria Salmonella, E. coli O157:H7, and Campylobacter and by a group of viruses known as the Norwalk and Norwalk-like viruses. For-cause FSA As part of FSIS’s new information technology system, a for-cause proce- dure is generated when a prompt threshold is reached. An inspector

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APPENDIX D 75 will be instructed to assess the pres- ence and implementation of controls by answering questions regarding vul- nerable points. Inspectors will record answers to questions about vulnerable points and will decide if further regu- latory actions are appropriate. Generic E. coli A normal bacterial inhabitant of the intestines of all animals, including humans. Normally E. coli serves a useful function in the body by suppressing the growth of harmful bacterial species and by synthesizing appreciable amounts of vitamins. It is not typically a foodborne pathogen. Hazard Analysis Critical A process control system that Control Point (HACCP) identifies where hazards might occur in the food production process and puts into place stringent actions to prevent the hazards from occurring. By strictly monitoring and controlling each step of the process, there is less chance for hazards to occur. Hazard Assessment A proposed inspection activity in Verification (HAV) which FSIS in-plant inspectors review certain components of the facility’s process controls (e.g., HACCP moni- toring and verification activities). HAV is considered an intensified rou- tine inspection activity that is con- ducted by specifically trained in-plant inspectors. Indicator of process control A measurable attribute that indicates whether a process maintains or surpasses an acceptable degree of risk or hazard control. An adequate

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76 APPENDIX D indicator is an attribute that can be measured with objectivity and for which limits that define the need for corrective actions can be determined. Intensified Verification Follow-up verification testing done by Testing (IVT) FSIS when a product sample from any operation involving any ready-to-eat 90RTE meat or poultry product is found to be positive for L. monocyto- genes. This intensified verification testing is done after the establishment has taken corrective and preventive actions. IVT could occur because of a history of having produced adulterated product, for investigative purposes, or because there is a concern that the es- tablishment may not be properly con- trolling for pathogens. Kill step When referring to a food process, the step in the production process (e.g., heat treatment) that will reduce the pathogen level in the product to an undetectable level. Lift analysis A data mining tool that can identify associations between two variables separated in time. A “lift” is a measure of how much better prediction results are using a model than could be obtained by chance. Since lift is computed using a data table with actual outcomes, lift compares how well a model performs with respect to the data on predicted outcomes. Lift indicates how well the model improved the predictions over a random selection, given actual results. Lift allows a user to infer how a model will perform on new data. It works by

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APPENDIX D 77 binarizing the input and the output data streams and aggregating binary observations accumulated over time in a 2-by-2 contingency table. A Gram-positive bacterium that has Listeria monocytogenes been found in at least 37 mammalian species, both domestic and feral, as well as at least 17 species of birds and possibly some species of fish and shellfish. It can be isolated from soil, silage, and other environmental sources. L. monocytogenes is quite hardy and resists the deleterious ef- fects of freezing, drying, and heat re- markably well for a bacterium that does not form spores. Most L. mono- cytogenes are pathogenic to some de- gree. Listeria spp. Species of Listeria, a Gram-positive bacteria, found as single short rods or chains approximately 0.5 micron wide and 1 micron long. Listeria may swim with 1-5 flagella to invade human cells. Microorganism An organism (bacterium or protozoan) of microscopic or ultramicroscopic size. Noncompliance report (NR) A record completed by FSIS inspection program personnel each time they determine that an establish- ment is not in compliance with regulatory requirements. The NR explains the nature of the regulatory action and informs the establishment’s management of the noncompliance. Once issued, an establishment must

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78 APPENDIX D take action to remedy the situation and should take measures to prevent its recurrence. Notice of Intended Type of enforcement action taken by Enforcement FSIS against establishments that fail to comply sufficiently with applicable regulatory requirements. Organoleptic Any sensory properties of a product, involving taste, color, odor, and feel. Organoleptic testing involves inspec- tion through visual examination, feeling, and smelling of products. Outbreak With reference to food, the occurrence of two or more cases of a similar illness resulting from ingestion of a common food. Pathogen An agent of disease. The term pathogen most commonly is used to refer to infectious organisms such aas include bacteria, viruses, and fungi. Less commonly, pathogen refers to a noninfectious agent of disease such as a chemical. Performance standard According to FSIS, a standard pre- scribing the objectives or levels of per- formance (e.g., pathogen reduction standard for a raw product) that an establishment must achieve. Process control Within the limits of a stable and predictable process variation, a hazard is controlled to an acceptable level. This variation needs to be defined and the process must be monitored so that corrective actions are implemented before limits are surpassed.

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APPENDIX D 79 Pulsed field gel A molecular method that identifies electrophoresis organisms by their genotypes. It is an electrophoretic technique in which the gel is subjected to electrical fields alternating between different angles, allowing very large DNA fragments to snake through the gel and, hence, permitting efficient separation of mixtures of such large fragments. The resulting electrophoretic patterns are highly specific for strains from a variety of organisms and provide an opportunity to examine multiple variations throughout the genome of the organism so as to identify specific strains and accurately link them with disease outbreaks. Ready-to-eat (RTE) foods Products that have received a lethality treatment. The lethality treatment, generally a cooking procedure, must be designed to eliminate pathogens or harmful bacteria. This lethality treat- ment makes the product safe to eat without additional preparation by the consumer to achieve food safety. Recall Withdrawing of a product (e.g., food) from the marketplace in response to detection of a problem. Reasons for a recall may be the potential for the product to be hazardous to health but might also include a labeling error that would have no health consequences. Relative risk ranking Prioritization of items based on the level of risk to which they will expose the population.

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80 APPENDIX D Risk-based inspection Inspection methods that are based on system the risks inherent in processing and slaughter operations. RTE L. monocytogenes One of several options that establish- ments producing L. monocytogenes- alternatives 1, 2, or 3 exposed RTE meat and poultry prod- ucts are required by regulation to adopt for those products that have been exposed to the environment after a lethality step (i.e., post-lethality). The L. monocytogenes alternative categories are as follows: Alternative 1—Establishments that apply both a post-lethality treatment to an RTE product to reduce or eliminate microorganisms on the product and the use of an antimicrobial agent or process as part of the product formu- lation. Alternative 2—Establishments that apply either Alternative 2A—A post-lethal- ity treatment to limit the growth of L. monocytogenes on the product, or Alternative 2B—An antimicro- bial agent or process as part of the formulation. Alternative 3—Establishments that rely only on testing and sanitation measures. RTE001 Risk-based FSIS testing program for L. monocytogenes in which establish- ments are selected for testing based on risk factors identified in its peer- reviewed L. monocytogenes risk assessment.

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APPENDIX D 81 Any of various gram-negative, rod- Salmonella shaped bacteria of the genus Salmonella that are pathogenic in humans and animals. Salmonella verification An FSIS program launched in 1998 to testing monitor the effectiveness of its PR/HACCP rule on Salmonella performance standards for slaughter establishments and establishments that produce raw ground meat product. This program assesses process control in individual establishments. The program also provides feedback to stimulate industry action to reduce human exposure to Salmonella in raw meat and poultry. Eight product classes are subject to sampling: three ground products (beef, chicken, and turkey), and five carcass classes (young chickens; young turkeys; market hogs; steers or heifers; and cows or bulls). Serotype A group of closely related micro- organisms distinguished by a characteristic set of antigens. Shiga toxin-producing A group of E. coli that cause disease E. coli (STEC) by producing Shiga toxin. The most commonly identified STEC in North America is E. coli O157:H7. STEPS (System for Tracking A database developed by FSIS that E. coli Positive Suppliers) identifies suppliers of trim to grinding Database operations whose ground beef product is positive for E. coli O157:H7. W3NR The noncompliance reports (i.e., regulatory requirements) that were

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82 APPENDIX D considered by an FSIS panel to be most strongly related to public health and, thus, indicative of a definite loss of process control. About 12 percent of all possible NRs were identified as W3NRs. Zero tolerance FSIS policy that has been established for E. coli O157:H7 in non-intact raw beef products and for Salmonella, L. monocytogenes, and E. coli O157:H7 in RTE meat and poultry products. Contamination of those products with these microorganisms is considered adulteration by FSIS; therefore, regulatory action is taken if these pathogens are present in those products.

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Appendix E Biographical Sketches of Committee Members Sanford A. Miller, Ph.D., Chair, is a senior fellow at the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland, College Park. In December 2000, he was named professor and dean emeritus of the Graduate School of Biomedical Sciences at the University of Texas Health Science Center at San Antonio, where he was the dean of the Graduate School of Biomedical Sciences and professor in the Departments of Biochemistry and Medicine from 1987 to 2000. He is the former director of the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration (FDA). Previously, he was a professor of nutritional biochemistry at the Massachusetts Institute of Technology. Dr. Miller has served on many national and international government and professional society advisory committees, including as chair of the Joint Food and Agriculture Organization-World Health Organization (FAO-WHO) Expert Consultation on the Application of Risk Analysis to Food Standards Issues. His honors include the Conrad A. Elvehjem Award of the American Institute of Nutrition, the Babcock- Hart Award of the Institute of Food Technology, the Esther Peterson Consumer Service Award from the Food Marketing Institute, the Sterling B. Hendricks Award from the U.S. Department of Agriculture, and election to fellow of the American Society for Nutrition. In June 2000, he was the recipient of the FDA’s Distinguished Alumni Award. He has been a member of many National Academy of Sciences committees, including the Food and Nutrition Board’s Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Subcommittee on Upper Reference Levels of Nutrients, and Panel on Macronutrients. He was named a national associate of the National Academies in 2002. He is author or coauthor of more than 200 original scientific publications. Dr. 83