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Index A "Acceptable" level of contamination, 72, 251, 292 Acceptance sampling, 111, 113, 256 Acid-spray systems, 166 Acquired immune deficiency syndrome, 53, 126 Active case ascertainment, 33-34 Adulteration and adulterants defined, 15 E. cold 0157:H7 as, 77, 141, 261 enforcement testing, 82 federal regulation of, 14-15, 19, 77, 82, 144-145 of ground beef, 77, 141, 144-145, 156-160, 261 L. monocytogenes as, 160 performance standards, 156-160 of processed foods, 16 of produce, 216 of ready-to-eat foods, 160 Salmonella as, 155-216 Aerobic mesophilic organisms, international criteria for produce, 322-323, 330-337, 355-356 international criteria for dairy products, 364 Aerobic microorganisms, international criteria for produce, 322-323, 326-327, 332- 335, 338-347, 350-351, 354-355 379 Aerobic plate counts for dairy products, 360-363 international criteria, 218, 326-333, 338- 339, 348-353, 360-363 for produce, 218, 326-333, 338-339, 348- 353 Agricultural Marketing Act of 1946, 185 Aldrin, 305 American Public Health Association, 15 Amnesiac shellfish poison, 304 Anabolic steroid hormones, 146 Anaerobic sulfite-reducing bacteria, international criteria for produce, 330- 333 Animal and Plant Health Inspection System (APHIS), 49, 51, 153 Animal drug residues in meat and poultry, 146-147, 262 in milk, 79, 232 "no residue" standard, 147, 262 performance standards, 17, 18, 146-147 in seafood, 183 zero tolerance standard, 24 Animal feeds, Salmonella contamination, 50 Antibiotics, 54, 79, 147, 183 Antimicrobial resistance AmpC gene profile, 58 antibiotic therapy and, 54, 147 Campylobacter, 32-33, 86

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380 as endpoint in risk characterization, 80-81 in Enterobacteriaceae, 32-33, 58-59 monitoring, 32-33, 51, 52, 58-59 public health impacts, 86 risk assessment, 86 Salmonella, 32-33, 37-38, 54, 58-59 sharing of data on, 51, 52 AOAC International, 51 Apple cider, 55-56 Appropriate level of protection (ALOP) cost-benefit considerations, 122- 124 defined, 92, 274-275 FSOs and, 92-93, 255 Argentina, produce from, 198 Arsenic, 305 Australia, microbiological criteria, 233, 321, 322-323, 362-363 B Bacillus spp. B. cereus, 77, 242-243, 307, 318, 322-327, 334-335, 338-339, 342-343, 346-347, 352-355 B. subtilis, 324-327, 342-343, 346-347, 354-355 in dairy products, 242-243 heat resistance, 230 international criteria for produce, 322-327, 334-335, 338-339, 342-343, 346-347, 352-355 in ready-to-eat foods at point of sale, 318 risk assessment, 77 Bauman, Howard, 21 Beef and beef products. See also Ground meats; Meat and poultry products adulteration of, 144-145, 156-160 behavioral risk-factor survey, 37 boxed meat, 134 case-ready meat, 134 cooked beef, roast beef, and cooked corn beef products, 55, 145-146 E. cold 0157:H7, 29, 31, 42, 45, 86, 144- 145, 156-160, 172 HACCP system, 162-163 pathogens linked to, 44 performance standards, 162-163 processed products, 134 production, 133-134, 145-146 raw meat, 41 risk assessment, 86 INDEX Salmonella in, 19, 32-33, 37-38, 55, 58-59, 161 Behavior. See Consumer behavior Behavioral Risk Factor Surveillance System (BRFSS), 35, 37, 46 Benzene hexafluoride, 305 Best Aquaculture Practices, 194 Boric acid, 14 Bovine spongiform encephalopathy, 47-48, 59, 230 Bovine tuberculosis, 24 Brucella abortus, 70, 226, 234-235 Brucella militensis, 242-243 Burden of disease allocating, 30, 33, 43-46, 52, 153, 250 measuring, 30, 37-39 C Canada Cadmium, 305 Calcivirus, 199 California League of Food Processors, 212 California Strawberry Commission, 203 Campylobacter spp., 18 antimicrobial resistance, 32-33, 86 C. jejuni, 199, 242-243, 307, 308 case-control study, 34 complications and sequellae, 37 in dairy products, 44, 242-243, 362-363 in drinking water, 44 incidence, 40-41, 42 international criteria for, 318, 324-327, 338- 339, 342-343, 346-347, 354-355 national goals, 42 in poultry, 44, 45, 49, 86, 88, 172, 173 prevalence, 169-170, 173 in produce, 199, 218, 324-327, 338-339, 342-343, 346-347, 354-355 in ready-to-eat foods at point of sale, 318 reservoir, 45 risk assessment, 86, 88 surveillance strategies, 30, 36, 40-41, 173 dairy product criteria, 160, 233, 235 outbreaks, 235, 236 produce criteria, 320, 322-323, 340-341 risk assessment study, 87 seafood safety, 193 surveillance system, 32 Canned foods. See Low-acid and acidified canned foods

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INDEX Canners League of California, 212 Case-control studies, 34, 45 Cattle inspection, 20 Center for Science in the Public Interest, 199 Center for Veterinary Medicine (CVM), 51, 146, 147 Centers for Disease Control and Prevention, 23, 31, 185 antimicrobial resistance monitoring, 32-33, 51, 58-59 surveillance activities, 31, 32-33, 34, 35, 82, 199 Cheese and cheese products aging period, 60-day, 226, 234-236, 245, 272 Brucella abortus in, 226, 234-235 E. cold 0157:H7 in, 226, 236 emerging food safety concerns, 235-236 FDA Food Compliance Program, 237-238 identity standards, 234, 271-272 imported, 237-238 inspection, 237-239 L. monocytogenes in, 160, 226, 236 labeling, 237, 272 microbial standards for, 12, 160, 236, 270, 272, 367-368 from pasteurized milk, 233 raw-milk, 41, 234-236 Salmonella in, 235-236 Chemical risk assessment dose response assessment, 75-77 exposure assessment, 77-80 hazard identification, 75 microbial risk assessment compared, 74-83 pesticides, 77, 80, 217 quantitative, 73 risk characterization, 80-83 Chesapeake Bay, 17 Childhood diarrhea! illnesses, 38, 225 Chile, produce from, 198 Chloramphenicol, 147, 183 Chlordane, 304 Chlordecone, 304 Chlorination, 165 Cholera, 29 Chromium, 305 Ciguatera poisoning, 44, 185, 191 Clostridium species C. botulinum, 70, 96, 107, 111, 113, 146, 161, 184, 191, 199, 211-216, 268, 304, 307, 308 381 C. perfringens, 43, 145, 161-162, 307, 318, 322-325, 328-329, 334-335, 338-339, 342-343, 346-349, 352-355 in canned foods, 70, 96, 107, 111, 113, 211- 216, 268-269 D values, 214 heat resistance, 212, 214, 230 incidence of infections, 43 international criteria, 318, 322-325, 328- 329, 334-337, 346-349, 352-355 in meat, 145, 161-162 outbreaks, 211-212, 215, 216 in produce, 199, 322-325, 328-329, 334- 338, 342-343, 346-349, 352-355 in ready-to-eat foods, 145, 318 in seafood, 184, 191 stabilization standards, 113, 143, 146, 161- 162 Code of Federal Regulations HACCP in, 70 sanitation standards, 141 zero tolerance language, 24-25 Codex Alimentarius Commission Committee on Food Hygiene, 92 definitions of food safety terms, 273, 283, 289, 291 HACCP guidelines, 71 maximum residue level, 81 milk product criteria, 364 produce criteria, 205, 209 seafood criteria, 193, 194 Coliforms. See also Fecal coliforms international criteria for dairy products, 360-364 international criteria for produce, 322-327, 330-335, 338-339, 348-353, 356-357 Commercially sterile standard for produce, 213, 334-335 Congenital toxoplasmosis, 38 Consumer behavior difficulties in changing, 127 food safety education impacts, 46-47, 54, 173, 174 and pathogenesis, 53, 54 surveys, 35, 37, 46-47 Consumer safety warnings, 41 Contamination with microorganisms. See also Cross-contamination; Fecal contamination dairy pathways, 241-244 hot spots, 78-79, 111, 256

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382 meat and poultry pathways, 142-144, 169- 173, 263, 300 monitoring herds and flocks, 172-173 multiple points during processing, 79-80, 160 pre-slaughter interventions, 169-172, 263 produce pathways, 201, 202, 203, 204, 206, 209 Continuous process improvement, 108-109, 110, 113, 139, 151, 256, 258 Control point defined, 274-275 Cooperative State Public Health Service Program, 270 Cornell University, 203 Council of State and Territorial Epidemiologists, 31 Countercurrent scalders and chillers, 165-166 Coxiella burnetti, 70, 228, 229-230 Criterion. See also Food safety criteria; Microbiological criteria; Performance criteria; Process control criteria; Product criterion defined, 274-275 Critical control points (CCPs). See also Hazard Analysis and Critical Control Point system defined, 71, 274-275 fecal contamination as, 164 FSOs and, 89, 94, 255 inappropriate identification of, 72-73, 139- 140, 159 monitoring, 282-283 processing times and temperatures, 70, 308 targeting, 250 tolerances at, 71-72 validation, 289 Cross-contamination pathways, 50, 51, 52, 79-80, 84, 149, 155, 158, 159, 164-165, 250, 254 prevention, 51, 55, 88, 164-165 rates, 80, 254 surrogate data, 84 Cryptosporidium C. parvum, 206, 207, 208 in juices, 56, 199, 206, 207, 208 maximum contaminant level, 16 pathogenesis, 53, 54 trends, 42 Cuba, produce criteria, 320, 322-323, 352-353 Cyclospora infections, 42, 44, 199, 201 C. cayetanesis, 201 INDEX D 2,4-D, 304 Dairy products. See also Cheese and cheese products; Milk and milk products Campylobacter in, 44, 242-243, 362-363 contamination pathways, 241-244 E. cold in, 360-363 E. cold 0157:H7 in, 44, 50, 242-243 grading and inspection program, 238-239 HACCP implementation, 70, 240-241 international microbiological criteria for, 359-364 Listeria in, 41, 160, 242-243, 271, 360-363 outbreaks related to, 241-244 pathogens linked to, 44, 241-244, 269 performance standards, 225-247 public health impacts of standards and criteria, 241-244 recommendations, 4, 236, 244, 269-272 Salmonella in, 44, 53, 242-243, 271 USDA role, 238-239, 366-369 Data collection and dissemination. See also Monitoring hazards in the food chain; Public health surveillance on antimicrobial resistance, 51, 52 baseline data, 150, 152, 205, 267 for developing criteria and standards, 102, 103, 104, 106-107, 253-254 electronic exchange of laboratory data, 51 environmental and product testing, 48 gaps in knowledge, 83-85, 102, 103, 104- 105, 107, 116, 148, 255 on generic E. cold data, 151 interagency cooperation, 51, 82, 88, 152, 219, 267 Microbiological Data Program, 205 pilot studies to collect data, 106-107, 116, 148, 253 product monitoring and testing, 115-116 public health impacts, 54-59 recommendations, 2, 48, 106, 116, 151, 250, 253-255, 257, 267 residues in food, 81-82 in risk assessments, 83-85, 87, 253, 255 sampling protocols, 48-49, 111, 113, 114, 115, 253-254, 256 standardization of, 50-51 for statistical process control, 115-116 strategies, 29-31, 32, 48, 50-51, 267 surrogate data, 84 surveys, 28-31, 32, 33, 34, 48, 50-51, 54-59

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INDEX DDT, TDE, and DDE, 304 Deer, 56, 206 Defect action level defined, 275-276 for filth, 310-313 for produce, 217-218, 306-319 Definitions of food safety terms, 273-293 Denmark, Salmonella surveillance, 46, 51, 173 Developing criteria and performance standards appropriate data for, 102, 103, 106- 107, 148, 251 combination strategy, 104-106, 113, 147- 148, 252, 268 competing factors, 149 expert-based strategy, 104 historic background, 16- 17 laboratory-based strategy, 102-104 for meat and poultry, 147-149, 262 recommended process for, 3, 105, 106, 116, 252-254 science-based approach, 3, 101-106, 115- 116, 147-149, 252-254 for seafood, 184 transparency in, 3, 114-115, 116, 148, 162, 192, 219, 252-253, 262 Diagnostic testing and investigation, 39, 125- 126, 229, 257 Dieldrin, 305 Diquat, 304 Disability Adjusted Life Years, 38 Disinfection of seeds, 57-58 DNA, 54 DNA probe methods, 125 Dose-response assessment chemical, 75-77, 80, 82 data gaps in, 83 and FSOs, 90-91, 93 microbial, 53, 75-77, 83, 90-91, 254 surrogate data, 84 Dose-response relationships, 53. See also Pathogenesis of microorganisms chemical vs. microbial, 76, 78 microbial models, 81 outbreaks and, 53 Drinking water Campylobacter in, 44 maximum contaminant levels, 16 quality and safety, 15-16 risk assessment, 87 Dyes, 14 383 Ee-CAM, 51 Economics of food safety criteria costs and benefits of regulations, 118- 119, 165-168, 257, 262-263 effectiveness considerations, 117, 127-128 efficiency considerations, 117 equity considerations, 117- 118 indirect impacts, 168-169 innovation and, 120-121, 124, 168-169 inspection methods, 138 lessons from environmental regulations, 120 limits of science and, 126-127, 257 meat and poultry standards, 165-169, 262- 263 pasteurization, 245 pathogen reduction standards, 119, 121, 166-168 PR/HACCP rule costs and benefits, 165- 169, 262-263 process control strategies, 116-124 public health impacts, 23, 168- 170 recommendations, 257, 262-263 Regulatory Impact Assessment, 116, 165- 167 in risk management, 119, 121-124 for seafood, 188- 194 strengthening performance standards, 107 uncertainty in, 124 Ecuador, produce from, 198 Egg Quality Assurance Programs, 49, 56-57 Eggs. See Shell eggs and egg products Electronic Foodborne Outbreak Reporting System, 34 eLEXNET, 51 EnterNet, 32, 34 Enterobacter sakazakii, 231 Enterobacteriaceae antimicrobial resistance, 32-33, 58-59 as indicator organisms, 318 international criteria for produce, 334-337, 352-353 Enterococci, international criteria for produce, 330-331 Environmental regulations, 120 Environmental stresses, 53-54 Escherichia cold (generic) assay methods, 125 in dairy products, 360-363

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384 as indicator organism, 23, 114, 141, 142, 143-144, 149-152, 163, 166, 209, 258- 259, 318 international criteria, 319, 322-325, 328-339, 342-343, 346-347, 352-357, 360-363 meat and poultry, 141, 142, 143, 144, 149- 152, 163, 258 process control criteria, 99-100, 108, 143- 144, 149-152 in produce, 50, 99-100, 209, 319, 320, 322- 325, 328-329 in ready-to-eat foods at point of sale, 318 in seafood, 305, 308 a surrogate for E. cold 0157:H7, 83 time and temperature guidance for controlling, 308 tube dilution screening method, 15 Escherichia cold 0157:H7 as adulterant, 77, 141, 158, 261 in alfalfa sprouts, 57-58 assay methods, 158 complications and sequellae, 37, 79 cross-contamination pathways, 84, 156, 158, 201, 204, 216 in dairy products, 44, 50, 226, 236, 242-243 in ground beef, 29, 31, 42, 44, 45, 86, 141, 144-145, 153-154, 156-160, 163, 261 HACCP plan, 153-154, 163 incidence, 42, 158, 160 international criteria, 318, 322-325, 328- 329, 342-343, 346-347 in juice, 55-56, 96-97, 114, 199, 206, 208, 209-210, 268 national goals, 42 outbreaks, 21, 29, 31, 32, 44, 57, 163, 206 pathogenesis, 158, 159 performance standard, 156-160 prevalence, 169-170, 171, 173, 261 in produce, 44, 57, 199, 201, 204, 205, 206, 216, 219, 318, 322-325, 328-329, 342- 343, 346-347 in ready-to-eat foods at point of sale, 318 reduction measures, 158 research recommendations, 159, 261 reservoir, 44, 159 risk assessment, 86 in seafood, 303, 307 subtyping, 34, 43, 49 surrogates for, 83 surveillance, 42, 43 zero tolerance policy, 158, 163, 173, 261 INDEX European Union Cost Action 920, 88 criteria for dairy products, 233, 360-362 definitions of food safety terms, 279, 281, 283 maximum residue level, 81 surveillance system, 32, 34, 173 Exposure assessment, 77-80, 83 F Farm safety objectives, 95 Fecal coliforms international criteria for produce, 322-323, 334-335, 338-339, 350-351, 355-356 for shellfish, 17, 184 Fecal contamination. See also Escherichia cold (generic) as CCP, 164 eggs, 56 generic marker for monitoring, 23, 48, 141, 142, 143-144, 149-152, 163, 166, 258- 259, 318 inspection for, 14, 21, 110 of meats, 18, 149-152, 163, 164, 169-170, 171 monitoring, 23, 47, 48 of produce, 50, 198, 202, 203, 204, 209, 320 of shellfish harvest waters, 15, 17, 47, 55 streptococcal, 150 Federal Advisory Committee Act, 192 Federal Food and Drugs Act of 1906, 15, 217 Federal Food, Drug, and Cosmetic Act of 1938, 15, 18, 216, 237 Federal Meat Inspection Act, 14, 19, 136, 144- 145, 258 Filth defect action levels, 310-313 theory of disease, 13-14, 15, 248 Finland, Salmonella monitoring, 57, 173 Fish and Fisheries Hazards and Control Guide. 186, 190-192, 193-194, 264 Fluridone, 305 Food additives, 77 Food and Agriculture Organization, 88 Food and Drug Administration authority, 17, 74, 227, 228, 237-238, 240, 270 definitions of food safety terms, 282, 284, 288, 290

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INDEX Division of Dairy and Egg Safety, 227, 233 drug approval process, 74, 75-76, 77-78 Food Compliance Program, 237-238 HACCP regulations, 71, 251 Model Food Code, 91, 139 monitoring programs, 47 Office of Regulatory Affairs, 237 predecessor, 14 produce guidance document, 203 risk assessment role, 80 seafood guidance levels, 183- 184, 303-308 State Training Branch, 240 surveillance role, 32-33, 49-50, 51, 58, 205, 267 Food Compliance Program, 237-238 Food-processing operations. See also Process control criteria for canned foods, 215 grinding, 78, 153, 156-158, 165, 167, 261 high-pressure, 59, 121 and hot spots of contamination, 78-79 innovative, 121, 215, 219 multiple points of contamination in, 79-80 stability and capability considerations, 107- 109 times and temperatures, 55, 70, 261, 308 Food Processors Institute, 213 Food Quality Protection Act of 1996, 216 Food Safety and Inspection Service (FSIS), 18, 33 authority, 21, 77, 136, 140 Consumer Safety Officers, 140 definitions of food safety terms, 279, 283, 285, 289 effectiveness of, 41, 110 HACCP-Based Inspection Models Project, 105, 106-107, 110 poultry inspection, 134, 136 risk assessment, 87 surveillance role, 49, 51, 81, 110, 148 training, 140 Food Safety Begins on the Farm, 203 Food safety criteria. See also Developing criteria and performance standards; Economics of food safety criteria authority to enact and enforce, 17, 18-19, 21, 74, 77, 106, 248-249 for dairy products, 11-12, 225-247 default, 94 FSOs linked to, 89-90, 94-96, 249-250 in HACCP systems, 185-187, 240-241 385 historical perspective on, 13-27 for meat and poultry, 9-10, 16, 18, 141-162, 173-174 policy tools to establish, 7-8, 69-132 for produce, 11, 96, 97-98, 99, 113-114, 115, 202-205, 207-211, 213-216, 266- 268 public health objectives linked to, 6-7 for seafood, 10- 11, 183- 184, 185- 194 updating, 115, 116, 120, 248 verification, 89, 249-250 Food safety education, 41, 46-47, 54, 88, 158, 159, 173, 174, 188, 192, 261, 270 Food safety management system integrating FSOs into, 91, 92, 95, 255 public health goals in, 95 risk assessment in, 95 Food safety objectives (FSOs) and ALOP, 92-93, 123, 255 and CCPs, 89, 94, 255 defined, 5, 89, 275-276, 292 equation, 91-92 establishing, 90-91 food safety criteria linked to, 89-90, 94-96, 249-250 and GMPs, 93-94, 98 and HACCP, 71-72, 89, 93-95, 98, 190, 251-252, 255 and hazard management, 92 integration into food safety management system, 91, 92, 95, 255 interim, 91, 98 international approaches, 92, 93 limitations of, 98-101 for low-acid canned food, 96, 99 and microbiological criteria, 89-90 nonquantitative control measures and, 88- 89 and performance criteria, 94, 96-98, 249- 250 and performance standards, 94, 96, 255 promoting industry change with, 98 and public health goals, 89, 90, 92, 95, 123, 255 recommendations, 251-252, 255 regulatory flexibility and, 89, 249 and risk assessment, 90-91, 92, 93, 95, 100, 190, 255 using, 98 verification of compliance, 94, 96, 100

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386 Food safety regulations. See also Pathogen Reduction/HACCP Final Rule; Performance standards; Process control criteria for adulterants, 14-15, 19 costs and benefits of, 118-119, 121-124, 127-128 effectiveness issues, 118, 123-124 efficiency issues, 117, 122-123 equity issues, 117-118 HACCP in, 70, 71 lessons from environmental regulations, 120 Food safety tools developing criteria and performance standards, 101-107 economic issues, 116-124 food safety objectives as, 88- 101 HACCP as, 69-73 limits of science, 126-128 new diagnostic tools, 125-126 risk assessment as, 73-88, 121-124 statistical process control as, 107-116 Foodborne Disease Active Surveillance Network (FoodNet), 2, 23, 33-34, 35, 36, 37, 39, 40-41, 42, 46, 153, 160, 173, 250 Foodborne infections. See also Outbreaks; specific pathogens and foods behaviors associated with, 35, 37, 45-47, 53, 54 complications and sequellae, 37-38 economic impacts of, 37 pathogen-commodity linkages, 43-46, 55, 199 trends in, 39-43, 153, 199-201 France cheese exports, 237-238 produce criteria, 218, 352-353 Fresh fruits and vegetables current criteria and standards, 202-205 grower certifications, 204 guidance documents, 202-203 industry overview, 197-202, 266 internalization of pathogenic bacteria, 204, 266 monitoring, 50 pathogens linked to, 44, 199, 201 Salmonella outbreaks, 30 G Gastric acidity, 54 Giardia lamblia, 16, 199 Global SalmSurv, 34 Glyphosate, 305 INDEX Good Agricultural Practices, 93-94, 202, 203- 204, 205, 216, 266, 267 Good Laboratory Practice (GLP) guidelines, 75 Good Manufacturing Practices (GMPs), 194 FSOs and, 93-94, 98, 252 HACCP implementation and, 72, 185, 207 for produce, 202, 205, 207, 209, 213, 216, 217-218, 266, 267 Grade A Pasteurized Milk Ordinance (PMO), 227-228, 231, 240, 241, 253, 270 Grading of dairy products, 238-239 Grinding operations, 78, 153, 156-158, 165, 167, 261 Ground meats adulteration, 77, 145-146, 156-160, 261 color as indicator of doneness of cooked meat, 37, 46, 47 consumer education, 158 contamination pathways, 78, 153, 156, 158, 159, 165, 170 cooking temperatures, 46, 47, 158 current and proposed testing, 157 E. cold 0157:H7 in, 29, 31, 42, 44, 45, 77, 144-145, 155, 156-160, 163, 261 generic E. cold indicator, 151, 157, 259 HACCP applied to, 159, 165 irradiation, 158, 159 microbiological risk of hot spots in, 79 performance standards, 145- 146, 156- 160, 165 poultry, 165 prevalence of pathogens in, 42 Salmonella in, 19, 55, 58, 153, 157, 260 source of, 133 Guidance to Industry—Reducing Microbial Food Safety Hazards for Sprouted Seeds, 269 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, 203 Guillain Barre syndrome paralysis, 37 H HACCP-Based Inspection Models Project (HIMP), 105, 106-107, 110, 137-138 Hamburger. See Ground meats Hazard Analysis and Critical Control Point (HACCP) system, 69-71. See also Pathogen Reduction/HACCP Final Rule adjustments to, 115, 262 for dairy products, 70, 240-241, 270

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INDEX for E. cold 0157:H7, 153-154 elements of, 70, 72 food safety criteria applied in, 185-187, 240-241 FSOs and, 71-72, 89, 93-95, 98, 190, 251- 252, 255 generic E. cold marker, 23, 149- 150 generic plans, 71, 118 for ground products, 165 implementation and enforcement concerns, 21-22, 70, 71-72, 138, 139-140, 155- 156, 188, 251, 258 and innovation, 21, 188- 189, 190 and inspection, 137, 138, 139- 140 international guidelines, 71 irradiation incorporated in, 159 in juice processing, 41, 71, 98, 113, 114- 115, 207, 208, 209 limitations of, 94-95, 251 in low-acid canned food process, 162, 213 in meat and poultry industry, 20, 70, 121, 149-150, 153, 159, 162-165, 258 microbiological guidance in, 20 monitoring, 29, 52, 70, 72 origin and purpose, 21, 70 in pasteurization, 70, 94 performance standards applied in, 162-165 pilot programs, 240-241, 270 principles, 71-73 for produce, 204-205, 266-267 public health impacts of, 1, 41, 69-70, 137, 188 recommendations, 73, 251-252, 266-267 regulatory requirements, 70, 71 reports recommending adoption of, 20-21 risk characterization in, 82 in seafood industry, 20, 41, 71, 184-187, 188-194, 264, 265 structure, 21 trainingandtrainingmanuals,70-71,140, 141, 188, 191, 208, 209, 213, 240-241, 251 USDA Inspection Models Project pilot program, 137- 138 validation, 140, 166, 204, 266-267, 288-289 verification of compliance with, 72, 82, 140, 163, 185, 186, 187, 290-291, 256 water reuse, 298-299 website, 71 Hazard identification, 75, 77, 83 Hazard management, 92 Hazards and Controls Guide Advisory Committee, 192, 193 387 Healthy People 2010 Goals, 42 Helminth parasites, 44 Hepatitis A, 33, 44, 199, 201, 206 Heptachlor and heptachlor epoxide, 304 High-pressure processing, 59, 188- 189 Histamine fish poisoning (scombroid), 44, 180, 184, 185, 186-187, 265, 304 Historical perspective on food safety fecal coliform indicators for shellfish, 17 filth theory of disease, 13-14, 15, 248 fragmentation of authority, 18-19, 248 recommendations for new regulatory approaches, 20-25 scientific and societal changes, 17- 18 Hot-water rinse systems, 166-167 I Ice cream, 53 Immunocompromised patients, 53, 54 Immunological assays, 125, 170 Imported foods cheeses, 237-238 food safety policies, 41, 49-50, 133, 137, 168, 205, 237-238 inspection, 137, 237-238 meat and poultry, 133, 137, 168 produce, 197-198, 205, 267 product recalls, 183 seafood, 180, 181-183, 184, 193, 264 Innovation in food processing for canned foods, 215, 219 economics of food safety criteria, 120-121, 124, 168-169 and flexibility in regulation, 89, 100, 120, 124 HACCP and, 21, 120, 169, 188-189, 190 lessons from environmental regulations, 120 and performance standards, 120-121 poultry processing, 50 and process criteria, 120-121 in seafood processing, 188 Insects, defect action levels, 310-315 Inspection con si stency of proce s s, 140- 141 of dairy products, 237-238 destructive tests, 110 effectiveness, 110 economic issues, 138 fecal contamination focus, 14, 21

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388 federal system, 136-137; see also Food Safety and Inspection Service HACCP system implementation and enforcement, 137, 138, 139-140 HIMP pilot program, 137-138 imported foods, 137, 237-238 laboratory analysis, 139 legislation, 14, 136, 137, 138, 258 meat and poultry, 14, 18, 20, 49, 110, 136- 141, 258 New Enhanced Line Speed, 136 New Evisceration System: Maestro, 136 Nu-Tech, 136 organoleptic, 14, 18, 185 of retail processors, 139 sampling techniques, 48 seafood, 185, 263 of slaughter facilities, 14, 49 by state and local governments, 136-137, 139, 258 state programs with federal oversight, 138 statistical approaches, 110-111, 112 Streamlined Inspection System, 136 withdrawal from a facility, 143, 155 Interagency cooperation and collaboration, 51, 82, 88, 139 International Commission on Microbiological Criteria for Foods definitions of food safety terms, 273, 278, 280, 282, 284, 286, 288, 290, 292 food safety management scheme, 92, 93 and HACCP, 70 produce criteria, 319, 322-323, 330-331, 354-355 International criteria for dairy products, 359-364 FSO approaches, 92, 93 international cooperation on, 193-194, 264 monitoring efforts, 173 for produce, 218, 319-357 for ready-to-eat foods at point of sale, 318- 319 seafood, 193-194, 264 surveillance efforts, 32, 34, 46, 51 International Fresh Cut Produce Association, 202-203 International Meat and Poultry HACCP Alliance, 70 International Organization for Standardization (ISO) standards, 51, 91 INDEX International Seafood Safety Exchange Program, 194, 264 Interstate Milk Shippers Certification Program, 226-227 Interstate Milk Shippers Conference, 189 Interstate Shellfish Sanitation Conference, 188- 189 Ireland microbiological guidelines, 318-319 produce criteria, 218, 324-329, 340-349, 354-357 Salmonella surveillance, 173 Irradiation of foods, 59, 121, 127, 158, 159, 261 Irrigation water, 58, 198-199, 204, 216 Israel produce criteria, 326-333, 338-339, 348- 353, 355-356 J Japan, salmonellosis outbreaks, 57 Johne's disease, 230 Joint FAD/WHO Expert Committee on Food Additives, 211 Expert Consultation on Risk Assessment of Microbiological Hazards in Foods, 81, 193-194, 205 Juice HACCP Alliance, 71, 208, 267 Juice HACCP Final Rule, 113 - 114 Juice HACCP Hazards and Controls Guidance, 208, 267 Juices Cryptosporidium in, 56, 199, 206, 207, 208 current criteria and standards, 96, 97-98, 99, 113-114, 115, 202, 207-211, 267-268 5-D reduction standard, 96, 97-98, 99, 114, 207-208, 209-211, 219, 267-268 E. cold 0157:H7 in, 55-56, 96-97, 114, 199, 206, 207, 208, 209-210, 219, 268 HACCP systems, 41, 71, 98, 113, 114-115, 207, 208, 209 industry overview, 205-207 international criteria, 209, 211 NACMFC standards, 97-98, 114 outbreaks related to, 206, 207 pasteurization, 56, 206, 208, 209 pathogen reduction standards, 207-208, 267-268 patulin in, 208-209, 211

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INDEX performance standard, 209-210 process control strategies, 113-114 sampling plans, 268 scientific basis for current criteria, 209-211 Salmonella in, 56, 96-97, 199, 206, 207, 209, 219, 268 warning labels, 208 The Jungle (Sinclair), 14 L Laboratory accreditation, 51 Laboratory analysis. See also Diagnostic testing and investigation electronic exchange of data, 51 immunological assays, 125, 170 of inspection program samples, 139 method validation, 51 PCR assays, 79, 125 Lactic acid bacteria decontamination, 166 international criteria for produce, 324-325, 332-333 Ladd, E.F., 14 Lead, 305 Legislation. See also individual statutes and fragmentation of regulatory system, 18 inspection-related, 14, 19, 136, 137, 138 Lethality standards for meat and poultry products, 145, 146, 148, 160, 161, 181, 262 Listeria spp. as adulterant, 160 contamination pathway, 160 in dairy products, 41, 160, 226, 236, 237, 242-243, 271, 360-363 incidence of bacteria or listeriosis, 40-41, 42, 160 as indicator organisms, 318 international criteria for, 218, 318, 322-325, 328-329, 340-343, 346-347, 350-351, 354-357, 360-363 L. monocytogenes, 24, 32, 41, 44, 46, 77, 81, 86, 87, 88, 160, 180, 199, 218, 226, 236, 271, 303, 307, 308, 318, 322-325, 328-329, 340-343, 346-347, 350-351, 354-357, 360-363 in meat and poultry products, 41, 44, 87, 160, 173-174 national goals, 42 389 outbreaks, 41, 43, 173-174 prevalence, 173-174 in produce, 199, 218, 318, 322-325, 328- 329, 340-343, 346-347, 350-351, 354- 357 in ready-to-eat foods, 41, 44, 81, 86, 87, 88, 160, 180, 318 risk assessment, 45, 77, 86, 87, 88 in seafood, 180 serotyping, 32, 34, 43 surveillance, 43 tolerance, 160, 180 Litigation, 19, 155-156 Local and state agencies, surveillance by, 29, 32, 33, 34, 35 Low-acid and acidified canned foods acidification step, 216, 268 and botulism, 70, 107, 111, 113, 211-216, 218-219, 268-269 container manufacture and handling, 213 current criteria and standards, 213-216 12-D reduction standard, 107, 111, 213, 218-219, 268-269 FSO for, 96, 99 HACCP processes, 70, 162, 213 home-canned products, 212, 216 industry overview, 211-213 process control strategies, 113, 215, 216 scientific basis for criteria, 214-216 thermal processes, 214-215, 268-269 training of processors, 213, 215, 268 M Management practices on farms, 50, 170 Massachusetts Health Act of 1797, 13 Material Safety Data Sheets, 300 Maximum contaminant level, 16 Maximum residue level, 81 Meat and poultry products adulteration, 144-145, 156-160 animal drug residues, 146-147 consumer safety warnings on, 41 contamination pathways, 142-144, 169-173, 300 cured products, 162 developing criteria and standards for, 9-10, 147-149, 162, 258 economic issues, 165- 169

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392 National Research Council, 150 definitions of food safety terms, 278, 280, 282 National Residue Program, 81-82 National Seafood Inspection Program, 185 National sentinel surveillance system, 23, 30, 33-34 National Shellfish Sanitation Program, 15, 306 Nationwide Federal Plant Microbiological Surveys, 148, 150 Nationwide Microbiological Baseline Data Collection Programs, 148, 150 Nebraska Beef Ltd., 156 Necrotizing enterocolitis, 231 Netherlands, produce criteria, 344-347, 352- 353 New Zealand, microbiological criteria, 233, 321, 322-323, 338-341, 350-353 Nickel, 305 No-observed- adverse-effect level (NOAEL) , 75, 76-77, 80, 211 Notifiable disease reports, 31-33 Norwalk-like virus (Noroviruses) infections, 36, 44, 52, 199 Norway poultry monitoring, 49, 173 produce criteria, 324-325, 332-333, 350- 353, 355-356 o Other Consumer Protection defects, 110 Outbreaks. See also individual pathogens and commodity groups algorithm, 31, 57 burden of, 38 clusters, 30, 32, 33 data gaps in studies of, 83 defined, 34 dispersed, 30 and dose-response relationships, 53 etiology determinations, 38-39 genetic "fingerprints," 30, 32 investigations, 28, 29, 30-31, 33, 36, 38-39, 43, 44, 45-46, 55, 75 and regulatory reforms, 14, 15, 21, 29 reporting, 31-33, 34-36, 38, 42-43, 225, 250 risk assessment from data on, 75, 76 travelers' diarrhea, 36 trends, 43 typhoid fever, 14, 15, 198 INDEX Oysters closing beds to harvest, 52 Model Ordinance for processing, 189, 265 pathogens associated with, 14, 17, 45, 55, 188-189, 190, 265 "processed for added safety" declaration, 190 sanitation on oyster boats, 55 p Paralytic shellfish poison, 184, 304, 306 Pasteurization chemical performance standards, 232 defined, 228 economic and administrative feasibility, 245 of eggs, 49, 52, 57, 59, 172 emerging safety concerns, 230-231 HACCP in, 70, 94 of juices, 56, 206, 209 of meat and poultry, 121 of milk, 70, 94, 99, 113, 225, 226, 228-231, 245, 253, 271 process control, 113 public health objective, 228 scientific basis for current requirements, 229-230 temperature/time requirements, 226, 228- 230, 231, 232, 271 Pathogen Reduction/HACCP Final Rule, 292. See also Hazard Analysis and Critical Control Point system adjustments to, 115, 120 assessment of, 33 economic costs and benefits of, 120, 121, 165-169, 262-263 indirect impacts, 169-170 innovative interventions, 21, 120, 169 and inspection, 137, 138, 139- 140 mandatory provisions, 163 in meat and poultry slaughter and processing, 41, 48, 121, 137, 142-143, 165-169, 173, 262-263 monitoring, 48, 49, 108 product sampling, 48 public health impacts, 33, 41, 153, 169-170, 173 research recommendations, 262-263 verification of compliance, 48, 72, 82, 108, 290-291, 256

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INDEX Pathogen reduction standards. See also Lethality standards; Stabilization standards economics of, 119, 121, 166-168 enforcement of, 164 intervention strategies, 166-168 for juices, 207-208, 267-268 forlow-acid canned foods, 107, 111 for meats and poultry, 142-144, 145, 161- 162, 166-168, 259-260 rationale for, 149- 150 recommendations, 156, 259-260 Salmonella performance standard, 19, 23, 94, 99, 140, 141, 142, 143-144, 145, 152-156, 161, 163, 166, 167, 259-260 strategies for achieving, 121 Pathogenesis of microorganisms Cryptosporidium, 53, 54 data gaps on, 83 host-related factors, 53, 54, 75, 76, 78, 79 microbial-related factors, 36, 53-54, 75, 76- 77, 79, 125, 212 monitoring, 53-54 predictive models, 84 reservoirs, 43-44, 51-53 testing for, 79 virulence factors, 53 Pathogens. See also Antimicrobial resistance; Pathogenesis; Serotypes and subtypes; specific pathogens commodity food groups linked to, 43-46, 70, 107, 111, 113 culture techniques, 125 limiting conditions for growth, 96, 307 mobile genetic elements, 54, 125 molecular fingerprinting, 30, 32, 52 national information system on, 82 prevalence in food chain, 42, 83, 253 projected growth, 286 rapid tests for, 121, 125-126, 257 time and temperature guidance for controlling, 308 Patulin, 208-209, 211 Pennsylvania Egg Quality Assurance Program, 56, 172 Performance criteria defined, 150, 151, 284-285 FSOs and, 94, 96-98, 249-250 scientific basis for, 149-162, 188-194, 209- 211, 214-216 393 Performance standards. See also Developing criteria and performance standards; Lethality standards; Pathogen reduction standards; Stabilization standards additives, 17 adjustments to, 115, 116 for adulterants, 156-160 animal drug residues, 17, 18, 146-147 appropriate data for developing, 102, 103, 104, 106-107, 253-254 baseline data, 150, 152 for dairy products, 225-247 defined, 5, 284-285, 292 E. cold 0157:H7, 156-160 economics of, 116-124 enforcement of, 140 FSOs and, 94, 96, 255 generic, 17 for ground products, 145-146, 156-160, 165 in HACCP systems, 140, 162-165 innovation in food processing and, 120-121 for juice, 209-210 "may render" standard, 17 for meat and poultry industry, 16, 18, 41, 107, 141-165, 167-168, 173-174 "ordinarily injurious" standard, 17, 19 for pesticide residues, 15- 16, 17 "poisonous or deleterious" standard, 17 poor, 104 for poultry, 18, 107, 143-144, 146, 163-165 for processed foods, 16 public health impacts of, 160, 173- 174, 188-194, 218-220, 260 for ready-to-eat foods, 107, 148 safety factor in, 107, 148, 161, 162, 229 Salmonella, 19, 23, 94, 99, 140, 141, 142, 143-144, 145, 152-156, 161, 163, 166, 167, 259-260 scientific and societal changes and, 17-18 scientific basis for, 149-162, 188-194, 209- 211, 214-216, 229-230 for seafood, 16, 17, 179-194 specific, 17 validation, 209-210 verification of compliance, 72, 82, 94, 96, 100, 117, 256, 290-291, 256 Personal injury litigation, 16 Peru, produce from, 198 Pesticide residues, 15-16, 17 guidelines/tolerances, 25, 269, 304, 305 monitoring, 47

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394 performance standards, 15-16, 17 in produce, 216-217, 269 risk assessment, 77, 80, 217 in seafood, 304, 305 zero tolerance standard, 25 Phages, 54 Pillsbury Company, 21, 70 Plasmids, 54, 58 Policy tools to establish science-based food safety criteria, 7-8, 69-132 measures of effectiveness of, 117 microbial risk assessment as, 20, 85-88 microbiological standards as, 273 monitoring as, 52 zero tolerance as, 24-25 Polychlorinated biphenyls, 304 Polymerase chain reaction (PCR) assays, 79, 125, 229 Pork HACCP system, 162-163 pathogens linked to, 41, 44, 172 performance standards, 162-163, 167-168 PR/HACCP rule and, 41, 167-168 processing, 41, 167-168 production, 136 Salmonella in, 40, 44, 50, 51 Y. enterocolitica in, 41, 44, 172 Poultry. See also Meat and poultry products; Shell eggs and egg products Campylobacter in, 44, 45, 49, 86, 88, 172, 173 cooked products and partially cooked breakfast strips, 146 cross-contamination pathways, 164- 165 E. cold indicator, 143, 144 fecal contamination, 18 flock-based screening and control measures, 56-57 ground products, 165 HACCP system, 20, 163-165 industry characteristics, 134- 136, 146 innovations in processing, 50, 173 inspection, 18, 20, 110, 134-135, 136 microbiological threats from, 18 monitoring, 49 ovarian infection in layer hens, 56 pathogens linked to, 44 performance standards, 18, 107, 143-144, 146, 163-165 processing, 107, 164-165, 166, 167 INDEX production complex, 134, 135 raw, 41, 143-144 risk assessment approach, 20, 86, 88 Salmonella in, 23, 40, 41-42, 44, 56-57, 88, 145, 161, 164, 172, 173 Poultry Products Inspection Act, 136, 258 Preservatives, 14 President's Council on Food Safety, 87, 101, 106 Prions, 48, 230 Process control criteria. See also Inspection; Statistical process control automated, 113 combination strategy, 104-106, 113 control charts and capability analyses, 108, 112, 113 defined, 286-287 E. coli, 99-100, 108, 142, 149-152 economics of, 116-124 effectiveness of, 137 examples of approaches, 113- 115 innovation and, 120-121 for juice, 113-114 for low-acid canned foods, 113 for meat and poultry, 142-144, 145-146, 149-152, 258-259 for milk, 113 nonquantitative measures and, 88-89 in pasteurization, 113 pathogens associated with, 198 premises for, 111-112, 149-150 raw-input acceptance sampling, 113 science-based approach, 108, 149- 152 standards, 17 verification of compliance, 108, 112, 113, 117, 142-144 Processed foods. See also Food-processing operations adulterants, 16 mislabeling, 16 performance standards, 16 Processing. See Food-processing operations Processing safety objective defined, 286-287 integration in food safety management system, 94, 95, 96, 255 verification of, 94, 96, 100 Produce and related products. See also Canned foods; Fresh fruits and vegetables; Juices; Sprouts Campylobacter in, 199, 218, 324-327, 338- 339, 342-343, 346-347, 354-355

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INDEX Clostridium in, 199, 322-325, 328-329, 334-338, 342-343, 346-349, 352-355 contamination pathways, 201, 202, 203, 204, 206, 209 defect action levels, 217-218, 309-316 E. cold 0157:H7 in, 44, 57, 199, 201, 204, 205, 206, 216, 219, 318, 322-325, 328- 329, 342-343, 346-347 fecal contamination, 50, 198, 202, 203, 204, 209, 320 generic E. cold indicator, 50, 99-100, 209, 319, 320, 322-325, 328-329 guidance documents, 202-203, 205, 216, 219, 267, 269 HACCP system, 204-205, 266-267 imports, 197-198, 205, 267 incidence of pathogens, 205 international criteria, 205, 218, 319-357 intervention strategies, 202-205, 208, 216, 31 266 Listeria in, 199, 218, 318, 322-325, 328- 329, 340-343, 346-347, 350-351, 354- 357 monitoring, 49-50 outbreaks related to, 199-201 pathogens linked to, 44, 199, 201, 206 pesticide residues in, 216-217, 269 public health impacts of standards, 41, 218- 220, 268-269 recommendations, 204, 266-269 risk assessment, 205 risk factors, 198-199, 200, 204 Salmonella in, 44, 57-58, 199, 201, 205, 206, 216, 219, 319, 320, 321, 322-343, 348-353, 356-357 sanitation practices, 203, 204, 206, 207, 267 Shigella in, 50, 199, 201, 205, 324-325, 332-337 surveillance, 205, 267 Produce Safety Initiative, 205 Product criterion, defined, 286-287 Psychotropic count, for microorganisms in produce, 332-333 Public health goals. See also Appropriate level of protection defined, 286-287 in food safety management system, 95 and FSOs, 89, 90, 92, 123, 255 progress toward, 42 Public health impacts of antimicrobial resistance, 86 395 of Campylobacter in poultry, 86 of consumer education, 46-47, 54, 173, 174 of dairy criteria and standards, 241-244 of data collection and dissemination, 54-59 economic, 23, 168-170 of HACCP implementation, 41, 69-70, 163 of meat and poultry standards, 41, 150-151, 173-174, 260 of Pathogen Reduction/HACCP Final Rule, 33, 41, 153, 163, 169-170, 260 of performance standards, 160, 173-174, 188-194, 218-220, 260 of produce standards, 41, 218-220, 268-269 of Salmonella, 23 of shell egg requirements, 56, 172 of surveillance, 28-29, 54-59 of Vibrio in raw shellfish, 86 Public Health Laboratory Information System, Public health objective, 189, 228 defined, 5, 286-287 food safety criteria linked to, 6-7 Public health surveillance of antimicrobial resistance, 32-33, 58-59 behavioral risk-factor, 35, 37, 46-47 burden of disease, 30, 33, 37-39, 43-46, 52 of Campylobacter, 30, 36, 40-41 case control studies, 31 case studies, 31 data applications to improve safety, 28-29, 33, 34, 48, 54-59 data collection strategies, 29-31, 32, 48, 50- 51, 219, 250, 267 defined, 28 of E. cold 0157:H7, 42, 43 federal role, 31, 32-33, 34, 35, 49-50, 51, 58, 81, 82, 110, 267 future of, 59-60 and HACCP systems, 29, 52, 70, 72 index of consumer behavior, 46-47 international efforts, 32, 34, 46, 51 laboratory tools, 30 limitations of, 35-37 of Listeria, 43 by local and state agencies, 29, 32, 33, 34, 35 monitoring hazards in the food chain 31, 47-53, 250 notifiable disease reports, 31-33 outbreak investigations, 28, 29, 30-31, 33, 36 ., 30,

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396 outbreak reporting, 30, 34-36 pathogenesis of microorganisms, 53-54 of produce, 205, 267 public health impacts of, 28-29, 54-59 rationale for, 28 recommendations, 2, 33, 34, 154, 172, 250, 260 residues in meat, 81-82 results from, 37-47 of Salmonella, 30, 31, 36, 39-41, 43 sentinel site approach, 23, 30, 33-34 serotype- and subtype-based reporting, 31- 33, 34, 38, 45-46, 48, 49, 51, 153 strategies in, 8, 29-31, 36, 40-41 tools of, 8, 28-37 trends in foodborne disease, 30, 39-43 Public health system origins and early regulatory history, 13-14, 29 prevention cycle, 29 Pulsed-field gel electrophoresis, 30 PulseNet, 2, 32, 43, 250 Pure Food and Drug Act of 1906, 212 Q Q fever, 228, 229 R Ready-to-eat foods adulteration of, 160 Camplyobacterin, 318 Clostridium in, 318 E. cold in, 318 international criteria, 318-319 Listeria monocytogenes in, 41, 44, 81, 86, 87, 88, 318 performance standard for meat, 107, 148 risk assessment, 86, 87, 88 Salmonella in, 148, 318 seafood, 180, 184 Recommendations animal drug residue tolerance, 262 authority to enact and enforce criteria, 2, 106, 248-249 dairy product safety, 4, 236, 244, 269-272 data collection and dissemination, 48, 106, 116, 151, 154, 250, 253-255, 257, 267 INDEX developing science-based food safety criteria, 3, 105, 106, 116, 252-254, 258 diagnostic tools, 257 E. cold 0157:H7 research, 159, 261 economic cost-benefit analyses, 257, 262- 263 FSIS inspector training, 141 FSO implementation, 251-252 HACCP implementation, 4, 73, 141, 251- 252, 266-267 integrated intervention trials, 263 meat and poultry safety criteria, 3-4, 151, 154, 156, 172, 258-263 monitoring, 49 nonfocal contamination research, 172, 263 pathogen reduction criteria, 156, 259-260 Pathogen Reduction/HACCP rule, 262-263 process control criteria, 258-259 produce safety, 4, 204, 266-269 risk assessment, 80, 82-83, 253, 254-255 Salmonella performance standard, 156, 259- 260 seafood safety, 4, 192-194 statistical process control, 113, 116, 253, 256 surveillance, 2, 33, 34, 154, 172, 250, 260 Recontamination and growth, 96, 119 Refrigeration/chilling for Clostridium control, 145, 146, 162 of milk, 232 of shell eggs, 56 Regulations. See Environmental regulations; Food safety regulations; Performance standards Regulatory system and approaches. See also Hazard Analysis and Critical Control Point system authority to enact and enforce criteria, 1, 2, 5-6, 106, 248-249 command-and-control structure, 21, 117 and competitiveness, 120 current, 24-25, 273 development of approaches, 20-25, 101- 107, 116 examples of approaches, 22-23 flexibility considerations, 1, 5-6, 21, 89, 100, 106, 116, 120, 124, 126, 189, 192, 249, 253, 257 fragmentation of, 18-19, 248 innovations and, 21, 89, 100, 120, 124, 125- 126

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INDEX microbiological standards, 273 recommendations, 2, 251-257 reforms recommended by earlier reports, 18, 19, 20-22 science-based, 6, 101-107, 110-115 theoretical basis for, 16 zero tolerance concept, 24-25 Reptiles, Salmonella in, 40 Research Triangle Institute, 46, 110 Reservoirs of diseases monitoring, 51-53 by pathogen, 43-46 Residue Violation Information System, 82 Resource allocation, 37, 39 Retail meat processors, 139 Retail safety objectives, 94, 95 Risk allocation, 46 Risk analysis, components, 73-74 Risk assessment. See Chemical risk assessment; Microbial risk assessment Risk characterization, 80-83, 254 Risk communication, 73, 74 Risk management chemical vs. microbial, 74 defined, 73 economics of, 119, 121-124 FSOs and, 96 systemwide perspective, 59 S "Safe harbor" processes, 94, 118, 146, 162, 236, 262 Safety factor in performance standards, 107, 148, 161, 162, 229 Salmonella as adulterant, 155-156 Anatum serotype, 242-243 in animal feeds, 50 antimicrobial resistance, 32-33, 37-38, 52, 54, 58-59 Baildon serotype, 201 baseline data, 153 Berta serotype, 242-243 burden of disease, 38 complications and sequellae, 37-38 cooking temperatures and humidity and, 55 in dairy products, 44, 58, 235-236, 237, 242-243, 271, 360-364 Dublin serotype, 242-243 397 economic impact, 23 in eggs and egg products, 39-40, 41, 44, 49, 50, 56-57, 59, 86, 87, 88, 111 Enteritidis serotype, 31, 32, 38, 39-40, 41, 43, 49, 50, 56-57, 59, 86, 87, 111, 172, 173, 201, 207, 242-243 Gaminera serotype, 207 in ground beef, 19, 55, 58 Hadar serotype, 42 Hartford serotype, 207 Heidelberg serotype, 38, 39, 40, 42, 235 incidence, 39-40, 41-42, 43, 163, 165 Infantis serotype, 201 international criteria, 318-319, 322-343, 348-353, 356-357, 360-364 Javiana serotype, 38, 201, 242-243 in juices, 56, 199, 206, 207, 208, 268 Kentucky serotype, 42 lethality standard, 146, 148, 161, 262 meat and poultry products, 19, 23, 32-33, 37-38,40,41-42,44,50,51,55,58-59, 88, 99, 141, 142, 143-144, 145, 146, 148, 161, 163, 164, 169, 170-171, 172, 173, 318 Mbandaka serotype, 201 monitoring, 23, 48, 49-50, 58-59 Montevideo serotype, 38 Muenchen serotype, 38, 201, 207 Muenster serotype, 236 national goals, 42 Newport serotype, 30, 38, 39, 40, 41, 58-59, 201 Oranienburg serotype, 38, 242-243 outbreaks, 30, 31-32, 38, 43, 45-46, 52, 53, 54, 57-58, 198, 201, 206, 242-243 pathogenesis, 53, 54 performance standard, 19, 23, 94, 99, 140, 141, 142, 143-144, 145, 152-156, 161, 163, 166, 167, 259-260 Poona serotype, 201 in poultry, 23, 40, 41-42, 44, 56-57, 88, 145, 161, 164, 172, 173 prevalence, 153-154, 169, 170-171, 260 in produce, 30, 44, 49-50, 56, 57-58, 96-97, 199, 201, 205, 206, 216, 219, 319, 320, 321, 322-343, 348-353, 356-357 public health impacts, 23 qualitative test, 163 in ready-to-eat foods, 148, 161, 262, 318 in reptiles, 40 risk assessment, 56, 86, 87, 88

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398 Rubislaw serotype, 207 Saint Paul serotype, 38 in seafood, 44, 99, 183, 184, 303, 307, 308 serotypes and serotyping, 31-32, 34, 38, 39- 40, 45-46, 51, 201 Stanley serotype, 57 surveillance, 30, 31, 36, 39-41, 43, 46, 51, 52, 57-58 Thompson serotype, 38 Typhi serotype, 206 Typhimurium serotype, 31, 32, 38, 39, 40, 41, 42, 171, 173, 207, 236, 242-243 underreporting of, 36 water contamination with, 58 Sampling protocols, 48-49, 114, 115, 253-254 acceptance sampling, 111, 113, 256 for baseline data, 152 for cheeses, 237-238 for ground meats, 142, 143 linking results of, 49 for meats and poultry, 142-144, 150, 152, 153 PR/HACCP rule, 137, 138 for produce, 268 raw-input, 113 three-class plan, 142-143, 150 two-class plan, 143, 144, 153 Sanitation in construction, 295 custom exempt facilities and, 302 in dairy industry, 225, 232 dressing room/lavatory facilities, 55, 299 early public health efforts, 13-14, 225 employee hygiene, 55, 203, 204, 301-302 equipment and utensils, 232, 299-300 groundskeeping and pest control, 294 lighting and, 295-296 for meat and poultry standards, 141, 147, 155, 171, 262, 296, 298, 300, 301 performance standards, 147, 294-302 in plumbing and sewage, 55, 296-297 in produce production and handling, 203, 204, 206, 207, 267 public health impacts, 55 for sanitary operations, 300-301 seafood processing, 185 Standard Operating Procedures, 72, 140, 207, 267 ventilation and, 296 in water supply and water, ice and solution reuse, 297-299 INDEX Sanitizers, Food Grade, 301 Seafood. See also Shellfish antibiotic residues, 183 aquaculture products, 180, 181-183, 184 CCPs, 184-185, 186, 191 chemical contaminants, 185, 186- 187, 265, 304, 305 Clostridium in, 184, 191 current food safety criteria, 10-11, 183-184. 185-194 diversity of food species, 179, 184, 263 E. cold 0157:H7 in, 303, 307 economic feasibility of criteria, 188-194 FSOs, 190 generic E. cold indicator, 305, 308 guidelines/tolerances for, 186, 190-192, 193-194, 264, 303-308 HACCP system for, 20, 41, 71, 183, 184- 187, 188-194, 264, 265 harvest location restrictions, 265 imports, 180, 181-183, 184, 193, 264 industry production characteristics, 181-183 inspection system, 185, 263 international criteria and cooperation, 180, 181-183, 184, 193-194, 264 limiting conditions for pathogen growth, 307 Listeria in, 180 microbiological threats from, 17, 179- 180, 184, 303, 305 monitoring, 185, 186- 187, 265 neurotoxins, 184, 185, 191, 304 outbreaks associated with, 185 pathogens linked to, 44, 125, 180 performance standards, 10-11, 16, 17, 179- 194 processing authority, 192 processing innovations, 188-189 processors, 184-185 ready-to-eat products, 180, 184 recommendations, 192-194, 263-265 safety control, 184-185, 186-187 Salmonella in, 44, 183, 184, 303, 307, 308 sanitation standards, 185 scombotoxicity, 44, 180, 184, 185, 186-187, 265, 304 surveillance, 181 time and temperature guidance, 187, 265, 308 Seafood HACCP Alliance, 71, 188, 191, 208 Sentinel site surveillance, 30, 33-34

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INDEX Serotypes and subtypes allocating burden of disease by, 38, 45-46 E. cold 0157:H7, 34, 43, 49 incidence of disease by, 39-40 Listeria, 32, 34, 43 recommended use of, 34, 153 Salmonella, 31-32, 34, 38, 39-40, 45-46, 49, 51 as surveillance tool, 31-33, 34, 38, 48, 49, 51, 153 Sewage Campylobacter in, 44 as irrigation water, 198-199, 203 sanitation performance standards, 296-297 Shell eggs and egg products fecal contamination, 56 grading and disinfection process, 56 ovarian infection in layers, 56 pasteurization, 49, 52, 57, 59, 172 pathogens linked to, 44 public health impacts of criteria, 56, 172 quality assurance programs, 50, 56-57, 111, 172 refrigeration requirement, 56, 87 residue surveillance program, 81-82 risk assessment, 56, 86, 87, 88 risk factors, 179- 180 Salmonella in, 39-40, 41, 49, 50, 56-57, 59, 86, 87, 88, 111 Shellfish. See also Oysters fecal coliform standard, 17, 184, 186 fecal contamination of harvest waters, 15, 17, 47, 55, 186 microbiological standards, 15 monitoring, 47, 52 and Norwalk-like virus infections, 44 pathogens linked to, 44, 86, 88, 99, 179, 188-189, 190 performance standard, 190 raw, 47, 86, 88, 99, 179, 180 recreational harvesting, 180 risk assessment, 86, 88 sanitation method, 15 screening methods, 15 shrimp aquaculture, 181- 183 and typhoid fever, 14, 15 Vibrio spp. in, 86, 88, 179, 188-189, 265 Shigella, 307, 308 dose-response relationship, 53, 84 international criteria for, 324-325, 332-337 399 in produce, 50, 199, 201, 205, 324-325, 332-337 reservoir, 42 S. dysenteriae, 84 S. flexneri, 201 S. sonnet, 201 surveillance, 42, 49-50 transmission routes, 99 Simazine, 305 Sinclair, Upton, 14 Slaughter operations and facilities. See also Meat and poultry products accountability, 23, 137 binomial slaughtering, 51, 88, 173 distribution in United States, 133 fecal contamination marker, 23 inspection, 14, 49 preventing contamination and amplification prior to, 50, 51, 169-172 safety objectives, 94 South Africa, produce criteria, 320, 322-325 Spain produce criteria, 218, 320, 322-323, 330- 333, 336-337, 355-356 salmonellosis outbreak, 54 Sprouts alfalfa, 57-58 current criteria and standards, 202, 216, 266-267 E. cold 0157:H7 in, 57-58, 204, 216 guidance documents, 216, 269 international standards, 320, 321 Salmonella in, 57-58, 199, 201, 216 seed disinfection, 57-58, 216 Stabilization standards for meat and poultry products, 145, 146, 148, 160, 161-162, 262 Standard Milk Ordinance, 226 Staphylococcus assay methods, 125 coagulase positive standard for, 334-335, 340-341, 350-351, 362 in dairy products, 237, 242-243, 360-361, 362 enterotoxic, 77, 237, 242-243, 334-335 food poisoning, 43 international criteria, 318, 322-329, 332- 337, 344-345, 348-353, 356-357 in pork, 44 produce criteria, 322-329, 332-337, 344- 345, 348-353, 356-357

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400 in ready-to-eat foods at point of sale, 318 risk assessment, 77 S. aureus, 44, 77, 237, 242-243, 303, 307, 308, 318, 322-329, 332-337, 344-345, 348-353, 356-357 State and local health departments laboratories, 32 recommendations, 33 surveillance activities, 29, 32, 33, 34, 35 State regulation of dairy industry, 227, 244 with federal oversight, 138 inspection programs, 137-138, 139 of retail meat processors, 139 Statistical process control advantages of, 109 capability indices, 108, 112, 113, 116, 256 continuous improvement linked to, 108- 109, 110, 113, 139, 256, 258 control charts and histograms, 112, 113, 116, 256 data collection for, 115- 116 inspection methods, 110- 111, 112 premises for, 111-112 recommendations, 113, 116, 253, 256 stability of variation, 107-108, 111, 112- 113 time series analyses, 108, 112, 253 training of regulators, 109 Steam vacuum systems, 166 Sternberg, George Miller, 14 Streptococcus as indicator of fecal contamination, 150- 151 S. faecalis, 332-333 Subtypes. See Serotypes and subtypes Sulfamerazine, 304 Sulfamethoxine/ormetoprim, 305 Sulfite residues, 185- 186 Supreme Beef Processors v. USDA, 19, 155- 156 Surveillance. See Public Health surveillance Sweden produce criteria, 352-353, 355-356 Salmonella surveillance, 173 Switzerland, produce criteria, 352-353 T Thermometer use in cooking, 46, 47 Time series analyses, 33, 106 INDEX Tissue Residue Information Management System, 82 Tolerable level of risk "acceptable" level of contamination contrasted, 292 defined, 288-289 Tolerances, 17, 71-72 for antibiotics, 147 at CCPs, 71-72 chemical vs. microbial, 75-76, 81, 82, 185 "none detectable" standard, 160 for pesticide residues, 216-217 Toxins, microbial international criteria for produce, 334-335, 344-345 risk assessment, 77 Toxoplasma, 38, 44 Transportation of animals contamination during, 50, 171 safety objectives, 94, 95 Travelers' diarrhea, 36 Trichinella, 44 Trisodium phosphate-based systems, 166 Tube dilution method, 15 Typhoid fever, 14, 15, 17, 29, 44, 198, 225, 235 U Undulant fever, 235 United Kingdom, 50 University of California, 229 U.S. Army, 21, 70 U.S. Code zero tolerance language, 24-25 U.S. Department of Agriculture Agricultural Marketing Service, 205, 238- 239, 366-369 Agricultural Research Service, 52, 121 authority, 17, 18, 19, 155 Bureau of Chemistry, 14-15, 212 Commodity Program, 201 dairy product inspection and grading program, 238-239, 366-369 HACCP implementation, 71, 137- 138, 251 Office of Markets, 238 "poison squad," 14-15 risk assessment role, 80, 86, 87, 88 Standardization Branch, 239 surveillance role, 32-33, 205

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INDEX U.S. Department of Commerce, 18, 185 U.S. Department of Health and Human Services, 18, 88 U.S. Environmental Protection Agency authority, 17, 18, 74 pesticide residue tolerances, 216-217, 269 regulatory framework, 15- 16 seafood tolerance levels, 183- 184, 303-308 U.S. General Accounting Office, 20, 139, 148, 188 U.S. Public Health Service, 225, 226-227, 229 U.S. Surgeon General, 15, 226-227 V Vaccination of animals, 88, 127 Validation defined, 288-289 of CCPs, 289 of HACCP plans, 140, 288-289 of laboratory methods, 51, 192 Monte Carlo simulation, 114, 209 of performance standards, 209-210 of product sampling and testing methods, 114, 115, 253 Verification of compliance, 72, 82, 94, 96, 100, 108, 112, 113, 117, 142-144, 256, 290-291 Yersinia spp. defined, 290-291 of food safety criteria, 89, 249-250, 256 FSOs and, 94, 96, 100 of HACCP compliance, 72, 82, 290-291, 256 moving-window method, 114, 209 of processing safety objective, 94, 96, 100 Vibrio species, 17 diagnostic methods, 125 food commodities associated with, 45, 86, 88 infectiousness, 53, 54 international criteria for produce, 218, 318, 326-329, 344-345, 348-349, 356-357 public health impact, 86 in raw shellfish, 86, 88, 179, 188-189, 190, 265 in ready-to-eat foods at point of sale, 318 reservoir, 45 risk assessment, 86, 88 seafood guidelines/tolerances, 303 surveillance strategies, 30, 42 401 trends in infections, 42 V. cholerae, 53, 303, 307, 308, 318 V. parahaemolyticus, 42, 86, 125, 189, 218, 265, 303, 307, 308, 318, 326-329, 344- 345, 348-349, 356-357 V. vulnificus, 17, 45, 125, 179, 188, 189, 190, 265, 303, 307, 308 Voluntary Food Safety Guidelines for Fresh Produce, 202-203 W Water. See also Drinking water; Irrigation water reuse standards, 298-299 Wesleyan University, 14 Western Growers Association, 203 Wholesome Meat Act of 1967, 18, 138 Wiley, Harvey W., 14 World Health Organization (WHO), 32, 34, 88 y Yeasts, international criteria for produce, 322- 323, 330-331, 332-333, 352-353, 355- 356 in dairy products, 242-243 in pork, 41, 44, 172 trends in incidence, 40-41, 173 Y. enterocolitica, 41, 172, 173, 242-243, 307, 308 z Zero tolerance for animal drug residues, 24 defined, 24, 25, 290-291, 292 for E. cold 0157:H7, 158, 163, 173, 261 for L. monocytogenes, 160, 180 lay concept, 24, 25 for pesticide residues, 25 as policy tool, 24-25 public health impacts, 163, 261 in regulations and laws, 24 sensitivity of analytical methods and, 25, 115, 160, 253

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Representative terms from entire chapter:

international criteria