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First, it is unclear that the observed or perceived increases in transference of antibiotic resistance to humans are associated with the use of antibiotics in the food-animal industry. Second, there are no scientific data on resistance emergence and pathogen transfer in situations in which a therapeutic drug intervention is prescribed during subtherapeutic drug use for growth promotion that began in the absence of disease and when no prior disease state existed. Third, there are only sparse data to relate the dosages of a drug necessary to foster resistance to those dosages used and the observed degree of resistance.

The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce Alberts and Dr. William A. Wulf are chairman and vice-chairman, respectively, of the National Research Council. Page vii Preface The raising of livestock for meat, milk, and eggs has been an integral component of the food production system in this country since its first settlement in the 1600s. S. capacity for food production is tremendous and remarkable, considering that now less than 2 percent of the population is genuinely vested in the raising of food for the rest of the country.

Page xv Contents Executive Summary 1 The Committee Process, 3 Food-Animal Drug Use, 4 Approval and Oversight of Food-Animal Drugs, 5 Monitoring of Drug Residues, 6 Resistance to Antibiotic Drugs, 6 Conclusions, 9 Major Recommendations, 10 Development, Approval, and Availability of Food-Animal Drugs, 10 Resistance to Antibiotic Drugs, 11 Alternatives to Drug Use in Food Animals, 11 1 Drugs Used in Food Animals: Background and Perspectives 12 The Role of This Report, 13 Review of Previous Reports, 15 The Antibiotic Issue, 19 A Possible Scenario, 20 The Emergence of Antibiotics in Our Lives, 20 Food-Animal Antibiotic Resistance and Human Health, 22 2 Food-Animal Production Practices and Drug Use 27 Overview, 27 The Poultry Industry, 29 An Integrated Industry, 30 History and Trends in Drug Use, 31 Page xvi Routes of Drug Administration, 34 Feed, 34 One-Day-of-Age Injection, 34 Water Medication, 34 Growth Promotion, 38 Disease Control, 38 Salmonella Control, 38 Escherichia coli Control, 39 Clostridium Control, 39 The Swine Industry, 40 Disease Control and Use of Drugs and Chemicals, 41 Growth and Metabolic Performance, 42 The Dairy Industry, 44 Disease Control and Prophylactic Treatments, 45 Therapeutic Treatment of Disease, 45 Antibiotic Drug Use, 47 Production Enhancers, 48 The Beef Industry, 48 Disease Prevention, 50 Trends in Drug Use, 50 Therapeutic Drug Use, 51 Vaccinations, 53 The Veal Industry, 53 The Sheep Industry, 54 Minor Species, 56 The Aquaculture Industry, 56 Quality-Assurance Programs and Animal Health Maintenance, 60 Poultry Quality-Assurance Programs, 60 Pork Quality-Assurance Programs, 61 Dairy Quality-Assurance Programs, 63 Beef Quality-Assurance Program, 67 Summary of Findings, 68 3 Benefits and Risks to Human Health 69 Overview, 69 Prevention, 71 Treatment, 72 Benefits of Antibiotic Use, 73 Possible Hazards of Antibiotic Use, 75 Antibiotic Resistance as a Human Health Risk, 76 Antibiotic Resistance Trends, 78 Human Health Risks from Drug Residues in Foods, 81 Antibiotic Toxicities, 83 Allergenicity, 84 Page xvii Relative Risks: Residues versus Microbial Contamination, 85 Summary of Findings, 86 4 Drug Development, Government Approval, and the Regulatory Process 88 Overview, 88 Restructuring the Regulatory and Approval Process, 91 Reforming the Regulatory Process, 95 The Animal Medicinal Drug Use Clarification Act, 96 The Animal Drug Availability Act, 99 Human Health Risk, Residues, and Approval, 100 Perspectives on Developing Drugs, 101 Worldwide Harmonization of the Animal Drug Approval Process, 104 Summary of Findings and Recommendations, 106 Recommendations, 107 5 Drug Residues and Microbial Contamination in Food: Monitoring and Enforcement 110 Drug Residue Standards and Screening, 111 Tracking Drug Residues in Food, 113 Drug Residues in Meat and Poultry, 115 Drug Residues in Fish and Seafood, 119 Drug Residues in Milk, 119 The Grade A Pasteurized Milk Ordinance, 121 Drug Residue Testing in Milk, 122 Drug Monitoring in Milk, 124 Unresolved Dairy Testing Issues, 125 Food-Borne Pathogens and Contamination of Food, 126 Determination of Pathogens, 127 A Nine-Year Survey of Reported Food-Borne Illness, 133 Integrating Issues of Residues and Microbial Contamination, 137 Summary of Findings and Recommendations, 140 Recommendations, 141 6 Issues Specific to Antibiotics 142 Development and Functionality of Antibiotic Drugs, 143 Identifying and Screening Antibiotics, 145 Bacterial Resistance, 148 Antibiotic-Resistant Bacteria and Animal Management, 150 Subtherapeutic versus Therapeutic Use of Drugs, 153 Human and Veterinary Clinical Implications of Antibiotic Resistance, 161 Cases to Test the System, 166 The Fluoroquinolones Issue, 168 The Virginiamycin Issue, 175 Page xviii Summary of Findings and Recommendations, 176 Recommendations, 177 7 Costs of Eliminating Subtherapeutic Use of Antibiotics 179 Considerations in Determining the Effect of a Ban, 180 Definition of Subtherapeutic Use, 180 Measurement Choice, 180 Viable Antibiotic Substitutes, 182 Total Versus Partial Ban, 182 Consumer Behavior, 183 Results of Economic Analysis and Conclusions, 184 Appendix, 186 Technical Notes for Table 7-1, 186 Chicken Data, 186 Turkey Data, 187 Beef Data, 187 Pork Data, 187 8 Approaches to Minimizing Antibiotic Use in Food-Animal 188 Animal Management, 190 Ambient Temperature and Heat Stress, 190 Overcrowding and Behavioral Stress, 193 Vaccination Strategies to Prevent Disease, 193 DNA Vaccination, 195 Beneficial Microbial Cultures, Probiotics, and Competitive-Exclusion Alternatives, 195 Biosecurity, 197 Fly Control, 199 Moisture, Mud, and Manure, 199 Enhancing Natural Mediators of Immune Function, 200 Killed Bacterial Adjuvants: Biomodulation of Cytokine and Immune Function, 202 Nutrition, 202 Disease Eradication 206 Genetics, 207 Recommendations, 208 References 210 About the Authors 235 Index 239 Page xix Tables and Figures Tables 1-1 Summary of Previous Major Reports on Food-Animal Antibiotics, 16 2-1 Coccidiostats Approved for Use in Broilers, Turkeys, and Layers, 32 2-2 Major Claims of Antibiotics Approved for Use in Chickens and Turkeys, 32 2-3 Cost of Drug and Vaccine Use in Broilers from 1989 to 1994, 35 2-4 Turkey Medication and Vaccine Cost Analysis, 36 2-5 Cost of Medication and Vaccination Used for Turkeys and Broilers in the United States, 37 2-6 Major Claims of Antibiotics Approved for Use in Hogs, 42 2-7 Major Claims of Chemotherapeutics Approved for Use in Hogs, 43 2-8 Intramammary Antibiotics Approved for Dairy Cattle, 45 2-9 Distribution of Health Costs per Cow by Functional Category, 46 2-10 Estimated Annual Losses Caused by Mastitis, 47 2-11 Major Claims for Systemic Antimicrobials Approved for Use in Beef and Dairy Cattle, 52 2-12 Steroid Products Labeled for Improved Growth and/or Feed Efficiency in Cattle, 53 2-13 Major Claims of Antibacterials Approved for Use in Sheep, 55 2-14 Major Claims for Drugs Approved for Use in Minor Species, 57 2-15 FDA-Approved New Drugs for Use in Aquaculture, 59 Page xx 3-1 The Effect of Implementation of a Veterinary Preventive-Medicine Scheme on Offal and Carcass Rejections from 12 Finishing Farms, 76 4-1 Food-Animal Populations in the United States, 102 4-2 Comparative Value of FDA-Regulated Industries, / 102 4-3 Annual Sales of Animal Drugs, 103 5-1 FSIS Animal Drug Residue Test Results, 118 5-2 Drug Residue Analysis Results for Grade A and Non-Grade-A Milk, 121 5-3 Survey Report of Microbiological Hazards in Swine, 128 5-4 Survey Report of Microbiological Hazards in Cattle, 130 5-5 Survey Report of Microbiological Hazards in Lamb, 132 5-6 Survey Report of Microbiological Hazards in Poultry, 134 6-1 E.