1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2. National Antimicrobial Resistance Monitoring System (NARMS) Retail Data Dr. David G. White Center for Veterinary Medicine U.S. FDA Veterinary Medicine Advisory Committee September 25, 2006

3. v The National Antimicrobial Resistance Monitoring System (NARMS) is a national collaborative network between the FDA, CDC and USDA as well as public health laboratories in all 50 states and local health departments in four major cities v NARMS was developed to monitor changes in susceptibility/resistance of select zoonotic bacterial pathogens and commensal organisms recovered from animals, retail meats and humans to antimicrobial agents of human and veterinary importance v NARMS monitors susceptibility/resistance phenotypes using three testing sites: n FDA/CVM (retail meat and poultry) n CDC (humans) n USDA (animal/slaughter) NARMS

4. NARMS/Retail Meats Overview v 10 FoodNet sites v Similar sampling scheme nRandom sampling of stores nEach site purchases 10 packages each of chicken breasts, pork chops, ground turkey, and ground beef v All ten sites culture meat and poultry rinsates for Salmonella and Campylobacter v In addition, four sites (GA, MD, OR and TN) culture rinsates for E. coli and Enterococcus v Isolates are sent to FDA-OR for confirmation of identification and antimicrobial susceptibility testing Retail Food Study Sites; FoodNet laboratories

5. NARMS Retail meats sampled for Salmonella 2002200320042005 Chicken breast61689711721192 Ground turkey64285711651195 Ground beef64288011861196 Pork chop61389911761196 Total2513353346994779 2002, 6 states; 2003, 8 states; 2004 and 2005, 10 states

6. NARMS/Retail food preliminary data Salmonella 2002 - 2005 2002, 6 FoodNet sites, n = 153 2003, 8 FoodNet sites, n = 212 2004, 10 FoodNet sites, n = 324 2005, 10 Foodnet sites, n = 355* Preliminary data

7. NARMS/Retail food Salmonella Ceftriaxone MIC Distributions by Year Preliminary data 2002, 6 FoodNet sites, n = 153 2003, 8 FoodNet sites, n = 212 2004, 10 FoodNet sites, n = 324 2005, 10 Foodnet sites, n = 355* Total Salmonella = 1044 isolates N=7 0.07%

8. NARMS/Retail food Salmonella Ceftriaxone MIC Distributions by Meat Type Total Salmonella = 1044 isolates: CB = 454; GT = 514; GB = 41; PC = 35 Preliminary data N=7 0.07%

9. NARMS/Retail food Salmonella Ceftiofur MIC Distributions by Year Preliminary data 2002, 6 FoodNet sites, n = 153 2003, 8 FoodNet sites, n = 212 2004, 10 FoodNet sites, n = 324 2005, 10 Foodnet sites, n = 355* Total Salmonella = 1044 isolates N=138 13.2%

10. NARMS/Retail food Salmonella Ceftiofur MIC Distributions by Meat Type Total Salmonella = 1044 isolates: CB = 454; GT = 514; GB = 41; PC = 35 Preliminary data N=138 13.2%

11. β-lactamases vCan be either chromosomal or plasmid borne vPlasmid mediated TEM-1 and TEM-2  -lactamases are the most widely disseminated among Gram negative bacteria vClass A extended-spectrum ß-lactamases (ESBLs) (CTX-M or enzymes derived from the classic TEM-1 and SHV-1) and plasmidic class C ß-lactamases (FOX and CMY, among others) have been described among Salmonella and E. coli isolates recovered from animals

12. β-lactamases among NARMS Salmonella recovered from retail meats 2002 - 2005 NARMS Retail: 1044 Salmonella isolates collected between 2002 – 2005 138 isolates > 8 μg/ml ceftiofur Chicken breast = 98 isolates Ground turkey = 29 isolates Pork chop = 3 isolates Ground beef = 8 isolates bla CTX-M genes0/138 bla CMY genes132/138

13. Ceftiofur vs. Cefquinome MIC Distributions among Ampicillin Resistant Salmonella Recovered from Retail Foods (N=97) 2002, 6 FoodNet sites, n=28 ampR isolates 2003, 8 FoodNet sites, n=69 ampR isolates Preliminary data

14. Cefquinome MIC Distributions among Ceftiofur Susceptible and Resistant Salmonella isolates (N=97) Salmonella MICs < 2 μg/ml = 52 isolates Salmonella MICs > 8 μg/ml = 45 isolates Preliminary data bla CMY positive

15. NARMS Retail meats sampled for E. coli 2002200320042005 Chicken breast390477476480 Ground turkey395447466480 Ground beef399470480 Pork chop390479478480 Total1574187319001920 Only four sites (GA, MD, OR and TN) culture rinsates for E. coli and Enterococcus

16. NARMS/Retail food preliminary data E. coli 2002 - 2005 2002, 6 FoodNet sites, n = 1065 2003, 8 FoodNet sites, n = 1258 2004, 10 FoodNet sites, n = 1346 2005, 10 Foodnet sites, n = 1441* Preliminary data

17. NARMS/Retail food E. coli Ceftriaxone MIC Distributions by Year 2002, 6 FoodNet sites, n=1065 isolates 2003, 8 FoodNet sites, n=1258 isolates 2004, 10 FoodNet sites, n=1346 isolates Preliminary data N=0 Total E. coli = 3669 isolates

18. NARMS/Retail food E. coli Ceftriaxone MIC Distributions by Meat Type Preliminary data N=0 Total E. coli = 3669 isolates: CB = 1078; GT = 1013; GB = 944; PC = 634

19. NARMS/Retail food E. coli Ceftiofur MIC Distributions by Year 2002, 6 FoodNet sites, n=1065 isolates 2003, 8 FoodNet sites, n=1258 isolates 2004, 10 FoodNet sites, n=1346 isolates Preliminary data Total E. coli = 3669 isolates N=89 2.4%

20. NARMS/Retail food E. coli Ceftiofur MIC Distributions by Meat Type Preliminary data Total E. coli = 3669 isolates: CB = 1078; GT = 1013; GB = 944; PC = 634 N=89 2.4%

21. β-lactamases among NARMS E. coli recovered from retail meats 2002 - 2004 NARMS Retail: 3669 E. coli isolates collected between 2002 – 2004 89 isolates > 8 μg/ml ceftiofur Chicken breast = 73 isolates Ground turkey = 8 isolates Pork chop = 4 isolates Ground beef = 4 isolates bla CTX-M genes0/89 bla CMY genes82/89

22. v NARMS currently monitors susceptibility to several β-lactam antimicrobials including cefoxitin, ceftiofur, and ceftriaxone among Salmonella and E. coli isolates v Among 1,044 Salmonella recovered from retail foods between 2002 – 2005 n13.2% ceftiofur resistant (> 8 μg/ml) n0.7% ceftriaxone resistant (> 64 μg/ml) v Among 3,669 E. coli recovered from retail foods between 2002 – 2004 n2.4% ceftiofur resistant (> 8 μg/ml) n0% ceftriaxone resistant (> 64 μg/ml) Summary

23. v NARMS secondary ESBL plate includes the 4 th generation cephalosporins, cefepime and cefquinome n0.06 – 32 μg/ml nIn 2007, all ampicillin resistant Salmonella and E. coli will be further tested on secondary ESBL plate v Detection of β-lactamases among ceftiofur resistant Salmonella and E. coli nNo CTX-M extended-spectrum β-lactamases (ESBL) were detected nCMY genes most commonly identified vAre not currently associated wtih resistance to 4 th generation cephalosporins vAssociated with shifts in cefquinome MICs to a less susceptible population, however, MICs are still below CLSI resistant breakpoint established for other 4 th generation cephalosporin (cefepime > 32 μg/ml) v NARMS will continue to monitor any shifts in decreased susceptibility to cefquinome and other cephalosporins of animal and human health significance Summary

24. Acknowledgements ► FDA –Dr. Elvira Hall-Robinson –Dr. Heather Harbottle –Dr. Patrick McDermott –Dr. Terry Proescholdt –Dr. Robert Walker –Dr. Antoinette Walker –Dr. Marleen Wekell ► CDC –Lauren Stancik-Rosenthal –Felicita Medalla –Dr. Tom Chiller –Dr. Fred Angulo ► FDA –Jason Abbott –Sherry Ayers –Karen Blickenstaff –Sonya Bodeis-Jones –Peggy Carter –Patti Cullen –Linda English –Sharon Friedman –Althea Glenn –Susannah Hubert –Stuart Gaines –Shawn McDermott –Sadaf Qaiyumi ► FoodNet EIP funded sites ► CDC PulseNet ► USDA -Dr. Paula Fedorka-Cray