1. Antibiotics in Agriculture: Science, Public Policy, and the Marketplace Rebecca Goldburg, Senior Scientist,Environmental Defense November, 2004

2. The Antibiotic Resistance Crisis  Federal Interagency Task Force, 2001:  Antimicrobial resistance is “a growing menace to all people”  Without effective action, treatments for common infections “will become increasingly limited and expensive – and, in some cases, nonexistent.“

3. Relative Causation Medical overuse is a major factor But, massive agricultural use of antibiotics likely also plays a large role in generating and distributing resistance genes Precise quantification of relative contributions probably impossible…... but simultaneous action on medical and agricultural fronts is not!

4. Key terminology Non-therapeutic  Generally added to feed  For “growth promotion”  For “routine prophylaxis” – compensate for crowded conditions Therapeutic  Treat sick animals or those likely to get sick because of illness in the herd or flock

5. “Routine Prophylaxis” Crowding Stress Poor hygiene Poor diet Premature weaning

6. Livestock Therapy Human Therapy OtherLivestock Non-Therapeutic % 6 8 15 70 U.S. antimicrobial use Half from classes used in human medicine UCS estimates

7. RxRx Medically important antibiotics used as non-therapeutic feed additives Macrolides Penicillins Tetracyclines Streptogramins Aminoglycosides Lincomycin Sulfonamides Bacitracin

8. HUMANS (General Populace) Routes of Exposure Antibiotics WORKERS ENVIRONMENT Resistant Bacteria Animals FOOD

9. Transfer of Resistance Genes  Bacteria “teach” each other to outwit antibiotics  Plasmids and more  Readily transferred  Even to distantly related bacteria  Confirmed in human gut, mouth

10. Via FOOD handling, consumption HUMANS (General Populace) Routes of Exposure Antibiotics Via WORKERS Handling of feed, manure; transfer to family, community Via ENVIRONMENT Contamination of water, soil, air by bacteria and antibiotics Resistant Bacteria Animals “AR genes … once evolved in bacteria of any kind anywhere, can spread indirectly through the world’s interconnecting commensal, environmental and pathogenic bacterial populations to other kinds of bacteria anywhere else.” -- O’Brien, 2002

11. The Role of Residues Antibiotic residues NOT major focus of concern –Testing finds occasional violations of residue standards But, even if residue standards fully met, antibiotic resistance problem remains!

12. Public-health consensus National Academies Institute of Medicine, 2003: "Clearly, a decrease in antimicrobial use in human medicine alone will have little effect on the current situation. Substantial efforts must be made to decrease inappropriate overuse in animals and agriculture as well."

13. WHO Review: A Phaseout is Doable “Internationally there has been considerable speculation about the effects of antimicrobial growth promoter termination on efficiency of food animal production, food safety, and consumer prices. These issues have been addressed in the “Danish experiment,” and there have been no serious effects.”

14. Government Policy and Marketplace Initiatives  Government policy  Phaseouts of antibiotic feed additives in Sweden, Denmark, and then EU  US – FDA, Congress  Marketplace  Restaurant chains, suppliers  Market opportunities

15. Environmental Defense’s role Coalition to Keep Antibiotics Working (KAW)Coalition to Keep Antibiotics Working (KAW) – members include  Union of Concerned Scientists  Humane Society of the United States  National Catholic Rural Life Conference  Environmental Defense Alliance for Environmental InnovationAlliance for Environmental Innovation – arm of Environmental Defense that works with businesses to voluntarily adopt policies and practices that protect the environment

16. FDA’s Draft Guidance 152 New FDA policy Mostly guidance to industry for assessing NEW antimicrobial drugs for animals Acknowledges FDA needs to review existing approvals, but no timetable for doing so

17. Fluoroquinolones in poultry  Oct. 2000: FDA proposed to ban fluoroquinolones for therapeutic use in poultry  Bayer contesting  FDA administrative law judge ruled against Bayer in 2003  Multi-year process of appeals ensues  Meanwhile, poultry drug remains on market

18. Citizen Petition to FDA, March 1999  FDA “tentative” response Feb. 01: “The Agency’s experience with contested, formal with- drawal proceedings is that the process can consume extensive periods of time and Agency resources.”  Asked FDA to issue rules phasing out non-therapeutic use of 7 classes of medically important antibiotics.  FDA cited as examples:  DES - 6 years  DES - 6 years  Nitrofurans - 20 years  Nitrofurans - 20 years

19. 8 classes x 6 – 20 years per class = 48 - 160 years

20. “Preservation of Antibiotics for Medical Treatment Act” (Sen. Kennedy/Snowe; Rep. Brown/Gilchrest)  Phases out nontherapeutic use of 8 classes of human-use antibiotics  Unless FDA concludes ‘safe’  Ag-use data  Transition support

21. Endorsers About 375 endorsers, including: –American Medical Association –American Academy of Pediatrics –Alabama State Nurses Association –Iowa Farmers Union –American Grassfed Association –Consumer Federation of America

22. Marketplace: Private sector actions  Major poultry producers -- Perdue, Tyson Foods, Foster Farms, ConAgra, Gold Kist, Claxton, and Wayne Farms – say they have reduced or eliminated routine uses of medically important antibiotics or the use of fluoroquinolones in sick birds

23. McDonald’s Policy Bans growth promoters after 2004 for “direct suppliers,” i.e. poultry Creates purchasing preference for other suppliers Establishes guidelines for “sustainable use” – e.g. preventative use of antibiotics Applies globally Developed with Environmental Defense

24. Economic Opportunity Consumer interest in products from animals raised –Without routine/ any antibiotics –Without hormones –Under standards for humane treatment –By independent ”family” farmers

25. “Family Farm Foods” New initiative: Marketing alliance to be based in Louisiana National scope with regional subunits Link producers to retailers Clear, consistent production protocols

26. National Brand using Visa Model

27. Family Farm Foods Key organizations: Agriculture of the Middle The Association of Family Farms, Inc. Family Farm Foods of Mississippi Other supporters: Land grants Foundations Nongovernment organizations SYSCO, Winn Dixie

28. Conclusions Strong scientific case for reducing antibiotic use in animal agriculture Federal government is beginning to address the issue Some major food companies are reducing antibiotic use, particularly in poultry Coupling reduced antibiotic use with other production attributes may offer an opportunity for independent farmers

29. Leading the Flock: McDonald’s Antibiotic Policy