Regulating Antibiotics in Animal Feed

1. Regulating Antibiotics in Animal Feed 2011 Future Trends in Animal Agriculture Symposium

2. Overview • Antibiotics are carefully regulated. • Risks to human health tend to be exaggerated • Assessed risk is low • Recognized benefits of antibiotics • FDA engaged in a collaborative stakeholder process to further manage potential risks

3. Protecting animal and public health Regulation & USE of Antibiotics

4. Antibiotic Use Antibiotics preserve our nation’s safe and abundant food supply by: • Disease treatment • Disease control • Disease prevention • Growth promotion Therapeutic Use CODEX, AVMA

5. Approval Process

6. Label Claim vs. Route of Administration • Not to be confused with route of administration • Feed • Water • Injection • Oral bolus • Antibiotics are used in feed for more than growth promotion • Practical means of medicated large groups of animals • AHI estimates about 13% of antibiotics used only for growth (2007)

7. Making accurate comparisons Risks Tend to be exaggerated

8. Current Numbers • In 2008 Congress passed a law requiring companies to report sales data to FDA – pretty much the same sales data that had been reported voluntarily through AHI. A public summary of that data is made available each year by FDA. • Following the public release of the data from AHI, a writer asked FDA by email how much is used in human medicine. He received an email estimate – based on some calculations from yet a different data source, which became the source of the “80 percent of all antibiotics are used in animal agriculture” statement. • 80% was then repeated throughout the media and by members of Congress, despite being an inaccurate and misleading number.

9. FDA says the 80% comparison is invalid Antimicrobial Drugs Approved for Use in Food-Producing Animals – 2009 Source: Animals Consume Lion's Share of Antibioticsby Ralph F. Loglisci | Dec 27, 2010

10. - Letter from FDA to Congresswoman Slaughter April 19, 2011

11. FDA Corrects the Record

12. Animal Antibiotics not used in Humans • Included in FDA report but do not select for antibiotic resistance • Ionophores (3.7 million Kg.) • Bambermycins • Carbadox • Arsenical antibiotics • Some sulfonamides • 40% of FDA total not used in human medicine

13. GAO Report: European Example Decreasing overall quantity of use in animals doesn’t necessarily improve human health: “Danish officials told us that Denmark’s resistance data have not shown a decrease in antibiotic resistance in humans after implementation of the various Danish policies… ” GAO-11-801, September 7, 2011

14. University of Maryland Study Shows reduction in ABX resistance in farms that stopped using antibiotics The enterococcus bacteria examined are common intestinal bacteria not foodborne pathogens. FDA found that chicken enterococcus differ from human strains in a study on virginiamycin resistance.

15. Human Animal Source: Robin J. Bywater and Mark W. Caswell. Journal of Antimicrobial Chemotherapy 2000; 46:643-645.

16. Infectious Disease Society of America “Facts about AR” • Staphylococcus infections (MRSA) • Acinetobacter baumanni • Vancomycin Resistant Enterococcus (VRE) • Pseudomonas aeruginosa • Streptococcus pneumoniae • Neisseria gonorrhea • Drug resistant TB, Clostridium difficile, Klebsiella species • No food-borne or animal reservoirs

17. CDC Diseases/Pathogens Associated with Antimicrobial Resistance Bacteria Acinetobacter Anthrax Gonorrhea Group B streptococcus Klebsiella pneumoniae Methicillin-resistant Staphylococcus aureus (MRSA) • Few organisms associated with food • Emphasizes human-to-human spread of resistant organisms

18. Understanding risk associated with antibiotic use Assessed Risk is Low

19. Risk Assessment Studies - Hurd, .H. S.; S. Doores; D. Hayes; A. Mathew; J. Maurer; P. Silley; R. Singer; RN Jones. Public Health Consequences of Macrolide use in Food Animals: A Semi-quantitative Risk Assessment. J. Food Protection 2004; 67:980-992. - Claycamp, H. Gregg and Barry H. HoobermanRisk Assessment of Streptogramin Resistance in Enterococcus faeciumAttributable to the Use of Streptogramins in Animals. Draft for Comment, 23-Nov-2004. - Human Health Risk Assessment of Penicillin/Aminopenicillin Resistance in Enterococci Due to Penicillin Use in Food Animals. Cox, et. al., Risk Analysis, Vol. 29, No. 6, 2009.

20. Yearly Risk • Become injured on the job 1 in 49 • Die from heart disease 1 in 384 • Die from the flu 1 in 130,000 • Contract illness or die from the chicken pox 1 in 4.4 million • Die from a bee sting 1 in 6 million • Acquire resistant Campylobacter from macrolide-treated poultry which results in <1 in 14 million treatment failure* • Acquire resistant E. faecium from <1 in 29 billion macrolide- treated beef which results in treatment failure * * From Hurd et. al. 2004 The following risks were calculated by the Harvard Center for Risk Analysis to show how likely humans are to:

21. How animal antibiotics protect people and animals Recognizing Benefits

22. Animal Health Benefits • The effect of airsacculitis on bird weights, uniformity, fecal contamination, processing errors, and populations of Campylobacter spp. and Escherichia coli. Russell SM., Poultry Science 2003; 82 (8): 1326-1331. • Potential Human Health Implications of Swine Health, H. Scott Hurd (2007) • Public Health Reports, “Swine Health Impact on Carcass Contamination and Human Foodborne Risk” (2008)

23. Current and upcoming controls for animal antibiotics Responding to Resistance

24. Regulatory Response • FDA taken several action to address antibiotic resistance • 1996 FDA implements Veterinary Feed Directive • 1998 FDA implements National Antimicrobial Resistance Monitoring System (NARMS) • 2003 Guidance 152 – Risk assessment required for new antibiotics • 2010 Guidance 209 – Phase out growth promotion and require VFD for medically important AB’s

25. AHI Response • We welcome the opportunity to work with FDA to meet their objectives of reducing antibiotic use for growth promotion; and, • Increasing veterinary oversight over the use of medically important antibiotics in feeds. • GOAL: All medically important antibiotics will be used therapeutically under the supervision of a veterinarian.