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

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

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

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

Approval Process

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)

Risks Tend to be exaggerated Making accurate comparisons Risks Tend to be exaggerated

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.

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

- Letter from FDA to Congresswoman Slaughter April 19, 2011

FDA Corrects the Record

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

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

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.

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

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

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

Understanding risk associated with antibiotic use Assessed Risk is Low

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. Hooberman Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable 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.

Yearly Risk Become injured on the job 1 in 49 The following risks were calculated by the Harvard Center for Risk Analysis to show how likely humans are to: 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

How animal antibiotics protect people and animals Recognizing Benefits

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)

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

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

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.