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. Regulation & USE of Antibiotics
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. Risks Tend to be exaggerated
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 how much is used in human medicine. He received an 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 Antibiotics by 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 , 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:

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
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)

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: 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 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
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 in 384
Die from the flu in 130,000
Contract illness or die from the chicken pox 1 in 4.4 million
Die from a bee sting 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

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):
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. Responding to Resistance
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.