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ANTIBIOTIC RESISTANCE AND THE USE OF ANTIBIOTICS IN ANIMAL 

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ANTIBIOTIC RESISTANCE AND THE USE OF 

ANTIBIOTICS IN ANIMAL AGRICULTURE 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

JULY 14, 2010 

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(II) 

COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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(V) 

C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 7 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 8 

Prepared statement .......................................................................................... 10 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 16 

Hon. Janice D. Schakowsky, a Representative in Congress from the State 

of Illinois, opening statement .............................................................................. 17 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 18 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 19 

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement ................................................................................. 20 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 21 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 22 

Hon. Zachary T. Space, a Representative in Congress from the State of 

Ohio, opening statement ...................................................................................... 23 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 24 

Prepared statement .......................................................................................... 26 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

prepared statement .............................................................................................. 230 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 232 

Hon. Roy Blunt, a Representative in Congress from the State of Missouri, 

prepared statement .............................................................................................. 237 

Hon. John Sullivan, a Representative in Congress from the State of Oklahoma, prepared statement ................................................................................... 239 

WITNESSES

Joshua Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug 

Administration, U.S. Department of Health and Human Services ................. 28 

Prepared statement .......................................................................................... 31 

Answers to submitted questions ...................................................................... 316 

John Clifford, D.V.M., Deputy Administrator, Veterinary Services, Animal 

and Plant Health Inspection Service, U.S. Department of Agriculture .......... 42 

Prepared statement .......................................................................................... 44 

Answers to submitted questions ...................................................................... 322 

Rear Admiral Ali S. Khan, M.D., M.P.H., Assistant Surgeon General, Acting 

Deputy Director, National Center for Emerging and Zoonotic Infectious 

Diseases, Centers for Disease Control and Prevention, U.S. Department 

of Health and Human Services ........................................................................... 49 

Prepared statement .......................................................................................... 51 

Answers to submitted questions ...................................................................... 324 

Per Henriksen, D.V.M., Ph.D., Head of Division, Division for Chemical Food 

Safety, Animal Welfare and Veterinary Medicinal Products, Danish Veterinary and Food Administration ............................................................................ 77 


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VI 

Per Henriksen, D.V.M., Ph.D., Head of Division, Division for Chemical Food 

Safety, Animal Welfare and Veterinary Medicinal Products, Danish Veterinary and Food Administration—Continued 

Prepared statement .......................................................................................... 80 

Answers to submitted questions ...................................................................... 327 

James R. Johnson, M.D., F.I.D.S.A., F.A.C.P., Professor of Medicine, University of Minnesota, and Fellow, Infectious Diseases Society of America .......... 104 

Prepared statement .......................................................................................... 107 

Answers to submitted questions ...................................................................... 332 

Gail R. Hansen, D.V.M., M.P.H., Senior Officer, Human Health and Industrial Farming Group, Pew Charitable Trusts .................................................... 123 

Prepared statement .......................................................................................... 125 

Christine Hoang, D.V.M., M.P.H., C.P.H., Assistant Director, Scientific Activities Division, American Veterinary Medical Association .................................. 163 

Prepared statement .......................................................................................... 165 

Answers to submitted questions ...................................................................... 334 

Randall Singer, D.V.M., M.P.V.M., Ph.D., Associate Professor of Epidemiology, Department of Veterinary and Biomedical Sciences, College of Veterinary Medicine, Division of Epidemiology, School of Public Health, University of Minnesota .................................................................................................. 183 

Prepared statement .......................................................................................... 185 

Richard Carnevale, D.V.M., Vice President, Regulatory, Scientific and International Affairs, Animal Health Institute ......................................................... 204 

Prepared statement .......................................................................................... 206 

Answers to submitted questions ...................................................................... 341 

Stuart Levy, M.D., Professor of Molecular and Biology, Professor of Medicine, 

Tufts University ................................................................................................... 216 

Prepared statement .......................................................................................... 218 

SUBMITTED MATERIAL

Letter of July 13, 2010, from Centers for Disease Control to Mr. Pallone, 

submitted by Mr. Waxman .................................................................................. 241 

Statement of San Francisco Medical Society, submitted by Mr. Waxman ......... 257 

Statement of Physicians for Social Responsibility in Los Angeles, submitted 

by Mr. Waxman .................................................................................................... 258 

Documents for the record submitted by Ms. Schakowsky .................................... 259 

Statement of Hon. Leonard L. Boswell, submitted by Mr. Waxman ................... 313 


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(1) 

ANTIBIOTIC RESISTANCE AND THE USE OF 

ANTIBIOTICS IN ANIMAL AGRICULTURE 

WEDNESDAY, JULY 14, 2010 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 2:12 p.m., in Room 

2123 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. [Chairman of the Subcommittee] presiding. 

Members present: Representatives Pallone, Dingell, Schakowsky, 

Baldwin, Barrow, Christensen, Murphy of Connecticut, Space, 

Braley, Waxman (ex officio), Shimkus, Buyer, Pitts, Sullivan, Murphy of Pennsylvania, Blackburn and Gingrey. 

Staff present: Ruth Katz, Chief Public Health Counsel; Sarah 

Despres, Counsel; Rachel Sher, Counsel; Stephen Cha, Professional 

Staff Member; Emily Gibbons, Professional Staff Member; Virgil 

Miler, Professional Staff Member; Alvin Banks, Special Assistant; 

Allison Corr, Special Assistant; Eric Flamm, FDA Detailee; Karen 

Lightfoot, Communications Director, Senior Policy Advisor; Elizabeth Letter, Special Assistant; Lindsay Vidal, Special Assistant; 

Mitchell Smiley, Special Assistant; Clay Alspach, Minority Counsel, 

Health; and Ryan Long, Minority Chief Counsel, Health. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. The meeting of the Health Subcommittee is called 

to order, and the subcommittee is convening today for its third 

hearing to discuss antibiotic resistance and its threat to public 

health. Today we will examine the use of antibiotics in food-producing animals and the impact of this use on human health. 

Antibiotics, as you all know, are among the most significant medical innovations of the 20th century. The CDC lists control over infectious disease as one of its top 10 great public health achievements of the last century, and antimicrobials are crucial to that accomplishment. And yet we must collectively be alarmed that we are 

undermining the power of antibiotics by failing to use them judiciously. In past hearings, we have heard testimony about physicians that are prescribed antibiotics just in case their patients have 

bacterial infections, and we all know patients that have stopped 

taking their antibiotics once they felt better, even if they didn’t finish the treatment. It is clear that the consequences of such actions 

are severe. Manmade antimicrobial resistance weakens our options 


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2 

to treat pneumonia, food-related diseases including E. coli and Salmonella, and hospital-acquired infections, commonly known as 

MRSA. 

Our examination of antibiotic resistance would not be complete 

without a discussion of the use of antimicrobials in animals. It is 

very timely that we are having this hearing today. Last month the 

FDA issued draft guidance detailing its position that using medically important antimicrobial drugs for food production purposes 

threatens the protection and promotion of the public health. FDA 

will state today that antibiotics should only be given to animals 

under supervision of a veterinarian and should only be used to assure animal health and not to promote growth. We will have the 

opportunity today to hear from the major experts and stakeholders 

in the field about reactions to FDA’s draft guidance and the overall 

debate on how animal use of antibiotics impacts human health. 

As we consider future action to limit antibiotic resistance, it 

would be helpful to hear about the Danish experience. Starting in 

1995, the Danish government implemented aggressive steps to 

limit the use of antibiotics in food-producing animals and collected 

extensive data that they and the World Health Organization used 

to evaluate the effects of these actions. Clearly, any future action 

to limit antibiotic resistance must be carefully considered and guided by science. 

We have two great panels today of government and private witnesses with 10 people total testifying who will contribute to this 

discussion, and I know that many of the witnesses rearranged their 

schedules today to be here including Dr. Josh Sharfstein at the 

FDA. We greatly appreciate your ability. However, I am going to 

have to say one thing you are not going to like, and that is that 

unfortunately as too many times has been the case here, we did not 

get the testimony within 48 hours before the hearing. I know that 

the hearing was changed, I guess, from tomorrow to today but we 

notified everybody 3 weeks ago of that, and the FDA testimony arrived at about 6 p.m. Tuesday, which was last night, and the CDC 

testimony also arrived late in the day on Tuesday, which obviously 

doesn’t make the 48 hours, so please in the future, it is really important that we get the testimony 48 hours before the hearing. 

Otherwise we really can’t adequately prepare for the hearing, so I 

just want to mention that, and I don’t want to be difficult but it 

really is important. 

[The prepared statement of Mr. Pallone follows:] 


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Chairman Frank Pallone 

Antibiotic Resistance and the Use of Antibiotics in Animal 

Agriculture 

June 14, 2010 

Good afternoon. The Subcommittee is convening today for 

its third hearing to discuss antibiotic resistance and its threat to 

public health. Today we will examine the use of antibiotics in 

food-producing animals and the impact of this use on human 

health. 

Antibiotics are among the most significant medical 

innovations of the 20th century. The CDC lists "control over 

infectious disease" as one of its top 10 "great public health 

achievements" of the last century and mentions antimicrobials as 

crucial to that accomplishment. 

And yet, we must collectively be alarmed that we are 

undermining the power of antibiotics by failing to use them 

judiciously. In past hearings we have heard testimony about 
4 


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physicians that have prescribed antibiotics "just in case" their 

patients have bacterial infections. And we all know patients that 

have stopped taking their antibiotics once they felt better-even if 

they didn't finish the treatment. It is clear that the consequences of 

such actions are severe-man made antimicrobial resistance 

weakens our options to treat pneumonia, food-related diseases 

including e-coli and salmonella, and hospital-acquired infections 

commonly known as MRSA [mer-sa]. 

Our examination of antibiotic resistance would not be 

complete without a discussion of the use of antimicrobials in 

animals. It is very timely that we are having this hearing today; 

last month, the Food and Drug Administration issued draft 

guidance detailing its position that using medically important 

antimicrobial drugs for food production purposes threatens the 

protection and promotion ofthe public health. FDA will state 

today that antibiotics should only be given to animals under the 

2 
5 


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supervision of a veterinarian and should only be used to assure 

animal health-and not to promote growth. 

We will have the opportunity today to hear from the major experts 

and stakeholders in the field today about reactions to FDA's draft 

guidance, and the overall debate on how animal use of antibiotics 

impacts human health. 

As we consider future action to limit antibiotic resistance, it 

will be helpful to hear about the "Danish Experience." Starting in 

1995, the Danish government implemented aggressive steps to 

limit the use of antibiotics in food-producing animals, and 

collected extensive data that they and the World Health 

Organization used to evaluate the effect ofthese actions. 

Clearly, any future action to limit antibiotic resistance must 

be carefully considered and guided by Science. We have two great 

3 
6 


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panels today of government and private witnesses-with 10 people 

total testifying. 

I know that many of the witnesses re-arranged their schedules 

to be here today, including Dr. Josh Sharf stein of the FDA. We 

appreciate your flexibility and I am certain that we will gain some 

valuable information today. 

And now, a statement from our Ranking Member, Mr. 

Shimkus. 

# 

4 
7 

Mr. PALLONE. With that, I will yield to our ranking member, the 

gentleman from Illinois, Mr. Shimkus. 

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. SHIMKUS. Thank you, Mr. Chairman, and thank you for obviously the admonition about getting testimony in, and I appreciate 

that. I know it is not easy. 

Thank you all for coming. The debate centers around whether 

antibiotic use in animals presents a safety risk for humans. Rather 

than focus on theory, we must really rely on the science behind the 

issue. So far there is nothing that links use in animals to a buildup of human resistance, and so I will be focusing on, I know it 

sounds crazy, but real science, real peer-reviewed science and testing, which in previous testimony, and I have the record from the 

previous hearings that we have done none in this country. There 

has been no testing in this country on this connection. So the challenge will be to not move in public policy until we have verifiable 

peer-reviewed science to address this issue. 

We do know through the hearings that people are overusing and 

misusing antibiotics and that leads to faster development of resistance of drugs in the body, and when it comes to people getting sick 

from foodborne antibiotic-resistant strains, evidence shows it is 

again from humans through handling food, not animals. Even then 

because of our rigorous oversight, foodborne illnesses in the United 

States have continued to decline over the past decade. Nevertheless, as science develops and we learn more, we can always work 

to improve risk-based approach to making people and the foot they 

eat safer. We should explore ways to strengthen our hazardous 

analysis and critical control points, plans across the spectrum from 

farm to fork. 

At the same time, FDA should continue its strict approval path 

of antibiotics for animal use. The FDA process is resulting in increasing amounts of approved antibiotics that are not used in 

human medicine at all. As a result, those classes of antibiotics have 

no potential impact on human resistance while yielding benefits on 

the farm. Still, there are some who would ban use of antibiotics in 

animals similar to what occurred in Denmark in the late 1990s, 

and I know the chairman mentioned that, and I will be talking 

about that research too. Since the ban, Danish animals’ death and 

diseases have increased. To control these increases, therapeutic use 

of antibiotics to treat sick animals more than doubled to a level 

greater than all antibiotic use combined prior to the year of the 

ban. So they banned it and we use more. Animals are not 

healthier; they are sicker. So that is why we do appreciate this 

hearing, and this question, we did make humans safer? No. Only 

did humans not become any less resistant, they became more resistant to antibiotics in Denmark. Resistance increased in Salmonella, penicillin, tetracycline. At the same time those resistances 

in the United States have decreased to about half the level of Denmark. Before we go down a path that will have a devastating economic impact on our agriculture industry, we must ensure science 

drives this debate. 


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8 

So again, I want to thank you, Mr. Chairman, for holding this 

hearing. 

The last thing I do want to mention is that we have 10 witnesses 

today. This is our third or fourth hearing on antibiotics. We have 

not had a single hearing on the new health care law passed. We 

have asked for the CMS actuary. We have asked for Secretary 

Sebelius. Now we have a recess appointment, Dr. Berwick, who we 

like to see, who said some interesting things about rationing care 

and that we would do it with our eyes open, but I guess what is 

as telling as anything else why we need to have a hearing is, it 

seems that in the $160 million that we provided to Pennsylvania 

for the high-risk pool, abortion and abortion services are being expanded at taxpayers’ expense. I thought this was a promise made 

to the pro-life Democrats in voting for the bill through the Executive Order. Obviously that was not the case and that is why we 

should have a hearing, and I yield back my time. 

Mr. PALLONE. Thank you, Mr. Shimkus. 

The chairman of our full committee, the gentleman from California, Mr. Waxman. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you very much, Mr. Chairman. I am 

pleased you are holding this third of a series of hearings on antibiotic resistance. This is a serious public health problem. 

Our first hearing provided the context for understanding the nature of the problem, the scope, the statistics and the science that 

make up this emerging public health crisis. The focus of today’s 

hearing, the use of antibiotics in animals, is an issue that has been 

raised by numerous members of this subcommittee as well many 

of our previous witnesses, representing both the public and private 

sectors, and I think we would all agree that the topic is complicated and controversial. 

I believe we would also all agree on this point: By definition, antibiotic resistance is bred by the very use of antibiotics, be it by humans or by animals. To remain effective, then, antibiotics need to 

be used judiciously. 

As we learned at our last hearing, antibiotics are being overprescribed in humans. That is a very real and difficult problem and 

one that requires our full and immediate attention. 

But the issue with animals is something else. For animals, we 

use antibiotics for purposes other than treating illnesses in the animal. As we will hear today, animals raised for food production are 

routinely provided antibiotics to prevent infections. In stark contrast to animals, we would be shocked if a pediatrician ever ordered antibiotics for an entire nursery school class to keep the children from being infected with strep throat. But in this country, 

that is standard practice for a barnyard full of pigs or cows or 

chickens. In addition, animals regularly are fed these drugs not to 

treat any illness at all but simply to promote growth. In both situations, this is an overprescribing of a very different sort. 

There appears to be universal agreement on yet another point: 

The key to reducing antibiotic resistance is to reduce the use of 


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9 

antibiotics. The Food and Drug Administration recently announced 

one approach for achieving this goal with respect to animals. In 

June, the agency issued draft guidance which recommends that 

antibiotics not be given to animals to promote growth and that 

when these drugs are used, they should be administered only 

under the supervision of a veterinarian. This sounds to me like a 

very good first step. 

But we must do more to tackle this piece of the antibiotic resistance puzzle and we must do so as part of a comprehensive strategy 

designed to safeguard the vitally important public health tool that 

is our antibiotics. I would like to put into the record a letter from 

Dr. Frieden, the director of the Centers for Disease Control to 

Chairman Pallone, and according to Dr. Frieden, ‘‘The Centers for 

Disease Control and Prevention finds there is a compelling body of 

evidence to demonstrate this link between antibiotic use in animals 

and the resistance from the antibiotics.’’ 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. Without objection, so ordered. 

Mr. WAXMAN. It is critical we encourage the development of new 

drugs. It’s also essential to preserve the antibiotics we already 

have. That means we must move expeditiously to slow the advancement of antibiotic resistance in both humans and animals. In each 

instance, our strategy must be based on science. I agree with that 

statement. But science, not just the science that may fit our constituency but real science and the scientific evidence is now strong 

enough to create a consensus among major public health groups 

and experts around the world that the time has come to reduce the 

use of antibiotics in animals. Organizations as diverse as the American Medical Association, the Institute of Medicine, the World 

Health Organization, and as we will hear from both CDC and the 

FDA, they all agree: We must take action now. 

This brings us to today’s hearing. It is an important hearing. Mr. 

Chairman, I want to thank Dr. Sharfstein. He has been very accommodating to be here today. He accommodated us by rearranging his schedule. I happen to know that by watching television 

he has been very busy. I didn’t see him out in Los Angeles at any 

of the beaches, so I think he has been working pretty hard and I 

have noticed he has been involved in Avandia. We would like those 

statements in earlier, but I think they ought to cut you a little 

slack. At least I am going to make that comment. And the same 

is true for others but we do need these statements as early as possible. 

I thank all the witnesses who are here. I particularly thank you, 

Mr. Chairman, for this hearing. I think this is going to be an interesting one. Let us follow the science. Thank you. Yield back. 

[The prepared statement of Mr. Waxman follows:] 


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Statement of Chairman Henry A. Waxman 

Committee on Energy and Commerce 

Subcommittee on Health 

Hearing on "Antibiotic Resistance and the Use of 

Antibiotics in Animal Agriculture" 

July 14,2010 

Thank you, Mr. Chairman, for holding today's 

hearing, the third in the Subcommittee's series to examine 

the growing and serious problem of antibiotic resistance. 

Our first hearings provided the context for 

understanding the nature of the problem - the scope, the 

statistics, and the science that make up this emerging public 

health crisis. 

The focus oftoday's hearing -- the use of antibiotics in 

animals -- is an issue that has been raised by numerous 

Members of the Subcommittee as well many of our 

previous witnesses, representing both the public and private 

sectors. I think we would all agree that the topic is 

complicated and controversial. 
11 


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I believe we would also all agree on this point: By 

definition, antibiotic resistance is bred by the very use of 

antibiotics, be it by humans or by animals. To remain 

effective, then, antibiotics must be used judiciously. 

As we learned at our last hearing, antibiotics are being 

overprescribed for use in humans. That is a very real and 

difficult problem and one that requires our full and 

immediate attention. 

But the issue with animals is something else. For 

animals, we use antibiotics for purposes other than treating 

disease. 

2 
12 


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As we will hear today, animals raised for food 

production are routinely provided antibiotics to prevent 

infections. In stark contrast to animals, we would be 

shocked if a pediatrician ever ordered antibiotics for an 

entire nursery school class to keep the children from being 

infected with strep throat. But in this country, that is 

standard practice for a barnyard full of pigs, or cows, or 

chickens. In addition, animals regularly are fed these drugs 

-- not to treat any illness at all -- but simply to promote 

growth. In both situations, this is "overprescribing" of a 

very different sort. 

There appears to be universal agreement on yet 

another point: The key to reducing antibiotic resistance is 

to reduce the use of antibiotics. 

3 
13 


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The Food and Drug Administration recently 

announced one approach for achieving this goal with 

respect to animals. In June, the agency issued draft 

guidance which recommends that antibiotics not be given 

to animals to promote growth and that when these drugs are 

used, they should be administered only under the 

supervision of a veterinarian. This is a good first step. 

But we must do more to tackle this piece of the 

antibiotic resistance puzzle. And we must do so as part of a 

comprehensive strategy designed to safeguard the vitally 

important public health tool that is our antibiotics. 

It is critical that we encourage the development of new 

drugs. But it also essential to preserve the antibiotics we 

already have. That means we must move expeditiously to 

slow the advancement of antibiotic resistance in both 

humans and animals. 

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In each instance, our strategy must be based on 

science. And the scientific evidence is now strong enough 

to create consensus among major public health groups and 

experts around the world that the time has come to reduce 

the use of antibiotics in animals. Organizations as diverse 

as the American Medical Association, the Institute of 

Medicine, the World Health Organization, and as we will 

hear from both CDC and the FDA, all agree: We must take 

action now. 

Which brings us to today' shearing. We will have 

before us authorities from all sides of the antibiotics in 

animals debate - government officials, professionals in 

human and animal medicine, public health experts, drug 

industry representatives, and researchers. I encourage all 

Subcommittee members to join in sorting through the many 

views we will listen to today to see if we can identify an 

appropriate science-based policy to include as part of a 

comprehensive plan for addressing this rising public health 

emergency. 

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Let me thank all of our witnesses in advance of their 

testimony for their participation in today's hearing. We 

very much appreciate your time and interest and look 

forward to hearing from you. 

6 
16 

Mr. WAXMAN. Can I ask, Mr. Chairman, two statements by 

unanimous consent be added to the record, one from two California-based groups, the San Francisco Medical Society and Physicians for Social Responsibility in L.A. regarding the use of antibiotics for animals? 

Mr. PALLONE. Mr. Chairman, the—— 

Mr. WAXMAN. I ask unanimous consent their statements be 

added to the record. 

Mr. PALLONE. The Republicans just want to look at it. 

Mr. WAXMAN. I certainly want them to look at it. Whether they 

agree with the statements or not, I think that the groups—— 

Mr. SHIMKUS. Reserving the right to object. We don’t want to get 

into—— 

Mr. WAXMAN. I will pull back and have you look at it, and then 

we will ask unanimous consent at a later time. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Mr. PALLONE. OK. So we are going to proceed without at this 

point. I don’t know, you took me back when you talked about seeing him on the beaches. I didn’t realize you traveled from beach to 

beach. 

Mr. WAXMAN. I was in L.A. My district has a lot of beaches and 

I didn’t see him at any of them. 

Mr. PALLONE. Next is the gentleman from Indiana. Oh you want 

to reserve your time. OK. 

Then we go to the gentleman from Pennsylvania, Mr. Pitts. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. Thank you, Mr. Chairman. 

This is now the third hearing this subcommittee has held on antibiotic resistance. First was on April 28th of this year and second 

was held on June 9th. There is no doubt that over the last 50 years 

antibiotics have saved countless lives worldwide. There is also no 

doubt that we are experiencing a growing amount of bacterial resistance to antibiotics, and many infectious diseases are becoming 

increasingly difficult to treat as a result. 

For the purposes of this hearing, however, the key question is 

this: Does the use of antibiotics in feed-producing animals cause 

antibiotic resistance in humans? An exchange between Chairman 

Emeritus Dingell and Dr. Thomas Frieden, director of the Centers 

for Disease Control and Prevention, during the April 28th subcommittee hearing is instructive, and I will briefly quote. Mr. Dingell asked, ‘‘There appears to be much debate over whether the 

practice of adding antibiotics to agricultural feed is thought to promote drug resistance. What does current science and surveillance 

tell us on this point?’’ Dr. Frieden answered, ‘‘I am not aware of 

evidence in this country that has documented the spread from animals to humans, feed animals to humans.’’ Mr. Dingell then replied, ‘‘I am getting the impression from what you are telling us 

here is that we really don’t know what the nexus between the feed 

with antibiotics is and when there is a point of danger and what 

is the level of danger and what research is going on.’’ Mr. Dingell 

was right. There is much that we don’t know about how the use 


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of antibiotics in animals causes or does not cause antibiotic resistance in humans. 

Clearly, more study must be done. However, until we have definitive scientific evidence, it seems to me that legislation like H.R. 

1549, the Preservation of Antibiotics for Medical Treatment Act, or 

PAMTA, as they are calling it, which seeks to eliminate the use of 

antibiotics in animals except for treatment purposes, is premature 

and potentially dangerous. I am pleased that it appears that the 

FDA is working with the scientific and medical community in its 

new guidance, and I am interested to see what the comment period 

produces. As I have said before, we should study and explore every 

possible cause of antibiotic resistance but we should let the scientific evidence guide us. 

I look forward to hearing from our distinguished panel of witnesses today. Thank you, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you. 

The gentlewoman from Illinois, Ms. Schakowsky. 

OPENING STATEMENT OF HON. JANICE D. SCHAKOWSKY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman, for your leadership 

on this issue. 

The CDC has described antibiotic resistance as one of the world’s 

most pressing health problems and overwhelming data proves that 

antibiotic resistance is increasing in this country. This is a safety 

issue, a public health issue and quite frankly an issue of national 

security. 

Mr. Chairman, I would like to submit for the record statements 

regarding the need for legislative action to protect the effectiveness 

of antibiotics, legislation like the Preservation of Antibiotics for 

Medical Treatment Act. These letters are from organizations including the American Medical Association, the American Academy 

of Pediatrics, Consumers Union, Union of Concerned Scientists, 

and over 1,000 individual physicians from across the country who 

have concluded that the non-judicious use of antibiotics in livestock 

is a problem of public health. So if I could submit these for the 

record? 

Mr. SHIMKUS. Reserving the right to object, Mr. Chairman, just 

so we get a chance to look at them. 

Ms. SCHAKOWSKY. On June 28th, the FDA released draft guidance on this issue. The report states that ‘‘The overall weight of 

evidence supports the conclusion that using medically important 

antimicrobial drugs for production or growth-enhancing purposes in 

food-producing animals is not in the interests of protecting and promoting the public health.’’ In other words, pumping animals full of 

non-medically necessary antibiotics is not good for public safety. I 

want to point out that this guidance carries no enforcement mechanism but rather asks the industry to voluntarily follow these suggestions. 

It is obvious to me that legislation is needed. Eighty percent of 

the meet randomly tested by the National Antimicrobial Resistance 

Monitoring System shows traces of antibiotic-resistant bacteria. 

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cent of the 98,000 people a year who die from hospital-related infections had a microbe resistance to one or more antibiotics. 

Mr. Chairman, I have looked forward to this hearing for quite 

some time because it provides an opportunity to get the facts 

straight. I want to leave today knowing who has clear jurisdiction 

over the use of antibiotics in feed. If it is more than one agency, 

I want to know what the agencies are doing to work together and 

who is in the lead, and I want to feel confident that the agencies 

do not forget about this issue once this hearing is gaveled to a 

close, and I yield back. 

Mr. PALLONE. Thank you. 

Next is the gentlewoman from Tennessee, Ms. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Thank you, Mr. Chairman, and thank you to 

those of you who prepared testimony and are here before us today. 

Certainly this is a topic that all of us are concerned about. Whether 

or not it should be the topic that is taking the time that we have 

today and the taxpayers’ money, I will add, is a subject of another 

debate. 

And Mr. Chairman, I will have to tell you, as we look at what 

is rolling out with this new health care law, I think it is very evident to us that that is where our time needs to be spent. When my 

children were little, and there was an issue in front of them that 

needed to be addressed, I would always remind them that avoiding 

the issue did not make it easier to handle the issue in the long 

term. If you want to address the problem, it is important that you 

hit it head on, and we are hearing from people of the numerous 

problems that exist with this health care bill that has been passed 

by this Congress and signed into law. There is a lot of concern over 

there over the expansion of agencies. There is tremendous confusion over the implementation or the expected implementation of 

that bill. There is surprise by taxpayers that benefits are going to 

be W–2’d back to them on their health insurance. We are hearing 

from employers all during the July 4th break as we talked about 

freedom and the imperative of preserving freedom. We heard from 

employers who were saying we are so concerned about the cost. 

Look at what it is going to cost us to provide insurance under this 

new list of mandates with all of these new agencies, with all of 

these new directives. That, believe it or not, translates into jobs 

lost, and the employers are concerned about that. Now, maybe my 

colleagues across the aisle are not that concerned but I can tell you 

losing the number of jobs that have been lost in the past 15 months 

is a tremendous concern. There is talk about rationing. There was 

a recess appointment. Talk about national security. How about securing the border? That is something that needs attention from 

this Congress. Definitely that is an issue that is of great importance to the American people. 

Now, while the use of antibiotics in animals and the transference 

of that to humans is important and we are concerned, we know 

that there is a lack of large amounts of data on this issue. Does 

it need our attention? Yes. Do we need to keep a focus on this as 


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we go forward? Yes. But what is an imperative right now is that 

we look at what the people of this country are saying they want 

us to address, an ill-conceived health care bill that was passed that 

is a government takeover of health care and they want to make 

certain that we tend to getting that off the books. I yield back. 

Mr. PALLONE. Next is the gentleman from Connecticut, Mr. Murphy. 

Mr. MURPHY OF CONNECTICUT. Thank you, Mr. Chairman. I am 

eager to hear more about the subject that we are convened to learn 

about today, so I will waive my opening statement. 

Mr. PALLONE. The gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, thank you. 

As past hearings have highlighted, we have a potential antibiotic 

crisis on the horizon. Simply put, we do not have enough new antibiotics in the development pipeline to meet the health care needs 

of the 21st century. Therefore, I believe it is important for this 

committee to review the current regulatory structure and promote 

incentives that will encourage greater antibiotic production. To 

that end, I look forward to working with my colleagues on both 

sides of the aisle to achieve this worthy goal and to look forward 

to the testimony, of course, from our witnesses today. 

Mr. Chairman, on another note, following up a little bit from the 

opening statement of Ms. Blackburn, I am appalled that President 

Obama used the July 4th recess to appoint Dr. Donald Berwick as 

the new CMS administrator without allowing a single public hearing. During the health reform debate, this Administration promised 

the American people that reform would not ration health care. In 

fact, the White House’s own Web site under the heading ‘‘health insurance reform reality check’’ claims to debunk, and I quote, ‘‘the 

myth that reform will mean a government takeover of health care 

or lead to rationing.’’ According to Dr. Berwick, however, the question, and this is his quote, ‘‘is not whether or not we will ration 

care but whether we will do so with our eyes open.’’ To be frank, 

Dr. Berwick’s outspoken support of health care rationing is completely at odds with the Obama Administration’s statements on 

whether rationing is good for our country. 

In his inaugural address, President Obama said that, and I 

quote, ‘‘On this day, we gather because we have chosen hope over 

fear, unity of purpose over conflict and discord.’’ In the July 26, 

2008, edition of the British Medical Journal, Dr. Berwick chose 

hope when describing his support for the British health care rationing system and this is another quote from Dr. Berwick: ‘‘The only 

sentiment I feel for the NHS [National Health Service] that exceeds my admiration is my hope. I hope you will never, ever give 

up on what you have begun.’’ Mr. Chairman, my hope is that we 

have some clarity on this issue. Either the President and his Administration support or they are opposed to health care rationing. 

The American people deserve answers, and unfortunately, this recess appointment has stolen those answers from them. 

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gram. Further, given past statements and opposition to rationing, 

I believe that the Administration owes us answers to very, very 

simple questions. Number one: Does President Obama support Dr. 

Berwick’s philosophy on health care rationing, and number two, 

does President Obama agree with Dr. Berwick’s statement that any 

humane civilization must, again, Dr. Berwick ‘‘redistribute wealth 

from the richer among us to the poor and the less fortunate.’’ Given 

that Dr. Berwick now runs our seniors’ health care program, I sincerely believe the American people deserve a public hearing so we 

can get answers to these questions, and with that, Mr. Chairman, 

I will yield back. 

Mr. PALLONE. The gentlewoman from the Virgin Islands, Ms. 

Christensen. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 

REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. 

For decades, the scientific literature worldwide has shown that 

non-therapeutic low-dose antibiotic use in farm animals has caused 

increased resistance in humans yet I understand that in 1977 

when FDA attempted to take steps to curtail such use, Congress 

ignored the research and the effort was lost. So thank you, Chairman Pallone and Ranking Member Shimkus for your attention to 

this important issue. Under your leadership, I am sure that we are 

not going to repeat that unfortunate interception, which is resulting in what is now termed a crisis in antibiotic resistance. 

I commend the FDA for the draft guidance they have issued this 

year, and while I think it is a good first step, I think it is up to 

the Congress to go further and pass H.R. 1449, the Preservation of 

Antibiotics for Medical Treatment Act. Led by Denmark and Europe, it has been proven that good animal husbandry and judicious 

use of antibiotics has successfully reduced resistance without adversely affecting industry or profits. This is yet another area where 

our country is threatening to fall behind, and this is unacceptable, 

not only in terms of our leadership but because it places Americans 

at undue and unnecessary risk. It also has the potential to put our 

meat and poultry industry at risk. There can be no denying that 

swift and definitive action must be taken to protect the health of 

current and future generations as well as to protect the health of 

our future economy. 

I welcome the witnesses and look forward to their testimony. 

Mr. PALLONE. Thank you, Ms. Christensen. 

I have two statements that Mr. Waxman put forward for the 

record, one from the San Francisco Medical Society and Physicians 

for Social Responsibility in—well, one from the San Francisco Medical Society, the other from the Physicians for Social Responsibility 

in Los Angeles regarding the use of antibiotics, and I would ask 

unanimous consent that these statements be entered into the 

record. Without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. And then we had another statement from Ms. 

Schakowsky. There were one or two letters from Ms. Schakowsky 

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imous consent that those also be entered into the record. Without 

objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PALLONE. And next is the gentleman from Michigan, our 

chairman emeritus, Mr. Dingell. 

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. Mr. Chairman, I thank you for your courtesy and 

I commend you for the hearing. 

Today’s hearing is the third in a series of hearings on the emerging public health threat posed by antibiotic resistance. The specific 

focus of this hearing has proven to be the more controversial aspect 

of the concern raised by public health experts. Its controversy 

spends decades and very frankly some very serious and important 

answers are required. 

I introduced legislation on this topic in 1980, the Antibiotics 

Preservation Act. That bill would have directed the Secretary to 

designate antibiotic drugs which may or may not be used in subtherapeutic doses in animal feed or ingredients of animal feed unless such use is required to meet a compelling need. Interested parties expressed very passionate opinion on the legislation during 

hearings that year. I remember being troubled by the efforts of 

FDA Commissioner von Eschenbach in 2007 to approve use of certain antibiotics of last resort in food-producing animals. While 

there is substantial disagreement between major parties on the 

magnitude of the problem and the proper approach, I believe all 

sides would generally agree on two things. One, antibiotic resistance is a growing public health threat. According to the Infectious 

Diseases Society of America, about 2 million people across bacterial 

infections in U.S. hospitals each year. Ninety thousand people die 

as a result. About 70 percent of these infections are resistant to at 

least one drug. 

It appears the injudicious use of medically important antimicrobial drugs in animal agriculture increases the level of antimicrobial resistance in animals and humans. A variety of scientific 

committees, task forces and organizations including a number of 

government organizations have studied the issue. The general conclusion drawn from these studies is that the injudicious use of antimicrobial drugs is not in the interest of protecting and promoting 

human health, and while that includes many different things, it is 

a warning to us. 

While we can agree on these two points, there is a great deal of 

uncertainty as to how to address this critical issue and getting 

proper information on this matter is necessary to properly address 

it. We must not take for granted the current authority that rests 

in the Food and Drug Administration to responsively address this 

matter. I was encouraged by recent actions in that agency, specifically the issuance of a draft guidance, and look forward to updated 

programs in their work in other areas including the development 

of new antimicrobials. 

I hope today’s hearing will provide some interest on a few critical 

questions that come to my mind. First, is the problem best solved 


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by a one-size-fits-all approach or should the impact of each drug be 

separately considered? Two, are additional authorities and resources justifiably needed to fully address the problem? I might 

just observe, I think so. Three, do the benefits of curbing the use 

of antimicrobial drugs outweigh the risk of doing so? Four, what 

data should be reasonably required of regulators to justify future 

action on the use of antimicrobials in animal feed? And lastly, how 

do we define judicious use in a way that removes all ambiguity and 

helps us attain our public health goals while not impairing our 

other concerns about animal health and about the business of agriculture? I believe the answers to these questions will guide us as 

we seek ways to address the problem we have before us. Our attempt to address the problem should not be rushed. It must be 

based on sound science and good information. It must be done in 

a way that protects both human and animal health, and it should 

not unnecessarily disrupt the animal agricultural community. 

I look forward to hearing the views and thoughts of our witnesses this afternoon. I am especially interested in hearing the 

views of our agency experts on this matter. 

Again, Mr. Chairman, I thank you for this and I commend you 

for your leadership. I yield back the balance of my time. 

Mr. PALLONE. Thank you, Chairman Dingell. 

Next for an opening statement, the gentleman from Pennsylvania, Mr. Murphy. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY OF PENNSYLVANIA. Thank you, Mr. Chairman, for 

holding this hearing. 

For decades, doctors have known that the widespread use of antibiotics is going to speed the development of bacterial mutation in 

antimicrobial resistance but what we don’t do is give antibiotics to 

every schoolchild just to prevent infection. 

Today, 70 percent of all health care-associated infections in the 

United States are resistant to at least one antibiotic. These infections cost some $50 billion a year. One antibiotic-resistant infection, MRSA, kills more people in the United States every year than 

HIV/AIDS. But what would happen if it finally becomes resistant 

to the few remaining effective antibiotics? 

Of course, this resistance is not limited to human health. The 

vast majority of evidence for the last three decades points to linkage between routine low-level antibiotic use in food animals and 

the transfer of antibiotic-resistant bacteria to people, often through 

the food supply. The American Medical Association, the American 

Academy of Pediatrics, the American Public Health Association and 

the American College of Preventive Medicine have all called for a 

significant reduction in the amount of antibiotics we use in food 

animal production. Antibiotics have four purposes: to treat disease, 

control the spread of disease once an infection has occurred, prevent disease from occurring and promote the growth in animals. 

Last month, the FDA issued guidance to drug makers, animal 

farmers, veterinarians that represents a step toward ending antibiotic use for growth promotion and increasing veterinary oversight 


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of animal antimicrobial drugs that are available over the counter 

at feed mills. Some drug makers are already moving in this direction, and I encourage pharmaceutical companies, farmers and the 

FDA to keep working together to limit any unnecessary use of antibiotics. 

I look forward to hearing from the FDA and other witnesses of 

how they intend to ensure that disease prevention does not become 

growth promotion by another name. There are other solutions out 

there that will keep our food supply safe, our society healthy and 

our antibiotics effective, and I hope this hearing today will awaken 

our colleagues to the very real threat to public health posed by the 

declining effectiveness of antibiotics. Any use of antibiotics anywhere can cause bacteria to select for resistance but overuse and 

misuse of antibiotics simply gives bacteria an environment-rich situation to develop resistance and multiply. 

To really cut health care costs, save lives and preserve the effectiveness of these vital drugs, we have to eliminate unnecessary antibiotic use everywhere we find it, in hospitals, nursing homes, the 

general community and sometimes even on the farm. 

With that, I yield back. 

Mr. PALLONE. Thank you, Mr. Murphy. 

The gentleman from Ohio, Mr. Space. 

OPENING STATEMENT OF HON. ZACHARY T. SPACE, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO 

Mr. SPACE. Thank you, Mr. Chairman. 

We have before us a public health issue of significant importance. Studies have indicated the antibiotics upon which our doctors and hospitals relied are losing their effectiveness in treating 

very serious illnesses. This resistance is a very real problem and 

indeed a very scary one. Our committee is right to investigate it 

and right to consider potential solutions. 

I am, however, worried about some of the discussions relating to 

limiting the use of antibiotics in the agricultural setting. My Congressional district is home to a significant agricultural industry 

which directly employs over 17,000 people and countless more indirectly. It is the linchpin of our economy and an industry easily affected by regulation here in Washington, D.C. Many of the farmers 

in my district rely on the use of antibiotics to keep animal populations healthy and run productive businesses. And while we must 

be mindful of the importance of equipping farmers and veterinarians with the tools they need to treat animals when they are sick, 

obviously we all have to be mindful of the strategic necessary of 

preventing illnesses from spreading. 

Today’s witnesses offer a variety of opinions on this issue, many 

of which take different approaches to the same issue. I look forward to the testimony and to learning more about their perspectives. I believe it is critical that we study the evidence further and 

take into account all options and all sides of the issue before deciding whether to move forward. If the committee does decide to move 

forward on this issue, it is my hope we will move in a moderate 

and bipartisan fashion while working with stakeholders in the agricultural industry. This issue is an important one and worthy of 


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careful consideration, and we must be vigilant in ensuring that the 

policies we create are carefully thought out. 

And with that, Mr. Chairman, I yield back. 

Mr. PALLONE. Thank you, Mr. Space. 

The gentleman from Iowa, Mr. Braley. 

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA 

Mr. BRALEY. Thank you, Chairman, for holding this important 

hearing on the use of antibiotics in animal agriculture, and I also 

want to thank all the witnesses who came here today, and I hope 

that we can have a meaningful conversation on this issue. 

Most Americans when they go into a supermarket and buy some 

pork or chicken or beef have no idea where that food came from 

how or how it wound up in the supermarket or in their kitchen. 

A lot of public health officials have never been to a farm and seen 

with their own eyes and talked to production people involved in agriculture about how that food is taken care of and how it is grown 

and how it is processed and how it is shipped off to the packing 

house where it is ultimately dealt with and sent to their table. 

A lot of parents take their kids into doctors’ offices and demand 

the use of antibiotics for something that won’t even respond because it is a viral infection. We are a culture that looks for simple, 

easy answers when oftentimes we are talking about complex tradeoffs, and it is no different here talking about the very real public 

health concerns about antibiotic resistance and very real production concerns about food safety and food supply. 

When I was a student at Iowa State University, it was a wellknown accepted fact that it was more difficult to get into the Iowa 

State Veterinary Medicine College than the University of Iowa College of Medicine, and yet we seem to think that public health research is somehow in some way more superior than animal veterinary research even though oftentimes they come from the same 

raw data. 

So my hope for this hearing is that we can all agree on some fundamental things: A, that antibiotics are essential for fighting bacterial infections in humans, and yet there is still significant disagreement in some sectors about the specific relationship between 

the use of antibiotics in feed products as they relate to consumption 

of food and how that affects antibiotic resistance in humans. I have 

always been an advocate for science-based approach and I think 

this is an issue that demands careful, thoughtful consideration of 

all scientific points of view. Rather than come to conclusions based 

upon ideology, I think we need to look through the entire body of 

research available. There many well-intentioned people on both 

sides of this debate, and my hope is, we can continue to have 

meaningful discussions around tables like this, talk about the best 

forward to move forward to make sure we continue to have a safe, 

reliable food supply and are doing everything we can to protect 

human health. We need to continue to assess how antibiotics are 

being used in animals but also across the spectrum in ways that 

they are being abused and creating the type of antimicrobial resistance we are seeing today, and we also need to make sure that as 

we listen and learn from the witnesses who have come here today, 


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we continue to fund the necessary research to get to the bottom of 

how these problems relate to one another and how we make the 

best informed decisions to protect the public health interest. 

So I want to thank you all for being here today. I look forward 

to your input, and I yield back. 

[The prepared statement of Mr. Braley follows:] 


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July 14, 2010 

Congressman Bruce Braley 

Opening Statement 

House Energy & Commerce Subcommittee on Health 

Hearing on "Antibiotic Resistance and the Use of Antibiotics in 

Animal Agriculture" 

Thank you Chairman Pallone, and thank you for holding 

this hearing on the use of antibiotics in animal agriculture. I 

would also like to thank the witnesses who came here today 

and hope that we can have a meaningful conversation on 

this issue. 

I think we can all agree that antibiotics are essential for 

fighting bacterial infections in humans, but there is wide 

disagreement on how antibiotics use in animals could impact 

antibiotic resistance in humans. 

I have long been an advocate of a science-based 

approach, and this case is no exception. Rather than come 
27 


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to conclusions based on ideology, I think we need to take a 

thorough look at the entire body of research available on this 

subject. 

There are plenty of well-intentioned people on both 

sides of this debate. It is my hope that we can continue to 

get all parties to come to the table and talk about the best 

way to move forward to make sure we continue to have a 

safe, reliable food supply and are doing everything we can to 

protect human health. 

We must continue to assess how antibiotics are being 

used in animals, but recognize that there is a role for the 

judicious use of these antibiotics. 

I look forward to hearing from our witnesses today and 

believe we need to continue researching and evaluating this 

public interest issue. 

Thank you, Mr. Chairman, for taking up this important 

issue, and thank you to the witnesses for coming in today. 

2 
28 

Mr. PALLONE. Thank you. 

And we also have the gentleman from Georgia, Mr. Barrow. 

Mr. BARROW. I thank the chairman. 

I can add nothing to the comprehensive statement of my colleague, Mr. Braley, so I will waive an opening. 

Mr. PALLONE. I thank the gentlewoman. 

That concludes our opening statements so we will now turn to 

our first panel. I want to welcome you. Let me introduce each of 

you. First on my left is Dr. Joshua Sharfstein, who is the Principal 

Deputy Commissioner for the Food and Drug Administration. And 

then we have Dr. John Clifford, who is Deputy Administrator for 

Veterinary Services, Animal and Plant Health Inspection Service 

for the Department of Agriculture, and finally is Rear Admiral Ali 

Khan, who is Assistant Surgeon General, Acting Deputy Director 

of the National Center for Emerging and Zoonotic Infectious Disease with the Centers for Disease Control. 

I think you know the drill, 5-minute opening statements. And I 

should mention, I guess we are expecting votes, but I am going to 

proceed and then we will see. We may have to—well, we will have 

to interrupt at some point but I think we might as well start with 

Dr. Sharfstein. 

STATEMENTS OF JOSHUA SHARFSTEIN, M.D., PRINCIPAL DEPUTY COMMISSIONER, FOOD AND DRUG ADMINISTRATION, 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; 

JOHN CLIFFORD, D.V.M., DEPUTY ADMINISTRATOR, VETERINARY SERVICES, ANIMAL AND PLANT HEALTH INSPECTION 

SERVICE, U.S. DEPARTMENT OF AGRICULTURE; AND REAR 

ADMIRAL ALI S. KHAN, M.D., M.P.H., ASSISTANT SURGEON 

GENERAL, ACTING DEPUTY DIRECTOR, NATIONAL CENTER 

FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASE, CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

STATEMENT OF JOSHUA SHARFSTEIN 

Dr. SHARFSTEIN. Good afternoon, Chairman Pallone and Ranking 

Member Shimkus and members of the subcommittee. I am Dr. 

Joshua Sharfstein, Principal Deputy Commissioner of the Food and 

Drug Administration, an agency of the Department of Health and 

Human Services. Thank you for holding this hearing. Thank you 

for the opportunity to discuss FDA’s role and work with respect to 

antimicrobial resistance, and we appreciate your leadership. 

In my testimony, I will describe FDA’s actions to combat resistance and discuss the newly released draft guidance entitled ‘‘The 

Judicious use of medically important antimicrobial drugs in foodproducing animals.’’ 

As I will discuss in more detail later, in the draft guidance FDA 

concludes that the overall weight of evidence to date supports the 

conclusion that using medically important antimicrobial drugs for 

production purposes is not in the interest of protecting and promoting the public health. Developing strategies for reducing antimicrobial resistance is critically important for protecting both 

human and animal health, both of which are very important to scientists and regulators at the FDA. 


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Antimicrobial resistance is being addressed on a number of 

fronts. Dr. Khan from CDC will talk about the data associated with 

human resistance as it relates to antimicrobial use, and his agency’s leadership in efforts to fight resistance in human medicine, but 

I do want to make a comment as a pediatrician. 

I remember vividly in 1998 when I was a pediatric resident and 

the Centers for Disease Control and the American Academy of Pediatrics published principles for the judicious use of antibiotics in 

common pediatric infections including the common cold, ear infections, sinusitis and sore throat. I remember giving conferences on 

the basis of that and I remember the format of the papers and how 

they printed off the computer. Children have many infections, and 

as Congressman Braley mentioned, there was a big issue of parents 

coming and expecting antibiotics, and these were very strict guidelines for pediatrics on when to use antibiotics and when not to. 

There was a major effort in pediatrics starting around that time to 

reduce prescribing, to reduce antimicrobial resistance, and it had 

an impact. A recent study in the Journal of the American Medical 

Association showed that antibiotic prescription rates for children 

under 5 with respiratory infections decreased by 41 percent between 1995 and 2005. That study was published last year. 

Many centers at FDA are addressing the public health concern 

about antimicrobial resistance including the Device Center, which 

works on diagnostics, the Biologic Center, which works on vaccines, 

the Drug Center, which works on Drugs. Because today’s hearing 

focuses on antimicrobials in agriculture, I want to talk about the 

efforts at the Center for Veterinary Medicine. 

Our efforts start with surveillance through the National Antimicrobial Resistance Monitoring System. CVM works with CDC 

and USDA in overseeing surveillance of resistance in multiple 

areas. In addition, CVM has an approach for assessing resistance 

associated with the use of drugs intended for food-producing animals. There was a guidance issued, Guidance 152, which explains 

an approach when there is a new product coming onto the market, 

how we assess whether there is a risk from antimicrobial resistance and how that translates into our regulatory pathway. 

However, many antimicrobial drug products that were approved 

prior to the implementation of this guidance have not been evaluated, and a particular concern are those antimicrobials that are 

considered medically important drugs, meaning those that are important in human medicine and are approved in food-producing 

animals for production or growth-enhancing purposes. 

To address this concern, the Center for Veterinary Medicine released a guidance, as you have heard, on June 28. This is intended 

to inform the public of FDA’s thinking on this issue and to minimize resistance by outlining broad principles for assuring that 

medically important antimicrobial drugs are used judiciously in 

animal agriculture. The draft guidance reviews major public health 

reports on this topic including reports by the Institute of Medicine, 

the Government Accountability Office, the World Health Organization and its affiliated agencies. Those reports include multiple peerreviewed studies conducted around the world including in the 

United States. 


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Based on this evidence, in this draft guidance FDA recommends 

phasing-in measures that would, one, limit medically important 

antimicrobial drugs to uses in food-producing animals that are considered necessary for assuring animal health, and two, include veterinary oversight or consultation. These steps would help reduce 

overall use of medically important antimicrobial drugs and reduce 

the selection pressure that generates antimicrobial resistance. 

Prior to issuing the draft guidance, FDA consulted with a wide 

variety of stakeholders. We spoke with CDC and USDA and got 

their input on the recommendations. I visited a farm in southern 

Illinois, which was a very interesting experience, and we are committed to working with all stakeholders across the spectrum, our 

sister agencies as we get comments from the public on the right 

way to implement this policy. We are seeking comment through 

August 30, 2010, and we look forward to a very productive dialog 

to figure out a very sensible path through this issue that promotes 

both human and animal health. Thank you. 

[The prepared statement of Dr. Sharfstein follows:] 


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.. ,....~f-' i JI?' DEPARTMENT OF HEALTH AND HUMAN SERVICES 

~ ------------ PubhcHeaJthServlce 

STATEMENT OF 

JOSHUA M. SHARFSTEIN, M.D. 

Food and Drug Administ[ll.liQIl 

S,lvcrSprjllg,MD 20993 

PRINCIPAL DEPUTY COMMISSIONER 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

UNITED STATES HOUSE OF REPRESENTATIVES 

JULY 14, 2010 

RELEASE ONLY UPON DELIVERY 
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INTRODUCTION 

Good aftemoon, Chainnan Pallone and Members of the Subcommittee, I am Dr. Joshua M. Sharfstein, 

Principal Deputy Commissioner of the Food and Drug Administration (FDA or the Agency), which is 

an agency ofthe Department of Health and Human Services (HHS). Thank you for the opportunity to 

discuss FDA's role with regard to antimicrobial resistance. We appreciate your leadership on this 

important public health matter. 

Preserving the effectiveness of current antimicrobials and encouraging the continued development 

of new oncs, are vital to protecting human and animal health against infectious microbial 

pathogens. A 2004 report from the Infectious Diseases Society of America (IDSA) notcd that 

"About two million people acquire bacterial infections in U.S. hospitals each year, and 90,000 die 

as a result. About 70 percent of those infections are resistant to at least one drug." Resistant 

pathogens lead to higher health c1jre costs because they often require more expensive drugs and 

extended hospital stays. The problem is not limited to hospitals. Clinicians practicing in every 

field of medicine, including my own field of pediatrics, encounter resistant infections frequently. 

So, too, do veterinarians. Community-acquired infections are frequently resistant to multiple 

antimicrobial drugs, such as community-acquired methicillin-resistant Staphylococcus aureus 

(CA-MRSA), common respiratory pathogens including Streptococcus pneumoniae, and gramnegative bacilli. which can infect humans through contaminated food. 

In my testimony, I will provide background information on antimicrobial resistance, describe FDA's 

actions to combat resistance and promote product development, and discuss the newly released draft 

guidance entitled, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing 

Animals," 
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As I will discuss in more detail later, in the draft guidance, FDA concludes that the overall weight of 

evidence available to date supports the conclusion that using medically important antimicrobial drugs 

for production purposes is not in the interest of protecting and promoting the public health. Developing 

strategies for reducing antimicrobial resistance is critically important for protecting both public and 

animal health. 

BACKGROUND 

Antimicrobial drugs are used to treat infections caused by microorganisms. The term 

"antimicrobial" refers broadly to drugs with activity against a variety of microorganisms 

including bacteria, viruses, fungi, and parasites (such as malaria). The term "antibacterial" refers 

to drugs with activity against bacteria in particular. Another term commonly used to describe an 

antibacterial drug is "antibiotic." This term refers to a natural compound produced by a fungus 

or another microorganism that kills bacteria that cause disease in humans or animals. Some 

antibacterial drugs are synthetic compounds; i.e., they are not produced by microorganisms. 

Though these do not meet the technical definition of antibiotics, they are referred to as antibiotics 

in common usage. 

Antimicrobial resistance is the ability of bacteria or other microbes to resist the effects of a drug. 

Antimicrobial resistance occurs when bacteria change in some way that reduces or eliminates the 

effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections. 

Many factors contribute to the spread of antimicrobial resistance. In some cases, doctors prescribe 

antimicrobials too frequently or inappropriately. Sometimes patients do not complete the prescribed 

course of an antimicrobial, making it more likely that surviving microbes will develop resistance. 

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Antimicrobial use in animals contributes to the emergence of resistant microorganisms that can 

infect people. Through international trade and travel, resistant microbes can spread quickly 

worldwide. 

Antimicrobial agents have been used in human and veterinary medicine for more than 50 years, 

with tremendous benefits to both human and animal health. Many infections that were fatal, or 

left individuals with severe disabilities, are now treatable or preventable. However, because 

resistance to antimicrobial drugs is expected to occur with their use, it is essential that such drugs 

be regulated and used judiciously to delay the development of resistance. Misuse and overuse of 

these drugs contribute to an even more rapid development of resistance. After several decades of 

successful antimicrobial use, we have seen and continue to see the emergence of multi-resistant 

bacterial pathogens, which are less responsive to therapy. Antimicrobial resistant bacterial 

populations are emerging because of the combined impact of the various uses of antimicrobial 

drugs, including their use in humans and animals. 

New classes or modifications of older classes of antimicrobials over the past six decades have been 

matched slowly but surely by the development of new bacterial resistance mechanisms. As of 

today, antimicrobial resistance mechanisms have been reported in the scientific literature for all 

known antibacterial drugs that are currently available for clinical use in human and veterinary 

medicine. In some cases, strains have been isolated that are resistant to multiple antibacterial 

agents. 
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U.S. INTERAGENCY TASK FORCE ON ANTIMICROBIAL RESISTANCE 

The U.S. Interagency Task Force on Antimicrobial Resistance (Task Force) was created in 1999 

to develop a national plan to combat antimicrobial resistance. FDA co-chairs the Task Force, 

along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of 

Health. 

The Task Force also includes the Agency for Healthcare Research and Quality, Centers for 

Medicare and Medicaid Services, the Health Resources and Services Administration, the United 

States Department of Agriculture (USDA), the Department of Defense, the Department of 

Veterans Affairs, and the Environmental Protection Agency. In 2001, the U.S. Agency for 

International Development joined the Task Force to help address global antimicrobial resistance 

issues. 

In 2001, the Task Force published the "Public Health Action Plan to Combat Antimicrobial Resistance" 

(Action Plan). The Action Plan has four major components: surveillance, prevention and control, 

research, and product development. The Interagency Task Force has been working on a revised Action 

Plan. The revised Action Plan, which is currently undergoing interagency review, will provide more 

specific action items than the 2001 Action Plan and will include goal dates for completing many of the 

action items. 

ANTIBIOTIC REDUCTION IN HUMAN MEDICINE 

The issue of antimicrobial resistance is being addressed on a number of fronts. My colleague 

from CDC will discuss the data associated with human resistance as it relates to antimicrobial 
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use in food-producing animals and on his agency's leadership in efforts to fight resistance in 

human medicine. As a pediatrician, 1 remember when CDC and the American Academy of 

Pediatrics published principles in 1998 (Dowell SF, Marcy SM. Phillips WR, Gerber MA, 

Schwartz, B. Pediatrics. 1998; I 0 I: I 63-165) for the judicious use of antibiotics in common 

pediatric infections: the common cold, otitis media, acute sinusitis, and pharyngitis. Children 

oftcn have a high number (3-8) of viral upper respiratory infections each ycar and it is important 

to not be using antibiotics for viral infections which will not respond to them but will increase 

the child's probability of having a resistant organism when they do have an infection due to a 

bacteria. Otitis media, or ear infections, are one of the most common infections of childhood 

where an antibiotic may be needed. By three years of age, greater than 80% of children have had 

at least one episode of acute otitis media and 46% have had three or more episodes of ear 

infections. Judicious use of antibiotics helps decrease the probability that this common infection 

will be caused by an organism that is resistant to the more commonly used antibiotics (Fcigin & 

Cherry: 1998). This initiative has been successful in reducing antibiotic prescription rates. 

Pediatricians are now using more discretion when administering antibiotics to their patients. A 

recent study in the Journal of the American Medical Association, which utilized national 

databases, reported that antibiotic prescription rates for children under five years of age with 

respiratory tract infections (including infections such as the common cold) decreased by 41 % 

between 1995-1996 and 2005-2006 (JAMA 2009;302:758-66). 

FDA'S ACTIVITIES TO COMBAT Al'o'TIMICROBIAL RESISTANCE 

Many Centers at FDA are addressing the public health concern about antimicrobial resistance. 

For example, research and regulatory efforts at the Center for Biologics Evaluation and Research 

(CHER) have contributed to the development and continued availability of effective vaccines 
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which have eliminated or markedly decreased antimicrobial resistance by reducing or nearly 

eliminating some types of infections. Additionally, the Center for Devices and Radiological 

Health (CDRH) leads several efforts to clarifY regulatory requirements for both industry and the 

scientific community on clearance of diagnostic tests for use in antimicrobial resistance 

initiatives. 

Since today's hearing focuses specifically on the use of antimicrobials in animal agriculture, my 

testimony will highlight the efforts at the Center for Veterinary Medicine (CVM). I will also 

provide a brief update to Dr. Janet Woodcock's recent testimony before this Subcommittee about 

the initiatives at the Center for Drug Evaluation and Research (CDER). 

Center for Veterinary Medicine (CVM) 

FDA's strategy for addressing the antimicrobial resistance issue starts with surveillance through 

the National Antimicrobial Resistance Monitoring System (NARMS). NARMS is a multifaceted system that monitors trends in the prevalence of antimicrobial-resistance among bacteria 

isolated from humans, retail meats, and food animals. CVM is the lead coordinator ofNARMS 

and collaborates with CDC, the United States Department of Agriculture's (USDA) Agricultural 

Research Service and State public health laboratories. NARMS data are critical for monitoring 

antimicrobial drug resistance among Salmonella and other enteric bacterial organisms from 

human and animal populations, as well as retail meats. Such data provide important information 

to regulatory officials, physicians, and veterinarians for assessing trends and identifYing 

appropriate risk mitigating measures. Additionally, NARMS provides a national source of 

enteric bacterial isolates that are invaluable for conducting antimicrobial resistance research. 

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As part of the new animal drug approval process, CVM developed and implemented an approach 

for assessing antimicrobial resistance concerns associated with the use of antimicrobial drugs 

intended for use in food-producing animals. This approach uses risk assessment methodologies to 

assess the potential human health impact from the proposed antimicrobial use in animals and 

outlines risk management strategies that may be applied. In 2003, FDA published Guidance for 

Industry # 152, "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their 

Microbiological Effects on Bacteria of Human Health Concern." (To view FDA guidance 

documents, please visit hrtp:llwwwfda.govIRegulatorylnformalionIGuidancesldefauIt. him). 

Guidance #152 provides recommendations to drug sponsors on the use ofa qualitative risk 

assessment approach for evaluating the likelihood that an antimicrobial drug used to treat a foodproducing animal may cause an antimicrobial resistance problem in humans. The risk assessment 

approach recommended in the guidance considers a broad set of information, including the 

importance of the drug in question to human medicine. This information is collectively considered 

in determining whether the proposed antimicrobial product will pose a risk to public health. 

FDA believes the approach outlined in Guidance # 152 for evaluating the safety of antimicrobial 

drugs as part of the drug approval process is scientifically sound and is protective of the public 

health. However. many antimicrobial drug products, approved prior to the implementation of 

Guidance # I 52 in 2003, have not been evaluated under the current processes for assessing safety 

with respcct to antimicrobial resistance. Of particular concern are those antimicrobials that are 

considered medically important drugs (i.e., those drugs or classes of drugs that are important in 

human medicine) and are approved for use in food-producing animals for production or growthenhancing purposes. 

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Judicious Use Guidance for Antimicrobials in Food-Producing Animals 

To address this concern, CVM released a draft guidance on June 28, 2010, entitled, "The 

Judicious Use of MedicalJy Important Antimicrobial Drugs in Food-Producing Animals" 

(http://wwwfda.govldownloadsIAnimaIVeterinaryIGuidanceComplianceEnforcementlGuidance/ 

orlndustryIUCM216936.pdfJ. This draft guidance is intended to inform the public of FDA's 

current thinking on the use of medicalJy important antimicrobial drugs in food-producing 

animals. It is intended to help minimize antimicrobial resistance by outlining several broad 

principles for assuring that medically important antimicrobial drugs are used judiciously in 

animal agriculture. 

The draft guidance reviews the major public health reports on this topic - including reports by 

the Institute of Medicine, the Government Accountability Office, and the World Health 

Organization. FDA believes the overall weight of evidence available to date supports the 

conclusion that using medically important antimicrobial drugs for production purposes is not in 

the interest of protecting and promoting the public health. 

In the draft guidance, FDA recommends phasing in measures that would (1) limit medically 

important antimicrobial drugs to uses in food-producing animals that are considered necessary 

for assuring animal health and (2) include veterinary oversight or consultation. These steps 

would help reduce overall use of medically important antimicrobial drugs, thereby reducing the 

selection pressure that generates antimicrobial resistance. Prior to issuing the draft guidance, 

FDA consulted with USDA to seek their input on the recommendations. FDA and USDA are 

committed to working collaboratively to address this important public health issue. 

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FDA is seeking public comment on the draft guidance through August 30,2010. FDA is 

committed to working with USDA, animal drug sponsors. the veterinary and public health 

communities, the animal agriculture community, and all other interested stakeholders in 

developing a strategy to address antimicrobial resistance concerns in a manner that is protective 

of both human and animal health. For example, FDA intends to work closely with USDA, 

producers, and veterinarians on strategies for increasing veterinary involvement in the use of 

antimicrobial drugs and for assuring that specific animal health needs arc met as the measures 

outlined in the guidance are implemented. 

Center for Drug Evaluation and Research (CDER) 

FDA's efforts to address antimicrobial resistance are not limited to uses of antibiotics in foodproducing animals. It is important that (I) our existing antibacterial drugs for humans be used 

prudently to preserve their effectiveness and (2) that new antibacterial drugs for humans be 

developed as we expect that resistance will develop to existing therapies over time. In her recent 

testimony, Dr. Woodcock described several initiatives under way to address challenges in human 

medicine at CDER, which include gathering scientific data to inform the development of 

recommendations on designing informative, ethical, and feasible clinical trials; issuing draft 

guidance documents concern ing cl inical trial designs for study ing antibacterial drugs; and 

working towards publishing additional draft guidance documents in the coming months to 

address the development of antimicrobial drugs intended for use in treating skin infections and 

hospital-acquired/ventilator-associated bacterial pneumonia. In addition, FDA recently 

announced a public workshop to be held August 2-3, 2010, regarding issues in the design and 

conduct of clinical trials for antibacterial drug development. The public workshop is intended to 

provide information for and gain perspectives from health care providers, researchers, academia, 

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industry, and regulators on various aspects of design and conduct of clinical trials for 

antibacterial drugs. 

CONCLUSION 

Addressing antimicrobial resistance is a challenging task which requires the expertise and efforts 

of many entities. FDA will continue to work with Federal, State, local, and foreign government 

officials, medical professionals including the veterinary community, the regulated industry and 

all of FDA 's stakeholders, in developing sound strategies to address and advance both human 

and animal health. 

Thank you for the opportunity to discuss FDA's activities with regard to antimicrobial resistance. 

I would be happy to answer any questions. 

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42 

Mr. PALLONE. Thank you, Dr. Sharfstein. 

Dr. Clifford. 

STATEMENT OF JOHN CLIFFORD 

Dr. CLIFFORD. Good afternoon, Chairman Pallone and Ranking 

Member Shimkus and other members of the subcommittee. My 

name is Dr. John Clifford and I am the Deputy Administrator for 

Veterinary Services with the Department of Agriculture’s Animal 

and Plant Health Inspection Service. In this position, I also serve 

as the U.S. Chief Veterinary Officer for animal health. 

Today the subcommittee is looking at an important issue that 

has far-reaching consequences for human and animal health. 

USDA believes that it is likely that the use of antimicrobials in 

animal agriculture does lead to some cases of antimicrobial resistance among humans and in animals themselves, and we believe 

that we must use medically important antimicrobials judiciously. 

USDA is committed to playing an active role in preserving the effectiveness of medically important antimicrobials. 

USDA believes that policy decisions must be science-based and 

will provide research to inform the debate. To do this, USDA will 

work with our federal partners including those at this table. 

What constitutes judicious use and how it applies is a central 

question to this debate. This must be answered with a sound scientific evaluation and with data-based decision-making. USDA is 

working to conduct surveillance and research and a number of 

agencies within the Department are actively engaged on projects to 

better understand the issue. My written statement details many of 

these efforts. 

Beyond my department, FDA has an existing process for completing risk assessments concerning the use of antimicrobials. 

USDA believes that this process provides a rational, science- and 

data-based approach to making decisions about specific antimicrobial use. This is preferable to the approach that broadly eliminates antimicrobials for specific uses. 

As we move forward, we must carefully address what current research says and identify gaps in our scientific knowledge. We are 

committed to working with our federal partners as we have been 

on these important issues. We need more data so that the policy 

can properly balance risk between animal and human health 

needs. 

USDA is also looking to expand its existing partnership. For instance, USDA is interested in expanding our work with HHS to improve outreach with veterinarians in the animal agriculture community. We need to work together to conduct research and develop 

new therapies that protect and preserve animal health without increasing the risk of resistance to medically important 

antimicrobials. 

USDA is also interested in making our veterinary experts available to provide guidance and share information with veterinarians 

and producers. This Nation’s farmers and ranchers want to do the 

right thing. If we provide them with the resources and information 

so they can make informed decisions, they will do the right thing. 

Mr. Chairman, I can assure you that USDA recognizes the challenges of antimicrobial resistance and that the entire Department 


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is taking these challenges very seriously. We are committing to ensuring that medically important antimicrobials are used judiciously, which will preserve both human and animal health. 

I will be happy to answer any questions that you or your members of the committee may have. Thank you. 

[The prepared statement of Dr. Clifford follows:] 


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Testimony of Dr. John Clifford 

Deputy Administrator for Veterinary Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

Before the House Committee on Energy and Commerce's 

Subcommittee on Health 

Hearing on Antibiotic Use in Animal Agriculture 

July 14,2010 

Mr. Chairman and Members of the Subcommittee, my name is Dr. John Clifford, and I am the 

Deputy Administrator for Veterinary Services with the Department of Agriculture's (USDA) 

Animal and Plant Health Inspection Service (APHIS). In this position, I also serve as USDA's 

Chief Veterinary Officer. 

Today, the Subcommittee is looking at an important issue that has far-reaching consequences for 

both human and animal health. USDA believes that it is likely that the use of antibiotics in 

animal agriculture does lead to some cases of antibacterial resistance among humans and in the 

animals themselves and it is important that these medically important antibiotics be used 

judiciously. 

USDA is committed to playing an active role in preserving the effectiveness of medically 

important antibiotics; in addition to ongoing research, we are committed to identifYing 

opportunities to reduce usage and maintain the effectiveness of these drugs - whether through 

the development of new treatment options for animals, such as vaccines, or through outreach and 

education to this country's agricultural producers so that they have better information on 

antibiotic use. 

USDA believes that decisions regarding the issue of antibiotic use must be science-based and is 

interested in providing the most current scientific information when it can, and collaborate with 

HHS' CDC, FDA, National Institutes of Health (NIH), and other Federal agencies on this 

important issue. 

Several agencies within USDA are actively working to conduct surveillance and research on key 

issues related to antimicrobial resistance. Within USDA, APHIS, along with Agricultural 

Research Service (ARS), Food Safety and Inspection Service (FSIS), Economic Research 

Service (ERS), and National Agricultural Statistics Service (NASS) are actively engaged on a 

series of projects to better understand these issues. I have provided more information about these 

many ongoing projects in the Appendix at the end of this testimony. 

CHALLENGES USDA FACES 

Last month, FDA issued guidance on antimicrobial resistance. This guidance provides an 

opportunity to seek comments and find answers to many important questions. For instance, 

determining how to apply the concept of "judicious use" in the field will be critical. USDA 
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believes that making this type of detennination must be based on sound scientific evaluation, and 

data-based decision making. USDA believes that animal health impacts must be considered in 

the context of the decision making process. 

FDA, under its regulatory authority, has an existing process for completing risk assessments 

concerning the use of antimicrobials. USDA believes that this process provides a rational, 

science- and data-based approach to making decisions about specific antimicrobial use as 

opposed to an approach that broadly eliminates antimicrobials for specific uses. 

In addition, we note that the ecology of antimicrobial resistance is very specific to its conditions, 

such as the characteristics of the bacterial organism itself and the patterns of antimicrobial use in 

human health settings and food production systems. It is also inextricably linked to other 

ecologic niches such as bacterial populations associated with wildlife, soils, waste disposal, etc. 

There are ebbs and flows between these niches, and these constant changes are important to 

consider within this context. These fluctuations may make it difficult to apply broad solutions to 

a variety of unique conditions. While USDA and its federal partners are conducting surveillance 

and research on antimicrobial resistance, we currently lack robust monitoring tools that would 

allow for an understanding of this ecology and the impact of proposed solutions. 

To that end, we must carefully address what current research says, and identifY gaps in our 

scientific knowledge. Antibiotics have been widely used in veterinary and human medicine for 

over haifa century, and the benefits to the health of both is widely acknowledged. Research also 

shows that increased usage of some antimicrobial drugs likely does lead to resistancel

,2. But 

how much and how quickly? 

On the question of veterinary oversight and consultation, which was also included in the FDA 

guidance document, USDA believes it is important to consider the challenges due to the lack of 

large animal veterinarians in rural areas. Due to larger distances and traveling times in rural 

areas, it may be difficult for producers to consult with veterinarians on these types of decisions. 

USDA believes it is important to work together with Federal partners, veterinarians, and other 

stakeholders to find feasible solutions to implement this recommendation. 

USDA'S ROLE GOING FORWARD 

USDA is committed to continue partnering with other federal agencies to address these details 

and to find feasible solutions to some of the challenges. USDA is also looking to expand its 

existing partnerships. For instance, USDA is interested in expanding our work with HHS in 

identifYing how to reduce antibiotic use through improved outreach and collaboration with 

veterinarians and the animal agriculture community. In addition, we believe that additional 

research should be pursued that explores whether alternatives to medically important antibiotics 

are available. We need to work together to conduct research and develop new therapies that 

protect and preserve animal health, without increasing the risk of resistance to medically 

1 Bonten et al. Vancomycin-resistant enterococci: why are they here, and where do they come from? The Lancet 

Infectious Diseases December 2001; 1(5): 314-325. 

, Dutil et al. Certiofur Resistance in Samonella enteric Serovar Heidelberg from Chicken Meat and Humans, Canada. 

Emerging Infectious Diseases January 2010; 16(1): 48-54. 

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important antibiotics. Included in our efforts, we must identify alternative animal health 

management techniques - tools and technologies, including newer and better vaccines and 

diagnostic tests. That portion of the partnership would extend beyond our federal partners to 

farmers and producers themselves. USDA wants to partner with them to facilitate the judicious 

use of antibiotics in ways that are feasible to farmers and ranchers. 

For instance, USDA is interested in making our veterinary experts available to provide guidance 

and share information with veterinarians and producers. In some rural areas, access to an 

experienced veterinarian is limited, especially when dealing with large animals. Given the larger 

distances in rural areas, we must do more to ensure that prdducers are receiving the assistance 

they need to make informed decisions about the use of antibiotics with their animals. 

Mr. Chairman, I can assure you that USDA recognizes the challenges of antibiotic resistance, 

and that the entire Department is taking these challenges very seriously. We are committed to 

ensuring that medically important antibiotics are used judiciously, which will preserve both 

human and animal health. USDA already is and will continue to play an active role in preserving 

the effectiveness of those drugs. We are performing surveillance, conducting research, and 

increasing education. Together, those three facets will help protect American agriculture, while 

preserving the needs of human medicine. 

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APPENDIX: CURRENT USDA EFFORTS AND PARTNERSHIPS 

Various USDA agencies are engaged in the research and analysis of antibiotic use and 

antimicrobial resistance to keep USDA at the forefront of maintaining a stable and healthy 

system of American agriculture. APHIS partners with other USDA agencies to include: 

Agricultural Research Service (ARS), Food Safety and Inspection Service (FSIS), Economic 

Research Service (ERS), and National Agricultural Statistics Service (NASS). We work together 

in various capacities to collect samples and data, develop diagnostic methods, and analyze data. 

Beyond our partnerships within USDA, the Department also regularly collaborates with other 

federal agencies. Antibiotic resistance is a multi-faceted issue, and we have and continue to 

partner with agencies, such as the HHS' CDC, FDA, and NIH. 

USDA is a member of the Interagency Task Force on Antimicrobial Resistance. The Task 

Force, which was created in 1999, is co-chaired by the CDC, FDA and NIH, and includes a 

broad range of federal partners. The Task Force developed a comprehensive document, A Public 

Health Action Plan to Combat Antimicrobial Resistance, which reflects a broad-based consensus 

offederal agencies on actions needed to address antimicrobial resistance. The Action Plan 

provides a blueprint for specific, coordinated federal actions to address the emerging threat of 

antimicrobial resistance. 

In 2007, the Task Force held a public meeting, soliciting input to update the Action Plan. The 

revised Action Plan is undergoing agency clearance, after which time it will be available for 

public comment. 

Also key to our efforts to address antimicrobial resistance is the National Antimicrobial 

Resistance Monitoring System (NARMS). NARMS was established in 1996 as a partnership of 

the FDA, ARS, FSIS, APHIS and CDC. The NARMS program monitors changes in 

antimicrobial drug susceptibilities of selected enteric bacterial organisms in humans, animals, 

and retail meats. The system is intended to provide meaningful data to help identifY 

antimicrobial drug resistance in humans and animals, and to provide timely updates to 

veterinarians and physicians on patterns of resistance. It is part of the overall federal strategy to 

combat antimicrobial resistance that fulfills the need for a national surveillance program to 

monitor resistance among foodborne pathogens in humans and animals. 

USDA supports NARMS through three of its agencies. FSIS contributes isolates from its 

regulatory program for Salmonella and isolates ofCampylobacter from its microbiological 

baseline data collection surveys. APHIS has contributed isolates from clinically ill animals and 

from healthy animals on farms. And ARS conducts all testing and analysis of isolates collected 

by USDA. ARS reports the information it compiles yearly and shares this information and data 

on the Internet at: http://www.ars.usda.govlMainidocs.htm?docid=6750. The impact of 

NARMS has been to assist the FDA in regulatory decision making on animal antimicrobial 

drugs, practitioners on prudent use practices, and commodity organizations on quality 

improvement. 

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In addition to these efforts, APHIS has been collecting an increasing amount of data on 

production practices and samples containing bacteria that have been used to evaluate levels and 

impacts of antimicrobial use on livestock operations throughout the United States. This data and 

the samples are collected through the National Animal Health Monitoring System (NAHMS), 

which conducts national studies on the health and health management of domestic livestock and 

poultry populations. Bacterial isolates gathered via NAHMS have been tested for antibiotic 

resistance and included in NARMS. The data collected yielded information on, among other 

things, the types of antimicrobials used to treat various common diseases in animal populations, 

how producers decide to treat and what to treat with, how antimicrobial drugs are delivered to 

the animals (via feed, water, or parenterally), and primary influencers on the antimicrobial drug 

decision-making process. All of these factors are critical to understanding how to optimize 

antimicrobial drug use in animal populations. 

APHIS, in collaboration with ARS, has also been collecting samples to be cultured for bacteria 

as part of the NAHMS program, which are subsequently evaluated for antimicrobial drug 

resistance as part of the NARMS program. These studies provide information on the extent of 

antimicrobial drug resistance among potential food borne pathogens and commensal organisms in 

livestock populations. Such information is critical to risk assessments that evaluate the potential 

for transfer ofthe resistant organism or resistance determinants through the food chain. 

An additional step USDA is taking to better understand the complexities of this issue is through 

our work with the Codex ad hoc !ntergovemmental Task Force on Antimicrobial Resistance. 

The Task Force was established by the 29th meeting of the Codex Alimentarius Commission. 

FDA is the lead agency for the U.S., serving as the Delegate. USDA's FSIS co-leads and is the 

Alternate Delegate. 

The Task Force has a four-year timeline to produce a guidance document, which is expected to 

be complete in October 2010. The intent of this guidance is to assess the risks to human health 

associated with the presence and transmission of antimicrobial resistant microorganisms and 

antimicrobial resistance genes through food and feed, as well as to develop appropriate risk 

management advice based on that assessment to reduce such risk. 

5 
49 

Mr. PALLONE. Thank you, Dr. Clifford. 

Dr. Khan, or Admiral Khan, I guess. 

STATEMENT OF ALI KHAN 

Admiral KHAN. Good afternoon, Chairman Pallone, Ranking 

Member Shimkus and other members of the subcommittee. I am 

Ali Khan from CDC, and thank you for the invitation to address 

the subcommittee today. 

Antimicrobial agents are used to treat infection by different disease-causing microorganisms. Resistance occurs whenever and 

wherever antibiotics are used, in the community, on the farm or in 

health care settings. Antibiotics are a subset of antimicrobials used 

specifically to fight bacterial infections. Many of the bacteria in our 

food that cause human disease are also in food animals. These 

healthy food-producing animals commonly carry bacteria in their 

intestinal tract and they can cause disease in humans including 

Salmonella and Campylobacter are two examples. Today I will 

focus on the human health impact of antibiotic-resistance bacteria 

as they relate to food animals. 

There is unequivocal and compelling evidence that the use of 

antibiotics in animals leads to the development of drug-resistant 

bacteria that have adverse impacts on human public health. This 

has been demonstrated for numerous production animals—pigs, 

cattle, poultry—for numerous pathogens—Salmonella, E. coli, 

Campylobacter enterococcus—and in numerous countries—Denmark, England, Spain, Canada, and right here in the United 

States. Antibiotic-resistant pathogens move through the food supply, so use of antibiotics in animals results in resistant bacteria in 

food animals. These resistant bacteria then can be present in the 

food supply and be transmitted to humans. And finally, these resistant bacterial infections can result in adverse human health consequences such as increased hospitalizations or potentially death. 

Please allow me to describe some specific examples. Let us see 

if slide one works here. Can somebody bring up the first slide potentially? 

Mr. PALLONE. Do we have technicians here? Oh, there you go. 

Admiral KHAN. Let us go to the next one. Perfect. 

[Slide shown.] 

So Campylobacter is one of the leading causes of foodborne bacterial disease in the United States. It causes approximately 2 million cases per year. And studies have unequivocally demonstrated 

movement of resistant pathogens through the food supply linked to 

antibiotic use in animals. So what you can see nicely in this slide 

to the far left is antibiotic—well, that depends on what side of the 

screen you are looking at, to the far left of the slide. There is probably less than 1 percent resistance in those bacteria, and then following the use of fluoroquinolones and the licensing for fluoroquinolones in poultry, what you can see is a dramatic increase 

starting 2 to 3 years later that has persisted despite a decision by 

FDA a couple of years ago to stop the use of fluoroquinolones. 

Now, this failure to see a subsequent decline in resistance really 

is a cautionary tale for us and it suggests that the movement of 

resistance from animals to humans should be considered a sentinel 

event and demonstrates that resistance once it occurs may not be 


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easily reversed and that prevention is a much better strategy that 

a control strategy. 

[Slide shown.] 

The next slide shows similar data in the United Kingdom. Again 

what you can see is introduction in the yellow box of a type of 

quinolone antibiotic in animals and then the increase shows, the 

increase in resistance, not just in a number of different animal species but in humans also. 

And then finally, the Canadian data, which is really quite dramatic, published this year from Quebec, and what this shows is 

changes in cephalosporins. This is a common antibiotic that we use, 

changes in cephalosporin resistance in chicken and human Salmonella and chicken E. coli strains that appear to be related to 

changes in the use of a type of similar antibiotic in animals, and 

what you see is a marked decline in those resistance in the E. coli 

and the Salmonella following a decision for voluntary reduction of 

the antibiotic in animals, and what is not on this slide is, if you 

follow out to 2, 3 years, there was a limited reintroduction of that 

antibiotic for animals, and you see a little spike again as the antibiotic is reintroduced. So very nice, clean evidence of what happens. You introduce the animal. You reduce the antibiotic into the 

animal population and increase in resistance, and then some examples of a decrease in resistance associated with discontinuing the 

antibiotic in animals. 

Now, studies in Europe have also demonstrated the most compelling and direct links between non-therapeutic use, often referred as 

subtherapeutic use or use for growth promotion, et cetera, in foodproducing animals and subsequent antimicrobial resistance in humans. So the ban of growth promoters in Denmark has prevented 

spread of vancomycin-resistant enterococcus in humans, reduced 

resistance in pathogens like Campylobacter and reduced serious 

human infections, for example, due to specific types of resistant 

Campylobacter, and this conclusion has been independently 

verified by the World Health Organization. 

Finally, antibiotics are a critical in our Nation’s defense against 

infectious diseases and we need to take strong measures to make 

sure that we maintain their effectiveness. This subcommittee and 

my colleagues at HHS and USDA have focused on elements of a 

comprehensive strategy to protect public health by avoiding resistance that stems from the overuse of antibiotics in animals. Consistent with this one health approach to the prevention of infectious diseases, CDC supports these efforts to minimize non-judicious use of antibiotics in both animals and humans for better 

human health, animal health and environmental stewardship. 

Thank you again for the invitation to testify today and I will be 

happy to answer any questions. 

[The prepared statement of Admiral Khan follows:] 


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Testimony before the 

Subcommittee on Health 

Committee on Energy & Commerce 

U.S. House of Representatives 

Statement of 

Ali Khan, MD, MPH 

Assistant Surgeon General and Acting Deputy Director, 

National Center for Emerging & Zoonotic Infectious 

Diseases (proposed), 

Centers for Disease Control & Prevention, 

U. S. Department of Health & Human Services 

For Release upon Delivery 

Expected at 2:00 ~.m. 

Wednesday, July 14 h, 2010 

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Good morning Chairman Pallone, Ranking Member Shimkus, and members of the 

Subcommittee. I am Ali Khan, an Assistant Surgeon General and acting Deputy Director of the 

National Center for Emerging & Zoonotic Infectious Diseases (proposed), at the Centers for 

Disease Control & Prevention (CDC). Thank you for the invitation to address the Subcommittee 

on the available data as it relates to antimicrobial use in food animals. Today I will expand upon 

the recent testimony before this Subcommittee by CDC Director Dr. Thomas Frieden, and 

describe: 1) CDC's role in monitoring antimicrobial resistance in humans as it relates to the food 

supply, 2) data available from North America, 3) data available from Europe, and 4) why 

appropriate antimicrobial use is critical to protecting human and animal health, as outlined in the 

Food and Drug Administration's (FDA) recently released draft guidance. 

Background 

Antimicrobial agents 1 are used to treat infections by different disease-causing microorganisms, 

including bacteria, mycobacteria, viruses, parasites and fungi. In the vast majority of cases 

where antimicrobials are used, the microorganisms have found a way to evade or resist the 

antimicrobial agent. 2 Resistance occurs wherever antimicrobials are used 3 __ in the community, 

on the farm, and in healthcare settings. Antimicrobial resistance is a global problem, and our 

most significant global health threats include multi-drug resistant tuberculosis and drug-resistant 

malaria. Today, however, I will focus on a specific antimicrobial resistance, antibiotic-resistant 

bacteria as they relate to food animals. 

1 Antimicrobial agents or antimicrobials are general terms for the drugs. chemicals, or other substances that either kill 

or slow the growth of microbes. Among the antimicrobial agents in use today are antibiotic drugs (which kill bacteria). 

antiviral agents (which kill viruses), antifungal agents (which kill fungi), and antipansitic drugs (which kill parasites). 

An antibiotic is a type of antimicrobial agent made from a mold or a bacterium that kills. or slows the growth of other 

microbes, specifically bacteria. Examples include penicillin, streptomycin, and other antibiotics discussed below, 

2 Levy, S, Marshall B, Antibacterial resistance worldwide: causes, challenges and responses. NATURE MEDICINE 

SUPPLEMENT 10:12, 2004. 

J Tacconelll, Evelina. Antimicrobial use: risk driver of multi-drug resistant microorganisms in healthcare 

sellings.Current Opinion in Infectious Diseases. 2009, 22:352-358. 

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Many of the bacteria in food that cause disease are found in the intestinal tract of animals or 

people. Healthy food-producing animals commonly carry bacteria that can cause illness in 

humans, including Sa/monella and Campy/obacter. 

When an ill person is treated with an antibiotic to which the bacteria is resistant, the antibiotic 

will not help and may even make the illness worse. In addition, sub-therapeutic use may be 

more likely to contribute to the development of resistant bacteria. The illness may last longer, 

be more serious, or more expensive to treat. 

In 1989, the Institute of Medicine (10M) published a report which concluded that the committee 

could not find direct evidence that subtherapeutic use of penicillin and tetracycline in animal 

feed was associated with a human health consequence.' The committee was unable to 

distinguish the human health consequence of subtherapuetic use in animals from the 

widespread therapeutic use of penicillin and tetracycline in humans and animals (primarily due 

to a lack of data on quantities of antimicrobials used). In 2002, the Alliance for Prudent Use of 

Antimicrobials (APUA) FAAIR Report (Facts about Antimicrobials in Animals and the Impact on 

Resistance) concluded that antimicrobial use in animals does contribute to human antimicrobial 

resistance and results in an adverse human health consequence.s The committee concluded: 

"the elimination of nontherapeutic use of antimicrobials in food animals and in a9riculture will 

lower the burden of antimicrobial resistance in the environment, with consequent benefits to 

human and animal health." 

To protect both human and animal health, appropriate antibiotic use is encouraged for foodproducing animals, which is similar to actions associated with use in humans. CDC's activities 

4 Human health risks with the subtherapeutic use of penicillin or tetracyclines in animal feed 

Committee on Human Health Risk Assessment of Using Subtherapeutic Antibiotics in Animal Feeds, Institute of 

Medicine, Division 01 Health Promotion and Disease Prevention. Published 1989 by National Academy Press in 

Washington, D.C. 

S Clinical Infectious Diseases 2002;34:i-I DOl: 10.10861512410.The Need to Improve Antimicrobial Use in Agriculture 

Ecological and Human Health Consequences available at http://www.journals.uchicago.eduitociddI2002134IS3. 

CDC July 2010 

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related to resistance from antibiotic use in humans have focused on two goals: preventing the 

emergence and spread of resistant bacteria, and increasing appropriate antibiotic use to reduce 

the emergence of resistance. In order to minimize the selective pressure of antibiotics, it is 

important to make sure that when antibiotics are used, they are used appropriately, for either 

humans or animals. Through population-based surveillance, CDC is able to provide national 

estimates of disease burden and to track changes in disease burden over time for both resistant 

community-associated and health care-associated bacterial infections. CDC's educational 

campaign Get Smart: Know When Antibiotics Work has reduced antibiotic use for acute 

respiratory tract infections among both children and adultsB Parallel to antibiotic use in 

humans, movement toward appropriate antibiotic use for food-producing animals is needed, as 

discussed in FDA's draft guidance .. 

Antimicrobial resistant pathogens can move through the food supply. The use of certain 

antibiotics in animal feed has been a major driver for some drug-resistant organisms, such as 

vancomycin-resistant enterococci.' There is also evidence of an association between drug use 

in food animals and the emergence of resistance in some more common enteric pathogens like 

Salmonella'" Drug-resistant infections in humans could emerge from exposure to bacteria 

harbored by animals that are pathogenic to humans. or the genes that cause that resistance 

could move from bacteria harbored by animals to those bacteria harbored by humans. 

6 CDC's Get Smart: Know When Antibiotics Work program is a comprehensive public health effort to help reduce the 

rise of antibiotic resistance. Partnerships with public and private health care providers, pharmaCists, a variety of retail 

Dutlets'cand the media result in broad distribution of the campaign's multi-cultural/multi-lingual health education 

materials for the public and health care providers. Through Get Smart. CDC develops clinical guidance and 

principles for appropriate antibiotic use to prevent and control antibiotic resistant upper respiratory infections. Data 

from the National Ambulatory Medical Care Survey (NAMCS) confirm the campaign's impact on reducing antibiotic 

use for acute respiratory tract infections among both children and adults. There has been a 20 percent decrease in 

prescribing for upper respiratory infections (in 1997 the prescription rate for otitis media in children < 5 years of age 

was 69 prescriptions per 100 children compared to 47.5 per 100 children in 2007) and a 13 percent decrease in 

prescribing overall for all office visits (overall antibiotic prescribing dropped from 13.8 prescriptions per 100 office 

visits to 12.0 prescriptions per 100 office visits comparing 1997-98 to 2005-06). The Get Smart: Know When 

Antibiotics Work campaign contributed to surpassing the Healthy People 2010 target goal to reduce the number of 

antibiotics prescribed for ear infections in children under age 5. 

7 Bonten et ai., Lancet 2001. Endtz et at.. J Clin Microbiol1997. Klare et aI., Microb Drug Res 1999. Schouten et al.. 

Lancet 1997. 

B Dutil et al.. Emerg Infect Dis 2010. Angulo et al .. J Vet Med 2004. Spika et ai, NEJM 1987. Holmberg et ai., NEJM 

1984. 

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NARMS 

The National Antimicrobial Resistance Monitoring System (NARMS) for Enteric Bacteria was 

established in 1996 for the purpose of 1) monitoring trends in the prevalence of antibiotic 

resistance among bacteria isolated from humans, retail meats (began 2002), and food animals; 

2) disseminating public health infonmation on antibiotic resistance; 3) promoting interventions 

that reduce resistance among enteric bacteria; and 4) informing the approval process for the 

use of antibiotic agents in veterinary medicine. NARMS is a collaboration among CDC (human 

samples), the Food and Drug Administration's (FDA) Center for Veterinary Medicine (retail 

meats), and the United States Department of Agriculture's (USDA) Agricultural Research 

Services (animal samples). 

CDC's Role in NARMS 

For the human component of NARMS, participating health departments forward every twentieth 

non-Typhi Salmonella isolate, every Salmonella Typhi, every twentieth Shigella isolate, and 

every twentieth E. coli 0157 isolate ~eceived at their public health laboratories to CDC for 

antibiotic susceptibility testing. 9 Sites participating in FoodNet, the Foodborne Diseases Active 

Surveillance Network, also submit a representative sample of Campylobaeter isolates from 

humans to CDC for susceptibility testing. '0 In addition, NARMS participates in outbreak 

investigations involving these bacteria and conducts further studies on resistance mechanisms. 

'Antimicrobial susceptibility testing currently involves the determination of the minimum inhibitory concentration (MIC) 

for 17 antimicrobial agents: amikacin, ampicillin, amoxicillin-clavulanic acid, apramycin, cefoxitin, ceftiofur, 

ceflriaxone, cephalothin, chloramphenicol, ciprofloxacin, gentamicin, imipenem, kanamycin, nalidixic acid, 

streptomycin, sulfamethoxazole, tetracycline, and trimethoprim-sulfamethoxazole_ 

10 FoodNet sites submit all Campylobacter isolates (Georgia, Maryland, New Mexico, Oregon, Tennessee), every 

other isolate (California, Colorado, Connecticut, New York), or every fifth isolate (Minnesota) to NARMS based on the 

burden of campylobacteriosis in each site. Susceptibility testing of Campylobacter is performed to determine the 

MICs for nine antimicrobial agents: azithromycin, ciprofloxacin, clindamycin, erythromycin, florfenicol, gentamicin, 

nalidixic acid, telithromycin, and tetracycline. 

CDC July 2010 

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NARMS data for human isolates have been collected continually since 1996, which makes trend 

analysis possible; the data provide information about patterns of emerging resistance, which in 

turn guide mitigation efforts. Because antibiotic use in food-producing animals may result in 

antibiotic resistance among bacteria that can be transmitted to humans through the food supply, 

antimicrobial resistance data from humans are important for the development of public health 

regulatory policy for the use of drugs in food-producing animals. 

In addition to NARMS, CDC has developed a prudent use educational program called "Get 

Smart: Know When Antibiotics Work on the Farm" to promote appropriate antibiotic use in food 

producing farm animals. CDC funds and provides technical assistance for several state-based 

efforts to educate veterinarians and food producers including those in the dairy and beef 

industries. Educational modules have been developed for use in veterinary professional 

curricula, which are case-based and are tailored for given animal species and/or food animal 

production type. 

North American Data 

Non-typhoidal Salmonella causes approximately 1.4 million cases of disease in humans in the 

United States each year. Patients with complicated or severe infections are treated with 

fluoroquinolones or cephalosporins, and of these two drug classes, only cephalosporins are 

approved for treatment of children with these infections. Since NARMS began surveillance in 

1996, cephalosporin resistance among Salmonella isolated from humans has increased 

significantly, and a similar resistance also has been found among Salmonella isolated from 

livestock and retail meats. In many cases, the same types of bacteria and genetic mechanisms 

of resistance are found in both human and animal sources. 

For example, studies related to Salmonella as both a human and animal pathogen, including 

many stUdies in the United States, have demonstrated that (1) use of antibiotic agents in food 

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animals results in antibiotic resistant bacteria in food animals, (2) resistant bacteria are present 

in the food supply and are transmitted to humans, and (3) resistant bacterial infections result in 

adverse human health consequences (e.g., increased hospitalization"). The following 

examples demonstrate the movement of resistant pathogens through the food supply, and 

exacerbate our concern about the link between the use of antibiotics in animals and 

eventual human health effects: 

a Multi-drug resistant (MDR) Salmonella Newport has emerged, which has caused 

numerous outbreaks where the source was ground beef. Ground beef samples have 

been found with the same molecular fingerprint as the human strain.'2 

a As described in scientific articles published this year, Cephalosporin-resistant 

Salmonella Heidelberg has emerged among humans, and molecular fingerprinting 

indicates that strains responsible for human infections are indistinguishable from 

cephalosporin-resistant Salmonella Heidelberg isolated from retail poultry sources.'3 

These findings support work done by the Canadian Integrated Program for 

Antimicrobial Resistance Surveillance (CIPARS) that demonstrated a strong 

correlation between cephalosporin-resistant Salmonella Heidelberg isolated from 

retail chicken and the incidence of cephalosporin-resistant Salmonella Heidelberg 

infections in humans across Canada. CIPARS also published this year that in 

Quebec, changes in cephalosporin-resistance in chicken and human Salmonella 

Heidelberg and chicken E. coli strains appeared to be related to changes in ceftiofur 

use in poultry hatcheries." 

11 Varma et al., J Infect Dis 2005. 

12 Gupta et aI., J Infect Dis 2003. CDC MMWR Morb Mortal Wkly Rep 2002. 

13 Foister et al., Foodbome Pathog Dis 2010 and Zhao et aI., Appl Environ Microbial 2008. 

14 Dutil et aI., Emerg Infect Dis 2010 

CDC July 2010 

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Studies of another bacterium, Campylobacter, also demonstrate movement of resistant 

pathogens through the food supply. Campylobacter is one of the leading causes of cultureconfirmed foodborne bacterial disease in humans in the United States, and consumption of 

poultry has been shown to be an important risk factor for Campylobacter infection. 

Fluoroquinolones and macrolides are the drug classes of choice for treating Campylobacter 

infections. Following the approval of fluoroquinolones for use in poultry, resistance to this class 

of drugs among human Campylobacter isolates rose sharply, to more than 20%.15 FDA has 

since withdrawn approval of fluoroquinolones for use in poultry, and NARMS continues to 

monitor Gampylobacter from humans, retail meats and food animals for fluoroquinolone 

resistance. 

Persistence of fluoroquinolone-resistant Campylobacter in domestic food animal and retail meat 

sources suggests that these strains may be able to compete well with susceptible strains in food 

animal environments, even in the absence of antimicrobial selective pressure. 16 Additional 

studies are underway to better understand the contribution of foreign travel to fluoroquinoloneresistant campylobacteriosis and estimate the burden of illness associated with domesticallyacquired infections. 

The Danish Experience 

Multiple studies about the Danish experience have demonstrated the link between nontherapeutic use of antimicrobial agents in food-producing animals, particularly swine and broiler 

15 Multiple NARMS related publications available at 

http://www.cdc.qov/search.do7 subset=enterics&q=pathogeQcampylobacter&filter=p 

16 Zhang Q, Lin J, Pereira S. (2003) Fluoroquinolone-resistant Campy/abaeter in animal reservoirs: dynamics of 

development, resistance mechanisms and ecological fitness. Anim Health Res Rev 4:63-71 

CDC July 2010 

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chickens, and antimicrobial resistance found in animals and humans.17,18,19,20,21,22 Nontherapeutic uses include promoting growth and improving feed efficiency; drugs for these 

purposes are typically given in animal feed. 

In 1995, the Danish government banned the non-therapeutic use of avoparcin for growth 

promotion in Denmark; the European Union (EU) adopted the same ban in 1997. In 1998, 

Denmark banned use of virginiamycin for growth promotion, Subsequently, the Danish cattle 

and broiler industries voluntarily stopped the non-therapeutic use of all antibiotics for growth 

promotion in 1998, while the Danish swine industry through voluntary and regulatory action 

stopped all non-therapeutic use of antibiotics for growth promotion in swine above 35 kg by 

February 1998 and for all age groups by December 1999. The EU phased in bans for certain 

drugs in 1999, and then voted to phase out all non-therapeutic use of antibiotics for growth 

promotion in 2002, which began 2006. 

Since the stoppage of non-therapeutic use in Denmark, therapeutic use in swine has increased. 

However, total antimicrobial consumption in swine has decreased from 100 to 49 milligrams of 

antimicrobials per kilogram of meat produced, a 50% reduction, In addition, stopping the use of 

various non-therapeutic antibiotic growth promoters (e.g., avilamycin, avoparcin, spiramycin, 

17 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark: The WHO 

international review panel's evaluation of the termination of the use of antimicrobial growth promoters in 

Denmark.Available at: http://www.who.inUsalmsurv/en/Expertsreoortgrowthpromoterdenmark.pdf. 

18 DANMAP. 2008. Use of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from food 

animals; foods and humans in Denmark. Available at: http://www.danmap.org/pdfFilesIDanmap 2008.pdf, 

19 Aarestrup, F,M., A,M. Seyfarth, H.D. Emborg, K. Pedersen, R.S. Hendriksen, and F. Bager. July 2001. "Effect of 

Abolishment of the Use of Antimicrobial Agents for Growth Promotion on Occurrence of Antimicrobial Resistance in 

Fecal Enterococci from Food Animals in Denmark," Antimicrobial Agents and Chemolherapy 45(7): 2054-2059. 

Available at: http://aac.asm.org/cgi/reorinU45/7/2054, 

20 Boerlin, p .. A. Wissing, F. M. Aarestrup, J. Frey, and J, Nicolet. 2001. "Antimicrobial Growth Promoter Ban and 

Resistance to Macrolides and Vancomycin in Enterococci from Pigs," Journal of Clinical Microbiology 39(11): 4193-

4195, Available at: http·i1jcm.asm.org/cgi/reprinU39/11/4193. 

21 Evans, M.C. and H.C. Wegener, 2003. "Antimicrobial Growth Promoters and Salmonella spp" Campylobacter 

spp, In Poultry and Swine, Denmark," Emerging Infectious Diseases 9(4): 489-492, Available at: 

http://www.cdc.gov/ncidod/eid/voI9n04/pdfs/02-0325.pdf 

22 Gravea, K., V.F. Jensen, K, Odensvik, M. Wierup, and M. Bangen. 2006. "Usage of veterinary therapeutic 

antimicrobials in Denmark, Norway and Sweden following termination of antimicrobial growth promoter use," 

Preventive Veterinary Medicine 75(1·2): 123·132. 

CDC July 2010 

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tylosin, virginiamycin) has resulted in a major reduction in antimicrobial resistance as measured 

among several different bacterial species in food animals and food. Furthermore, resistance to 

these drugs among Enterococcus isolated from broilers, swine, and the meat from these 

animals decreased. In 2003, the World Health Organization (WHO) could not determine the 

ban's direct and total effect on antimicrobial resistance in humans because of limited data.'3 

However, more recent susceptibility data from enterococci isolated from healthy persons in the 

community show a decline in resistance of enterococci isolated from healthy people in the 

community in Denmark following the ban on antimicrobial growth promoters. " 

Production and economic impacts from the ban are described in a 2003 WHO report. Mortality 

among weaning age pigs increased several years before as well as a few years after nontherapeutic use stopped, but has drastically decreased in recent years, indicating that the 

termination had no effect on swine mortality. In addition, the WHO reports that: "Overall, total 

volume of pork production in Denmark continued to increase in the period following the 

termination of antimicrobial growth promoters ... The net costs associated with productivity 

losses incurred by removing antimicrobial growth promoters from pig and poultry production 

were estimated at 7.75 DKK (1.04 €) per pig produced and no net cost for poultry. This 

translates into an increase in pig production costs of just over 1 %."'5 

In summary, non-therapeutic use has been shown to lead to an increase in resistant strains in 

animajs in Denmark. The Danish experience demonstrates that it is possible to stop these 

uses, reduce overall use of antibiotics in animals, reduce resistant circulating bacteria that can 

23 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark: The WHO 

international review panel's evaluation of the termination of the use of antimicrobial growth promoters in Denmark. 

Available at: http://www.who.inUsalmsurv/en/Expertsreportgrowthpromoterdenmark.pdf. 

24 Annual reports of the Danish Integrated Antimicrobial Resistance Monitoring and Research Programme (DANMAP) 

available at www.danmap,org 

25 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark: The WHO 

international review panel's evaluation of the termination of the use of antimicrobial growth promoters in 

Denmark.Available at: http://www.who.inUsalmsurv/en/Expertsreportgrowthpromoterdenmark.pdf. 

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infect humans, and not have industry or consumers significantly affected by decreased 

production or increased costs. 

Conclusion 

Antibiotics are a critical asset in our nation's defense against infectious disease, and we need to 

take strong measures to ensure that we maintain their effectiveness. Since antimicrobial agents 

were first used widely in the last century, almost every type of clinically relevant bacteria has 

developed antibiotic resistance. This Subcommittee, and my colleagues at HHS, have rightly 

focused on elements of a comprehensive strategy -avoiding resistance that stems from overuse in both humans and animals, and developing new antibiotics. CDC continues to take steps 

to minimize inappropriate use of antibiotics in humans, and today's hearing is an important 

opportunity to highlight the need for parallel steps to minimize inappropriate antibiotic use in 

animals. 

As a nation, we must do more to respond to this growing problem. CDC supports FDA's 

approach, as described in recent guidance, that the use of antimicrobials should be limited to 

protecting human and animal health. Purposes other than the protection of animal or human 

health should not be considered judicious use. 

Thank you again for the invitation to testify before you today. I will be happy to answer any 

questions you may have. 

CDC July 2010 

Page 11 
62 

Mr. PALLONE. Thank you very much. I thank all of you. 

We have three votes, the last votes of the day, about half an hour 

or so, and so we are going to stand in recess. 

Mr. SHIMKUS. Mr. Chairman, will you yield for a minute? During 

the break, could we ask the majority since those slides weren’t provided as far as I know in the testimony, that we get copies of those 

slides? 

Mr. PALLONE. Yes, we will get copies for you. 

Mr. SHIMKUS. Thank you. 

Mr. PALLONE. So we will stand in recess. 

Mr. WAXMAN. Mr. Chairman, before we break, may we renew our 

unanimous consent request to put the—— 

Mr. PALLONE. I am sorry, Mr. Chairman. 

Mr. WAXMAN. Oh, we did it already? 

Mr. PALLONE. They have all been entered including Ms. 

Schakowsky’s. They have all been entered. 

Mr. SHIMKUS. I was all over it for you. 

Mr. PALLONE. The subcommittee stands in recess. 

[Recess.] 

Mr. PALLONE. The subcommittee hearing will reconvene. We are 

going to have questions now, and I will start with myself for 5 minutes. 

This is sort of—I am going to cover all three of you with this. 

I will start with Dr. Sharfstein. 

At the end of last month, as you mentioned, the FDA released 

a draft guidance on the judicious use of medically important antimicrobial drugs in food-producing animals, and as I understand it, 

the guidance essentially says that antibiotics that are important for 

treating human disease should not be used in animals except as 

needed to assure their health, and it also says that veterinarians 

should be involved when the antibiotics are used for that purpose. 

So I guess my point is to note that today medically important antibiotics, whether important for treating people or treating animals, 

are used for non-therapeutic purposes, and so many of the people 

who use them for those purposes, Dr. Sharfstein, haven’t necessarily reacted to your guidance in a positive way. 

So my questions are about the scientific basis for the guidance. 

What led you to develop the guidance? Did you meet with stakeholders such as industry that would be affected by the policies? 

What has been the general reaction to the guidance? Who supported it? Who has opposed it? I mean, we know that the producers 

aren’t happy about it. On the day your guidance was released, the 

president of the National Pork Producers Council said FDA didn’t 

present any science on which to base this. So that is my question, 

really, is it scientifically based? What is your response to the 

naysayers? 

Dr. SHARFSTEIN. Well, we look forward to the comment period 

and we will review everything that we get from different groups officially. I actually have been impressed at the interest across many 

different areas of the animal agriculture in working with FDA and 

I will note that the Animal Health Institute, that they welcome the 

guidance, and the AVMA said that they were pleased that we are 

committed to working with the veterinary profession to address 

antimicrobial resistance concerns. 


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So I think it may be—you know, I wouldn’t necessarily buy into 

us versus them on this. I think that is a very sensible path. It really rests on a mountain of strong science, and one of the documents 

we cite, I think is really excellent. It is the WHO 2003 report which 

walks through six lines of evidence that exists, citing multiple 

studies including a number done in the United States, and the six 

are outbreak investigations which trace Salmonella infections to 

farms, epidemiological investigations which demonstrate that people are more likely to have visited or lived on a farm prior to illness, that they have antimicrobial-resistant infections, field studies 

including some I think you will hear about on the next panel where 

they actually prospectively demonstrate how antimicrobial use in 

food animals selects for the emergence of resistance, case reports 

including children who have been sick, spatial and temporal associations where countries where they use less antimicrobial agents 

you see less antimicrobial resistance in bacteria, and finally, molecular subtyping, so this is the sixth type of evidence, and I will be 

happy to submit this to the record—it is cited in our report—where 

you actually can trace the specific bacteria around, and they find— 

and one of the studies I found most interesting, I think it was from 

Minnesota, is that the resistant strains of the bugs in humans 

match the resistant strains in the animals and those match the 

sensitive strains in the animals except for the resistance genes, but 

the sensitive strains in humans don’t match those. So you think it 

basically looks like the resistance is coming from the animals and 

the animal resistance is developing in the animals, and they do 

that by molecular analysis of the actual bacteria. 

So I really do think there is a very strong foundation of evidence. 

I think Dr. Khan—— 

Mr. PALLONE. Well, let me ask the other two guys. 

Dr. Khan, do you agree with Dr. Sharfstein on this, and Dr. 

Clifford, do you believe that growth promotion is an injudicious use 

of antibiotics? Basically if you would comment. 

Admiral KHAN. CDC supports the FDA position. The position is 

consistent with the one health approach and essentially how we 

use antibiotics for human use, and a number of members of the 

committee have pointed that tout. So we use antibiotics in humans 

specifically for treatment, for prophylaxis when it is a specific targeted individual or targeted drug for targeted indication, and those 

are the three uses in antibiotics. So, you know, I have kids in 

daycare, and lots of them are infected with all sorts of things. Nobody would ever propose that all children in daycare, for example, 

should be on antibiotics through that whole time frame. So this is 

very consistent with the one health approach and how we deal with 

antibiotics in humans. 

Mr. PALLONE. Dr. Clifford? 

Dr. CLIFFORD. We work very closely with FDA in consultation 

with this document and provided feedback to them. We think this 

is a good first step, and we welcome seeing the comments as well 

that FDA receives on this particular document. 

As far as whether growth promotion or judicious use of antibiotics, our position is that with regards to judicious use of medically important antibiotics, we are talking about treatment, control 

and prevention of animal health issues and disease. So there are 


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antibiotics, though, that are used, or antimicrobials that are used 

in animals that have no analog being used in human medicine and 

should not be of concern unless there is proven evidence to the 

human side. 

Mr. PALLONE. OK. Thank you all. 

Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Dr. Clifford, is there science to support the removal of antibiotic 

use for growth promotion? 

Dr. CLIFFORD. I am sorry? 

Mr. SHIMKUS. Is there science to support the removal of antibiotic use for growth promotion? 

Dr. CLIFFORD. You mean as far as the cause and effect? 

Mr. SHIMKUS. Right. 

Dr. CLIFFORD. There is some cases. 

Mr. SHIMKUS. Well, can you cite them? 

Dr. CLIFFORD. Well, obviously you can cite the Danish experience. 

Mr. SHIMKUS. No, I am talking about United States. 

Dr. CLIFFORD. Not right offhand, no, I cannot. 

Mr. SHIMKUS. Do you know of any U.S.-supported research peer 

review? 

Dr. CLIFFORD. I cannot cite any. 

Mr. SHIMKUS. You are similar to other testimony we received in 

April where Dr. Fauci and also quoted Dr. Frieden, and this is the 

hearing record. ‘‘To my knowledge and to Dr. Frieden’s knowledge, 

I don’t think any of those studies have been done in the United 

States.’’ 

I mean, I saw Dr. Sharfstein give you a note. The question is for 

you, not for Dr. Sharfstein. Dr. Sharfstein, I will ask you questions 

if you have—with my time available. 

Equating animals to people is like equating an apple to an orange. I am just—that is why we have vets and that is why we have 

doctors. That is why vets are not qualified to work on human 

beings or medical doctors qualified for animals unless I am sure in 

parts of southern Illinois years ago but—let me ask Dr. Sharfstein. 

What decreases in the level of human antibiotic resistance will we 

see if FDA proceeds with this Guidance 209 document as currently 

proposed? 

Dr. SHARFSTEIN. I expect that if we go forward with Guidance 

209 as currently proposed that this will reduce antibiotic resistance 

pressure. We will have less antibiotic resistance in animals and 

less antibiotic resistance in humans, and it will promote both 

human and animal health. 

Mr. SHIMKUS. And by what percent? 

Dr. SHARFSTEIN. I don’t think I can answer the exact percentage. 

Mr. SHIMKUS. And can you cite me a study, a U.S. study that 

verifies that analysis and that answer? 

Dr. SHARFSTEIN. Yes, I can. The Institute of Medicine’s 2003 report was very clear that this would be the right approach to take 

for this reason. 

Mr. SHIMKUS. Is that a study and is it peer-reviewed science? 

Dr. SHARFSTEIN. It is a study, and they do have a peer-review 

process at the Institute of Medicine. The Institute of Medicine is 


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considered our Nation’s leading scientific expert, you know, group. 

They looked at this issue. They said to do nothing is in effect to 

allow the continued evolution of antimicrobial-resistant microbes 

which poses serious and long-term—— 

Mr. SHIMKUS. And let me—and what do we see as a national government? Have we done any additional research to verify their 

findings? 

Dr. SHARFSTEIN. There has also been research in King County related to Campylobacter that is very compelling. There is a New 

England Journal study from Minnesota that is very compelling. I 

would be happy to submit all these studies for the record. 

Mr. SHIMKUS. We would like them all, please. 

Dr. SHARFSTEIN. Dr. Frieden mentioned in his letter to the committee that there is extensive data from the United States. 

Mr. SHIMKUS. Yes, correcting the record by which he was quoted 

in April, and we find that curious and also timely that that occurred. 

Dr. Khan, I want to go to your slides that you had presented to 

us, and if the staff could pull up slide number 1 for me from Dr. 

Khan’s. I am sorry. We should have given you a heads-up, but if 

we didn’t, we apologize. That is the right one. 

The antibiotics on chart 1 are mostly used for therapeutic use, 

not subtherapeutic use. Is that correct? 

Admiral KHAN. Yes. 

Mr. SHIMKUS. I see that there was no reduction in the little 

arrow there for those who have it. That is when it has been removed. There was no—in fact, there is an increase after it was removed. What does that say? 

Admiral KHAN. That says prevention is really a lot more important than control, so these may represent sentinel events. The moment you get a resistant bacteria from animals that makes it way 

into the human population, there is a different set of drivers for 

maintaining it in humans that makes it impossible to shut it down. 

Mr. SHIMKUS. Could it be that there is another cause for the resistance other than for which we are speaking of today? 

Admiral KHAN. I think the data is pretty unequivocal. Before the 

use of fluoroquinolone—— 

Mr. SHIMKUS. Well, let us go to the second slide. Let us talk 

about this unequivocal data here. This is the, I can’t pronounce it, 

quinolone resistance, Salmonella and typhimurium. First question. 

I was elected to Congress in November of 1996, took office in 1997. 

This chart ends in 1997, 14 years ago. Is there no data after that? 

Admiral KHAN. There is data after that. 

Mr. SHIMKUS. And what does that data show? 

Admiral KHAN. The data shows continued resistance. The purpose of this specific slide was to show that the introduction of this 

antibiotic into animals led to an increase in resistant bacteria in 

not just—— 

Mr. SHIMKUS. I think if you would add data, I think what we can 

find, and maybe this is why it was not submitted is that you are 

going to see a decrease, and if that is the case, I find it very perplexing and very troubling that we use data from 1997 and we 

don’t go to 14 years later to show the path. 


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Mr. Chairman, I know my time is expired, but the last thing, I 

also have problems with the third slide. That is the importance of 

getting data and information here in a timely manner so we can 

check sources, and to use World Health Organization data, to have 

dumbed down from the Danish study which will make the Danish 

products competitive because it is going to make us more difficult 

to compete. We are dumbing down our ability, is very problematic 

and I would agree with some of my colleagues, even on the other 

side, we better go very, very carefully and use real science in this 

antibiotics use of animals, and I yield back my time. 

Mr. PALLONE. Chairman Waxman. 

Mr. WAXMAN. Dr. Khan, just on that last question you were 

asked, if you had more data, you say it would show the same results as what you saw in 1997? 

Admiral KHAN. It depends on the country, sir. So in the U.K. 

there is continued persistence. In the United States, using National 

Antibiotic Resistance Monitoring System, NARMS, which is a system we use with FDA, that FDA, USDA and CDC sponsors, there 

is variable data for different pathogens that shows either continued 

increase or for some select Salmonellas decreases in resistance. The 

reason I used—so the first slide is actually U.S. data, 

fluoroquinolones in the United States, unequivocal that the moment you use the fluoroquinolones, within 2 to 3 years from less 

than 1 percent you went up to 20 percent resistance. That has remained—— 

Mr. SHIMKUS. Mr. Chairman, I don’t want to be disrespectful, but 

the point is, that is for therapeutic—— 

Mr. WAXMAN. Just a minute. You are disrespectful. 

Mr. PALLONE. Chairman Waxman has the time. 

Mr. SHIMKUS. Well, I was hoping you yield, but I apologize. 

Mr. PALLONE. No, he is not yielding at this time. 

Mr. WAXMAN. Go ahead. He doesn’t like the answer you are giving but let us hear what it is. 

Admiral KHAN. So that initial data, sir, the fluoroquinolone data 

is U.S. data. We also have abundant additional U.S. studies showing this. So if we look at Salmonella typhimurium DT–104, multiresistant outbreak amongst people, that was due to ground beef. If 

we look at Salmonella Newport, this is a multi-resistant strain—— 

Mr. WAXMAN. Well, let me ask you this because in USA Today 

on Monday, the director of the National Pork Producers Council 

said that, ‘‘According to top scientists with the Centers for Disease 

Control and Prevention and the National Institutes of Health, 

there are no scientific studies linking antibiotic use in livestock 

production with antibiotic resistance in people.’’ Is this an accurate 

reflection of CDC’s views? 

Admiral KHAN. Sir, Director Frieden has submitted a letter to 

the committee that specifically states that there is a compelling 

body of evidence to demonstrate this link that is summarized 

above, so there is multiple North American studies that describe 

how use of antibiotics in animals results in resistant bacteria in 

food animals. These resistant bacteria then are present in the food 

supply and transmitted to humans. And finally, these resistant 

bacteria can result in adverse human health consequences such as 


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increased hospitalization, and there is good scientific evidence for 

each one of those three assertions. 

Mr. WAXMAN. Well, a large part of the confusion seemed to stem 

from the question about the adequacy of the peer-reviewed literature showing a link between antibiotics use in animals and resistant infections in humans. Do you think there is substantial scientific evidence demonstrating a link between antibiotic use in animals and infections in humans, and can you discuss the implications of European versus USA data? 

Admiral KHAN. So there is an unequivocal evidence and relationship between use of antibiotics in animals and transmission of antibiotic-resistant bacteria causing adverse effects in humans following that pathway that I have outlined. The Danish data is also 

very clear on the use of subtherapeutic use of antibiotics for animals and what the consequences on resistance in humans. 

Mr. WAXMAN. Dr. Sharfstein, do you think there is substantial 

scientific evidence demonstrating a link between antibiotic use in 

animals and infections in humans? 

Dr. SHARFSTEIN. Yes, I do think that. 

Mr. WAXMAN. And is this scientifically controversial? 

Dr. SHARFSTEIN. I don’t believe so, no. 

Mr. WAXMAN. I wanted to ask a different line of questions, and 

that is regarding, as we consider antibiotic use in animals, we have 

heard concerns from some of the producers that reducing the routine use of antibiotics in animals could result in increased risk of 

foodborne illnesses. Since we have representatives of two of the 

country’s leading public health agencies, I would like to ask you 

about your assessment of the risks and benefits of reducing the use 

of antibiotic use in animals. I think it is important to understand 

that no one here is proposing to ban the use of antibiotics for animals. The goal here is to reduce the use of antibiotics that are important to human health and animals, particularly when that use 

provides little or no benefit to those animals. 

Dr. Sharfstein, as you know, it is the mandate of the Food and 

Drug Administration to ensure that the food supply is as safe as 

it can be, so would you be concerned if you believed that reducing 

the use of important human antibiotics in animals could result in 

increased risk to the food supply? 

Dr. SHARFSTEIN. Let me make sure I understand your question. 

Am I concerned or would it be concerned? 

Mr. WAXMAN. Are you concerned if you reduce the use of antibiotics in animals that affect humans that this could result in increased risk to the food supply? 

Dr. SHARFSTEIN. I think with our guidance, we are talking about 

the use for not-health purposes, so we don’t believe if we are eliminating the use for not-health purposes we are going to have adverse health consequences. 

Mr. WAXMAN. Is there evidence to support the claim that phasing 

out certain uses of antibiotics could increase risks to the food supply? 

Dr. SHARFSTEIN. I think if by certain uses you mean the uses we 

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Mr. WAXMAN. Dr. Khan, you are the Nation’s leading epidemiologist at CDC as well as the agency tasked with conducting outbreak 

investigations foodborne illness. Would CDC be concerned if it believed that phasing out certain use of antibiotics in animals would 

increase the risk of illness in humans? 

Admiral KHAN. No, sir, there is no scientific evidence suggesting 

a negative impact on human health for limiting the non-judicious 

use of antibiotics in animals. 

Mr. WAXMAN. Thank you. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Next is the gentleman from Indiana, who has 8 minutes. Mr. 

Buyer. 

Mr. BUYER. Thank you very much. 

Dr. Clifford, I have a question that deals with adulterated, counterfeit, knockoff drugs. We have a problem in our country, and 

countries around the world are challenged by this. Do you see any 

escalation or any evidence of adulterated counterfeit drugs in animal health? 

Dr. CLIFFORD. Congressman, since this really falls under FDA’s 

jurisdiction, I would have to turn to them to answer that question. 

Dr. SHARFSTEIN. In the United States—— 

Mr. BUYER. Hold on a second. 

Dr. SHARFSTEIN. Oh, I am sorry. 

Mr. BUYER. Hold on. Go ahead. Thanks. For animal health. 

Dr. SHARFSTEIN. For animal health, I think we are going to have 

to get back to you. I am not prepared to answer that. I have not 

heard of a significant counterfeit problem in the United States but 

I want to make sure and get back to you. 

Mr. BUYER. You know, as our problem is growing, it is only time 

before it migrates. It is going to follow the money, right? Bad guys 

follow the money. And that is why I asked the question. 

I want to thank the FDA for continuing the blitzes that you are 

doing at international mail facilities, so thank you for doing that. 

You are trying to ‘‘get the word out’’ to Americans that if you go 

on the Internet and you think that that is an approved Web site 

to order your pharmaceutical products, that you are really playing 

Russian roulette with your life, and so thank you for keeping these 

blitzes going and trying to get the word out. I noted in your testimony when you were with us in March, you had in your testimony, 

‘‘Protecting Americans from unsafe or contaminated drugs is not 

just an important responsibility of the FDA, it is our core charge.’’ 

Do you agree with that today? 

Dr. SHARFSTEIN. I do believe that. I think it is one of the reasons 

that FDA—— 

Mr. BUYER. So—— 

Dr. SHARFSTEIN [continuing]. Was established. 

Mr. BUYER. I am sorry? 

Dr. SHARFSTEIN. I was saying, it is one of the reasons FDA was 

established. 

Mr. BUYER. You also then in your testimony talked about FDA 

must adopt a new approach. Now, I think when you talked about 

your new approach, also you were concerned about the production, 

i.e., raw ingredients, that are used within our supply chain for 


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which people are buying at retail outlets within the gold standard 

of our own country. So ensuring that we maintain that gold standard, you are putting your eyes on that supply chain and production. 

I don’t have any problems with that. I think that is wonderful. I 

think the Administration is doing what it is supposed to do. I applaud you with regard to your striking the agreements with other 

countries, putting more inspections on other soils. That is awesome. 

With regard to your—it is twofold. Not only do you have that to 

do but we also have the mail facilities. Now, as we are doing this, 

we have got both of these going on at the same time, is we are trying to then do our electronic pedigree, and Mr. Dingell has a bill, 

and we are going to do work and do this electronic pedigree, but 

let me tell you what I was bothered about what I read in the 

Miami Dade about your last blitz. I think it is great. Like I said, 

you are doing the blitz. You did a 3-day blitz. You did everything 

you were supposed to do, your coordination with Customs, Border 

Protection, thousands of pieces of foreign mail. You X-rayed them. 

You separated them. You identified them, the suspicious pharmaceutical products. You ID’d them. You showed how many of them 

were counterfeit and knocked off, and then you sent them back. 

America has to be shocked, and the counterfeiters have to be excited that America is a place where you can counterfeit your drugs, 

send them to America, steal people’s money, and the American government will send the counterfeit drugs back to you so you can 

then send them to someone else that you can steal more money 

from. This is like one of the dumbest policies I think we have in 

this country. 

Now, last year I sent questions on this, and the answer from 

FDA is that FDA currently has authority to seek through the judicial process the destruction of any drug and other FDA-related 

products that relates to the Federal Food, Drug and Cosmetic Act. 

Now, the person right next to your inspectors, Customs, I mean, 

there is no wall. You have been there, right? There is no wall between these guys. That customs person, when they see it identified 

prima facie as knockoff, they destroy it. But if they hand off and 

give to the FDA person, the FDA says we can’t destroy it, put a 

label on it and they send it back. I know you have got to be uncomfortable with that as a policy. Are you? 

Dr. SHARFSTEIN. Yes. I mean, I have spoken to some of the inspectors who are, you know, as frustrated as you are. 

Mr. BUYER. All right. Now, if you are willing to step into a new— 

and that was your testimony that you gave to us in March, that 

you embrace and wanted to adopt a new approach with regard to 

the raw ingredients, through production and distribution always to 

U.S. consumers, I think I have an opportunity. I think, Mr. Dingell, 

we have an opportunity to help protect America, and that is embrace what the FDA is saying here, Mr. Dingell, and let us figure 

out how we can destroy these when they are identified, when your 

inspectors identify them. Let us not send them back to the counterfeiters so they can continue to rip off people. You know, Doc, come 

on, they are preying upon the most vulnerable of our population, 

which is awful. Would you be willing to work with Mr. Dingell and 


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I to come up with a policy here that can give your inspectors the 

ability to destroy these counterfeit, knockoff, adulterated drugs? 

Dr. SHARFSTEIN. Yes, and I believe we have been already starting that process by working with your staff and Congressman Dingell’s staff on this issue. 

Mr. BUYER. All right. Well, I want to be as proactive as we possibly can. John Dingell, to his credit, started this a long time ago 

with his paper pedigree, and he has always had a great interest. 

It goes all the way back many years into the 1970s, and I applaud 

what he has done. I think he has got to be pretty shocked on where 

America is today compared to where we were in the 1970s, and as 

a policy and I know you adopted this, I was just as frustrated with 

the last Administration but I am embracing your spirit, and if we 

are able to move ahead, Mr. Dingell, I want to join with you today 

and I want to work with the FDA and I want to resolve this matter. 

I want to yield to the chairman for a second. 

Mr. DINGELL. I thank the gentleman. He is most kind to me, and 

I want to thank him for the kind comments he has made about me. 

I want to assure him that my assurances of the last Congress, I 

would be happy to work with him, and I happen to agree with the 

gentleman about the problem of imports, about tracing pharmaceuticals and other drugs, and I am pleased to report to the gentleman that very shortly we will be circulating a draft for comments about pharmaceutical safety, and I hope that the gentleman 

when that occurrence happens that he will look at it with sympathy and I look forward to working with him because he is a valuable member of the committee, and I thank him. 

Mr. BUYER. I thank the gentleman. 

The last, can I do this piece of math? Thirteen—— 

Mr. PALLONE. The gentleman’s time has expired, but all the 

love—— 

Mr. BUYER. I ask unanimous consent for 30 seconds. 

Mr. PALLONE. Yes, with all the love and bipartisan here—— 

Mr. BUYER. God bless you. 

Mr. PALLONE. I certainly don’t want to stop the gentleman. 

Mr. BUYER. Thirteen international mail facilities, on average 

35,000 are pharmaceutical packages, times 365 days, that is 

1,666,075 packages a year. If 80 percent are counterfeit, adulterated or knocked off, that means there are 132,860 pharmaceutical 

packages that are coming into the country that are either adulterated, counterfeit or knockoff, and people are taking these and they 

are not metabolizing in the body in ways in which as doctors you 

intend. 

With that, I yield back. Thank you. 

Mr. PALLONE. Thank you. 

The gentlewoman from—I am sorry. Chairman Dingell is next. 

Mr. DINGELL. I thank you, Mr. Chairman. 

These questions are for all three witnesses. The first is yes or no. 

Is there a definitive link between antimicrobial use in animal feed 

and antibiotic resistance in humans? Starting with Dr. Sharfstein. 

Dr. SHARFSTEIN. Yes. 

Mr. DINGELL. Our next witness, Doctor. 

Dr. CLIFFORD. Yes, some. 


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Mr. DINGELL. Some? 

And you, Dr. Khan. 

Admiral KHAN. Yes, sir. 

Mr. DINGELL. Now, Dr. Sharfstein, please tell us what scientific 

studies support your claim. 

Dr. SHARFSTEIN. I think the best document that begins to summarize those is this 2003 study from the World Health Organization and it goes through outbreak investigations, epidemiological 

investigations, field studies, case reports, spatial and temporal associations and molecular subtyping. In each of those areas of research there are studies that support that statement. 

Mr. DINGELL. Now, Doctor, if you would like, I would be pleased 

to have you make other submissions supporting the statement 

which you just made. 

So next question to all three of our panel members. Are these 

studies based—rather is to Dr. Sharfstein. Are these studies based 

entirely on the European experience or do we have some that reflect experience in the United States? 

Dr. SHARFSTEIN. They are both based on European experience 

and some that are in the United States including one by someone 

I went to medical school with. 

Mr. DINGELL. Now, again, Dr. Sharfstein, it is my understanding 

that FDA currently has authority to withhold approval for certain 

animal drugs if they are use poses a risk to the public health. Is 

that correct? 

Dr. SHARFSTEIN. That is correct. 

Mr. DINGELL. OK. Now, does the likelihood that an antimicrobial 

drug used to treat a food-producing animal may cause antibiotic resistance to a problem in humans to pose a risk, and I put the risk 

to public health in quotes. What is the answer to that? Do you 

want me to repeat the question? 

Dr. SHARFSTEIN. Yes. 

Mr. DINGELL. Does the likelihood that an antimicrobial drug 

used to treat a food-producing animal may cause an antibiotic resistance problem in humans pose a ‘‘risk to public health’’? 

Dr. SHARFSTEIN. I think that the likelihood that that would happen does factor into the regulatory process as we approve new 

antimicrobials, so yes. 

Mr. DINGELL. And our other two witnesses, Dr. Clifford and Dr. 

Khan, what is you view on that question? 

Dr. CLIFFORD. Could you repeat that question again, please? 

Mr. DINGELL. It is a difficult question. All right. Does the likelihood that an antimicrobial drug used to treat a food-producing animal may cause an antibiotic resistance problem in humans pose a 

‘‘risk to the public health’’? 

Dr. CLIFFORD. I still—yes, I mean, it is possible for sure. 

Mr. DINGELL. Dr. Khan. 

Admiral KHAN. Yes, sir, and there is currently ample evidence 

that use of antibiotics in animals results in resistant bacteria in 

food animals, resistance is present in the food supply and transmitted to humans and that resistant bacteria result in adverse 

human health effects. So that data already exists and is summarized in various documents. 


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Mr. DINGELL. Now, gentlemen, again, based on this interpretation, and this is to Dr. Sharfstein, based on this interpretation, 

since 2003 FDA has considered the likelihood for antimicrobial resistance in the drug approval process. Is that correct? 

Dr. SHARFSTEIN. Yes. 

Mr. DINGELL. Now, has the interpretation been applied to all 

drugs currently on the market as well as new applications for 

drugs where the manufacturer is seeking access to the market? 

Dr. SHARFSTEIN. No, it has just been applied to new drugs coming on, and that is the reasons we would like to do this guidance 

is addresses some of the issues with the drugs that were already 

on the market. 

Mr. DINGELL. But you are not dealing with those which are already on the market. All right. 

Now, why has this interpretation not been used more widely for 

those drugs that were on the market prior to 2003? Is it for want 

of authority by Food and Drug? 

Dr. SHARFSTEIN. I don’t believe it is for want of authority, no. 

Mr. DINGELL. Now, Doctor, what are some of the barriers to new 

antibacterial drug development and what is FDA doing to help 

spur innovation in this area? 

Dr. SHARFSTEIN. I think there are two main barriers to antimicrobial drug development. One of them is the need for clear approval pathways so that companies can design studies that can 

reach the right endpoints and be approved, and FDA is working 

very hard to get the science right so we can have those clear approval pathways. There is a meeting by the end of July that will 

be the next step in that process. 

The second major issue is the issue of incentives for antibiotic development because it is expensive to bring drugs to market, and for 

antibiotics we don’t want them to be used that much when they are 

there so the market isn’t that great, so we believe there is a market issue as well as a pathway issue. FDA is supportive of discussions around the market incentive issue but it is a little bit outside 

of our sphere to really solve that problem. 

Mr. DINGELL. Thank you. 

Mr. Chairman, I have used more than my time. Thank you. 

Mr. PALLONE. Thank you, Mr. Chairman. 

Next is the gentlewoman from Illinois, Ms. Schakowsky. 

Ms. SCHAKOWSKY. Dr. Sharfstein, I am trying to understand then 

what the guidance says. Does it say it will only apply to new 

drugs? 

Dr. SHARFSTEIN. No, no. I am sorry. I must have been confused. 

Ms. SCHAKOWSKY. Oh, OK. 

Dr. SHARFSTEIN. There is a Guidance 152 that only applies to 

new drugs. I was referring to a guidance that was issued in 2003. 

I think that was what Chairman Dingell was referring to. This new 

guidance—one of the reasons that we are issuing this new draft 

guidance is because the old one doesn’t apply to existing drugs. 

This deals with some of the issues with existing drugs. 

Ms. SCHAKOWSKY. This would apply to all antibiotics? 

Dr. SHARFSTEIN. All medically important antibiotics. 

Ms. SCHAKOWSKY. Right. OK. So we have the FDA, the USDA, 

the CDC here today. Which agency has lead jurisdiction to ensure 


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then that the public is not at risk from overuse of antibiotics in 

livestock feed? 

Dr. SHARFSTEIN. I think FDA has regulatory authority over the 

use of antimicrobials in animals, but we work very closely with 

our—— 

Ms. SCHAKOWSKY. That was my next question. So how do you coordinate? Is there some sort of a—— 

Dr. SHARFSTEIN. Yes, the President’s Food Safety Working Group 

is one of the places that we have had very good discussions. This 

issue has been presented in a lot of discussions, and then separate 

from the big group, we have also worked individually. I think Dr. 

Clifford and the team at FDA were on the phone multiple times, 

and certainly CDC was within HHS, we are constantly talking to 

CDC at FDA. 

Ms. SCHAKOWSKY. The FDA voluntary guidelines address nontherapeutic use, right? 

Dr. SHARFSTEIN. It addresses what we call production uses, 

growth promotion, feed efficiency. 

Ms. SCHAKOWSKY. But I heard that poultry farmers have recently 

stated that from egg to slaughter, chickens and turkeys always 

need antibiotics to prevent disease. Now, here is my concern. If you 

are only talking about non-therapeutic use, what is to prevent 

farms from re-categorizing the purpose of the antibiotics they give 

to animals instead of actually ending the overuse? 

Dr. SHARFSTEIN. Well, I think you are getting to the concept of 

prevention, how we would approach preventive uses, and what the 

guidance, the draft guidance states is that it is not enough for 

someone to say I think this prevents disease, that is not enough, 

that our approach to prevention has to be based on evidence, and 

factors to consider include the evidence of effectiveness, the evidence that such a preventive use is consistent with accepted veterinary practice, evidence that the use is linked to a specific microbial 

agent, evidence that the use if appropriately targeted and evidence 

that no reasonable alternatives for intervention exist. So if we were 

going to look at prevention uses, which we do believe are important, can be important for animal health, we would apply kind of 

a scientific evidence-based set of criteria to that scenario. 

Ms. SCHAKOWSKY. Dr. Khan, are you comfortable with that as 

well? Because you talked about prevention being the best thing. 

Admiral KHAN. Very much, ma’am, and this is also consistent 

with how we use antibiotics in humans for prevention purposes, so 

a good example is meningococcus. It is a meningitis, inflammation 

of the brain. We do use it for prevention, a specific drug for prevention purposes, but it is specific to targeted people who get it. You 

get the drug twice a day for two days for targeted infection. You 

don’t get it forever, and everybody in the emergency room, for example, doesn’t get it. 

Ms. SCHAKOWSKY. Let me ask you this. To what extent would it 

be true to say that the use of antibiotics can be effective in masking unsanitary conditions where livestock is raised? In other words, 

if you use antibiotics, then you don’t have to be quite as precise 

about the level of cleanliness at places. Is this ever an issue? 

Dr. CLIFFORD. Production management with regards to farms 

and location of animals, that type of thing could be possible but 


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that is not a good management use of animals and it is not going 

to lead to their bottom line economically. If they run poor sanitation on a farm and have to use antibiotics to offset that, they are 

taking away cost and dollars from their operation, and the bottom 

line with production agriculture, it is economics. I mean, they are 

raising food and—— 

Ms. SCHAKOWSKY. But let me—can I ask one quick question? 

Dr. Sharfstein, the guidance has no enforcement component. How 

can we be sure that it will have any effectiveness at all? 

Dr. SHARFSTEIN. Well, the way we think of this is not much as 

a guidance or regulatory document, this we kind of put out as a 

white paper. This is sort of the foundation for how FDA intends to 

move in this area, and then it is basically like a foundation for us 

to build on. We have had some productive discussions with the various components of the animal agriculture industry and we expect 

that we will be seeing movement in this direction by their good efforts and I think their comments in response to the guidance indicate that, but I also think that as we move forward under this kind 

of framework, we will be open to the idea that we will then have 

to, you know, consider regulatory options. So this was not intended 

as a regulatory document. It was really intended as a here is what 

the science says, here is the right direction to move in, and really 

let us get comments on how to do this as well as possible with the 

minimal impact on agriculture and let us do it effectively, but we 

are going to see what we can get from setting this vision and then 

we are going to consider other things. 

Ms. SCHAKOWSKY. This is really a health hazard. It all sounds 

real slow but I hope that we will have a progress report that will 

show some movement before too long. Thank you. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

The gentlewoman from the Virgin Islands, Ms. Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and thank the 

panelists. I really thought I had missed this first round of questioning with the panel but I am glad I didn’t. 

Just maybe three questions. Dr. Sharfstein, welcome back. 

Dr. SHARFSTEIN. Thank you. 

Mrs. CHRISTENSEN. The FDA should now be implementing and 

receiving—I apologize if this question was asked—and receiving 

more detailed animal drug sales data under the Animal Drug User 

Fee Act Amendments that was signed into law in 2008. Has any 

data started coming in? 

Dr. SHARFSTEIN. Yes, we have started to get data. 

Mrs. CHRISTENSEN. I am concerned that we don’t seem to have 

a method in this country to track actual usage of these drugs in 

animals that become food. Is that concern warranted, and if so, 

when would be able to review an analysis of this new data to see 

whether additional reporting requirements might be necessary? 

Dr. SHARFSTEIN. Well, first, we are starting to pull together the 

data. We are just getting—I don’t think we have a complete set yet. 

I am not 100 percent sure about that, but I know that we are just 

sort of pulling it together, and I don’t think it will be too long before we will be able to share some of that information. But I think 

to your point, I think you are exactly right. The data under 


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ADUFA is just part of it. It is overall sales and a little bit by particular use, but it doesn’t really tell you how the antimicrobials are 

being used. It is not the kind of data, for example, that we might 

get about pediatric practice and pediatricians’ use of 

antimicrobials, and so I think that one of the things that we have 

been talking about, and there is a meeting very shortly in NARMS 

coming up is that there is a need for a better surveillance system 

and that is something where we hope to work very closely with 

USDA on. 

Mrs. CHRISTENSEN. Thank you. 

Dr. Khan, we talked a lot about the antibiotic resistance in animals and the fact that it creates resistance in humans but how do 

people become exposed to antibiotic-resistant bacteria through the 

food supply? Is it by eating contaminated meat and poultry or can 

cross-contamination become a problem? And does cooking resolve 

the problem? Could you just clarify for us how that happens? 

Admiral KHAN. Yes, ma’am, I would be glad to. There are multiple mechanisms by which resistant bacteria in animals can make 

their way into humans. The first is the most obvious. That would 

be the direct transmission or the direct route, and that would be 

directly from animals to humans, and we see that—— 

Mrs. CHRISTENSEN. Just from contact working with animals? 

Admiral KHAN. Direct contact, and we see that reported all the 

time. The second mechanism within that direct route is from food, 

so contamination of food that subsequently you are handling and 

you become infected. So we see that route as the direct route. 

There is also the indirect route of transmission, and this is where 

specific genetic material within a bacteria of animals can move into 

bacteria of humans and that resistance, so although the bacteria in 

animals doesn’t move to humans, the resistant pattern moves into 

humans and then can cause human resistant bacteria. 

Mrs. CHRISTENSEN. Thank you for that clarification. 

And Dr. Clifford, if funds were available, would the USDA be 

willing to initiate a pilot program where producers could receive assistance for transitioning to antibiotic-free methods and where results could be collected and reported? 

Dr. CLIFFORD. I think one of the issues that is out there is the 

lack of evidence of cause and effect when you remove these things, 

so I think it would be important to look at some of these types of 

things from the standpoint of a pilot project but also from the 

standpoint of the development of other methods and working with 

industry and such as vaccine development and other technologies 

to be able to better address this issue. 

Mrs. CHRISTENSEN. So do you have other priorities such as vaccines? New vaccines would be a higher priority than—— 

Dr. CLIFFORD. I am not saying which one would be the highest 

priority but I think all those things need to be looked at, and I 

think we as a body within the federal agencies need to be identifying, sitting down and working with the industry and others to 

identify the highest priorities and identify the way that we can 

best use our resources to address those. 

Mrs. CHRISTENSEN. In your testimony, you say that animal impacts must be considered in the context of the decision-making 


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process. Does that mean that there is some tension between USDA 

and FDA over the approach or are you all on the same page? 

Dr. CLIFFORD. Well, I think in general concept, we are on the 

same page. I mean, it is not that FDA and USDA are going to 

agree on every particular issue. I think it is important to note that 

as we all know, this is an extremely complex issue. My role as chief 

veterinary officer is the protection of animal health. Obviously I 

care very much about public health as well. So I think we have got 

to look at all of these things and balance these things, and this is 

a very complex issue and we don’t believe that one size fits all. 

Mrs. CHRISTENSEN. Thank you for your answers. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Ms. Christensen. 

Thanks a lot. Unfortunately, we are interrupted with two sets of 

votes today but I appreciate your bearing with us and also changing the date which we did on you a few weeks ago, so this is very 

helpful. Now, we will likely send additional questions in writing 

within the next 10 days or so, but I appreciate your being here 

today. Thanks so much. 

Marathon panel coming up here. Let me welcome the second 

panel. I hope you have enough room there kind of squeezed in. Let 

me introduce each of you. Starting on my left is Dr. Per Henriksen, 

who is Head of the Division for Chemical Food Safety, Animal Welfare and Veterinary Medicinal Products from the Danish Veterinary and Food Administration. And then we have Dr. James R. 

Johnson, Director of Infectious Disease Fellowship Program and 

Professor of Medicine at the University of Minnesota; Dr. Gail R. 

Hansen, who is Senior Officer for the Human Health and Industrial Farming Group of the Pew Charitable Trust; Dr. Christine 

Hoang, who is Assistant Director, Scientific Activities Division for 

the American Veterinary Medical Association; Dr. Randall Singer, 

Associate Professor of Epidemiology, Department of Veterinary and 

Biomedical Sciences, also from the University of Minnesota; Dr. 

Richard Carnevale, Vice President, Regulatory, Scientific and 

International Affairs from the Animal Health Institute; and Dr. 

Stuart Levy, who is Professor of Molecular and Microbiology and 

Professor of Medicine at Tufts University. 

As you know, we ask each of you to limit your comments to 5 

minutes, and then of course you can submit additional written comments as well, and we will start with Dr. Henriksen. 


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STATEMENTS OF PER HENRIKSEN, D.V.M., PH.D., HEAD OF DIVISION, DIVISION FOR CHEMICAL FOOD SAFETY, ANIMAL 

WELFARE AND VETERINARY MEDICINAL PRODUCTS, DANISH VETERINARY AND FOOD ADMINISTRATION; JAMES R. 

JOHNSON, M.D., F.I.D.S.A., F.A.C.P., PROFESSOR OF MEDICINE, UNIVERSITY OF MINNESOTA, AND FELLOW, INFECTIOUS DISEASES SOCIETY OF AMERICA; GAIL R. HANSEN, 

D.V.M., M.P.H., SENIOR OFFICER, HUMAN HEALTH AND INDUSTRIAL FARMING GROUP, PEW CHARITABLE TRUSTS; 

CHRISTINE HOANG, D.V.M., M.P.H., C.P.H., ASSISTANT DIRECTOR, SCIENTIFIC ACTIVITIES DIVISION, AMERICAN VETERINARY MEDICAL ASSOCIATION; RANDALL SINGER, D.V.M., 

M.P.V.M., PH.D., ASSOCIATE PROFESSOR OF EPIDEMIOLOGY, 

DEPARTMENT OF VETERINARY AND BIOMEDICAL SCIENCES, 

COLLEGE OF VETERINARY MEDICINE, DIVISION OF EPIDEMIOLOGY, SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF 

MINNESOTA; RICHARD CARNEVALE, D.V.M., VICE PRESIDENT, REGULATORY, SCIENTIFIC AND INTERNATIONAL AFFAIRS, ANIMAL HEALTH INSTITUTE; AND STUART LEVY, 

M.D., PROFESSOR OF MOLECULAR AND BIOLOGY, PROFESSOR OF MEDICINE, TUFTS UNIVERSITY 

STATEMENT OF PER HENRIKSEN 

Dr. HENRIKSEN. Thank you, Mr. Chairman, Mr. Ranking Member 

and members of the subcommittee for inviting me to testify. First 

I can say I am a veterinarian by training, got my degrees from 

Royal Veterinary and Agriculture University of Copenhagen, Denmark. I have been working as a scientist for more than 10 years. 

I have been working in the farmers’ organization as a health consultant for more than 5 years and working for the Danish government for more than 10 years. 

As a representative of the Danish government, I am aware that 

the use of antibiotic growth promoters is a contentious issue in the 

United States and that Denmark is often mentioned in the debate. 

Against this background, I wish to emphasize that the Danish government is not represented here today to advocate for or against 

any specific legislative proposals. However, we are a nation willing 

to share our experiences when requested and therefore we have accepted your kind invitation. 

I submitted five fact sheets for the record, and with the subcommittee’s indulgence, I will therefore shorten my remarks to 

allow for your questions. 

Mr. PALLONE. I want to interrupt and say that I understand you 

obviously came from Denmark here today to participate in this 

hearing, and we really appreciate your coming so far to be with us 

today. Thank you. 

Dr. HENRIKSEN. Thank you. 

Denmark is a major livestock producer in Europe and the world’s 

largest exporter of pork. Danish livestock production is highly industrialized, intensive and supplies modern management principles. Due to the significance for the Danish economy, the Danish 

government takes the competitiveness of the Danish farmers seriously. 


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Treatment with antibiotics is in many cases essential for human 

and animal health and an uncritical use of antibiotics can lead to 

several antibiotics becoming ineffective. Because antimicrobial resistance can be transferred between bacteria, regardless of whether 

the bacteria are pathogenic or not, the development of antimicrobial resistance in any kind of bacteria can constitute a problem. 

It is a fact that antimicrobial resistance can be transferred from 

animals to humans by consumption of meat, and every year also 

Denmark experience human outbreaks caused by consumption of 

meat contaminated with resistant bacteria. 

A ban on antimicrobial growth promoters was considered necessary for several reasons in Denmark. There was science-based 

evidence that the use of antibiotics in animal feed could create resistance in pathogenic bacteria to medically important antibiotics, 

and there was a real concern that doctors would run out of options 

for treating life-threatening infections in humans. Given the fact 

that very recently, a Danish Ph.D. project concluded that production animals and meat might be a source of human E. coli urinary 

tract infections, the Danish ban seemed to be an example of due 

diligence. 

Among the initiatives that are all mandated by the Danish government, I would like to mention the following: No prophylactic use 

of antimicrobials and mandatory low fixation of the veterinarians’ 

profit from sales of medicine. This fixation of low profit was an initiative of the Danish Veterinary Medical Association. The critically 

important antibiotics call fluoroquinolones can only be used in Denmark if a laboratory test shows that no other antibiotics can be 

used. Treatment guidelines for swine and cattle veterinary practitioners have been issued by the government. Continuous monitoring and research in antimicrobial resistance in animals, humans 

and food. Monitoring of foodborne pathogens in Danish as well as 

imported meat. Antimicrobial resistance is one of the parameters 

used to determine whether a shipment of imported food is dangerous or not. Control and action plans to combat Salmonella bacteria in poultry and pork and Campylobacter in poultry are implemented. And the most recent development includes mandatory action plans in swineherds above a certain threshold value for antibiotic use, the so called ‘‘yellow card.’’ 

It is important to note that, according to our experience, a ban 

on antibiotic growth promoters can immediately and dramatically 

reduce the amount of antibiotics used. In Denmark the decrease 

was 40 percent. Such a ban should not stand alone in the long run. 

This explains the fact that we have implemented this range of follow-up measures and we can expect also to have to take additional 

steps in the future. 

The ban of growth promoters has resulted in a marked reduction 

in antimicrobial resistance as measured among several different 

bacterial species in food animals. The percentage of macrolide resistance in porcine Campylobacter has decreased from 80 percent 

before the ban to less than 20 percent in 2006. A similar reduction 

from more than 75 percent vancomycin resistance in enterococci 

isolated from broilers before the ban to less than 5 percent. 


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Additionally, Denmark has a markedly lower level of resistant 

bacteria in meat compared to meat imported from other EU member states. I can mention as an example, that the percentage of 

cephalosporin resistance in E. coli isolated from Danish broilers’ 

meat is less than 5 percent, while more than 35 percent of E. coli 

isolated from broiler meat from other EU member states reveals 

cephalosporin resistance. This marked difference in resistance can 

be ascribed to our ban of growth promoters and low usage of 

antimicrobials compared to other EU countries. 

The Danish swine industry has been producing pigs without the 

use of growth promoters for many years now and has increased 

both the production and the productivity. The same picture applies 

in the broiler chicken and cattle industries. In the last few years, 

and particularly in 2009, we have noted an increase of usage of 

antimicrobials above the concurrent increase in pig production. 

However, as this increase appears more than 10 years after the 

ban, we do not relate this to the ban. Nevertheless, we take this 

recent increase in usage seriously and have imposed several initiatives. 

When presenting the Danish experience here in the United 

States, it is important to stress that Denmark is favored by a range 

of institutional characteristics which helped implementing the ban 

and the following steps. In Denmark, we can identify every herd, 

farmer and veterinarian and we are able to pinpoint the antimicrobial usage right down to the individual cow and to an age 

group of swine. This is due to our many databases on husbandry 

and medicine usage. And we have also monitored and researched 

in resistance for the past 15 years in a program called DANMAP. 

Our farming industry is highly organized in a cooperative structure 

with one common organization for farmers and food companies. We 

have a longstanding tradition for working towards a consensus between government, industry and the Danish Veterinary Medical 

Association. I would like to mention that the Danish Veterinary 

Medical Association along with the Danish Medical Association has 

supported a ban from the beginning. 

Working as an entity, the Danish swine industry has therefore 

played an important role and voluntarily stopped all non-therapeutic use of antibiotics starting in 1998, with a total state ban in 

place by January 2000. Only 2 weeks ago the Danish swine industry again issued a voluntary ban, this time against therapeutic 

treatment with the critically important antibiotic cephalosporin. 

Danish farmers are well educated and have easily learned to 

produce pigs without growth promoters. Instead, they use good 

management, weaning at 28 days instead of 21 days, initiatives 

concerning food and proper care of sick animals. These institutional 

advantages have enabled Denmark to take ambitious risk-mitigating strategies in order to combat antimicrobial uses and resistance and without endangering the economic sustainability of the 

swine industry. 

If you have any questions, I will gladly answer them, and I will 

also your attention to the fact sheet handed out. Thank you for 

your attention. 

[The prepared statement of Dr. Henriksen follows:] 


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CHECK AGAINST DELIVERY 

12 July 2010 

Danish testimony on the July 14th Hearing about Antibiotic Resistance in the 

Livestock Industry organised by the Subcommittee on Health 

By Per Henriksen, DVM, PhD, Head of Division for Chemical Food Safety, Animal Welfare and Veterinary Medicinal Products, The Danish Veterinary and Food Administration 

Thank you, Mr. Chairman, Mr. Ranking Member, and Members ofthe Subcommittee, for inviting me to testify. 

As a representative ofthe Danish government I am aware that the use of antibiotic growth promoters is a contentious issue here in the US and that Denmark is often mentioned in the debate. Against this background I wish to emphasize that the Danish government is not represented here today to advocate 

for or against any specific legislative proposals. However, we are an open nation, willing to share our experience when requested and therefore we have 

accepted your kind invitation. 

I have submitted five fact sheets for the record, and with the Subcommittee's 

indulgence, I will therefore shorten my remarks to allow for your questions. 

Denmark is a major livestock producer in Europe, and the worlds' largest exporter of pork. The Danish livestock production is highly industrialised, intensive and applies modern management principles. Due to the significance for 

the Danish economy the National Government takes the competitiveness of 

the Danish farmers seriously. 
81 


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Treatment with antibiotics is in many cases essential for human and animal 

health and an uncritical use of antibiotics can lead to several antibiotics becoming ineffective. 

Because antimicrobial resistance can be transferred between bacteria, regardless of whether the bacteria are pathogenic or not, the development of antimicrobial resistance in any kind of bacteria can constitute a problem. 

It is a fact that antimicrobial resistance can be transferred from animals to humans by consumption of meat and every year also Denmark experience human outbreaks caused by consumption of meat, contaminated with antimicrobial resistant bacteria. 

A ban on antimicrobial growth promoters was considered necessary for several reasons: There was science-based evidence that the use of antibiotics in 

animal feed could create resistance in pathogenic bacteria to medically important antibiotics, and there was a real concern that doctors would run out of options for treating life-threatening infections in humans. 

Given the fact that very recently, a Danish PhD project concluded that production animals and meat might be a source of human E. coli urinary tract infections, the Danish ban seemed to be an example of due diligence. 

Among the initiatives, that are all mandated by the Danish government, I 

would like to mention the following: 

• No prophylactic use of antimicrobials and mandatory low fixation of the 

veterinarians profit from sales of medicine. 

• The critically important antibiotics fluoroquinolones can only be used, if 

a laboratory test shows, that no other antibiotics can be used. 

Page 2/6 
82 


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• Treatment guidelines for swine and cattle veterinary practitioners have 

been issued. 

• Each individual veterinary practitioner is subjected to risk management 

and risk communication on prudent and reduced usage of antibiotics. 

• Continuous monitoring and research in antimicrobial resistance in animals, humans and food. 

• Monitoring of food borne pathogens in Danish as well as imported meat. 

Antimicrobial resistance is one of the parameters used to determine 

whether a shipment of food is dangerous. 

• Control and action plans to combat Salmonella bacteria in poultry and 

pork and Campylobacter in poultry are all implemented 

And the most recent development includes mandatory action plans in swineherds above a certain threshold value for antibiotics usage - the so called 'yellow card' initiative. 

It is important to note that, according to our experience, a ban on antibiotic 

growth promoters can immediately and dramatically reduce the amount of antibiotics used. In Denmark the decrease was 40%. But such a ban should not 

stand-alone in the long run. This explains the fact that we have implemented 

this range of follow up measures and we expect also to have to take additional 

steps in the future. 

I would now briefly present some results of the initiatives: 

The ban of growth promoters has resulted in a marked reduction in antimicrobial resistance as measured among several different bacterial species in food 

animals. The percentage of macrolide resistance in porcine Campylobacter has 

decreased from 80% before the ban to less than 20% in 2006. A similar rePage 316 
83 


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duction from more than 75 % vancomycin resistance in enterococci isolated 

from broilers before the ban to less than 5% in 2006. 

Additionally, Denmark has a markedly lower level of resistant bacteria in 

meat compared to imported meat from other EU member states. r can mention 

as an example, that the percentage of cephalosporin resistance in E. coli isolated from Danish broiler meat is less than 5%, while more than 35% ofE. coli isolated from broiler meat from other EU-member states reveal cephalosporin resistance. This marked difference in resistance can be ascribed to our ban 

of growth promoters and low usage of antimicrobials compared to other EU 

countries. According to data from the European Food Safety Authority the total consumption of antimicrobials in food producing animals in 2007 was 120 

metric tons in Denmark and almost 600 metric tons in another EU country 

with a comparable type of pig production. 

The ban of growth promoters came into force in 1995 and we noted a substantial decrease of 40% in the consumption of antibiotics in the years thereafter. 

The Danish swine industry has been producing pigs without the use of growth 

promoters for many years now and has increased both the production and the 

productivity. The same picture applies in the broiler chicken and cattle industries. 

15 years after the ban the overall amount of antibiotics used for animals in 

Denmark is still almost 40% below the pre-ban level. As some US observers 

has pointed out, there has been an increase in the consumption of antimicrobials for therapeutical use during the post-ban years, but it has to be remembered, that the pig production has increased 25% in the same period, which 

can account for more than the increase in consumption of antimicrobials. 

In the last few years and particularly in 2009 we have noted an increase of 

usage of antimicrobials above the concurrent increase in pig production. However, as this increase appears more than 10 years after the ban of growth promoters, we do not relate this to the ban. Nevertheless, we take this recent increase in usage seriously and have imposed the above-mentioned recent initiaPage 5/6 

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tive - the 'yellow card' where farms using antibiotics above a certain threshold 

are mandated to reduce their use. 

Salmonella levels have been between 0-2 % in eggs and chicken, and the Salmonella level in pork has remained low. 

When presenting the Danish experience here in the US, it is important to 

stress that Denmark is favoured by a range of institutional characteristics 

which helped implementing the ban and the following steps. 

• In Denmark we can identifY every herd, farmer and veterinarian and we 

are able to pinpoint the antimicrobial usage right down to the individual 

cow and to an age-group of swine. This is due to our many databases on 

husbandry and medicine usage. And we have also monitored and researched in resistance for the past 15 years in a targeted program called 

DANMAP. 

• Our farming industry is highly organised in a co-operative structure with 

one common organisation for farmers and food companies. We have a 

longstanding tradition for working towards a consensus between government and industry and this was also the case with the ban on antimicrobial growth promoters. 

• Working as an entity, the Danish swine industry has therefore played an 

important role and voluntarily stopped all non-therapeutic use of antibiotics, starting in 1998, with a total state ban in place by January 2000. 

Only two weeks ago the Danish swine industry again issued a voluntary 

ban; this time against therapeutic treatment with the critically important 

antibiotic Cephalosporin. 

• Danish farmers are well educated and have easily learnt to produce pigs 

without antibiotic growth promoters. Instead they use good management, 

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weaning at 28 days, initiatives concerning feed and proper care of sick 

animals. 

Thus, institutional advantages have enabled Denmark to take ambitious risk 

mitigating strategies in order to combat antimicrobial usage and resistance 

and without endangering the economic sustainability of the swine industry. 

In conclusion Denmark can state the following results: 

• Antimicrobial resistance is reduced after the ban 

• Total antibiotic consumption in food producing animals has been reduced by almost 40% from the mid 1990's till today 

• Animal health has not been compromised 

• Agricultural productivity has continued to improve 

• The farmer's economy has not been significantly threatened 

• Food safety in Danish products of animal origin has significantly improved as regards specifically Salmonella and Campylobacter 

• A range of institutional factors helped Denmark implement the ban 

• A ban on antibiotic growth promoters can be a very substantial and fulfilling first step in combating antimicrobial resistance, but should not 

stand alone in the long run 

If you have any questions I will gladly answer them, and I will also direct 

our attention to the fact sheets handed out. Thank you for your attention. 

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AOllflc:lJliitlJlwe! and fisheries 

and Food Administration 

FACT SHEETS 

12 July 2010 

On the Danish restrictions of non-therapeutical use of antibiotics 

for growth promotion and its consequences 

Denmark is a major livestock producer in Europe, and the worlds' largest exporter of pork. The Danish 

livestock production is highly industrialised, intensive and applies modern management principles. Due 

to the significance for the Danish economy the National Government takes the competitiveness of the 

Danish farmers seriously. 

The Danish initiatives in the area of non-therapeutic use of antibiotics for growth promotion and control 

of the use of therapeutic antibiotics were and still are - all taken to reduce the risk for occurrence ofresistant bacteria in the food chain. 

To provide facts on the background for the initiatives taken, the initiatives themselves, and our results 

The Danish Veterinary and Food Administration has developed five FACT SHEETS: 

r. General data on the Danish agricultural sector 

II. The Danish initiatives taken to mitigate the lisk of resistant bacteria in the food chain 

Ill. The OCCUlTence of resistant bactelia in herds, in food of animal origin, and in humans 

IV. Effects of the initiatives to reduce the use of antibiotics 

V. ConCUlTent development with regard to food borne pathogens in food of animal oligin 
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FACT SHEET I 

General data on Danish agriculture 

Denmark 

Denmark lies between 54° and 58° oflatitude north and 8° and 15° oflongitude east It is neighbouring 

Gern1any to the South, the North Sea to the West, Sweden to the East and Norway to the North. In addition to Denmark itself, the Kingdom also includes the Faroe Islands and Greenland. 

Population: 5.511.451 (2010) 

• Area: 43.098 square kilometres 

• Population density: 126,4 pr. square kilometre 

• Geographic region: Scandinavia 

Gross domestic product: Approximately 280 billion USD (2009) 

(I'he Ministry ofForeigl1 A11airs 1n Denmark) 

Agriculture 

The Danish agricultural sector in combination with the food industry employs some 150,000 persons and represents an export value of approximately 17 billion USD 

In 2008 approximately 5.800 pig farms, 5.200 dairy farms and 300 with specialised poultry production 

Census data 2008: 558.000 dairy cows (1.6 million cattle in total), 12.7 million pigs and 3,5 million hens 

Highly specialised - only 3% has more than one animal species 

Highly co-operatively organized sector where fanners own their slaughtering and processing 

companies 

Large co-operative companies including Danish CroWIl, the world's largest exporter of pork, 

with a group turnover at approximately 7,5 billion USD, and the dairy food company Aria Foods 

with a group turnover at approximately 7,8 billion USD 

• Farmers, co-operatives and most private companies in the Danish agricultural sector are part of 

the same joint organisation: Danish Agricultural and Food Council 

(Danish Agricultural and Food Council) 

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FACT SHEET II 

The Danish initiatives to mitigate the risk of 

resistant bacteria in the food chain 

EU and Danish government interventions 

PugeJ:/\S 

Since before the 1970s all veterinary medical products have been prescription only 

In 1994 the Central Husbandry Register (National Animal Identification System) was established, with national registration and identification of every herd in Denmark 

In 1994/95 any prophylactic use of antimicrobials was prohibited and the veterinarians' profits 

from direct sales of medicine were fixated at a very low level with a maximum of 10% 

In 1995 preventive veterinary strategies were implemented with herd health contracts on a voluntary basis and regular monthly visit from the veterinarian, irrespective of the actual herd health 

situation, in order to promote preventive veterinary strategies, optimizing antimicrobial use 

In 1995 the DANMAP programme (Danish Antimicrobial Resistance Monitoring and Research 

Pr%'famme, www,DANMAP,org) was established, The programme monitors and does research 

on antimicrobial usage and resistance in humans, animals and food and involves scientists, risk 

analysists and ri sk managers within both human and animal health 

In 1995, the Danish government banned the non-therapeutic use of avoparcin for growih promotion in Denmark; a ban that was extended to all EU countries in 1997, 

In January 1998, the Danish government banned the non-therapeutic use ofvirginiamycin for 

growth promotion, 

In December 1998 the EU implemented an overall ban of virginiamycin, bacitracin, tylosin and 

spiramycin for growth promotion, 

In 2000 the medicine database VetStat was established, recording every antibiotic prescribed to 

production animals on the age-group and herd and veterinarian level 

In 2002 fluoroquinolones were restricted to only be used if a current laboratory test shows that no 

other antibiotics can be used for that disease in that herd of production animals 
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In 2002, EU voted to phase out all non-therapeutic use of antibiotics for growth promotion (i.e. 

all non-prescription use) as of the beginning of 2006. 

From 2003 the Medicine Control Task Force, a special unit under the Danish Veterinary and 

Food Administration, was established. The special unit plans the risk-based control and assists 

the regional veterinary officers in difficult cases; the unit assists the police and the Prosecution. 

Action plan 2005 for reduction and prudent use of antimicrobials in swine, including 

treatment guidelines for swine veterinary practitioners 

direct risk communication with the individual swine veterinary practitioners with a high 

prescription rate. 

Action plan 2007 for reduction and prudent use of antimicrobials in cattle, swine and poultry, including 

direct risk communication including audit and supervision of prudent use of antimicrobials, every second year, of all veterinarians working with food-producing animals 

a task force was established between the Danish Medicines Agency, the Danish Veterinary and Food Administration and taxation authorities in order to secure that there are no 

economical relationships between veterinary practitioners and the pharmaceutical industry 

treatment guidelines for cattle veterinary practitioners. 

From 2009 an Early Notification Board on antibiotic usage in swine and cattle in cooperation 

with the industry, the Danish Veterinary Association and the Danish Veterinary and food Administration. 

From 2010 evidence based including pharmacokinetics and -dynamics - novel treatment guidelines for swine veterinary practitioners 

From 2010 ajoint Antimicrobial and Resistance action plan between the Ministry of Health and 

the Ministry of Food, Agriculture and Fisheries. 

From 2010 a National Antimicrobial Board for reduction of antimicrobial use and resistance with 

representatives from the Danish Veterinary and Food Administration, The Danish National 

Board of Health and scientists from both veterinarian and human health. 

From 2010 non-voluntary herd health agreements for swine and cattle with emphasis on health 

prevention strategies and animal welfare reducing antibiotic usage and resistance 

From 2010 establishment of threshold values for acceptable herd levels on mortality, antibiotic 

usage and certain welfare parameters in swine and cattle and enforced control in herds with levels above the threshold values 

From 2010 mandatory action plans for reduction of antibiotic usage in swine herds above the 

threshold value for antibiotics usage - the so-called 'yellow card' initiative 
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Voluntary actions taken by the Danish agricultural industry 

The Danish cattle and broiler industries voluntarily stopped the non-therapeutic use of all antibiotics for growth promotion in February 1998. 

The Danish swine industry voluntarily stopped all non-therapeutic use of antibiotics in swine 

above 35 kg by April 1998, and for all age groups by January 2000. 

The Danish swine industry enforced a voluntary ban on all usage of the high-risk antibiotics 

Cephalosporins from 1. July 2010. 

All the Danish agricultural industries initiatives were taken voluntarily and upon their own initiative and 

had nothing to do with any orders or fines from the authorities. Presumably, the industry found it 

worthwhile to have a production free from antimicrobial growth promoters, very low antimicrobial residues and a high standard on food safety. 

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FACT SHEET III 

The occurrence of resistant bacteria in herds, 

food of animal origin and in humans 

Risk of transmitting antimicrobial resistance from animals/food to humans 

40 

35 

30 

25 

20 

15 

10 

o 

Cephalosporin usage is for instance causing resistance in Escherichia coli (E. coli). This is shown, as 

prevalence of ESC positive E. coli from Danish farms with and without Cephalosporin consumption 

<6 month prior to sampling, shows that farms without Cephalosporin usage has only 8% ESC positive E.coli compared to 18% in herd using Cephalosporins .. ESC is a group of genes coding for resistance against 3. and 4. generation Cephalosporins. (Y. Agers0, DTU, 2010) 

Studies from 2009 detected ESC positive E. coli in 35 % of the samples from imported broiler meat 

(3.4% Danish broiler meat) (Figure I) (Y. Agers0, DTU, 2010) 

w CTl:-M-15 

Danish Imported Danish Imported Danish Imported 

pork pork beef beef broiler broiler 

meat meat 

Figure 1: % Ceftriaxone resi",1ant E. coli in each of six meat cMegories and distribution of ESC genes. 

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Antibiotic resistance in zoonotic and other bacteria 

Resistance in Salmonella Typhimurium in Danish animals and products, in imported products and in 

humans. For humans, the principal source is indicated. (Table 2) (DANMAP 2008). Shows the 

amount of resistance in imported meat is much higher and resistance in humans are often acquired 

abroad. 

Table 2.1 - 2.3. Comparison of resistance (%) among Salmonella Typhimmium from food animal" IlOrk of Danish 

and imported origin and llum~m cases acquired domestical1~' a), repolied as 8s-"!.ociated with traYcl abroad or with an 

unknown oligin, 2008 

% 

60 

50 +-----------------------~--------------------__ r_----------__ol 

40 t;fr--------IiI-------1I ~------------------111~--------_41 

30 

20 

10 IIIl 

III Catt!e 0 Pigs! 

% 

100 Table 2.2 Comparison of resistance (%) among Salmonella Typhimurium ,-- ~ .. ~~-----.--~----~-----~ r-~~--~-~- ~~ '-~--'---'-'~~-~---~-'I 

90 I-- I------il----__II-----------------ijl il 80 

70 

60 

50 

II 

~ -- R 

30 - - I-- r--

20 ~ - I-- I--- 10 1------1 - I-- I---

O~~I~~~~.~~. ~.~~~~m~~~,n~~~I~~~~~~__I1 

1m Pork Danish 0 Pork Imported EEl Broiler meat Imported 0 Turkey meat Imported t 
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% 

60 Table 2.3 Comparison of resistance ('Yo) among Salmonella Typhimurium ~_~~~,~_~~~~~_--c_~~~_~~~~~~~ '"'' , __ ~ 

50+-~--------------------------------------------------------,1 

40 

30 

Resistance in Campylobacter jejuni from food animals, food of Danish or imported origin and human cases categorized as acquired domestically or reported as associated with travel abroad 2008 

(Table 3) (DANMAP 2008), Shows that resistance in broiler meat is mainly imported and for a large 

proportion acquired abroad for humans, Pork and swine not in the table, as Campylobacter in swine 

in Denmark most often are C coIL 

Table 3. Com)larison of resistance (0/0) among Cnmpylobactcr je.iuni from food animals, food of Danish or imllOl1cd 

origin and human cases catcgori7.ed as acquired domestically or rCflortcd as associated with travel abroad 2008 

OJlll>Ound Cattle BroiJ€rs 8rotler meat Hurmns 

Damsn Damsh [)Qmsh trnported Domestically acqulred Travel ilbroad reporled 

Chloramphenicol 

&ythromycin 

Gentamicin 

Streptomyc.in 1 5 4 3 15 

Clprofloxucin 20 12 19 53 

NaUdixJC and 20 12 19 53 

Number of ISolates 90 82 26 152 185 41 

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Resistance in Escherichia coli from food animals, food of Danish and imported origin and army recruits, 

2008 (Table 4) (DANMAP 2008) 

Table 4. Occurrence of resistance (%J among Escherichia coli fmm food animals, food of Danish and imported 

origin and ann~' recruits, 2008 

Compound 

Tetracvc\)ne 

C!)fDramp..l'JerlICol 

Flortenlcol 

Amp;ClNm 

Ceptmlo!nm 

Cefliol'1.lf 

CefpodoXfme 

CefotClxlme 

Tl1methoprim 

Apramycm 

Gen:tamlcm 

SpecttrlomYCi!l 

Streptnll1ycln 

ClpmflDXactn 

Naltdl)(JCilOd 

C011SIm 

Num])er of Isolates 

Page 9/18 

12 

,I' 97 

BroliE'rmeal 

Imported 

% 

42 

14 

18 " 

.2 45 

lO 

26 

'" 

151 113 

Bee! 

DanISh !mported 

% % 

12 

10 28 

. " 30 2B 

24 25 

20 11 

15 26 

" I 

03 40 6£ % '6 
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FACT SHEET IV 

Effects of the initiatives to reduce the use of antibiotics 

Changes in antimicrobial usage in Danish agriculture from 1992 to 2009 

Total antimicrobial consumption in Denmark for all animals (Figure 1) has fluctuated over time; 

highest in 1994 and lowest in 1999. And the consumption is still 37% less in 2009 than in 1994. 

The production of pigs has increased continuously over time (The Danish Veterinary and Food 

Administration, 2010). 

Figure 1. Consumption of antibiotics (therdpeutic and nOll-therapeutic (AGP)) in all tYlle of animals in Denmark. 

U sage in tono('s and pig production in million heads. Swine comprises >80o/i) of all usage in animals. 

Page 10ilS 

Antibiotic usage in all type of animals in Denmark 1990·2009 and rate in pig 

production 2004·2009 
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Changes in antimicrobial resistance 

" " = 

.~ 

" ... 

?f. 

The stop for use of different non-therapeutic antibiotic growth promoters (avilamycin, avoparcin, 

spiramycin, tylosin, virginiamycin) has resulted in a reduction in antimicrobial resistance, for instance vancomycin resistance (figure 2) (www.DANMAP.org) 

Ynncoll1ycin J'esistance 

80 

60 

40 

20 

o 

6 

5 'Jo 

= o 

I-< 

4 ,5 

= .S 

3 a 

E 

~ 

2 = 0 (,.:, 

o 

Figure 2. Occurrence Oryancomycin resistance and consumption of avoparcin from 1995~2005 ~ Denmark 
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Tylosine is used for both growth promotion and therapy. This usage will also select for (lead to 

development of) resistance in Campylobacter. As shown in figure 3, the occurrence of macrolide 

resistance in Campylobacter coli from pigs has closely followed the consumption oftylosine in 

the food animal production (www.DANMAP.org) 

Campylobacter coli are the absolutely most common Campylobacter in Danish swine. C. 

jejuni is very rare in swine in Denmark. 

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 

Figure 3. Macrolide resistance among Camp~·lobacte .. coli from pigs and consumption oftylosine for growth promotion and tbenqly. 1995-2006, Denmark. 

Puge 12/18 
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Effects on productivity and animal health - Denmark 

Cattle 

No evidence, not even anecdotal, suggests any negative health effects of the growth promoters 

stop, as there were no increases in treatment of neither sick animals nor m0l1ality. 

Swine 

'" "0 

1: " 

§ 

" 0 

1j 

'0 " 

2 

"-

The Danish swine production has increased with similar rates before and after the nontherapeutic use offor growth promotion stopped (almost 50% from 1992 to 2008). Also the average annual number of pigs raised for slaughter per sow has continued to increase (figure 4) 

(DTU, Danish Technical University, 2009) 

35 

30 

I~GP slop I weaners 

25 

~ 23 :;; 

'" 25 .::: 21 3: 

g 

:;; 

20 Q. 

19 ~ 

0) 

a: 

15 17 

10 15 

Figure 4. Production of sll'ine and numbers of pigs produced )cr sow/~'ear in Denmark 

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480 

460 

Weaner mortality increased several years before as well as few years after non-therapeutic use 

stopped, but has drastically decreased in recent years, indicating little if any effect of the termination. Weaner average daily gain has increased after the termination. (Figure 5) (DTU, Danish 

Technical University, 2009). 

4 

3~ 

~ 

2~ o 

:0 

1 

360 +---+-+-+-f--f--f--i--l~i--l--+--+-+-+-+-+-+ 0 

Figu re 5. Daily weight gain of weaner pigs and mortality of weanerlligs in Denmark 

~ I.'J 

0 

0 

; 

~ '" 

" 

Finisher mortality has not been affected by the termination. Finisher average daily gain has continued to increase before and after the termination (Figure 7) (DTU, Danish Technical University, 2009). 

1000 

900 

800 

700 

600 

500 

400 

300 

200 

100 

o > 

__ FElKq qm"\~h (finishers) Dalla ,~nd c()ndemded (flnlshels) 

Figure 7. Daily \ycight gain, mortality and feed efficiency of finishing pigs in Denmark 

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Broilers 

Productivity and mortality was not affected by the termination, as shown in the figures beneath. 

Productivity varied both before and after the ban. The feed conversion ratio increased, but the 

amount spent on feed was gained again as there were no expenses on growth promoters. 

Productivity is measured not in number of broiler heads, but kg of broilers pr square meter in the 

stable (Figure 8, 9, 10) (DTU, Danish Technical University, 2009) 

AGP stop 

Fi~",re 8. Prodlletivit~· of broiler chicken in Denmark (kg produced I,er sqm) 

Figure 9. Mortality of broiler chicken ill Denmark 

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Fi".re 10. Feed conversion ratio in broilers in Denmark, change offset by reduced costs 

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FACT SHEETV 

Concurrent development with regard to 

food borne pathogens in food of animal origin 

Salmonella in pigs 

Action and control plans have been installed in Denmark since 1995. Prevalence of seropositive 

pigs in the breeding and multiplying herds is shown in Figure I, prevalence of seropositive pigs 

for slaughter in Fi6'Ure 2, and prevalence of bacteriologically positive carcasses in Figure 3. References for all Fi6'Ures (Annual Report on Zoonoses in Denmark, DTU, 2009) 

6,00 + ............. _ ...... _ ........................................... , .. L .. _ ... · .. · .. ·· .. -· .... _ .... --1 f 4.00 +·c-f..~l .. l---i .. ~~c..,....-.~--q,fL_Li __ .. f..'_·"'-"'_i 

~,9; 2.00 +-----.---'---.-. .l. ..... - .. -.-.... - ..... ---'---\l-.~ 

0.00 ,.-._-~-.. ~-.. --r ... ~---.. - .. -~_-.~~-... -

2003 2004 2005 2006 2007 2008 2009 2010 

% positive ~,,~% posltive (Eufofins) 

-%positive. 12 manedelsruilende gennemsnit 

Figure 1. Percent positive sam])les, bl"Ceding and multiplier (lig-s. 

18 

1\ 

" J\ I)"" ."", '-I v \l'/~ I~ 

'vV' 

Fi~'Urc 2. Percentage of positive meat juice samilies - slaughter pigs. 

2.5 .,------------------, 

2.0 +------------cr------j 

lOGS 2006 2007 2008 2009 

Figure 3 . Percentage of Ilositil·e carcasses at the slilUghterhouse. 

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Salmonella in layer flocks and in the broiler production 

Action and control plans have been installed in Denmark since the late 1980ies. The occurrence 

of salmonella in the layer sector (breeding flocks and layer flocks) is shown in Figure 4. Occurrence of salmonella in broilers is shown in Figure 5. Eggs and broilers from contaminated flocks 

are prevented from entering the market. References for Figures (Annual Report on Zoonoses in 

Denmark, DTU, 2009) 

6,0 

4,0 

2,0 

0,0 

Laymgf10cks 2001 JU BrcedUlg flocks :< month moving aVT (laymg ll.)cb) ~J07 2008 2009 

Kvartal 

__ Produktionsflokke Opdr",tsflokke maneders !0bende gennemsnit (prod f!okke) 

Figure 4. Prevalence (%) of salmonella ill Danish table-Ia)'et' f1ock~ 

" '" 

7% 

6% 

5% 

~ 4% 0;::: 

~ 

:€ 3% III 

o 

0- 2% 

1% 

0% 

Jan 2006 Jul Jan 2007 ~Jul Jan 2008 Jui 

Figu re 5. Prevalence of salmonella in Danish broiler flocks 

Page l8/18 

Jan 2009 Jul Jan 20"10 

2010 
104 

Mr. PALLONE. Thank you, Dr. Henriksen. 

Dr. Johnson. 

STATEMENT OF JAMES R. JOHNSON 

Dr. JOHNSON. Chairman Pallone—— 

Mr. PALLONE. Could you maybe bring that mic a little closer? I 

always gave Dr. Henriksen a lot of leeway, since he came from 

Denmark. The rest of you should try to stick to the 5 minutes. I 

think you have to either turn it on or move it closer. 

Dr. JOHNSON. It was the turning it on. Thank you. 

Chairman Pallone, Ranking Member Shimkus and members of 

the subcommittee, on behalf of the 9,000-plus members of the Infectious Diseases Society of America, or IDSA, I appreciate this opportunity to speak in support of the Health Subcommittee’s efforts 

to promote judicious use of medically important antibiotics in animal agriculture. I am James Johnson, an infectious diseases physician, a Professor of Medicine at the University of Member, and a 

member of IDSA’s antimicrobial resistance work group. 

I applaud the emphasis that Ranking Member Shimkus and Congressman Pitts as well as other speakers today have put on science 

as a foundation and guide for decision-making in this area. I would 

point out that IDSA is made up of research scientists, infectious 

disease commissions and public health epidemiologists who value 

and rely on the scientific method. IDSA supports rigorous science 

and critical impartial evaluation of the scientific evidence base. 

IDSA also publishes two of the premier peer-reviewed scientific 

medical journals in infectious diseases, Journal of Infectious Disease and Clinical Infectious Disease. These two journals have published dozens, if not hundreds, of peer-reviewed scientific studies 

on this topic. 

IDSA supports efforts to eliminate all non-judicious uses of antibiotics in human medicine and agriculture such as the Preservation 

of Antibiotics for Medical Treatment Act, or PAMTA, and the 

FDA’s recently announced public health approach toward antibiotic 

use in food animals. The elimination of non-judicious will mean the 

end of antibiotics for growth promotion, feed and efficiency and 

routine disease prevention in food animals. The United States also 

must strengthen efforts to ensure that all other food animal antibiotic use is supervised by a veterinarian within the boundaries of 

a valid veterinarian-client-patient relationship. 

Now, IDSA regards the development of antibiotics to treat lifethreatening infections as one of the most notable medical achievements of the past century. Unfortunately, these wonder drugs’ ability to cure is being increasingly compromised by emerging antibiotic-resistant pathogen, and there are few new antibiotics in development that will come to our rescue any time soon. As a result, 

infectious disease physicians and public health experts believe that 

we must do everything in our power to preserve existing antibiotics 

to protect both human and animal health. 

As noted in opening statements by several committee member including Congressman Murphy and the Administration witnesses, 

an extensive body of scientific evidence demonstrates that antibiotic use in food animals does contribute to the spread of resistant 

bacteria to humans, leading to drug-resistant infections with their 


wreier-aviles on DSK5TPTVN1PROD with HEARING
105 

many adverse consequences. Our written testimony cites sciencebased studies and reports from authoritative panels over the past 

40 years that support this position including studies supported by 

USDA and CDC. Eliminating non-judicious antibiotic uses in food 

animals would help protect the American people against drug-resistant infections and extend the utility of existing antibiotics. This 

concludes reflects a broad consensus within the medical, scientific 

and public health communities. Such measures have been advocated repeatedly by the World Health Organization and the National Academy of Sciences, and as you have heard here today, 

have already been implemented across Europe. 

IDSA is very encouraged by FDA’s new draft guidance to industry which establishes a policy framework for judicious food animal 

antibiotic use. We view this new guidance as an important first 

step. Both FDA’s guidance and PAMTA provide elements of the 

overall policy framework that Congress should consider as it moves 

forward to develop and enact legislation. 

We are concerned, however, by FDA’s apparent decision to rely 

on drug companies to voluntarily remove growth promotion and 

feed efficiency claims from their drugs’ labels. Past experience suggests that this will take years or decades and many companies will 

not comply. Therefore, we urge Congress to expedite the process 

through legislation. 

We also are concerned that FDA does not specify its plans for 

eliminating those uses of antibiotic in food animals for prevention, 

control and treatment that likewise may be non-judicious. These 

also must be addressed. 

U.S. experts also require access to reliable and standardized data 

regarding the scope of antibiotic consumption in humans and animals. The lack of data in both the human health and agricultural 

settings impedes our ability to respond effectively to the antibiotic 

resistance problem. Although the U.S. Animal Drug User Fee 

Amendments, or ADUFA, legislation of 2008, as mentioned earlier, 

strengthened FDA’s ability to collect animal antibiotic sales and 

distribution data. This was only for national-level data. What we 

need are local-level data reported by animal species. Of importance, 

also pharmacists do not control antibiotic distribution in the agricultural sector. Instead, feed mill operators are responsible for mixing animals into antibiotic feed and they control antibiotic distribution from the drug manufacturers to our Nation’s farmers. Given 

feed mills’ key role in distributing these lifesaving drugs, they must 

become better integrated into the infrastructure for protecting antibiotic by tracing and regularly reporting to the FDA the amount of 

antibiotics being consumed by each animal species. 

In conclusion, the Subcommittee on Health has a long history of 

leadership in addressing our Nation’s most pressing public health 

issues. Today, IDSA calls upon you to help protect our patients and 

the health of every American by adopting strong measures including PAMTA to end non-judicious antibiotic use in food animals and 

to require that other food animal uses of these precious drugs be 

supervised by a veterinarian within a valid veterinarian-client-patient relationship. We also urge the committee to move with haste 

to enact the Strategies to Address Antimicrobial Resistance, or 

STAR Act, which will significantly strengthen U.S. antibiotic resistVerDate Mar 14 2013 09:19 Mar 20, 2013 Jkt 077921 PO 00000 Frm 00113 Fmt 6633 Sfmt 6633 E:\HR\OC\A921.XXX A921

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ance efforts. Finally, we urge you to enact statutory incentives to 

spur new antibiotic development. 

Thank you, and I will be happy to answer questions. 

[The prepared statement of Dr. Johnson follows:] 


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~IDSA 

Testimony of the Infectious Diseases Society 

of America (IDSA) 

Antibiotic Resistance and 

the Use of Antibiotics 

in Animal Agriculture 

Presented by James Johnson, MD, FIDSA, 

FACP 

Before the House Committee on Energy and 

Commerce Subcommittee on Health 

July 14,2010 
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The Infectious Diseases Society of America's (IDSA) Statement on 

Antibiotic Resistance: Promoting Judicious Use of Medically Important Antibiotics in 

Animal Agriculture 

Before the House Committee on Energy and Commerce Subcommittee on Health 

July 14,2010 

The Infectious Diseases Society of America (mSA) appreciates this opportunity to speak in 

support of the House Energy and Commerce Committee Health Subcommittee's efforts to promote 

the appropriate ("judicious") use of medically important antibacterial drugs ("antibiotics") in 

animal agriculture. My name is James R.lohnson, MD, FlDSA, FACP. I am an infectious 

diseases specialist and a Professor of Medicine at the University of Minnesota School of Medicine. 

I also am a member oflDSA's Antimicrobial Resistance Work Group. 

lDSA represents more than 9,000 physicians and scientists devoted to patient care, prevention, 

public health, education, and research in the area of infectious diseases. Our members care for 

patients of all ages with serious infections, including meningitis, pneumonia, tuberculosis (TB) 

and HlV/AlDS, emerging infections like the 2009 HINI influenza virus, food-borne diseases 

caused by Salmonella, Campylobacter, and Escherichia coli (E. coli), and diverse infections 

caused by antibiotic-resistant bacteria. Among the most concerning antibiotic-resistant 

organisms are methicillin-resistant Staphylococcus aureus (MRSA), Enterococcus, E. coli, 

Salmonella, Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii. 

To better protect our patients and the general public against antibiotic-resistant bacterial infections, 

lDSA strongly supports efforts to eliminate all non-judicious uses of antibiotics in human medicine 

and animal agriculture (e.g., cattle, swine, and poultry production and aquaculture), including H.R. 

1549, the Preservation of Antibiotics for Medical Treatment Act (PAMTA) and the Food and Drug 

Administration's (FDA's) recently announced public health approach to address antibiotic use in 

animal agriculture. lDSA also supports the elimination of non-judicious uses of antibiotics in plant 

agriculture. Antibiotics currently are used inappropriately on fruit and vegetables (e.g., use of 

gentamicin as a pesticide in apple orchards\ However, we have been asked to limit our 

comments today to animal agriculture. 

In the animal agriculture context, the elimination of non-judicious uses will mean the end of 

antibiotic use for purposes of growth promotion, feed efficiency, and routine disease prevention. 

We also support requiring all remaining uses of antibiotics to be carried out under the supervision 

of a veterinarian and within the boundaries of a valid veterinarian-client-patient relationship. 

Finally, we urge Congress to enact legislation requiring the collection of antibiotic consumption 

data in the United States in a manner that parallels data collection advances achieved within the 

European Union. 

Today, many of us in the United States take antibiotics for granted--we do not realize how 

fortunate we are to have them. Many of our parents, grandparents, and great-grandparents were 

not so lucky. Prior to the discovery of antibiotics, many injuries and illnesses became death 
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sentences as there was no way to treat the common infections that were often associated with 

them. Antibiotics often are referred to as "miracle drugs," because patients traditionally only 

needed to take them for a number of days for most infections to be cured. 

The development of antibiotics to treat serious and life-threatening infections has indeed been 

one of the most notable medical achievements of the past century. However, there is growing 

concern among infectious diseases specialists that the effectiveness of antibiotics in treating 

infections is being increasingly compromised by the ever-growing presence of drug-resistant 

bacteria. Drug-resistant organisms are plaguing Americans, and others around the world, 

including otherwise healthy individuals, in the community and healthcare settings alike. 

Antibiotic resistance is a serious threat to public health, to patient care and safety, and to national 

security. Antibiotic-resistant infections are extremely difficult to treat and frequently recur. 

These infections often result in tremendous pain, suffering, and disfigurement in adults, children 

and infants, have caused millions of deaths worldwide, and have been estimated to cost the U.S. 

health care system between $21 billion and $34 billion annually. 

Chairman Pallone, Ranking Member Shimkus, and Subcommittee members, at the same time 

that the numbers of drug-resistant infections are increasing, we have seen a steep decline in the 

number of new antibiotics in development. This Subcommittee has conducted a series of 

hearings to gain a better understanding of the many factors that are contributing to the current 

antibiotic resistance crisis. These hearings are critically important, and lDSA applauds your 

efforts. rOSA was pleased to testifY before the Subcommittee on June 9, 2010 about antibiotic 

resistance and the dire antibiotic pipeline probJem2 As you may recall, IDSA's testimony 

explored several key themes: 

• Antibiotics are a vital resource and a precious gift from prior generations, and we have a 

moral obligation to ensure this resource is available for future generations. 

• Safe and effective antibiotics are urgently needed to treat serious and life-threatening 

infections caused by a growing list of drug-resistant bacteria. 

As with other diminishing resources (energy, forests, clean water, etc.), Congress and the 

Administration must establish policy to nurture both the conservation and restoration of 

antibiotics through the development of innovative antibiotics and other relevant tools 

(e.g., rapid diagnostics, vaccines, and other biologicals). 

• We must adopt, promote, and continue to refine effective strategies to prevent both the 

emergence and transmission of resistant organisms, which undercut the effectiveness of 

our current antibiotic arsenal. Transmission of resistant organisms can be prevented by 

good infection control practices, effective immunization policies, and (for food-borne 

organisms) hygienic food production, processing, distribution, and preparation. 

Emergence of drug-resistant bacteria can be reduced by ensuring that antibiotics are used 

judiciously in all settings. Antibiotic stewardship strategies are the best way to achieve 

this goaL 

Our statement today will examine in greater detail this last principle and specifically the need to 

eliminate all non-judicious uses of antibiotics in animal agriculture and to ensure that all 

antibiotic uses in animals be carried out under the supervision of a veterinarian within a valid 

2 
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veterinarian-client-patient relationship.; Considerable efforts have been taken in human 

medicine to eliminate non-judicious antibiotic use. As described in our prior testimony, 

antibiotic stewardship programs and practices are being established in health care settings across 

the country. Stewardship can take the form of restricting which antibiotics are included in the 

health facility formulary or requiring preauthorization to prescribe a specific therapy. Additional 

mechanisms can include antibiotic order forms, formal prospective audit and feedback, deescalation of therapy based upon microbiological data of what specifically is causing an 

infection, and dose optimization. Educational efforts focused on appropriate uses have targeted 

both providers and patients. Of critical importance, antibiotics used in human medicine require a 

prescription. In contrast to human medicine, although animal agriculture uses of antibiotics also 

contribute significantly to the development of drug-resistant pathogens, only limited measures 

have been taken in this setting to eliminate non-judicious uses. Also, appropriate marketing and 

distribution safeguards have not been implemented in the agricultural setting as tons of 

antibiotics are purchased over-the-counter without a prescription each year for use in animal 

agriculture. 

ANTIBIOTIC RESISTANCE: THE COSTS ARE GREAT 

The U.S. Centers for Disease Control and Prevention (CDC) has described antibiotic resistance 

as "one of the world's most pressing health problems", because "the number of bacteria resistant 

to antibiotics has increased in the last decade [and] ... many bacterial infections are becoming 

resistant to the most commonly prescribed antibiotic treatments." The World Health 

Organization (WHO) has identified antibiotic resistance as "one of the three greatest threats to 

human health." Infectious diseases physicians agree. The costs due to antibiotic resistance, both 

in the numbers of lives lost or devastated and in economic terms, are exceedingly high. 

Drug-resistant bacteria, such as MRSA and resistant enterococci and E. coli, affect many 

hospitalized patients, and resistant bacteria likewise are impacting a growing number of people 

in the community, including healthy athletes, parents, working people, and children. A 2007 

study published in the Journal of the American Medical Association3 demonstrates that annually 

in the U.S. more than 94,000 people are infected with invasive MRSA, and nearly 19,000 die 

from MRSA alone - which is more deaths than are caused by emphysema, HIV / AIDS, 

Parkinson's disease, and homicide. CDC reports that nearly 2 million health care-associated 

infections (HAIs) and 90,000 HAl-related deaths occur annually in the U.S.4 Most of these 

infections and deaths involve antibiotic-resistant bacteria. A February 2010 study published in 

, The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA; Public Law 103-396) defines a valid 

veterinarian-client-patient relationship as one in which: 

I. A veterinarian has assumed the responsibility for making medical judgments regarding the health of an 

animal and the need for medical treatment, and the client (the owner of the animal or other caretaker) has 

agreed to follow the instructions ofthe veterinarian; 

2. There is sufficient knowledge of the animal by the veterinarian to initiate at least a general or preliminary 

diagnosis of the medical condition ofthe animal; and 

3. The practicing veterinarian is readily available for follow-up in case of adverse reactions or failure of the 

regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is 

personally acquainted with the keeping and care of the animal by virtue of examination of the animal, 

andlor by medically appropriate and timely visits to the premises where the animal are kept 

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the Archives of Internal Medicine showed that two common types of HAl-sepsis and 

pneumonia-killed 48,000 people and increased health care costs by $8.1 billion in 2006 alone.s 

The direct and indirect economic costs associated with antibiotic-resistant infections are also 

enormous in terms of dollars spent, length of hospital stay, and loss of productivity. A recent 

analysis of antibiotic-resistant infections at Chicago Cook County Hospital6 , when extrapolated 

nationwide, indicated that annually in the U.S. antibiotic-resistant infections are responsible for 

more than $20 billion in excess health care costs, more than $35 billion in societal costs, and 

more than 8 million additional hospital days.7 

ANTIBIOTICS ARE UNIQUE 

In addition to their extremely high level of effectiveness and the value they provide to society, 

antibiotics are unique among medicines in one critically important way. Unlike other drugs, over 

time antibiotics lose their ability to treat the diseases for which they were developed-due to the 

ability of bacteria to develop resistance to the antibiotic. Therefore, in an effort to prolong 

antibiotics' effectiveness for as long as possible, infectious diseases physicians and professional 

societies urge that antibiotics be used appropriately and sparingly and seek ways to limit 

linnecessary use of thesc drugs. 

A CLEAR LINK BETWEEN ANTIBIOTIC USE IN ANIMAL AGRICULTURE AND 

ANTIBIOTIC-RESISTANT INFECTIONS IN HUMANS 

Physicians, health care professionals, and public health and food safety advocates are greatly 

concerned about non-judicious uses of antibiotics in animal agriculture. The relationship 

between antibiotic-resistant infections in humans and antibiotic use in animal agriculture is 

complex, but well-documented. A large and compelling body of scientific evidence 

demonstrates that antibiotic use in animal agriculture contributes to the emergence of resistant 

bacteria and their spread to humans. For example, it is well documented that fluoroquinolone 

use in poultry was a major source of fluoroquinolone-resistant Campyiobacter infections in 

humans, leading to treatment failures and an increased risk of death. Likewise, cephalosporin 

and fluoroquinolone use in food animals has led to cephalosporin and fluoroquinolone-resistant 

Salmonella infections in humans, also with adverse health consequences. A livestock-associated 

strain of MRSA, which was first encountered in the Netherlands in 2003 and now accounts for 

one fifth of human MRSA infections there,8 was recently found also in swine in Iowa, and 

IlIinois.9 This food animal-derived MRSA strain has caused various human infections, including 

hospital outbreaks; serious skin, wound, lung, and heart infections; and, in a dairy worker, 

necrotizing fasciitis - also known as flesh-eating bacterial infection. 10 Many of the 

antimicrobial-resistant E. coli strains that cause urinary tract and bloodstream infection in 

humans appear likely to derive from food animals, having become resistant on the farm. 

The evidence of a cause-and-effect link between food animal antibiotic use and drug-resistant 

infections in humans is broad-ranging and derives from numerous epidemiological, molecular 

epidemiological, ecological, and experimental studies. The threat to humans due to antibiotic 

use in animal agriculture includes both acquisition of resistant pathogens by humans (whether 

from the food supply. direct contact with animals, or environmental sources) and transfer of 

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resistance genes from animal to human bacterial populations. A broad consensus exists among 

relevant experts that, based on the available evidence, it is reasonable and prudent to conclude 

that the use of antibiotics in animal agriculture poses an important threat to human health that 

warrants urgent action. 

That antibiotic use in animal agriculture can give rise to resistance in humans has long been 

recognized by the infectious diseases and public health communities. A 1995 report by the 

Office of Technology Assessment!! listed at least a dozen earlier expert committee reviews of 

the health effects of antibiotic use in animal husbandry, dating to the 1969 Swann Report, a 

report by the Joint Committee on the use of Antibiotics in Animal Husbandry and Veterinary 

Medicine, chaired by Professor M. M. Swann. 

The Swann Report concluded: 

If the administration of antibiotics tofarm livestock, particularly at sub-therapeutic levels, 

poses certain hazards to human and animal health; in particular it has led to resistance 

in enteric [food-borne 1 bacteria of animal origin. This resistance was transmissible to 

other bacteria, and enteric bacteria were transferablefrom animals to man. " 

The United Kingdom banned the use of penicillin and tetracycline for growth promotion in 

1971. 12 

In a 2000 report from a new expert review panel,!3 the World Health Organization (WHO) 

stated: 

"Another source of resistance lies in ourfood supply. Since the discovery of the growthpromoting and disease,jighting capabilities of antibiotics, farmers, fish-farmers and 

livestock producers have used antimicrobials in every thing from apples to aquaculture. 

Currently, only half of all antibiotics produced are slated for human consumption. 

Ongoing and ojien low-level dosing for growth promotion and prophylaxis [disease 

prevention] inevitably results in the development of resistance in bacteria in or near 

livestock, and also heightens fears of new resistant strains between species. 

"VancomyCin-resistant Enterococcus faecium (VRE) is one particularly ominous example 

of a resistant bacterium appearing in animals that may have 'jumped' into more 

vulnerable segments of the human population. The emergence of VRE in food can be 

traced to the widespread use of avoparcin (the animal equivalent of the human antibiotic 

vancomycin) in livestock Moreover, with livestock production increasing in developing 

countries, reliance on antimicrobials is likewise expanding - ojien without guidelines in 

those nations where antibiotics are sold without prescription. 

"Ojien bacteria that are harmless to livestock are fatal to humans. This is true of a 

number of outbreaks that have taken the medical community by surprise. One example 

occurred in Denmark in 1998, when strains of multi drug-resistant Salmonella 

typhimurium struck 25 people, killing two. Cultures confirmed that the organisms were 

resistant to seven different antibiotics. Epidemiologists eventually traced the micro5 
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organism /0 pork and to the pig herd where it originated In 1998, 5, 000 people in the 

United States learned the hard way about antimicrobial resistance when they fell ill with 

mulli drug-resis/anl campylobacleriosis caused by contamina/ed chicken. The same 

drugs Ihal evenlually failed them had also been used in the poultry Ihat turned up on their 

plates. " 

In 2002, the journal Clinical Infectious Diseases published a special supplement,14 based on a 

two-year review by experts in human and veterinary medicine, public health, microbiology, 

biostatistics, and risk analysis of more than 500 scientific studies on the human health impacts of 

antibiotic use in agriculture, which concluded the "[uJse of antimicrobials infood animals 

contributes 10 the growing problem of antimicrobial resistance in animal and human infection" 

In 2003, a National Academy of Sciences report l5 stated, "Immediate action must be taken to 

preserve the effectiveness of available drugs by reducing the inappropriate use of antimicrobials 

in human and animal medicine." The authors recommended a ban on the use of antibiotics as 

growth promoters in animal agriculture if those antibiotics also are used in human medicine, 

A December 2003 report l6 of the proceedings of an expert workshop on the Scientific 

Assessment of Non-Human Antimicrobial Usage and Antimicrobial Resistance, sponsored by 

the United Nations Food and Agriculture Organization, WHO, and the World Animal Health 

Organization concluded: . 

"There is clear evidence of adverse human heal/h consequences due to resistant 

organisms resultingfrom non-human usage of antimicrobials, These consequences 

include infections that would not have otherwise occurred, increasedfrequencyof 

treatment failures (in some cases death) and increased severity of infections, as 

documented for instance by jluoroquinolone resistant human Salmonella infections, 

Evidence shows that the amount and pattern of non-human usage of antimicrobials 

impact on the occurrence of resistant bacteria in animals and on food commodities and 

Ihereby human exposure 10 these resistant bacteria, " 

In 2004, the U,S, Government Accountability Office issued a reportl7 to Congress stating, 

"Scientific evidence has shown that certain bacteria that are resistant to antibiotics are 

transferredfrom animals to humans through the consumption or handling o.f meat that contains 

antibiotic-resistant bacteria. Many studies have found that the lise of antibiotics in animals 

poses significant risks for human health. " 

A 2006 study l8 by a noted expert on aquaculture stated: "The accelerated growth of aquaculture 

has resulted in developments detrimental to the environment and human health, such as the 

widespread and unrestricted use of prophylactic antibiotics in this industry The use of a wide 

variety of antibiotics in large amounts, including antibiotics useful in human medicine, has 

resulted in the emergence of antibiotic-resistant bacteria in aquaculture environments, in the 

increase of antibiotic resistance injish pathogens, and in the transfer of these resistance 

determinants to bacteria of land animals and to human pathogens, It appears that global efforTS 

are needed to promote more judicious use of prophylactic antibiotics in aquaculture as 

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accumulating evidence indicates that unrestricted use is detrimental to fish, terrestrial animals, 

and human health and the environment." 

Finally, a 2009 reportl9 by the WHO Advisory Group on Integrated Surveillance of 

Antimicrobial Resistance states, "A large number of studies have shown that the use of 

antimicrobial agents infood animals favors antimicrobial resistance among non-typhoid 

Salmonella and Campylobaeter; later, these can transmit to and cause infeclions in people. This 

can then result in failure of antimicrobialtrealment in people with resistant irrfections. " 

THE DANISH AND BROADER EUROPEAN EXPERIENCE 

Denmark banned the prophylactic (Le., routine disease prevention) use of antibiotics in animal 

agriculture; it halted the growth promotion use of antibiotics in broiler chickens and adult swine 

(finishers) in 1998 and in all swine in 2000. Today in Denmark, all uses of antibiotics in animal 

agriculture must be accompanied by a prescription in a valid veterinarian-client-patient 

relationship, In addition, farmers, veterinarians and pharmacies must report the use and sale of 

antibiotics, and farm inspections are conducted regularly. In 2006, the entire European Union 

banned non-therapeutic use of antibiotics in animal agriculture due to the threat to human health. 

Contrary to claims made by some in the U.S. agricultural sector, experiences in Denmark and 

other parts of Europe have shown that reductions in antibiotic use do not lead to increased 

pathogen loads in animals or on carcasses, more food-borne illness in humans, greater total 

antibiotic use in animals, or impaired animal health or farm productivity. The WHO determined 

that Denmark's ban achieved its stated public health goal of reducing resistant organisms in food 

animals in order to prevent related human resistance from emerging. 

The ban on growth promoters has been shown to be beneficial to both animal and human health. 

As one example of Danish and European actions, Danish scientists determined that the use of 

avoparcin as a growth promoter led to a strain of VRE in food animals. Vancomycin and 

avoparcin are related drugs, and vancomycin is important to combating serious antibioticresistant human infections. In Europe, this strain ofVRE spread to humans through the food 

supply, particularly contaminated meat and poultry. Before the European ban on avoparcin use 

in animals, Europeans commonly carried VRE in their intestinal tract. Following the avoparcin 

and related bans, studies showed a drop in related resistance patterns in animals, as well as 

reductions in humans (both colonization and disease). 

The WHO also found that the Danish ban reduced human health risk without significantly 

harming animal health or farmers' incomes.2o In fact, Danish government and industry data 

show that livestock and poultry production has increased since the ban, while antibiotic 

resistance has declined in animal agriculture, in meat, and in healthy and infected humans (in the 

case of VRE, and with similar trends for Campylobacter), The growth promoter ban 

implemented throughout Europe in 2006 was followed in subsequent years by sustained 

decreases in food-borne illness in Europe.21 

A 2004 Swiss study22 analyzed prescription patterns for medicated feedstuffs in the Swiss canton 

of St. Gall to determine whether Switzerland's ban on antibiotics for growth promotion, 

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introduced in 1999, had caused an increase in the therapeutic use of antibiotics given orally to 

piglets and fattening pigs. The study found that the ban on growth promoters did not lead to an 

increase in therapeutic uses in swine. 

In Denmark, the only detectable impact of the growth promoter ban in animal agriculture was a 

short-term effect among weaning-age pigs.2l Specifically, while there was some reduction in 

weaner producti vity and a small increase in weaner mortality associated with the ban, these 

effects lasted only one year. Weaner productivity is currently higher and mortality lower than 

before the growth promoter ban took effect. 24 Danish pork production has increased by 40 

percent since the ban. 

A July 2010 study,25 conducted by notable experts in the field, led to the conclusion that: 

"From 1992 to 2008, a reduction of greater than 50 percent in antimicrobial 

consumption per kilogram of pig produced was observed in Denmark. This change was 

associated with the implementation of policies to discontinue the use of antibiotics as 

antimicrobial growth promoters. During the same period, overall swine productivity 

improved markedly, which suggests fhatthe change in antimicrobial consumption has not 

had a negative impact on long-term swine productiVity. " 

U.S. POLICY APPEARS TO BE MOVING IN THE RIGHT DIRECTION 

IDSA is encouraged by the growing support within Congress for the P AMT A legislation, which 

would phase out the use of the seven classes of medically significant antibiotics that are currently 

approved for non-therapeutic use in animal agriculture. rDSA also views favorably FDA's new 

draft Guidance to Industry 209,26 issued on June 28, which establishes a policy framework 

regarding the judicious use of medically important antibiotics in animal agriculture. We believe 

FDA's guidance is a step in the right direction. However, Congressional action is necessary to 

quickly and fully implement this new policy. Embedded within FDA's guidance are two key 

principles: 

I. The use of antibiotics important in human medicine should be limited in food-producing 

animals to those uses that are considered necessary for assuring animal health; and 

2. The use of antibiotics important in human medicine should be limited in food-producing 

animals to those uses that include veterinary oversight or consultation. 

IDSA strongly supports banning the use of antibiotics for growth promotion and feed efficiency, 

and requiring that all remaining uses of these drugs be carried out under the supervision of a 

veterinarian and within the boundaries of a valid veterinarian-client-patient relationship-which 

would effecti vely end over-the-counter sales of thousands of tons of antibiotics annually. The 

sale of antibiotics for use in human medicine requires a prescription; there is no sound reason to 

permit a lower standard for agricultural purposes, where considerably more antibiotics are used, 

and in much larger numbers of recipients. We also supp0l1 clearly defining the limited instances 

in which antibiotics may be used judiciously in animal agriculture for purposes of disease 

prevention, as well as more closely monitoring, through enhanced data collection, all remaining 

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uses (targeted disease prevention, control, and treatment) to prevent non-judicious use. 

Implementing these changes will better protect our patients and the U.S. public against resistant 

infections and will help preserve the curative power of existing antibiotics. Both PAMT A and 

the principles articulated in FDA's new guidance offer elements of the complete framework 

Congress should consider as it moves forward to develop and enact legislation. 

A concern with the FDA's guidance is the agency's apparent decision to rely on drug companies 

to voluntarily agree to remove growth promotion and feed effIciency claims from their drug 

labeling. Based on past experience, we believe this process will take years, if not decades, and 

that many companies are unlikely to comply. Therefore, we urge Congress to expedite this 

process by eliminating these uses through legislation. 

We are concerned that FDA's guidance does not provide sufficient detail about how it plans to 

address non-judicious uses of antibiotics of importance to human medicine related to disease 

prevention and therapeutic uses. Therefore, in addition to limiting the marketing status of these 

drugs to prescription only, we believe FDA and Congress must work together to: 

• Establish specific indications for antibiotic use and narrowly limit off-label uses of new 

and existing antibiotics; 

• Define proceaures for antibiotic administration that will expose only those animals that 

have a current need; 

• Expand post-approval surveillance under the National Antimicrobial Resistance 

Monitoring System (NARMS)" to include all drugs of importance to human medicine. 

As drafted, FDA's guidance will permit consultation with a veterinarian rather than the 

veterinarian's direct oversight of the treated animal before an antibiotic can be prescribed. 

Obviously, FDA took into account logistical issues (the vast rural expanses and limited number 

of veterinarians within the U.S.) when it considered this principle. However, the consultation 

allowance, if included in FDA's final guidance/regulation, provides opportunity for abuse as it 

does not require a veterinarian's direct oversight of the treated animal within the context of a 

valid veterinarian-client-patient relationship as defined by AMDUCA. Accordingly, legislation 

or regulation, depending on which option is chosen, must be carefully crafted. 

IDSA also urges a reassessment of existing FDA Guidance #152, which is the framework by 

which the agency approves new antibiotic products for use in animals. FDA must reevaluate the 

current ranking of drugs according to their importance to human medicine. In particular, the 

ii NARMS was established in 1996 as a collaborative effort between FDA's Center for Veterinary Medicine (CVM), 

U.S, Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC), NARMS 

monitors changes in antibiotic susceptibilities of selected enteric bacterial organisms in humans, animals, and retail 

meats to a panel of antibiotics important in human and animal medicine, Animal specimens for NARMS are 

collected from federally inspected slaughter and processing facilities, from healthy animals on farms, and from 

Veterinary Diagnostic Laboratories, including USDA's National Veterinary Services Laboratories. Animal and 

human isolates currently monitored in NARMS are non-typhoid Salmonella, Campyiobacler, E, coli, and 

Enterococci. CDC also tests additional human isolates including Salmonella typhi, Listeria and Shigella. Retail 

meats collected from grocery stores were recently added to NARMS sampling. Accessed online at: 

http://www,fda,gov/AnimaIVeterinary/SafetyHealthiAntimicrobiaIResistancelNationalAntimicrobialResistanceMon 

itoringSys!emldefault.htm, 

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agency should reconsider the criteria used to categorize antibiotics as "critically important" and 

"highly important" to human health. For example, IDSA believes fourth-generation 

cephalosporins should be considered "critically important," the same ranking currently given to 

third-generation cephalosporins. Third- and fourth generation cephalosporins are used to treat 

complicated, high-severity intra-abdominal infections, as well as invasive Salmonella infections 

in humans. WHO agrees with the categorization of fourth-generation cephalosporins as critically 

important.27 We also support broadening the scope of Guidance 152 criteria beyond enteric 

pathogens. The current focus on enteric-only pathogens fails to consider the human risk posed 

by horizontal gene transfer or clonal spread of resistant strains of bacteria, including such species 

as Enterococcus and E. coli, which are intestinal commensals in food animals but extraintestinal 

pathogens in humans. 

Additional investments into new vaccines for animals that would prevent infections and result in 

decreased antibiotic use in animals, as well as rapid diagnostics to more quickly identify 

bacterial infections, also would be helpful. These new tools would help to prevent the 

emergence and transmission of infections and help to protect both animal and human health. 

ELIMINATING NON-JUDICIOUS USES WILL NOT HARM U.S. FARMERS 

IDSA recognizes that eliminating non-judicious uses of antibiotics in animals will require 

changes in the agriculture industry's current practices. Ultimately, protection of the public's 

health must be our highest priority, and we believe terminating these uses can be accomplished 

in a way that minimizes costs to the agricultural sector. As previously noted, studies have shown 

that food animal producers in Derunark have adapted to such policy shifts without disruption to 

farm productivity or a negative impact on animal health. 

In addition, a USDA analysis of U.S. finishing pigs found that, "farms that use non-therapeutic 

antibiotics have costs a/production thaI differed little from those that do not. Any productivity 

improvementfrom use a/antibiotics has not been large enough to offset the additional expenses. 

suggesting the viability of alternative practices or technologies to reduce disease or improve 

feed efficiency atfinishing stages. ,,28 For U.S. poultry producers, the benefits of non-therapeutic 

antibiotics have been shown to be very limited and less than the cost of the drugs 29 

U.S. ANTIBIOTIC CONSUMPTION AND RESISTANCE DATA COLLECTION MUST 

BE STRENGTHENED 

To control the antibiotic resistance epidemic, U.S. experts (government and non-goverrunent) 

need ongoing access to reliable, standardized data regarding the scope of antibiotic consumption 

in humans and animals. "Consumption" data includes drug use data (i.e., prescribing data) as 

well as manufacturers' distribution and sales data. The lack of adequate U.S. antibiotic 

consumption data impedes our understanding of geographic and temporal trends in antibiotic 

resistance. Greater understanding of these factors will contribute to more effective and targeted 

interventions to reduce unnecessary antibiotic use and resistant infections. These include: I) 

targeting appropriate antibiotic use interventions to the geographic areas and drugs of greatest 

importance, and 2) predicting and responding to new resistance problems based on changes in 

antibiotic utilization. 

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In the agricultural context, the collection of accurate antibiotic consumption data will make 

information currently collected under the NARMS program of greater relevance, because it 

could be used to show possible correlations between antibiotic use and the development of 

resistance. The United States is far behind other countries in collecting, and benefiting from, 

antibiotic consumption data. The Danish Integrated Antimicrobial Resistance Monitoring and 

Research Program (DANMAP) performs continuous monitoring of both consumption data and 

resistance data in humans, animals, and food. Human consumption data is collected from the 

pharmaceutical industry and the Danish Medicines Agency, while DANMAP's "VetStat" system 

collects food animal data by species from pharmacies, farms, feed mills, and veterinary 

practitioners. On a Europe-wide level, the European Surveillance of Antimicrobial Consumption 

(ESAC) system collects human and more limited animal consumption data from 34 countries, 

while the European Antimicrobial Resistance Surveillance System (EARSS) collects resistance 

data. The inputs are largely standardized since countries must adhere to WHO standards 

regarding measurement ("defined daily doses") and classification of antibiotics. 

Better understanding of the correlation between antibiotic consumption and the development of 

resistance holds potential benefits for U.S. public health efforts. In the earlier example of the 

avoparcin ban in Europe, it was the DAN MAP and other surveillance efforts that helped the 

Danes and other Europeans see the benefit that elimination of avoparcin as a growth promoter in 

animal agriculture had on the reduction ofVRE in humans. 

The U.S. Animal Drug User Fee Amendments (ADUFA; Public Law 110-316) enacted in 2008 

contained a provision to begin to strengthen FDA's authority to collect animal antibiotic sales 

and distribution data from the manufacturer by requiring data based on a calendar year, as 

opposed to the anniversary date of the product's approval. However, the ADUFA data do not 

include retail-level use data and are at the national level only. To really understand how 

antibiotics are being used on U.S. farms, the ADUF A requirements must be strengthened to 

mandate collection of antibiotic use data at the local level as well. Consumption data also must 

be collected by species (swine, chicken, turkey, cattle) and in a unit of measure that can be 

compared across species and localities. European countries collect such data at the farm and 

feed mill level; so should the United States. Collection of such data, along with strengthened 

surveillance, will enable us to understand how and where antibiotics are being used, including 

non-judiciously. The urgency for better data will not be reduced once the FDA's new principles 

for growth promotion and veterinary supervision of antibiotics become operational. To the 

contrary, comparable and reliable data will become even more important as a way to monitor 

whether the agricultural sector (e.g., farms, feed mills, and others) are complying with these new 

principles. 

While IDSA supports further strengthening the ADUFA data collection provisions, we also 

believe there are steps that federal agencies can take under current authority to assist in 

surveillance and monitoring of antibiotic use in animal agriculture. The U.S. Department of 

Agriculture (USDA) could use the National Animal Health Monitoring and Surveillance System 

to monitor trends in the volume and type of antibiotics used in animal agriculture by adding 

targeted questions that would help determine the total volume and type of animal antibiotics 

used. They also could enhance the Agricultural Resource Management Survey to include 

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information about the volume and efficiency of antibiotic usage to help producers make better 

decisions about optimal use of antibiotics and to allow public health officials a better 

understanding of a potential source of resistance. Additionally, NARMS could be expanded to 

gather information about additional pathogens to provide public health officials a wider array of 

information to determine the magnitude oflhe antibiotic resistance problem. 

IMPACT STATEMENT AND MANAGEMENT PLAN 

IDSA supports requiring manufacturers of new antibiotics intended for use in animal agriculture 

to first evaluate the potential impact that approval of the drug would have on the development of 

antibiotic resistance and, subsequently, to develop a management plan to limit potential 

antibiotic resistance from occurring. New drug sponsors also should be required to submit 

updates to the impact statement and management plan within three years after the initial approval 

of the antibiotic. 

These impact statements and management plans should be made public so that researchers can 

use each to study and strengthen our understanding of the science of predicting, preventing, and 

controlling resistance development. However, IDSA believes that neither the impact statement 

nor the management plan should be used for enforcement purposes. 

CONCLUSION 

The problem of antibiotic resistance is complex and multi-factorial. In contrast to efforts by the 

medical community to begin to curtail human overuse and misuse of antibiotics, the U.S. is 

among the last developed countries to implement similar control polices for antibiotic use in 

animal agriculture. It is inescapable that non-judicious uses of antibiotics in animals' feed and 

water over prolonged periods for purposes of growth promotion, increased feed efficiency, and 

routine disease prevention contribute to antibiotic resistance and create health dangers for 

humans. 

No single strategy can solve the antibiotic resistance problem-a multi-pronged approach is 

required. We must promote the development of new priority antibiotics to treat serious and lifethreatening infections. We must prevent the emergence and transmission of resistant infections 

through research into new vaccines and diagnostics and implementation of other effective 

infection prevention and control initiatives. And we must eliminate all non-judicious uses of 

antibiotics, in human medicine and animal agriculture alike. 

The Subcommittee on Health has a long history of leadership in addressing our nation's most 

pressing public health issues. Today, we call on you to adopt strong measures to end nonjudicious uses of antibiotics in animal agriculture and to require that all other uses of these drugs 

in animals be carried out under the supervision of a veterinarian and within the boundaries of a 

valid veterinarian-client-patient relationship. Such measures have been advocated repeatedly by 

the World Health Organization, the National Academy of Sciences, and many medical and 

public health organizations, and successfully implemented by multiple European nations in the 

past one to two decades. We also urge the Committee to move with haste to enact PAMTA, as 

well as the Strategies to Address Antimicrobial Resistance Act (H.R. 2400), which we believe 

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will significantly strengthen U.S. antibiotic resistance data collection, surveillance, research, and 

prevention and control efforts. 

Any new policy on antibiotic use in animal agriculture should be mandatory, retroactive to 

already-approved drugs, and enforceable. This will help reduce antibiotic resistance in order to 

save lives and protect public health. 

Thank you again for the opportunity to testify on this important issue. IDSA stands ready to 

assist the Subcommittee in any way that we can. 

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!O Soavi L, Stellini R, Signorini L, et .1. Methicillin-resistant Slaphylococcus aureus ST398, Italy [letter]. Emerg. 

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II "Overcoming Antimicrobial Resistance," World Health Organizalion Report on Infectious Diseases 2000. 

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Scientific assessment, Geneva, 1-5 December 2003. Accessed online at: 

http://w ww. who. i ntlfoodsafetylm icrolmeeti ngslno v2 0031enl. 

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Address Risk to Humans B'om Antibiotic Use in Animals. GAO-04-490 April 22, 2004. Accessed online at: 

http://ww w .gao .gov Inew. itemsld044 911lli!f. 

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18 Cabello FC. "Heavy use of prophylactic antibiotics in aquaculture: a growing problem for human and animal 

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h):tp:llwww.ncbi.nlm.nih.goy/pubmedIl6SI7922. 

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h):tp:llapps. who.int/medicinedocs/index/assoc/s 167350/s 16 735e.pdf. 

20 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark. Review 

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21 European Food Safety Authority. 2009. "The Community Summary Report on trends and sources of zoonoses, 

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" Arnold S, Gassner B, Giger T, Zwahlen R. Banning antimicrobial growth promoters in feedstuffs does not result 

in increased therapeutic use of antibiotics in medicated feed in pig farming. Pharmacoepidemiol Drug Sa! 2004 

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23 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark. Review 

panel's evaluation of the termination of the use of antimicrobial growth promoters in Denmark. November 2002. 

Accessed online at: http://whqlibdoc.who.intlhq/2003/WHO CDS CPE ZFK 2003.1.pdf. 

24 Danish Ministry of Food, Agriculture, and Fisheries. December 12,2009. Information note regarding the Danish 

and EU restrictions of non-therapeutical use of antibiotics for growth promotion. Accessed online at: 

h):tp:1 Iwww.uk.foedevarestyrelsen.dkINRirdon lyres/63497 AA 7 -SESA -4C6A -9C7 4-

E56C33S3F26A/O/info om vaekstfremmerforbud saml oevrige riskmanagement sIr UK.pdf. 

" Aareslrup FM, Jensen VF, Emborg, HD, et a!. Changes in Ihe use of antimicrobials and the effects on productivity 

of swine farms in Denmark. Am J Vet Res 2010;71 :726-733. Accessed online at: 

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26 U.S. Departmenl of Health and HUman Services, Food and Drug Administration, Center for Veterinary Medicine. 

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936.pdf 

27 World Health Organization. "Critically Important Antimicrobials for Human Medicine: Categorization for the 

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123 

Mr. PALLONE. Thank you, Dr. Johnson. 

Dr. Hansen. 

STATEMENT OF GAIL R. HANSEN 

Dr. HANSEN. Chairman Pallone and Ranking Member Shimkus 

and members of the subcommittee, good afternoon, late afternoon, 

and thank you for inviting me. I am Gail Hansen. I am a veterinarian. I am a member of the AVMA, the American Veterinary 

Medical Association, and I also a Senior Officer with the Pew Charitable Trust. 

Obviously, I care very deeply about this issue and I have worked 

on antimicrobial resistance from a lot of different angles. I was a 

State public health veterinarian for the Kansas Department of 

Health and Environment in Kansas, obviously, in working with 

both human and animal diseases. I was also a veterinarian in private practice for several years in Washington, New York City, 

North Carolina, and before I even got into veterinary school I was 

interested in this topic because I worked for the Food and Drug Administration, what was then the Bureau of Veterinary Medicine, in 

1978. That was the year that FDA first proposed eliminating some 

drugs as growth promoters in animal feeds based on the science, 

and we are still here today. 

I want to pick out one experience with a bacteria called 

Campylobacter that you have heard about to illustrate the real 

problem of antibiotic resistance, and let me give you a quick background on Campylobacter. It is a real common foodborne disease 

similar to Salmonella and E. coli, which you may be familiar with. 

You get the same sort of symptoms. You have diarrhea, you have 

vomiting. It is pretty unpleasant. There can be some nasty complications that can occur with Campylobacter. I guess the good 

news about that is that we can treat it with antibiotic. The bad 

news is that the bacteria is becoming resistant to antibiotics. We 

also that this is a bacteria that is found in poultry and cattle. People get it from eating contaminated poultry or meat, as we have 

heard before. 

So let me talk to you about the Campylobacter outbreak that I 

dealt with in Kansas in 1998 in Salina, Kansas. We had a middle 

school where we had over 100 people that got sick with 

Campylobacter. The physicians were using Cipro and tetracycline 

to treat people because those are the drugs that all the books said 

you should use, but then we found out that Campylobacter, that 

Campylobacter was resistant to both of those drugs so the physicians couldn’t use those drugs. There was unequivocal evidence 

that the resistance came from antibiotic that were given to animals. Tetracycline was used and still is used in cattle and poultry, 

and at that time Cipro was used in poultry and it is still used in 

cattle today. 

So antibiotic resistance from feeding low levels of antibiotics to 

animals is real. It is here. We have got 40 years of science-based 

evidence and it is very clear. I have a book here which I have given 

you an annotated version of the bibliography of this that has some 

of the peer-reviewed studies that we have over the last 40 years, 

so there is plenty of science. 


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Antibiotics are overused in farm animals, in industry farming to 

the detriment of human health. Animals are fed low levels of antibiotics for growth promotion in the absence of disease, and especially when bacteria come in contact with low levels of antibiotics, 

it makes it much easier for them to become resistant to antibiotic. 

That whole thing of what doesn’t kill you makes you stronger 

works for the bacteria as well. And then that resistance gets transferred to people and ultimately the antibiotics that we use for people don’t work anymore for people and they don’t work for animals 

either, and that is pretty scary. 

But there are some effective alternatives to low-level antibiotic 

use available to farmers and ranchers. Just this last Saturday, I 

got back from a trip to Denmark looking at what Dr. Henriksen 

talked about, and how their industrial farmers are able to efficiently raise pork without the use of non-therapeutic antibiotics. 

Farmers only give antibiotics, as he said, when they are prescribed 

by a veterinarian for a specific disease. The farmers at that point 

worked with veterinarians and with others to find effective management strategies that work. 

So the American public really needs Congress to pass PAMTA. 

The FDA guidance document is not likely to fix the problem by 

itself. We need your help, and that is what PAMTA does. PAMTA 

disallows the use of seven classes of antibiotics that are critically 

important for human health to be used for non-therapeutic purposes unless it can be shown that the use doesn’t contribute to antibiotic resistance in people. It still allows antibiotics to be used to 

treat sick animals. We absolutely have to have that. But we want 

to make sure that we protect antibiotics for people and animals. 

We can help the farmers and ranchers get past this outdated and 

very dangerous practice of feeding antibiotics to healthy animals. 

Unfortunately, the American Veterinary Medical Association’s 

position on PAMTA is different from mine and from many other 

veterinarians. I am disappointed, I guess is the best word, that the 

AVMA has not yet come to the same conclusions that the American 

Medical Association and the American Nurses Association, the 

American Academy of Pediatrics has come to on the importance of 

this bill. 

Thank you for the opportunity to testify. I would be happy to answer any questions. 

[The prepared statement of Dr. Hansen follows:] 


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Testimony before the 

House Committee on Energy and Commerce, Subcommittee on Health 

July 14,2010 

Gail R. Hansen, D.V.M., M.P.H. 

Senior Officer, Human Health and Industrial Farming Campaign 

The Pew Charitable Trusts 

Good afternoon Chainnan Pallone, Chainnan Waxman, Chainnan Emeritus Dingell, Ranking 

Member Shimkus and members of the Health Subcommittee. My name is Gail Hansen and I am 

a Senior Officer with The Pew Charitable Trusts. I appreciate the opportunity to speak before 

you today about the routine use of antibiotics in food animal production. 

I am a veterinarian who cares deeply about animal and human health and welfare. I have spent 

most of my professional career working to keep animals and people healthy. For 12 years, I was 

in private clinical practice, mostly in companion animals. For another 15 years I served in local 

and state public health departments; 12 years as the State Public Health Veterinarian and three as 

the top Kansas State Epidemiologist. In Kansas I was responsible for creating and implementing 

policy, for coordinating disease tracking and conducting outbreak investigation for all infectious 

diseases in the state. In addition, I served on the executive board of the National Association of 

State Public Health Veterinarians (NASPHV) for eight years and was the Infectious Disease 

Chair for the Council of State and Territorial Epidemiologists in 2007. I am a member of the 

American Veterinary Medical Association (AVMA) and was a U.S. Congressional Fellow for 

the AVMA from 2008-2009. 

My message to you today is simple: 

I) Antibiotics are overused in industrial fanning to the detriment of human health. 

Antibiotic overuse has spurred generations of bacteria that are causing life 

threatening illnesses that were once easily treatable with antibiotics. 

2) Effective alternatives are available to agribusiness. This has been demonstrated 

by practices adopted abroad, as well as in the United States. 
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3) Congress has the opportunity to enact legislation that will curtail the use of 

antibiotics in industrial food animal production without having significant 

economic impact on the industry. 

The health risks posed by antibiotic lise in industrial farming: Industrial farming routinely and 

extensively incorporates low dose concentrations of antibiotics in the feed and water of healthy 

food animals for growth promotion, feed efficiency and other uses where the animal has not been 

exposed to disease. A wide range of antibiotics, such as penicillin and tetracycline, are available 

over the counter for use in food animal production in this country!. The United States Food and 

Drug Administration (FDA) allows this practice under its current rules and regulations and yet 

almost none of the over the counter uses have been reviewed by the FDA to ensure they are safe 

with respect to antibiotic resistance. 

FDA approved over-the-counter antibiotic sales more than 50 years ago when our understanding 

of the mechanics and implications of antibiotic resistance was still in its infancy and the largest 

safety concern was drug residues in meat. The seven classes of antibiotics-lincosamides, 

sulfonamides, tetracylcines, aminoglycosides, macrolides, penicillin and streptograminsdeemed critically important for human use were never reviewed by FDA for implications to 

human health caused by antibiotic resistance. Today, the science of antibiotic resistance is more 

advanced and well-understood. The guidelines for new antibiotic approval and withdrawal have 

been updated to require resistance-related safety demonstration. However, the agency has said 

that it is extremely difficult for it to reevaluate previously approved drugs based on updated 

criteria. 

In 1977, when FDA attempted to take steps to curtail antibiotic use, the agency's efforts were 

thwarted by Congress2 Even the recommendations of the nation's leading research institutions 

were ignored. 3 

In the 1980s, the National Research Council and Institute of Medicine warned of the dangers of 

overuse of antibiotics in food animals.~ In 2003 the National Academy of Sciences, which were 
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created by Abraham Lincoln in 1863 to serve as scientific advisors to Congress, stated: "Clearly, 

a decrease in the inappropriate use of antimicrobials in human medicine alone is not enough. 

Substantial efforts must be made to decrease inappropriate overuse of antimicrobials in animals 

and agriculture as well." 5 

These findings are oflittle surprise to those of us who have studied medicine. Every 

introductory microbiology class teaches that using antibiotics at levels that are below a 

therapeutic dose sets up a perfect environment for bacteria to develop resistance. We now know 

that resistance to antibiotics can develop rapidly, extend to other antibiotics in the same or 

different class and be shared among bacteria in a variety of ways; up to 95 percent of antibiotic 

resistance is from sharing genetic material for resistance6

• 

Four decades of rigorous science and research confmn that the routine use of antibiotics in food 

animal production promotes the development of dangerous drug-resistant bacteria that can 

spread to humans. The notebook in front of me today contains 40 years of independent, peerreviewed studies demonstrating this scientific link. I am submitting with my written testimony 

today an annotated bibliography summarizing this research. 

Within this scientific literature one of the most compelling stories concerns Cipro®. Cipro® is 

an antibiotic that belongs to a class of drugs called fluoroquinolones and was a key antibiotic 

used to treat members of Congress and staff after the anthrax attack in October 200 I. In 

Australia, where fluoroquinolones have never been approved for use in food animal production, 

domestically acquired human infections with Cipro®-resistant Campylobacter are still either 

absent or rareJ This is in stark contrast to the situation in the U.S., where fluoroquinolone use in 

poultry was common from 1995 to 2005. There was controversy within the veterinary 

community about whether it should be allowed in poultry water due to the concerns that it would 

lead to antibiotic resistance in humans. FDA monitored resistance and saw that resistance to 

Cipro® in human illnesses was increasing at a rapid rate: from 12.9 percent in 1997 to 21.7 

percent in 2005. 8 In comparison, Cipro®-resistant Campylobacter rates in the U.S. had held 

steady at about I percent for the 10 years it was used exclusively in human medicine. In 

response, FDA began the process to remove fluoroquinolones from routine use in poultry in 
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2000. The drug class was banned from routine poultry use in 2005 after protracted legal 

challenges. 

Use of the antibiotic known as Avoparcin is another good example. Avoparcin is a drug that was 

widely used in Europe for growth promotion in animals, but not used in people. However, it was 

found to share resistance with a very closely related to and critically important human drug, 

vancomycin. Vancomycin is a powerful drug and is used only after treatment with other 

antibiotics has failed. In the countries where avoparcin was fed to livestock, animals had 

intestinal bacteria resistant to vancomycin as well. In the countries that didn't use avoparcin, 

including the U.S. and Sweden, livestock did not have intestinal bacteria resistant to 

vancomycin. When avoparcin use was banned in Denmark, a World Health Organization (WHO) 

report found that "the termination of [avoparcinJ in Denmark has dramatically reduced the food 

animal reservoir of enterococci resistant to these growth promoters, and therefore reduced a 

reservoir of genetic determinants (resistance genes) that encode antimicrobial resistance to 

several clinically important antimicrobial agents in humans. ,,9 In English, this simply means that 

banning the use of avoparcin as a growth promoter has significantly reduced the number of 

antibiotic resistant bacteria. 

There are additional examples of such links between antibiotic use in livestock and poultry and 

human cases of antibiotic resistance. For example, Dr. James Johnson, testifying today, is a 

prominent expert in the field of study connecting resistant urinary tract infections in women to 

resistant E. coli in food animals. 10 

There are proven alternatives tor manv uses o(antibiotics in industrial (arming: In contrast to 

the clear impacts on human health, the rationale for much of the antibiotic use in industrial 

farming is tenuous. 

First, using antibiotics for growth promotion is an outdated practice and yields questionable 

benefits to farmers in modem agriculture. In U.S. studies, little or no benefits were seen with 

nontherapeutic antibiotic use in poultry. II A United States Department of Agriculture study 

found that in growing and finishing pigs, those that are 6 weeks to 5 months old, the benefits of 
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using nontherapeutic antibiotics are so small that either none were found 12 or that they were 

insufficient to offset the expense of the antibiotics themselves. I) In Denmark, experts presumed 

that antibiotics produced a 10 percent feed efficiency advantage, based on data from the 1950s, 

but in modern agriculture, more recent studies have found almost no effect on feed efficiency. 14 

Even so, enormous numbers of animals are fed the drugs. By way of example, one drug 

company supplies antibiotics in feed for 632 million chickens per year. 15 

Second, it is not necessary, as some claim, to dispense antibiotics on a massive scale to protect 

food safety. On the contrary, rarely has food safety been shown to be adversely affected by 

decreasing the amount of nontherapeutic antibiotics given to food animals. In fact, in the U.S., 

there were significant reductions in the types of foodborne illness normally acquired from eating 

chicken between 1995 and 2000, the same period that the poultry industry reduced antibiotic 

use. 16 Denmark data shows removal of in-feed antibiotics similarly had no negative impact on 

food safety. 17 FDA Principal Deputy Commissioner Dr. Joshua Sharfstein confirmed in his 

House Rules Committee testimony last year, "Eliminating these [growth promotion and feed 

efficiency] uses will not compromise the safety of food.,,18 

This is not to say that antibiotics have no place in food animal production. As a veterinarian, I 

know that appropriate antibiotic use - to treat sick animals or prevent the spread of infection in 

animals at heightened risk - can be beneficial to animal and human health. But just as surely, 

inappropriate uses, where there is no disease present, are contrary to human health practices. 

Many other public health veterinarians and farmers agree with these principles and some have 

asked that I submit statements on their behalf with my written testimony. 

It also is clear that antibiotics for animal use should be kept to the same standards used in human 

medicine. Bacterial resistance does not have a different effect on humans and animals. 

Resistance can transfer between species of bacteria. Antibiotics should be prescribed only to 

treat individuals and groups of animals exposed to disease. Over the counter use of antibiotics is 

not allowed in human medicine or for our pet dogs and cats and should not be allowed in food 

animal production. 
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The World Animal Health Organization (OlE), the Food and Agricultural Organization of the 

United Nations (FAO) and the WHO recognize that the animal and human health sectors have a 

shared responsibility to minimize antibiotic resistance. 19 And as all three have jointly stated, 

antimicrobial usage, if necessary, should always be a part of, not a replacement for, an integrated 

animal health program. ,0 The routine use of antibiotics should never be a substitute for good 

animal health management and the routine use of antimicrobials in control programs should be 

regularly assessed for effectiveness and necessity. 

Efforts to prevent disease and maintain animal health and welfare should continuously be in 

place to reduce the need for routinely administered antibiotics. 21 In other words, hygiene, 

disinfection, bio-security measures, nutrition, cleaning practices, enhanced animal observation, 

changes in how much time a pen stays open after it has been cleaned, animal density, 

vaccinations and environmental changes all should be considered before antibiotics are 

administered. Veterinarians, together with farmers and ranchers, should be jointly responsible 

for the health of animals on a farm. It is not enough that veterinarians be involved with the 

mixing of antibiotics at the feed mill or at production company headquarters; they must regularly 

visit the animals and establish a proper veterinary-client-patient relationship. To help increase 

the number of large animal veterinarians available to do such work, Congress could consider 

legislation to incentivize entry into this field. 

The search tor solutions: As a veterinarian, when [look at antibiotic use in food animal 

production, I am dismayed. It is clear to me that the industry has become too reliant on 

antibiotics. Today, these life-saving drugs can mask poor animal husbandry practices that lead to 

diseases that otherwise might not occur. An animal production system that requires regular 

antibiotic inputs to keep the animals from becoming sick is a flawed system. We have long 

recognized that routine use of antibiotics in humans leads to antibiotic resistance. We do not try 

to prevent outbreaks of human diseases using population scale antibiotic treatment except in 

extremely rare circumstances. Instead, we control infections using vaccination, hygiene and other 

public health interventions. Yet, we have largely ignored these principles in modern food animal 
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production and enabled a system that relies too heavily on antibiotics to do what good animal 

husbandry could accomplish without putting human health at risk. 

Mr. Chairman, the Pew Campaign on Human Health and Industrial Farming was founded on the 

recommendations of a blue ribbon commission that cited the routine, non-therapeutic use of 

antibiotics on industrial farms as the number one public health problem created by these large 

operations. The Pew Commission on Industrial Farm Animal Production acknowledged that food 

animals will need to be produced in large-scale operations in order to feed Americans and others 

in the world as well as compete in the global marketplace. But it stated the current system 

utilizing routine low levels of antibiotics presented an unacceptable level of threat to public 

health and damage to the environment. 

To that end, I have just returned from a week-long fact-finding mission to Denmark to discover 

how they managed to successfully ban the nontherapeutic use of antibiotics in food producing 

animals in an industrial farm setting. Denmark is one of the world's largest exporters of pork. 

Danish food animal production is industrialized and highly intensive. 

Recognizing the potential for a health crisis, Denmark stopped the administration of antibiotics 

used for growth promotion in broiler chickens and adult swine (finishers) in 1998 and in young 

swine in 1999. Today in Denmark, all uses of antibiotics in food animal production must be 

accompanied by a prescription in a valid veterinarian-client-patient relationship and veterinarians 

cannot profit from the sale of antibiotics. In addition, farmers, veterinarians and pharmacies 

must report the use and sale 0 f antibiotics. Although the U.S. food animal production and animal 

drug industries often claim that the ban was costly and ineffective, the World Health 

Organization found that the Danish ban reduced human health risk without significantly harming 

animal health or farmers' incomes. 22 In fact, Danish government and industry data show that 

livestock and pOUltry production has increased since the ban, while antibiotic resistance has 

declined on farms and in meat. 23 

I saw first-hand how Denmark has learned to successfully raise animals using antibiotics only 

when prescribed by a veterinarian. On my trip, I had a chance to visit an industrial swine farm 

and interview the farmer and his veterinarian, tour the largest slaughter facility in Denmark, 
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discuss genetic improvements in swine and talk to a veterinarian from the Ministry of Food, 

Agriculture and Fisheries about the government's antibiotic use tracking system. [also had an 

opportunity to hear what researchers at both the Danish Technical University and the nongovernment affiliated Pig Research Center are doing on behalf of farmers. They focus on 

maximizing meat production without using nontherapeutic antibiotics, while continuing to 

improve the welfare of the animals and meet strict regulations within Denmark and the European 

Union. The trip was very informative and everyone was very forthcoming. The people I met 

extended an open invitation to any group that would like to learn for themselves what Denmark 

has done, what has worked, what has not worked and what they see as the future of Danish food 

animal production. 

In human medicine there are several successful programs in this country that promote the wise 

use of antibiotics; plus antibiotics are available by prescription only. For example, CDC's 

educational campaign, "Get Smart: Know When Antibiotics Work," teaches both the provider 

and the patient when and how antibiotics should be used. Data from the CDC's National 

Ambulatory Medical Care Survey confirm the campaign's impact on reducing antibiotic use for 

acute respiratory tract infections among both children and adults. The survey showed a 20 

percent decrease in prescribing for upper respiratory infections and a 13 percent decrease in 

prescribing overall for all office visits. 24 

As Dr. Sharfstein's testimony today noted, FDA just last month acknowledged the problem of 

overuse of antibiotics in industrial farming as an urgent public health issue. Over the past 30 

years, FDA has sporadically proposed methods to curtail the overuse of life-saving antibiotics in 

food animal production. And for more than 30 years, opponents have managed to block 

progress, while antibiotics become less and less effective in saving lives. The newly released 

FDA draft guidelines for antibiotic use correctly calls for eliminating the use of antibiotics for 

growth promotion and feed efficiency, which the FDA deems non-judicious. The agency's call 

for "judicious" use in preventing sickness suggests several principles for evaluating the 

appropriateness of such uses2 ; 
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While the draft guidelines are a welcome first step, agribusiness could continue to feed 

antibiotics to entire flocks or herds to prevent illnesses they may never encounter. This approach 

to prevention is not allowed in human medicine and it should not be allowed in animals. The 

draft guidelines are only voluntary and the agency has not indicated its plans to proceed with 

enforceable requirements. FDA must develop effective, mandatory solutions to the threat of 

antibiotic resistance to human and animal health. The Pew Charitable Trusts is joined by the 

leading health and medical organizations in this country in asking the agency to move 

expeditiously toward the issuance of regulations that will control the widespread use of 

antibiotics on industrial farms. Unfortunately, regulatory action has been a slow and arduous 

process, particularly in an atmosphere of industry resistance. 

In the meantime, Congress must not wait for FDA. Lawmakers should take swift action to pass 

the Preservation of Antibiotics for Medical Treatment Act (P AMT A, H.R. 1549). This 

legislation would disallow the routine use of seven classes of antibiotics vitally important to 

human health in food animal production unless animals or herds have been exposed to disease or 

unless drug companies can show with reasonable certainty that their use does not harm human 

health through antibiotic resistance. 

P AJ\1TA would continue to allow the use of antibiotics not deemed critically important for 

human use to be sold over the counter to farmers and ranchers as needed. This means drugs such 

as ionophores could still be used in food animal production, because they are not related to drugs 

used in human medicine and at this point, we believe, do not pose a risk to human health from 

antibiotic resistance. PAMTA would not bar the use of antibiotics for treatment of sick animals. 

There is general agreement that antibiotics have a place in animal production. PAMTA does not 

challenge that notion. The bill would still allow veterinarians to prescribe antibiotics to treat 

disease while minimizing the reservoir of antibiotic resistant bacteria. This is a solution that 

works well for human and animal health. 

As a member of the American Veterinary Medical Association (A VMA), I am disappointed in 

the stance that A VMA has taken to oppose P AMT A. Ironically, P AMTA is a pro-veterinarian 
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bill designed to restore the veterinary-client-patient relationship between food animals and 

medical care. There are many veterinarians in the A VMA who do not share the official 

viewpoint of the A VMA on P AMT A. The leading medical and public health organizations in 

the U.S. including the American Medical Association, American Academy of Pediatrics, 

American Nurses Association and the Infectious Diseases Society of America have all 

independently called for strictly limiting antibiotic resistance by curbing the amount of drugs fed 

to food animals. In addition, these groups all endorse P AMT A. 

The U.S. has a long, proud history of helping farmers and ranchers and maintaining our top place 

in the global food market. It is clear that antimicrobial resistance from our overuse of antibiotics 

in food animals has reached a crisis point. My experience in Kansas and my animal and human 

health expertise lead me to be confident that American farmers and ranchers along with our best 

scientists can find solutions. Congress can take a big step toward reducing overuse and 

protecting life-saving antibiotics by moving forward with PAMTA. Every day that we delay 

implementing effective and unambiguous legislation to curtail the overuse of antibiotics in food 

animal production, the risks to the American people increase. 

Thank you for the opportunity to testify on this very important issue. I am happy to answer any 

questions you may have. 

I Sarmah, A.K., Meyer, M.T., BoxaU, A.B. A global perspective on the use, sales, exposure pathways, occurrence, 

fate and effects of veterinary antibiotics (VAs) in the environment. Chemosphere 2006; 65:725-59. 

'FDA. June 28, 2010. Draft Guidance: "The Judicious Use of Medically Important Antimicrobial Drugs in FoodProducing Animals." 

http://www.fda.aov/downloads/An imal V eteri nary/Gu i da nceComp Ii a nee En forcemen i/G u ida nee fori nd ustry/U C M 216 

936.pdf. Accessed July 12.2010. 

J National Academy of Sciences (NAS). 1999. The Use of Drugs in Food Animals: Benefits and Risks. 

Washington, D.C.: National Academy Press. 

4 Institute of Medicine (10M). 1989. Human Health Risks with the SubtherapeuHc Use of Penicillin or Tetracyclines 

in Animal Feed. Washington, D.C: National Academy Press. 

j National Academy ofScienc« (NAS) 2003. Microbial Threats to Health: Emergence, Detection and Response 

(Smolinski MS, Hamburg :vi A, Lederberg J, eds). Committee on Emerging Microbial Threats to Health in the 21 5t 

Century, Board on Global Health. Washington, D.C.: Institute of Medicine of the National Academies, National 

Academies Press. 

6 Nwosu vc. Antibiotic resistance with particular reference to soil microorganisms. Research in t\4icrobiology. 

2001. 152:42[-30. 

7 Unicomb, L., Ferguson. J, Riley, T. V. and Collignon, P .. 2003. Fluoroquinolonc resistance in Campylobacter 

absent from isolates, Australia. Emerging infectiolls Diseases. 9:1482-l483. 
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8 Centers for Disease Control and Prevention. 2005. Annual report. CDC Emerging lnfections Program National 

Antimicrobial Resistance Monitoring System: enteric bacteria. 

http://www.cdc.gov/narms/annual/2005/NARMSAnnuaIReport2005.pdf. Accessed July 10, 2010. 

9 Aarestrup, F.M. Characterization of glycopeptide-resistant Enterococclls/aecillm (GRE) from broilers and pigs in 

Denmark: genetic evidence that persistence ofGRE in pig herds is associated with coselection by resistance to 

macrolides. Journal o/Clinical Microbiology. 2000; 38:2774-2777. 

10 See, for example: Johnson, 1.R., et al. 2007. Antimicrobial Drug-Resistant Escherichia coli from Humans 

and Poultry Products, Minnesota and Wisconsin, 2002-2004. Emerging tn/ectious Diseases 13:6., 

II Engster, H., D. Marvil, and B. Stewart-Brown. 2002. The effect of withdrawing growth-promoting antibiotics 

from broiler chickens: a long-term commercial industry study. Journal 0/ Applied Poultry Research. 11 :431-436. 

J:! Dritz. Effects of administration of antimicrobials in feed on growth rate and feed efficiency of pigs in mu!tisite 

production systems. Journal o/the American Veterinary Medical Association. 2002. 220(11): 1690-5. 

IJ USDA. The trans/ormation o/U.S. livestock agriculture; scale, efficiency, and risks. Electronic bulletin no. 43. 

January 2009. http://www.ers.usda.aov!Puhlications/EIB43. Accessed July 10, 20 I O. 

14 Henrik C. Wegener, Institute Director, Danish Technical University, July 5, 2010, personal communication. 

15 Hurd, H. S., S. Doores, D. Hayes, A. Mathew, J. Maurer, P. Silley, R. S. Singer, and R. N. Jones. 2004. Public 

health consequences of macrolide use in food animals: a detenninistic risk assessment Journal of Food Protection. 

67:980-992. 

16 Chapman. Use of antibiotics and roxarsone in broiler chickens in the USA: analysis for the years 1995 to 2000. 

Poultry Science. 81(3): 356-64. 

17 Evans, M. and Wegener, H. Antimicrobial Growth Promoters and Salmonella spp., Campylobacter spp. In Poutry 

and Swine, Denmark. Emerging {n/ectious Diseases. 9:4. April 2003. 

18 Joshua M. Sharfstein, M.D., Principal Deputy Commissioner of Food and Drugs, FDA Testimony before the 

House Committee on Rules, U.S. House of Representatives, July 13,2009. 

http://www.fda.gov/NewsEventslTestimony/ucmI71715.htm. Accessed July 12, 2010. 

"Joint FAO/OIE/WHO Expert Workshop on Non-Human Antimicrobial Usage and Antimicrobial Resistance: 

Scientific Assessment, December I - 5, 2003. 

http://whglibdoc.who.intlhgi2004/WHO CDS CPE ZFK 2004.7.pd[ Accessed July 11,2010. 

20 Ibid. 

21 WHO Global Principles for the Containment of Antimicrobial Resistance in Animals Intended for Food; Report of 

a WHO Consultation with the participaiion of the Food and Agriculture Organization of the United Nations and the 

Office International des Epizooties; Geneva, Switzerland. June 5-9,2000. 

http://whqlihdoc.who.intihg/2000iWHO CDS CSR "PH 2000A.pdf. Accessed July 11,2010. 

~.:! WHO, 2003. "Impacts of antimicrobial growth promoter termination in Denmark: The WHO international review 

panel's evaluation of the termination of the use of antimicrobial growth promoters in Denmark," 

http://whqlibdoc.who.intlhgI2003/WHO CDS CPE ZFK 2003.l.pdf. Accessed July 12,2010 

2J Letter from Dr. Jan Mousing, Chief Veterinary Officer of Denmark, to Congress, August 12, 2009, and "FACT 

sheet - Effects of Danish restrictions on non-therapeutic use of antibiotics.~' 

http://www.uk.foedevarestyrelsen.dk/NRlrdonlyres/63497 AA 7-8 E8A-4C6 r\-9C74-

ES6C3383F26NO/info om vaekstfremmerforbud samt oevrige riskmanaaement str UK.pdf; or see also letter to 

House Speaker Nancy Pelosi from Dr. Frank Aarestrup, Denmark Technical University, including copy of 

presentation given to congressional delegation, September, 2009. 

httD://www.louise.house.gov!index. php?option-com content&view-article&id-t J 14: rep-slaughtcr-releaje5-Jetterfrom-denmark-on-non-therapeutic-use-of-anti microbiais&catid=41 :press-re!eases<emid = 1 09 ~ and Kje!dsen. N.J., 

"Consequences of the removal of antibiotic growth promoters in the Danish pig industry," Danish Pig Production; 

and Danish Integrated Antimicrobial Resistance Monitoring and Research Program (DANMAP) 2007 report, pp. 81-

83, http://www.danmap.org/pdtFiles/Danmap 2007.pdf. Accessed July 12, 2010. 

2-l. Thomas Frieden, M.D. M.P.H., Director, Centers for Disease Control and Prevention Testimony, Committee on 

Energy and Commerce Subcommittee on Health, United States House of Representatives, April 28, 20lO. 

"FDA. June 28,2010. Drait Guidance: "TheJudicious Use of Medically Important Antimicrobial Drugs in FoodProducing Animals." 

http:/;'www. fda. ao v/downloadsl An i rna I Veterinary IGuidanceCo mp I lance En force ment/G uidance for I ndustryiU CM 216 

936.pdf. Accessed July 12, 20lO. 
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THE 

PEW 

CHARITABLE TRUSTS 

Antibiotic Resistance and Food Animal Production: 

a Bibliography of Scientific Studies (1969-2010) 

This bibliography lists the latest published scientific and economic literature concerning the contribution 

of routine antibiotic use in food animals to the growing public health crisis of human antibiotic 

resistance, Research on how antibiotic use in food animal production contributes to the growing health 

crisis of antibiotic resistance dates back more than 30 years, As Dr, Frederick J, Angulo, Acting 

Associate Director of Science in CDC's National Center for Environmental Health and the Agency for 

Toxic Substances and Disease, said in a August 1,2009, news article in tbeJollrnal of the American 

Veterinary Medical Association: 

"There is scientific consensus that antibiotic use in food animals contributes to 

resistance in humans, And there's increasing evidence that such resistance results in 

adverse human health consequences at the population leveL Antibiotics are a finite and 

precious resource, and we need to promote prudent and judicious antibiotic use," 

Table of Contents: 

Antibiotic Resistance in Animal Agriculture: Research includes how antibiotic resistance in 

animal agriculture impacts livestock, the environment and the spreading of infectious diseases 

(Pp,2-9), 

Swine: Research includes how producing swine impacts air, water and farm workers (pp. 10-13). 

Poultry: Research includes how producing poultry impacts farm workers, public health and the 

spreading of antibiotic-resistant bacteria (pp. 14-18). 

Retail Products: Research includes how the food production system impacts the food supply (pp. 

19-21). 

MRSA: Research includes how MRSA impacts certain areas across the country, veterinarians, 

health care employees and farmers (pp. 22-24). 

Antimicrobial-Resistant Infections: Research includes how infections are arising with 

implications toward the use of antimicrobials in food animal production (pp. 25-27). 
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ANTIBIOTIC RESISTANCE IN ANIMAL AGRICULTURE 

The impacts of antibiotic resistance in animal agriculture on livestock, the environment and the 

spreading of infectious diseases. 

Joint Committee on the use of antibiotics in animal husbandry and veterinary medicine ("Swann 

Report"). M.M. Swann. et al. Cmnd. 4190. London: Her Majesty's Stationery Office, 1969. 

Summary: Reports on the status of antibiotic use in man and animals. Outlines the uses and 

amounts consumed for both. Reviews the reasons for which antibiotics are administered to food 

animals, including disease prevention, use in growth promotion, stress reduction and therapy. 

States that there are possible dangers to the human population stemming from the administration 

of antibiotics to animals, such as the rise of antibiotic-resistant strains of bacteria in animals that 

could cause disease in humans. The resulting infection could then be difficult to treat due to the 

null effect of antibiotics. Other dangers include the transmission of resistance determinants from 

animal strains to human strains of bacteria. lt is known that such transfers take place and the fear 

is that resistance may be transferred to normal bacteria that inhabit the human bowel and/or to 

pathogens that may then cause disease. Discusses the prevalence of multiple antibiotic-resistant 

strains of bacteria and how they may arise. States that even though there are multiple antibiotics 

available for treatment of certain diseases, those reserved as a drug of choice may have a number 

of advantages over alternative treatment. Strains with multidrug resistance pose a greater threat in 

that the only effective drugs left for treatment in humans may be unsuitable because of toxicity or 

allergy. These infections are likely to arise where humans and animals share a pathogen such as 

Salmonella and the administration of antimicrobials to animals no doubt encourages the 

prevalence of resistance in these strains. Concludes that the use of antimicrobials in food animal 

production, especially when used in growth promotion, is of great concern and that limiting 

facton; should be put in place to secure the use of antibiotics of greatest importance in human 

administration for therapeutic uses only and in some cases excluded from animal use altogether. 

Changes in intestinal flora of farm personnel after introduction of a tetracycline-supplemented 

feed on a farm. S.B. Levy, G.B. Fitzgerald and A.B. Macone. New England Journal of Medicine. 1976. 

295(11): 583-588. 

Summary: Reports a study to determine if giving animals antibiotics in feed caused changes in 

intestinal bacterial flora and if work en; and neighbors of the farm were affected. Chickens were 

screened for bacteria before and after a diet that included tetracycline-supplemented feed. 

Resistance to tetracycline changed dramatically within 36 to 48 hours of changing the diet of the 

animals. Within two weeks, 90 percent of the chickens were found to excrete essentially all 

tetracycline-resistant organisms. Within five to six months, there was a large increase in 

tetracycline-resistant bacteria in farm dwellen; while the neighbors showed no change in bacterial 

count. 

An epidemic of resistant Salmonella in a nursery: Animal-to-human spread. R. W. Lyons, C.L 

Samples, H.N. DeSilva, K.A. Ross, E.M. Julian and PJ. Checko. Journal of the American Medical 

Association, 1980.243(6): 546-547. 

Summary: Studies the case of a pregnant woman, infected with Salmonella heidelberg, who 

worked on her father's farm until four days before delivery. Her baby subsequently developed 

mild diarrhea, as did two othen; sharing the hospital nun;ery. Salmonella heidelberg was isolated 

from each and in all cases was resistant to chloramphenicol, sulfamethoxazole and tetracycline. 

2 
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The strain was presumed to originate from a herd of infected dairy cows at the woman's father's 

farm as those bacteria showed the same resistance pattern as did those collected from the father. 

Emergence of multidrug-resistant Salmonella enterica serotype Typhimurium DTI04 infections in 

the United States. M.K. Glynn, C. Bopp, W. Dewitt, P. Dabney, M. Mokhtar and F.J. Angulo. New 

England Journal of Medicine, 1998.338(19): 1333-1338. 

Summary: Reviews Salmonella data collected by local and state health departments and public 

health laboratories between 1979 and 1996. Finds that a rapid increase of multidrug-resistant 

Salmonella enterica serotype typhimurium (DTl04), a strain widely distributed in food animals 

and known to cause disease in humans, occurred in this period. The percentage rose from 0.6 

percent in 1979-1980 to 34 percent in 1996. Concludes that more prudent use of antibiotics on 

farms is necessary to reduce the dissemination of multidrug-resistant Salmonella and emergence 

of further resistant strains. 

Epidemiologic aspects, control, and importance of multiple-drug resistant Salmonella typhimurium 

DTI04 in the United States. J.E. Akkina, A.T. Hogue, FJ. Angulo, R. Johnson, K.E. Petersen, P.K. 

Saini, PJ. Fedorka-Cray and W.O. Schlosser. Journal of the American Veterinary Medical Association, 

1999.214(6): 790-798. 

Summary: Studies an animal strain of Salmonella and its prevalence of infection in humans. 

States that multidrug-resistant Salmonella DTl04 is the second-most-prevalent Salmonella 

organism isolated from humans in England and Wales in the time frame of this study. Gives 

numerous examples of outbreaks in the U.S., most of which are traced to milk. Cattle, along with 

pigs, sheep, chickens, turkeys and several other animals, are known carriers of this strain. 

Transfer of antibiotic resistant bacteria from animals to man. H.C. Wegener, F.M. Aarestrup, P. 

Gerner-Smidt and F. Bager. Acta Veterinaria Scandinavica Supplementum, 1999. 92: 51-57. 

Summary: Describes zoonotic bacterial infections and their treatment. States that most 

Salmonella, campylobacter, yersinia and entero-haemorrhagic E. coli (EHEC) infections do not 

require antibiotic therapy, but in some cases these tools provide life-saving cures. Increasing 

levels of resistance in these bacteria, especially fluoroquinolone resistance, give rise for concern 

when it comes to human infections. Calls for infection control at the herd level and the need for 

prudent use of antibiotics in food animals. 

Ceftriaxone-resistant Salmonella infection acquired by a child from cattle. P. Fey, TJ. Safranek, 

M.E. Rupp, E.F. Dunne, E. Ribot, P.C. Iwen, P.A. Bradford, F.J. Angulo and S.H. Hinrichs. New 

England Journal of Medicine, 2000.342: 1242-1249. 

Summary: Reports the case of a 12-year-old boy who lived on a farm in Nebraska and was 

infected with a ceftriaxone-resistant strain of Salmonella enterica serotype typhimurium that was 

traced to his father's herd of cattle using molecular techniques. States that this finding adds to the 

growing body of evidence suggesting that the use of antibiotics in livestock is the prominent 

source of resistance to these agents in Salmonella infection. 

Appropriate regulation of antibiotics in livestock feed. R.L. Goforth and C.R. Goforth, Boston College 

Environmental Affairs Law Review, 2000. 28(1): 39-77. 

Summary: Reviews nontherapeutic uses of antimicrobials in food animals and their impact on 

human health. States that this practice is creating possibly irreversible effects on the viability of 
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antibiotics used to treat human disease. Concludes that despite short-term economic benefits 

associated with the widespread use of antibiotics in agriculture, the risk to human health justifies 

a change in policy. 

Antibiotic resistance in Campy/obaeter strains isolated from animals, foods and humans in Spain in 

1997-1998. Y. Saenz, M. Zarazaga, M. Lantero, M.J. Gastaneres, F. Baquero and C. Torres. 

Antimicrobial Agents and Chemotherapy, 2000. 44(2): 267-271. 

Summary: Studies Campylobacter isolated from foods, animals and humans. Finds that a high 

percentage of Campylobacter jejuni contaminates food (54.4 percent), broilers (81 percent) and 

pigs (88.9 percent). Isolates collected from broilers and pigs showed a 99 percent resistance rate 

to ciprofloxacin, with only a slightly lower number of human isolates (72 percent) also resistant. 

High resistance percentages to ampicillin, erythromycin, gentamicin and amikacin also were 

detected for C. coli isolated from these sources. Concludes that ·'more restrictive policies on the 

use of antibiotics in animals may result in an improvement of the current situation in the medium 

teffil." 

The effect of banning avoparcin on VRE carriage in The Netherlands. A.E. van den Bogaard, N. 

Bruinsma and E.E. Stobberingh. Journal of Antimicrobial Chemotherapy, 2000. 46: 146-148. 

Summary: Discusses the removal of avoparcin, an antimicrobial similar to vancomycin, from 

commercial food animal production in several settings. Sweden, which banned the use of 

antibiotics as growth promoters in 1986, has not reported any vancomycin-resistant Enterococci 

(VRE). This example strongly suggests that the removal of selective pressure will remove VRE 

from the human population over time. Denmark also banned the use of avoparcin in 1995 and 

saw the prevalence of poultry-isolated cases ofVRE drop from greater than 80 percent in 1995 to 

less than 5 percent in 1998. 

Epidemiology of resistance to antibiotics: Links between animals and humans. A. Van der Bogaard 

and E.E. Stobberingh. International Journal of Antimicrobial Agents, 2000. 14: 327-335. 

Summary: Discusses the ban on avoparcin in food animals in the European Union and resulting 

significant decreases in resistance to vancomycin (a related drug) in intestinal Enterococci 

bacteria in animals and humans. States that resistant bacteria from animals can infect or reach the 

human popUlation by direct contact and via food products of animal origin. Shows evidence for 

transfer 0 f resistant genes between bacteria in humans and animals and recommends reducing the 

amount of antibiotics used in food animals in order to protect public health and safeguard the 

efficacy of antibiotics in veterinary medicine. 

Quinolone and macrolide resistance in Campy/obaeter jejuni and C. coli: Resistance mechanisms 

and trends in human isolates. J. Engberg, F.M. Aarestrup, D.E. Taylor, P.Gerner-Smidt and I. 

Nachamkin. Emerging Infectious Diseases. 200 I. 7( I ):24-34. 

Summary: Reviews the increasing resistance of Campylobacter strains to macrolide and 

quinolone antibiotics in human clinical isolates with respect to the use of these agents in food 

animals. Data suggest that while erythromycin and other macrolides should continue to be the 

antibiotics of choice in most regions, fluoroquinolones may be of limited use in many areas as the 

overuse of enrofloxacin and other drugs in food animals has caused a sharp upswing in the 

resistance of Campylobacter to these antibiotics. 

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The need to improve antimicrobial use in agriculture: Ecological and human health consequences. 

Alliance for the Prudent Use of Antibiotics. Clinical Infectious Diseases, 2002 supplement. 34 (S3): S71-

144. 

Summary: Reviews more than 500 studies relating to agricultural uses of antibiotics and 

concludes that "elimination of non therapeutic use ofantimicrobials in food animals and 

agriculture will lower the burden of antimicrobial resistance." 

Potential mechanisms of increased disease in humans from antimicrobial resistance in food 

animals. M. Barza. Clinical Infectious Diseases, 2002. 34 (Suppl 3): S 123-125. 

Summary: Summarizes five potential mechanisms by which antimicrobial resistance may 

adversely affect human health. Two of the five relate to antimicrobial use in animals: (I) that 

resistant pathogens acquired by animals as the result of treatment with antibiotics transmit these 

pathogens through the food chain; and (2) that commensal flora of animals may acquire resistance 

traits from the previous pool of resistant pathogens, which then may be passed to human 

commensals and/or pathogens through the food chain. 

Antimicrobial residues in animal waste and water resources proximal to large-scale swine and 

poultry feeding operations. E.R. Campagnolo, K.R. Johnson, A. Karpati, C.S. Rubin, D.W. Kolpin, 

M.T. Meyer, J.E. Estaban, RW. Currier, K. Smith, K.M. Thu and M. McGeehin. The Science of the Total 

Environment, 2002, 299: 89-95. 

Summary: Reports on data from numerous antimicrobial residues collected from animal wastes, 

surface water and groundwater proximal to large-scale swine and poultry operations, Data 

indicate that animal waste applied as fertilizer to the land may serve as a contaminating source of 

antimicrobial residues for the environment as a detectable level of antimicrobial compounds was 

found in waste-storage lagoons and surface and groundwater proximal to these operations. 

Antimicrobial use and resistance in animals. S.A. McEwen, PJ. Fedorka-Cray. Clinical Infectious 

Diseases, 2002. 34 (SuppI3): S93-106. 

Summary: Describes antibiotic use in each animal class. Discusses a 1999 report on the 

economic effects of banning subtherapeutic antibiotic use in the U.S. Concludes that meat 

producers following good management practices would not be adversely affected by such a ban. 

Reviews antimicrobial-resistance-monitoring programs in bacteria of animal origin and the 

techniques involved. States alternatives to using antibiotics in food animals, such as providing 

good sanitation, air temperature, and clean water, as well as vaccine use and development and use 

ofprobiotics that consist of live, beneficial bacteria. 

Emergence, spread and environmental effect of antimicrobial resistance: How use of an 

antimicrobial anywhere can increase resistance to any antimicrobial anywherc else. T.F. O'Brien. 

Clinical Infectious Diseases, 2002. 34(SuppI3): S78-84. 

Summary: Discusses how a bacterial community responds to antimicrobial use by obtaining 

resistance genes as well as how these genes are spread around the globe and between different 

bacterial populations. States that in Europe a ban of avoparcin, an antibiotic similar to 

vancomycin, was implemented in 1997 because of rising concerns that strains of vancomycinresistant Enterococci were being used for growth promotion. 

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Generally overlooked fundamentals of bacterial genetics and ecology. A.O. Summers. Clinical 

Infectious Diseases, 2002. 34 (Suppl 3): S85-92. 

Summary: Reviews how treatment with any given antibiotic may result in resistance to several 

antibiotics because of the ability of bacteria to obtain genetic elements that code for multidrug 

resistance. States that the exchange of bacteria between a host and its environment is a continual 

processand that selective pressure applied to any part of the ecosystem will result in a highly 

resistant bacterial population. Also states that once resistance is acquired it will be hard to reverse 

because of molecular mechanisms inherent in bacteria that ensure future generations hold on to 

resistance characteristics. 

Human diseases caused by foodborne pathogens of animal origin. M.N. Swartz. Clinical Infectious 

Diseases, 2002. 34 (SuppI3): SIII-I22. 

Summary: Evaluates the likelihood that emergence of several resistant strains of bacteria 

occurred ftrst in animals rather than humans. Reviews studies that correlate antimicrobial use on 

farms to the occurrence of colonization and infection of farm workers and residents of the 

surrounding communities. Discusses the trend in antibiotic resistance in commensal 

microorganisms and their opportunistic infection of hospitalized patients. 

Antimicrobial resistance in livestock. B. Catry, H. Laevens, L.A. Devriese, G. Opsomer and A. Kruif. 

Journal of Veterinary Pharmacology and Therapeutics, 2003. 26: 81-93. 

Summary: Reviews resistance in animals from a veterinary perspective. Notes that resistance 

could result in economic losses and animal welfare problems for livestock producers and that "the 

resistance level in a population is directly related to amount of antimicrobial drugs used." States 

that commensal bacteria in healthy animals fed or administered antibiotics contain resistance 

genes that if ingested by humans could colonize the gut and transfer these genes to pathogenic 

bacteria. This transfer would result in treatment difficulty because of antibiotic resistance. 

Emergence of multidrug-resistant Salmonella enterica Serotype Newport infections resistant to 

expanded-spectrum cephalosporins in the United States. A. Gupta, et aL Journal of Infectious 

Diseases, 2003. 188: 1707-1716. 

Summary: Discusses the emergence of new strains of multidrug-resistant Salmonella in New 

England. Reports that isolates ofNewport-MDRAmpC among Salmonella serotype Newport 

from humans rose from 0 percent in 1998 to 53 percent in 200 I. This strain shows resistance to 

amoxicillinlclavulanic acid, cephalothin, cefoxitin and ceftiofur. Concludes that the use of 

antimicrobial agents in livestock is linked to the emergence of antimicrobial-resistant 

nontyphoidal Salmonella and that the emergence of Newport-MDRAmpC strains in humans has 

coincided with the same infections in cattle. 

Evidence of an association between use of anti-microbial agents in food animals and antimicrobial 

resistance among bacteria isolated from humans and the human health consequences of such 

resistance. FJ. Angulo, V.N. Nargund and T.C. Chiller. Journal of Veterinary Medicine. 2004. 51: 374-

379. 

Summary: Reviews antimicrobial-resistant infections occurring in humans as a result of 

antibiotic use in food animal production. States that "a review of outbreaks of Salmonella 

infections indicated that outbreaks were more likely to have a food animal source than outbreaks 

caused by anti-microbial-susceptible Salmonella." Reports that the human health consequences 

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resulting from bacterial resistance include infections caused by resistant pathogens, an increase in 

treatment failures and increased severity of disease. 

Nontherapeutic use of antimicrobial agents in animal agriculture: Implications for pediatrics. 

K.M. Shea. Pediatrics. 2004. 114(3): 862-868. 

Summary: Examines how antimicrobials are used in food animal production and how this 

practice could contribute to resistance in humans. Notes that children are at greater risk from 

resistant infections than the general population. 

Antibiotic use in agriculture and its impact on the terrestrial environment. K. Kumar, S.c. Gupta. 

Y. Chander and A.K. Singh. Advances in Agronomy. 2005. 87: 1-54. 

Summary: Discusses the impact of antibiotic use on disease treatment and growth promotion in 

animals. States that overuse of antibiotics results in the excretion of drugs that are not absorbed in 

the animal and that the resulting manure stock may be spread on fields, altering the soil bacteria 

and contaminating water sources. Notes that the continued prevalent use of antibiotics in 

agriculture is increasing the emergence of antibiotic-resistant bacteria both in both clinically 

relevant strains of pathogens and in normal commensal microorganisms. Concludes that "prudent 

use of antibiotics to a bare minimum along with alternative methods that minimize development 

and proliferation of resistant bacteria need investigation." 

Agricultural antibiotics and human health: Does antibiotic use in agriculture have a greater impact 

than hospital use? D.L. Smith, J. Dushoffand J.G. Morris, Jr. PLoS Medicine. 2005.2(8): 731-735. 

Summary: Reviews the emergence and spread of antibiotic-resistant bacteria and notes that 

mathematical models can help with understanding underlying mechanisms and guiding policy 

responses. Agricultural antibiotic use may generate novel types of antibiotic-resistant bacteria 

that spread to humans; models can help estimate how much additional disease has been caused by 

agricultural antibiotic use. Depending on the assumptions used, the model suggests that 

transmission from agriculture can have a greater impact than hospital transmission on human 

populations. 

The potential role of concentrated animal feeding operations in infectious disease epidemics and 

antibiotic resistance. M.J. Gilchrist, C. Greko, D.B. Wallinga, G.W. Beran, D.R. Riley and P.S. Thome. 

Environmental Health Perspectives, 2007. 115(2): 313-316. 

Summary: Reports the recommendations of a working group that was part of the 2005 

"Conference on Environmental Health Impacts of Concentrated Animal Feeding Operations: 

Anticipating Hazards - Searching for Solutions . ., Recommendations include the following: 

discontinue nontherapeutic use of antibiotics as growth promoters; establish nationwide 

surveillance programs to fully assess the contribution of antibiotic use in livestock production to 

the creation of ecological reservoirs of resistance or the transmission of that resistance to humans; 

identify resistant strains; and establish minimum separation distances for swine and poultry 

facilities to reduce the risk of influenza outbreaks and municipal-style waste treatment to limit 

microbial and nutrient contamination of surface and groundwater. 

Fluoroquinolone-resistant Campylobacter species and the withdrawal of fluoroquinolones from use 

in poultry: A public health success story. J.M. Nelson, T.M. Chiller, J.H. Powers and F.J. Angulo. 

Clinical Infectiolls Diseases, 2007. 44: 977-980. 

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Summary: Reviews fluoroquinolone use and the resulting effect of resistance occurring in the 

Campylobacter that followed the withdrawal of enrofloxacin from use in treating poultry. States 

that 13 percent of all resistant infections occur from travel abroad, showing that resistance is a 

global threat and that U.S. regulatory actions are not effective internationally. Concludes that 

"judicious use of antimicrobial agents should be stressed to preserve the efficacy of these 

important chemotherapeutic agents." 

Environmental health impacts of concentrated animal feeding operations: Anticipating 

hazards-searching for solutions. P.S. Thorne. Environmental Health Perspective, 2007. 115: 296-

297. 

Summary: Outlines potential risks to human health from concentrated animal feeding operations 

(CAFOs) and the research needed to better understand the impact of these operations on public 

health. Examples of policy change include establishment of a requirement for minimum 

separation distances, use of solid-waste storage tanks to eliminate the possibility of microbial 

contamination spreading to water sources and provision of clean water sources for drinking. 

Expresses concerns over air quality and the need for better surveillance in this area. Expresses a 

need to phase out the use of antimicrobial agents as growth promotants. 

Associations between antimicrobial resistance genes in fecal generic Escherichia coli isolates from 

cow-calf herds in western Canada. S.P. Gow, c.L. Waldner, 1. Harel and P. Boerlin. Applied and 

Environmental Microbiology, 2008. 74(12): 3658-3666. 

Summary: Studies antimicrobial-resistance gene distribution among cow-calf herds in western 

Canada. Finds that 65 percent of the 207 examined isolates of E. coli were resistant to at least one 

antimicrobial. Several patterns emerged from this research, suggesting that when a bacterium 

acquires resistance to one antimicrobial it is likely to become resistant to others because of the 

transfer of mobile genetic elements that harbor regions of multiple drug resistance. This suggests 

that even with careful restriction of antimicrobial use on farms, bacteria may still pick up 

resistance unrelated to the antimicrobials being used. 

Industrial food animal production, antimicrobial resistance, and human health. E.K. Silbergeld, J. 

Graham and LB. Price. Annual Review of Public Health, 2008. 29: 151-/69. 

Summary: Reviews the use of antimicrobials in agriculture and presents evidence for resistance 

stemming from their use in food animals. States that agricultural use of antibiotics can 

significantly shorten the useful life of these drugs, which are also used to treat disease in humans 

and animals. Suggests that estimates of nontherapeutic antibiotic use in agriculture fall between 

60 percent and 80 pereent of total antimicrobial production in the U.S. Concludes that "the use of 

antimicrobials for nontherapeutic purposes in agriculture is a major factor driving the emergence 

of antimicrobial resistance globally," and that "prudent public health policy thus indicates that 

nontherapeutic uses of antimicrobials in food animal production should stop." 

Effect of subtherapeutic administration of antibiotics on the prevalence of antibiotic-resistant 

Escherichia coli bacteria in feedlot cattle. T.W. Alexander, L.J. Yanke, E. Topp, M.E. Olson, R.R. 

Read, D.W. Morek, T.A. McAllister. Applied and Environmental Microbiology, 2008. 74(14): 4405-

4416. 

Summary: A study of E. coli resistance in feedlot cattle when they were administered a subtherapeutic level of antibiotics. Cattle previously not treated with antibiotics were brought to a 

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research feedlot where they were divided into groups each receiving a different regimen of subtherapeutic antibiotics along with one group as a control not being treated. Cattle were fed two 

different diets during their treatments, one silage based diet and another grain based. Cattle tested 

before entering the feedlot (before starting sub-therapeutic treatment) were colonized with E. coli 

resistant to tetracycline (TET) at a rate greater than 40 percent, suggesting a colonization ofTET 

resistant E. coli from birth (i.e. there is a high population of E. coli in circulation with TET 

resistance). Additionally the group fed chlortetracycline plus sulfamethazine (TET-SUL) showed 

an increased rate ofTET resistance. A grain-based diet also appeared to increase not only the 

finding of E. coli but also increased the rate of finding TET resistant E. coli. Noted is that when 

antibiotic treatment was stopped for a period of about one to two months during each diet there 

was not a significant decline in the shedding of resistant E. coli except in the TET -SUL group 

where a slight decline was observed. However, upon starting treatment again the decline was 

reversed and prevalence of resistance continued to climb. The authors do note that in previous 

studies a decline in resistance has been shown when antibiotics (selective pressures) were 

removed from diets of animals, but this may sometimes take years to see a marked decrease. In 

summary feeding of certain diets and addition of certain sub-therapeutic levels of antibiotics in 

feed will increase the rate of resistance in E. coli. 

The effects of transport and lairage on counts of Escherichia coli 0157 in the feces and on the hides 

of individual cattle. N. Fegan, G. Higgs, L. Duffy and R.S. Barlow. Foodborne Pathogens and Disease. 

2009.6(9):1113-1120. 

Summary: Reports on a study in which E. coli 0157 rates from feces and from hides of cattle 

were monitored to determine whether a change occurred during transport from the feedlot to 

slaughter. Concludes that "transport and lairage did not lead to an increase in the number or 

isolation rate of E. coli 0157 from cattle." 

Sublethal antibiotic treatment leads to muItidrug resistance via radical-induced mutagenesis. M.A. 

Kohanski, M. A. DePristo and J.J. Collins. Molecular Cell, 2010. 37:311-320 

Summary: Looks at mutation rates of E. coli exposed to sublethal doses of different antibiotics. 

Finds that when sublethal doses of antibiotics were given, cell production of radical oxygen 

species (ROS) occurred, leading to mutations. ROS can damage DNA, causing a mutation in 

such a way that the cells may acquire resistance to classes of antibiotics different from those with 

which they are being treated. Gives a clinical example of incomplete treatment with antibiotics 

(e.g., a missed pill), but one could postulate that in food animal production, where sub therapeutic 

levels of antibiotics are given for the purpose of growth promotion, this event may also occur. 

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SWINE 

Ways in which swine production affects air. waterandfarm workers. 

An outbreak of multidrug-resistant, quinolone-resistant Salmonella enterica serotype typhimurium 

DTl04. K. Molbak, D.L. Baggesen, F.M. Aarestrup, J.M. Ebbesen, J. Engberg, K. Frydendahl, P. 

Gerner-Smidt, A.M. Petersen and H.C. Wegener. New England Journal of Medicine. 1999.341: 1420-

1425. 

Summary: Reviews a 1998 Salmonella enterica serotype typhimurium DTI04 outbreak in 

Denmark. The outbreak had 25 confirmed cases, with II patients hospitalized and two deaths. 

Previous cases were resistant to five antibiotics; however, cases in this outbreak also were 

resistant to nalidixic acid and had reduced susceptibility to fluoroquinolones. Analysis traced the 

infection to a swine herd delivered to a slaughterhouse and the resulting retail pork was found to 

be the common food source. 

Conceutrated swiue-feediug operations and public health: A review of occupational aud 

community health effects. D. Cole, L. Todd and S. Wing. Environmental Health Perspectives. 2000. 

108: 685-699. 

Summary: Reviews the effects of industrial farms on community health. States that there are 

many potential routes of community exposure to industrial fanning hazards and that people 

residing near swine farms may be exposed to these agents through pathways such as airborne 

contaminants produced by building ventilation fans, soil transport of microbes from land-applied 

wastes and leaking lagoons that contaminate groundwater. States that more research is needed to 

detennine the far-reaching effects of industrial farms on community health. 

Occurrence and diversity of tetracycline-resistance genes in lagoons and groundwater underlying 

two swine production facilities. J.e. Chee-Sanford, R.L Aminov, U. Krapac, N. Garrigues-Jeanjean and 

R.L Mackie. Applied and Environmental Microbiology, 2001. 67(4): 1494-1502. 

Summary: States that 25 percent to 75 percent of antimicrobials administered to food animals 

are poorly absorbed in the gut and are excreted in feces. These unaltered substances are then 

applied to land by spreading of manure. Finds that a broad range of tetracycline-resistance genes 

occurred in two swine-waste lagoons and that upon release into the environment these genes can 

potentially mobilize and persist. Data suggest that the presence of the resistance genes is due to 

seepage and movement of groundwater underlying the lagoons and that it may be substantial, as 

resistance genes were found in a well 250 meters downstream of the lagoon sampled. 

Productivity and economic effects of antibiotics used for growth promotion in U.S. pork 

production. G. Y. Miller, K. A. Algozin, P. E. McNamara, E. J. Bush. Journal of Agricultural and 

Applied Economics, 2003. 35(3): 469-482. 

Summary: Studies the use of growth promoting antibiotics (GPA) in pork production. Finds 

that when GP A are removed from production operations that use less than four different rations 

(feed) there is a net decrease in return at sale of nine percent. However, when fanns use greater 

than four different rations there is an increase in feed conversion without the use of antibiotics. 

Furthermore, when farms used greater than four different rations and applied GPA, feed 

conversion decreased. The authors state "our results imply that antibiotics used for growth 

promotion are of value mainly when four or fewer different rations are used in finishing." 

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Antimicrobial resistance in commensal flora of pig farmers. H. Aubrey-Damon, K. Grenet, P. SailNdiaye, D. Che, E. Cordeiro, M.E. Bougnoux, E. Rigaud, Y. Le Strat, V. Lemanissier, L. ArmandLefevre, D. Delzescaux, J.e. Desenclos, M. Lienard and A. Andremont. Emerging Infectious Diseases, 

2004. 10(5): 873-879. 

Summary: Compares the carriage rates of antibiotic-resistant bacteria isolated trom pig farmers 

and non-farmers matched for sex, age and county of residence in France. Finds that farmers carry 

a higher percentage of resistant commensal bacteria than non-farmers. States that the rate of VRE 

colonization did not differ between farmers and non-farmers and that this finding suggests that the 

1997 ban of avoparcin was effective. 

Airborne multidrug-resistant bacteria isolated from a concentrated swine feeding operation. A. 

Chapin, A. Rule, K. Gibson, T. Buckley and K. Schwab. Environmental Health Perspectives, 2005. 113: 

137-142. 

Summary: Reports the results of studies air samples taken within confined hog operations for 

antibiotic-resistant bacteria. Ninety-eight percent of bacteria sampled had resistance to at least 

two antibiotics used in animal production and a greater potential for worker exposure to resistant 

bacteria, suggesting that exposure to air from swine operations may allow multidrug-resistant 

bacteria to be transferred from animals to humans. Notes that "these data are especially relevant 

to the health of swine CAFO [concentrated animal feeding operations J workers, their direct 

contacts in the community, and possibly nearby neighbors of swine CAFOs." 

Detectiou and occurrence of antimicrobially resistant E. coli in groundwater on or near swine 

farms in eastern North Carolina. M.E. Anderson and M.D. Sobsey. Water Science and Technology, 

2006.54(3): 211-218. 

Summary: Compares the extent of groundwater contamination from antibiotic-resistant E. coli 

trom industrial swine farms and reference sites. Sixty-eight percent of the E. coli from the swine 

farm sites were resistant to at least one antibiotic, while only one isolate from each of the 

reference sites showed resistance. Concludes that groundwater on or near swine farms may pose 

as an environmental pool for antibiotic-resistant E. coli and resistance genes. 

The effect of subtherapeutic chlortetracycline on antimicrobial resistance in tbe fecal flora of 

swine. lA. Funk, J.T. Lejeune, T.E. Wittum and P.J. Rajala-Schultz. Microbial Dntg Resistance, 2006. 

12(3): 210-218. 

Summary: Studies the occurrence of antimicrobial-resistant Salmonella due to the 

sub therapeutic use of chlortetracycline in the diets of swine. Concludes that "there was a positive 

association between inclusion of subtherapeutic chlortetracycline in the diet and resistance to 

multiple antimicrobials." 

Isolation of antibiotic-resistant bacteria from tbe air plume downwind of a swine confined or 

concentrated animal feeding operation. S.G. Gibbs, C.F. Green, P.M. Tarwater, L.e. Mota, K.D. Mena 

and P.V. Scarpino. Environmental Health Perspectives, 2006. 114: 1032-1037. 

Summary: Studies air samples from upwind, downwind and inside of a confined hog operation. 

Bacterial samples were tested for antibiotic resistanceand Staphylococcus aureus was the 

dominant species recovered. Samples taken within the bam displayed the highest rate of 

resistance; samples taken up to ISO meters downwind of the bam showed a higher level of 

resistance than samples taken upwind. Multiple antibiotic-resistant organisms were also found 

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within and around the bam. Concludes that this increase in antimicrobial resistance could have a 

negative on the health of people who live around these facilities. 

Community-acquired MRSA and pig-farming. X.W. Huijsdens, BJ. van Dijke, E. Spalburg, M.G. van 

Santen-Verheuvel, M.E. Heck, G.N. Pluister, A. Voss, W.J.B. Wannet and AJ. de Neeling. Annals of 

Clinical Microbiology and Antimicrobials, 2006. 5(26). 

Summary: Reports a mother and baby who were found to be carriers of MRS A A case study 

followed, fmding that the father was a pig farmer, a screening was done to test coworkers, pigs 

and family members. Three coworkers, eight of 10 pigs and the father were found to be carriers 

of MRSA. Molecular characterization of the samples clearly revealed transmission of MRSA 

from pigs to humans. These findings show clonal spread and transmission of MRSA between 

humans and pigs in the Netherlands. 

Are swine workers in the United States at increased risk of infection with zoonotic influenza virus? 

K.P. Myers, C.W. Olsen, S.F. Setterquist, A.W. Capuano, KJ. Donham, E.L. Thacker, J.A Merchant and 

G.C. Gray. Clinical Inftctious Diseases, 2006. 42: 14-20. 

Summary: Studies farmers, meat-processing workers, veterinarians and a control group to 

determine the extent of exposure to pandemic influenza strains originating from pigs. Finds that 

farmers are at greatest risk and tend to demonstrate a higher titer to both HI N 1 and HI N2 swine 

influenza virus isolates than control subjects do. 

Risk factors for antimicrobial resistance among fecal Escherichia coli from residents on forty-three 

swine farms. T.R Akwar, C. Poppe, J. Wilson, R.I. Reid-Smith, M. Dyck, J. Waddington, 

D. Shang, N. Dassie, and S.A. McEwen. Microbial Dnlg Resistance, 2007. 13(1): 69-76. 

Summary: Focuses on residents and workers of hog operations that fed antibiotics and those that 

did not. E. coli was obtained from 115 residents and tested for resistance; 25.8 percent of E. coli 

sampled was resistant to at least one antibiotic. Prevalence of resistant bacteria was higher among 

workers or residents of the farms where antibiotics were fed to hogs. Results indicate that farmers 

have an increased occupational hazard of exposure to antibiotic-resistant bacteria when antibiotics 

are fed to animals. 

Monitoring and source tracking of tetracycline resistance genes in lagoons and groundwater 

adjacent to swine-production facilities over a 3-year period. S. Koike, l.G. Krapac, RD. Oliver, AC. 

Yannarell, J.C. Chee-Sanford, R.I. Aminov and R.L Mackie. Applied and Environmental Microbiology, 

2007. 73(15): 4813-4823. 

Summary: Studies the dissemination of tetracycline-resistance genes from lagoons into the 

surrounding environment. DNA was extracted and analyzed by real-time quantitative PCR 

showing a similarity of99.8 percent for a selected resistance gene between collected groundwater 

sample DNA and that of the lagoons. States that this is clear evidence that animal waste seeping 

from lagoons can affect the environment by spreading resistance genes though groundwater 

contamination. 

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Antibiotic-resistant Enterococci and fecal indicators in surface water and groundwater impacted 

by a concentrated swine feeding operation. A.R. Sapkota, F.R. Curriero, K.E. Gibson and K.J. 

Schwab. Environmental Health Perspectives, 2007. 115(7): 104-1045. 

Summary: Reviews the risks associated with exposure to manure-contaminated water sources by 

industrial farms. The authors could not obtain specific data on levels of antibiotics in swine feed 

because it was premixed and delivered by a contracted integrator, which had deemed antibioticusage data proprietary information. Reports that elevated levels offecal indicators and antibioticresistant Enterococci were detected in water sources situated down-gradient from a swine facility 

compared with up-gradient surface water and groundwater. Concludes that "the presence of 

resistant bacteria in both drinking water and surface water sources contaminated by swine farms 

could contribute to the spread and persistence of both resistant bacteria and antibiotic resistance 

determinants in humans and the environment." 

Antibiotic resistant bacterial profiles of anaerobic swine-lagoon effluent. J.P. Brooks and M.R. 

McLaughlin. Journal of Environmental Quality, 2009. 38; 2431-2437. 

Summary: Focuses on three types of swine farms-farrowing, nursery and finisher. Antibioticresistant bacteria were screened for and isolated from all three types of farm lagoons. States that 

selective pressures appear to have an effect on the amount of resistant isolates recovered from 

swine-waste lagoons. Nursery lagoons appeared to be most contaminated, with antibioticresistant bacteria most likely due to the elevated use of antibiotics in these operations. Finisher 

farm lagoons contained the lowest concentration, signaling a lower use of antimicrobials in this 

environment. 

Prevalence, numbers and characteristics of Salmonella spp. on Irish retail pork. D.M. Prendergast, 

S.J. Duggan, U. Gonzales-Barron, S. Fanning, F. Butler, M. Cormican and G. Duffy. International 

Journal of Food Microbiology, 2009. 131; 233-239. 

Summary: Explores results of a survey of Salmonella in samples of pork from butcher shops and 

retail markets in Ireland and reports that it was found to contaminate 2.6 percent of samples 

assayed. S. Typhimurium was the dominant serotype found, at a rate of 85 percent; it is also one 

of the most frequently isolated serotypes from humans in the Irish population. Evidence of crosscontamination was found between samples, pointing to the need for good hygiene practices at the 

retail leveL 

Occurrence and persistence of erythromycin resistance genes (erm) and tetracycline resistance 

genes (tet) in waste treatment systems on swine farms. J. Chen, F. C. Michel Jr. S. Sreevatsan, M. 

Morrison, Z. Yu. Microbial Ecology, 2010. 

Summary: This study focuses on how to control antibiotic resistance (AR) that is generated by 

use of antibiotics in confined animal feeding operations (CAFOs). The authors suggest there are 

two ways to control AR; reduce the use of antimicrobials on farms or find an effective way to 

minimize AR dissemination off farms by destroying or containing AR on farms. This study 

focuses on the latter of those two ways and looks to gain perspective on how well swine farms are 

containing antibiotic resistance by treating animal manure that is produced in CAFOs before it is 

being disseminated into the environment. Three swine farms were sampled with different types 

of waste treatment systems. Upon testing in various stages of waste clean up the authors find that 

"AR arising from swine-feeding operations can survive typical swine waste treatment processes" 

and call for treatments that are more functional in destroying AR on farms. 

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POULTRY 

The effects of poultry production on farm workers. public health and the spread of antibiotic-resistant 

bacteria. 

Direct transmission of Escherichia coli from poultry to humans. A.A. Ojenyiyi. Epidemiology and 

Infection, 1989. 103(3): 513-522. 

Summary: Compares the resistance traits of E.coli collected from free-range poultry with those 

from poultry in a large-scale commercial facility. Reports that resistance to the antibiotics tested 

occurred only in those samples collected from birds in a commercial setting. Attendants from the 

commercial facilities also were found to contain resistant bacteria while samples from villagers in 

the community were negative. The authors also demonstrated that attendants contract bacteria 

from birds in their care by conducting a study where they infected birds with a known type of 

resistant E. coli and screened the attendants for the same bacteria. 

Quinolone resistance in Campy/obacter isolated from man and poultry following the introduction of 

fluoroquinolones in veterinary medicine. H.P. Endtz, G.J. Ruijs, B. van Klingeren, W.H. Jansen, T. 

van der Reyden and R.P. Mouton. The Journal of Antimicrobial Chemotherapy, 1991. 27(2): 199-208. 

Summary: Reports the results of tests for quinolone resistance in 883 strains of Campylobacter 

bacteria isolated between 1982 and 1989 from human stool and pOUltry products. Campylobacter 

isolated from poultry increased in resistance from 0 percent to 14 percent in that time, while 

resistance in human isolates rose from 0 percent to 11 percent. Results suggest that the increase is 

mainly due to use of enrofloxacin, a fluoroquinolone, in poultry. 

High-frequency recovery of quinupristin-dalfopristin-resistant Enterococcus faecium isolates from 

the poultry-production environment. J.R. Hayes, A.C. McIntosh, S. Qaiumi, J.A. Johnson, L.L. 

English, L.E. Carr, D.D. Wagner and S.W. Joseph. Journal of Clinical Microbiology. 2001. 39(6): 2298-

2299. 

Summary: Studies the extent of resistance to quinupristin-dalfopristin, a drug reserved for 

human use to treat vancomycin-resistant enterococci, in Enterococcus faecillm. Finds that 

resistance to this antimicrobial ranged between 51 percent and 78 percent in isolates screened 

from the food-production environment. 

Antibiotic resistance of faecal Escherichia coli in poultry, poultry farmers and poultry 

slaughterers, A.E. van den Bogaard, N. London, C. Driessen and E.E. Stobberingh. Journal of 

Antimicrobial Chemotherapy. 200 I. 47:763-771. 

Summary: Reports a survey of E. coli in poultry and workers who were in close contact with 

animals. Finds that the highest resistance rates were in turkeys, closely followed by broilers. 

Isolates collected from the laying-hen popUlation were much lower, possibly because of the 

infrequent use of antibiotics in these animals. In the human population the same results followed, 

with turkey workers' isolates showing greater resistance than those from broilers or laying-hens. 

Results also strongly suggest the transmission of resistant clones and resistance plasmids of E. 

coli from broilers and turkeys to humans. 

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The dioxin crisis as experiment to determine poultry-related Campy/obaeter enteritis. A. Veltinga 

and F. Van Loock. Emerging Infectious Diseases, 2002. 8(1): 19-22. 

Summary: Poultry was withdrawn in Belgium in June 1999 after a contaminant was found in 

feed. According to a model designed from the sentinel surveillance system, Campy/obaeter 

infections decreased by 40 percent during that month-from 153 cases per week to 94 cases. 

States that by using the ban as an epidemiologic tool, the rate of Campy/obacter infections 

attributable to poultry was determined to be greater than 40 percent. 

The effect of withdrawing growth promoting antibiotics from broiler chickens: A long-term 

commercial industry study. H.M. Engster, D. Marvil, B. Stewart-Brown. The Journa/ of Applied 

Poultry Research, 2002. 431-436. 

Summary: A comprehensive study where removal of growth promoting antibiotics (GPA) from 

broiler chickens was compared with those still receiving GPA. Average reduction of livability 

was only 0.2 percent on the Delmarva Peninsula (DMV) and 0.14 percent in North Carolina (NC). 

However, fluctuations were noted in livability from a reduction of 0.5 percent to a positive impact 

on livability of 0.3 percent. The average reduction in body weight was 0.03 Ib on DMV and 0.04 

Ib in NC but this decline did not start until after the first year of the triaL Feed conversion (weight 

of food/body weight gain) was not adversely affected in the study for either location. Removal of 

GPA also resulted in no reports offield outbreaks of disease and total farm condemnations were 

not affected. 

Fluoroquinolone-resistant Campy/obaeter isolates from conventional and antibiotic-free chicken 

products. L.B. Price, E. Johnson, R. Vailes and E. Silbergeld. Environmenta/ Health Perspectives, 2005. 

113: 557-560. 

Summary: Concludes that there is no difference in Campy/obaeter contamination between 

conventionally raised chickens and poultry raised antibiotic-free; however, conventionally raised 

poultry is more likely to be resistant to antibiotics than chickens raised antibiotic-free. The 

findings also suggest that fluoroquinolone-resistant isolates of Campy/obaeter may persist after 

the usage of fluoroquinolones in pOUltry production has ceased. 

Similarity between human and chicken Escherichia coli isolates in relation to ciprofloxacin 

resistance status. J.R. Johnson, M.A. Kuskowski, M. Menard, A. Gajewski, M. Xercavins and J. Garau. 

The Journal of Infoctiolls Diseases. 2006. 194(1): 71-78. 

Summary: Studies the similarities of E. coli isolates collected from humans and chickens that 

were resistant to ciprofloxacin. Finds that resistant E. coli in humans appears to have a profile 

similar to that of resistant E. coli collected from chickens, suggesting that the use of 

antimicrobials in poultry production is leading to resistant E. coli that are being transferred to 

humans, possibly though contaminated meats. 

Use of streptogramin growth promoters in poultry and isolation of streptogramin-resistant 

Enteroeoeeusfaecium from humans. A.L. Kieke, M.A. Borchardt, B.A. Kieke, S.K. Spencer, M.F. 

Vandermause, K.E. Smith, S.L. Jawahir and E.A. Belongia. The Journa/ of Infectious Diseases, 2006. 

194(9): 1200-1208. 

Summary: Examines virginiamycin use in pOUltry and its effect on cross-resistance to 

quinupristin-dalfopristin, a drug also in the streptogramin category that is intended for treating 

vancomycin-resistant Enterococcus faecium infections in humans. The study enrolled patients 

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from hospitals and vegetarians and compared the samples from humans with samples collected 

from retail poultry meats. Reports that "poultry exposure is associated with a quinupristindalfopristin resistance gene and inducible quinupristin-dalfopristin resistance in human fecal E. 

faecium. The continued use of virginiamycin may increase the potential for streptograminresistant E. faecium infection in humans." 

Subtherapeutic tylosin phosphate in broiler feed affects Campyiobacter on carcasses during 

processing. M.E. Berrang, S.R. Ladely, R.J. Meinersmann and P.l. Fedorka-Cray. Poultry Science, 2007. 

86: 1229-1233. 

Summary: Studies cross-resistance of tylosin and erythromycin (both macrolide drugs). 

Erythromycin is often the drug of choice for treating campylobacteriosis, and tylosin is approved 

at sub therapeutic levels for use in broiler feed for growth promotion. Seventy chicks were 

divided into two groups, half raised on tylosin, half without. Carcasses ofbroiters fed tylosin had 

lower numbers of Campylobacter, but all the Campylobacter found were resistant to 

erythromycin. No Campylobacter isolated from the control carcasses were resistant. Concludes 

that application of tylosin phosphate in feed results in lower numbers of Campylobacter, but those 

that remain are resistant to erythromycin. 

Growth promoting antibiotics in food animal production: An economic analysis. J.P. Graham, I.I. 

Boland and E. Silbergeld. Public Health Reports, 2007. 122:79-87. 

Summary: Examines the economic effect of removing antibiotics used for growth promotion in 

broiler chickens using data published by Perdue. Positive production changes were associated 

with use, but were insufficient to offset the cost of the antibiotics. The net effect of using growthpromoting antibiotics was a lost value of$.0093 per chicken (about 0.45 percent of total cost). 

Development of macrolide-resistant Campylobacter in broilers administered subtherapeutic or 

therapeutic concentrations of tylosin. S.R. Ladely, M.A. Harrison, PJ. Fedorka-Cray, M.E. Berrang, 

M.D. Englen and R.I. Meinersmann. Journal of Food Protection, 2007. 70(8):1915-1951. 

Summary: Looks at the impact of antibiotic use on increasing the amount of resistant bacteria in 

an environment. Poultry were divided into groups of 25 birds: the treatment group was given 

either therapeutic or sUbtherapeutic doses of tylosin beginning at two weeks of age while the 

control group was isolated and not given any antimicrobials. The animals fed subtherapeutic and 

therapeutic doses of tylosin tested positive for resistant bacteria; no resistant strains were found 

among the birds that did not get treated with tylosin. The birds treated with sub therapeutic doses 

of tylosin also showed increased resistance compared with the birds treated with therapeutic 

doses. 

Elevated risk of carrying gentamicin-resistant Escherichia coli among U.S. poultry workers. L.B. 

Price, J.P. Graham, L.G. Lackey, A. Roess, R. Vailes and E. Sitbergeld. Environmental Health 

Perspectives, 2007. 15(12):1738-1742. 

Summary: Examines poultry workers and residents on the eastern shore of Maryland and 

Virginia. Poultry workers had 32 times the odds of being colonized with gentamicin-resistant E. 

coli as community residents; the poultry workers also had an elevated risk of carrying multidrugresistant E. coli. Concludes that "occupational exposure to live animals in the broiler chicken 

industry may be an important route of entry for antimicrobial-resistant bacteria in to the 

community." 

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Antimicrobial resistance of old and recent Staphylococcus aureus isolates from poultry: First 

detection of livestock-associated methicillin-resistant strain ST398. M. Nemati, K. Hennans, U. 

Lipinska, O. Denis, A. Deplano, M. Struelens, L.A. Devriese, F. Pasmans and F. Haesebrouck. 

Antimicrobial Agents and Chemotherapy, 2008. Oct: 3817-3819. 

Summary: Compares the resistance profiles of Staphylococcus aurellS isolates collected from 

chickens in the 1970s with profiles from healthy chickens in 2006. Finds that resistant levels to 

eight of the drugs tested were significantly greater in the 2006 samples. 

Food animal transport; A potential source of community exposures to healtb bazards from 

industrial farming (CAFOs). A.M. Rule, S.L. Evans and E.K. Silbergeld. Journal of Infection and 

Public Health, 2008. 1(1): 33-39. 

Summary: Compares air samples collected while cars with bacterial-collection equipment were 

driven behind poultry transport vehicles with background samples taken during nonnal driving 

conditions. Twenty-five percent of samples collected while following poultry transport vehicles 

were resistant at least one antimicrobial, while all background samples were susceptible. 

Suggests that open-air poultry transport vehicles may playa role in spreading resistant bacteria 

that originated from the administration of antimicrobials to food animals. 

Relationsbips between multidrug-resistant Salmonella enterica Serovar Scbwarzengrund and both 

broiler cbickens and retail cbicken meats in Japan. T. Asai, K. Murakami, M. Ozawa, R. Koike and 

H. Ishikawa. Japanese Journal of Infectious Diseases. 2009.62: 198-200. 

Summary: A Salmonella strain that causes invasive salmonellosis in humans was isolated from 

broiler chickens and retail chicken meats in Japan. Numerous isolates showed multidrug 

resistance. 

Fate of antimicrobial-resistant Enterococci and Staphylococci and resistance determinants in stored 

poultry litter. J.P. Graham, S.L. Evans, L.B. Price and E.K. Silbergeld. Environmental Research, 2009. 

109: 682-689. 

Summary: Studies the storage of poultry litter and the stability of bacteria and resistance genes 

during storage. Finds that over a l20-day period, typical storage practices of poultry litter are not 

sufficient for eliminating drug-resistant Enterocci and Staphylococci, which may then be 

delivered to the environment by land application, aerosolization or water contamination during 

runoff. 

Antibiotic-resistant Enterococci and Staphylococci isolated from flies collected near confined 

poultry feeding operations. J.P. Graham, L.B. Price, S.L. Evans, T.K. Graczyk and E.K. Silbergeld. 

Science of the Total Environment, 2009.407(8): 2701-2710. 

Summary: Investigators collected poultry litter and trapped flies around poultry fanns to 

detennine the eKtent of bacteria present and their resistance-gene profile. Results suggest that 

flies around poultry operations harbor resistant bacteria in their digestive tracts and exterior 

surfaces. This could result in human exposure to resistant bacteria that arise from antimicrobial 

use on poultry fanns. Highlights the persistence ofresistant genes in the environment and the 

pool of resistance associated with the use of antibiotics in feed additives. 

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Salmonella Heidelberg Ceftiofur-related resistance in human and retail chicken isolates. Public 

Health Agency of Canada. 2009. 

Summary: In response to public health concerns about the rise of resistance in isolates of 

Salmonella and E. coli to ceftiofur, all broiler chicken hatcheries in Quebec voluntarily stopped 

using ceftiofur in February 2005. This publication reports a decrease in the number of ceftiofurresistant isolates in both chicken and human S. heidelberg isolates and in chicken Escherichia coli 

following the voluntary withdrawal of ceftiofur in hatching and day-old chicks in Quebec. 

Ceftiofur resistance in Salmonella enterica Serovar Heidelberg from chicken meat and humans, 

Canada. L. Dutil, R. Irwin, R. Finley, L. King Ng, B. Avery, P. Boerlin, A. Bourgault, L. Cole, D. 

Daignault, A. Desruisseau, W. Demczuk, L. Hoang, G.B. Horsman, J. Ismail, F. Jamieson, A. Maki, A. 

Pacagnella and D.R. Pillai. Emerging Infectious Diseases, 2010. 16(1): 48-54. 

Summary: Studies Salmonella Heidelberg, a frequently reported cause of infections in North 

America with sources linked to consumption of poultry, eggs or egg-containing products. 

Compares resistance rates of Salmonella Heidelberg isolates collected from retail chicken to 

ceftiofur, a third-generation cephalosporin, with rates of human infections that also were resistant 

to ceftiofur during a period from 2003 to 2008. During this time frame ceftiofur was removed 

from extralabel use in chicken hatcheries in Quebec, resulting in a dramatic decrease in ceftiofur 

resistance in Salmonella Heidelberg and E. coli in retail chicken. A similar decrease is shown in 

resistant human infections of Salmonella Heidelberg. Suggests that managing ceftiofur use at the 

hatchery level may control resistance rates to extended-spectrum cephalosporins. A partial 

reintroduction of ceftiofur use in hatcheries in 2007 caused a rise in ceftiofur resistance in E. coli. 

but at lower levels than those seen in 2003 to 2004. 

Veterinary pharmaceuticals and antibiotic resistance of Escherichia coli isolates in poultry litter 

from commercial farms and controlled feeding trials. V. Furtula, E.G. Farrell, F. Diarrassouba, H. 

Rempel, J. Pritchard, M.S. Diarra. POllitry Science, 2010. 89: 180-188. 

Summary; This study found that there were antimicrobial residues in broiler litter from both a 

controlled environment, where chickens were fed a diet offeed with additives of bacitracin, 

chlortetracycline, monensin, narasin, nicarbazin, penicillin, salinomycin and virginiamycin and 

from commercial farms where the same feed additives were also used. Antimicrobials are not 

fully absorbed by animals in some cases and will be excreted into the litter leaving a residue of 

antibiotics that may then be applied to" soil for crop fertilization. If application occurs, soil 

microbes will be SUbjected to these antibiotic pressures and may develop resistance themselves. 

There is also evidence for plants to uptake antimicrobial agents and can become a source of 

exposure to such compounds. E. coli isolates were collected from poultry litter from commercial 

farms and were found to be resistant to at least seven different antibiotics. Isolates from 

commercial farms showed a higher rate of resistance possibly due to the frequent use of feeds that 

are available with mUltiple antibiotics incorporated causing increased resistance. Resistance to 

such antibiotics as trimethoprim-sulfamethoxazole from isolates collected on commercial farms is 

of concern as this is a leading treatment of urinary tract infectiotls. 

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RETAIL PRODUCTS 

How industrialfood animal production affects the food supply 

An evaluation of methods to assess the effect of antimicrohial residues on the human gut flora. D. 

Corpet. Veterinary Microbiology. 1993.35(3-4): 199-212. 

Summary: Reviews the effects of antimicrobial residues on the human gut flora and concludes 

that "most resistant enterobacteria in the human gut of untreated people come from bacterial 

contamination of raw foods." This assumption stems from a study previously completed by the 

author in which a sterile diet was given to seven healthy volunteers with an outcome of reduced 

antibiotic-resistant bacteria in stools. 

Quinoline-resistant Campylobacter jejuni infections in Minnesota, 1992-1998. K.E. Smith, J.M. 

Besser, C.W. Hedberg, F.T. Leano, J.B. Bender, J.H. Wickland, B.P. Johnson, K.A. Moore and M.T. 

Osterholm. New England Journal of Medicine, 1999. 340(20): 1525-1532. 

Summary: Reports that ciprofloxacin-resistant C.jejuni was isolated from 14 percent of91 

domestic chicken products obtained from retail markets in 1997. The number of quinoloneresistant infections acquired domestically has increased, largely because of the acquisition of 

resistant strains from poultry. Resulting infections may require additional antimicrobial therapy, 

as fluoroquinolones such as ciprofloxacin are commonly prescribed for diarrheal illnesses caused 

by Campylobacter jejuni. 

Isolation of antimicrobial-resistant Escherichia coli from retail meats purchased in Greater 

Washington, DC, USA. C.M. Schroeder, D.G. White, B. Ge, Y. Zhang, P.F. McDermott, S. Ayers, S. 

Zhao, J. Meng. International Journal of Food Microbiology, 2003.85: 197-202. 

Summary: Retail meat samples were collected and analyzed from the DC area for presence of E. 

coli. Data on resistance to II antimicrobials are given with a large portion showing resistance to 

such antibiotics as tetracycline (59 percent), sulfamethoxazole (45 percent), streptomycin (44 

percent), ampicillin (35 percent) and gentamicin (12 percent). The authors conclude that their 

fmdings suggest retail meats may often be contaminated with resistant E. coli. 

Concurrent quantitation of total Campylobacter and total ciprofloxacin-resistant Campylobacter 

loads in rinses from retail raw chicken carcasses from 200 I to 2003 by direct plating at 42 degrees 

Celsius. R. Nannapaneni. R. Story, K.C. Wiggins and M.G. Johnson. Applied and Environmental 

Microbiology, 2005. 71(8): 4510-4515. 

Summary: Analyzes the total amount of Campylobaeter present in retail chicken as well as in 

ciprofloxacin-resistant isolates. Finds that ciprofloxacin-resistant Campylobacter persisted 

throughout the two-and-a-half-year study, showing a reservoir of resistance in the U.S. food 

market. 

Sulfamethazine uptake by plants from a manure-amended soil. H. Dolliver, K. Kumar and S. Gupta. 

Journal of Environmental Quality, 2007. 36: 1224-1230. 

Summary: Studies the uptake of sulfamethazine, an antibiotic extensively used in animal 

agriculture for therapeutic and sUbtherapeutic purposes, in corn, lettuce and potatoes when 

manure-amended soil is used as the growing medium. Following 45 days of growth, all plants 

tested were contaminated with the antibiotic in varying concentrations. 

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Antimicrobial drug-resistant Escherichia coli from humans and poultry products, Minnesota and 

Wisconsin, 2002-2004. J.R. Johnson, M.R. Sannes, C. Croy, B. Johnston, C. Clabots, M.A. Kuskowski, 

J. Bender, K.E. Smith, P.L. Winokur and E.A. Belongia. Emerging Infectious Diseases, 2007, 13(6): 838-

846. 

Summary: Studies susceptible and resistant E. coli collected from hospital patients, healthy 

vegetarians and poultry that were raised conventionally and without antibiotics. Suggests that 

many resistant human isolates may originate from poultry. Isolates from healthy vegetarians also 

follow this pattern, suggesting that avoidance of pOUltry consumption does not decrease the 

possibility of carrying drug-resistant E. coli from poultry. 

The isolation of antibiotic-resistant Salmonella from retail ground meats. D.G. White, S. Zhao, R. 

Sudler, S. Ayers, S, Friedman, S. Chen, P.F. McDermott, S. McDermott, D.D. Wagner and J. Meng. New 

England Journal of Medicine, 2007. 345(16):1147-1154. 

Summary: Researchers tested Salmonella from samples of ground chicken, pork, beef and 

turkey purchased at three supermarkets in the Washington, DC, area. Of200 samples, 41 (20 

percent) contained Salmonella. Eighty-four percent of those were resistant to at least one 

antibiotic and 53 percent were resistant to at least three antibiotics. Sixteen percent were resistant 

to ceftriaxone, the drug of choice for treating salmonellosis in children. 

Resistance in bacteria of the food chain: Epidemiology and control strategies. F.M. Aarestrup, H.C. 

Wegener and P. Collignon. Expert Reviews. 2008. 6(5): 733-750. 

Summary: Reviews bacterial resistance due to the use of antimicrobials in food animals and 

their transferability to humans in the form of pathogens. States that limiting the selective 

pressure in food animal production, especially those antibiotics that are critically important to 

human health, will help control the emergence of resistant bacteria most efficiently. 

Molecular analysis of Escherichia coli from retail meats (2002-2004) from the United States 

National Antimicrobial Resistance Monitoring System. J.R. Johnson, J.S. McCabe, D.G. White, B. 

Johnston, M.A. Kuskowski and P. McDermott. Clinical Infectious Diseases, 2009. 49: 195-201. 

Summary: Researchers screened 287 E. coli isolates collected by the National Antimicrobial 

Resistance Monitoring System (NARMS) for virulence-associated genes. Resistant and 

susceptible strains differed minimally based on the assessed virulence factors; however, the four 

meat types screened showed a great variance as chicken and turkey isolates had consistently 

higher virulence scores than beef and pork samples. These results support the hypothesis that 

antimicrobial-resistant E. coli in retail meats emerge from a host species-specific lineage due to 

the direct effect of selection pressure from use of antimicrobials or as part ofthe organisms' 

adaptations to their respective hosts. 

Transient intestinal carriage after ingestion of antibiotic-resistant Enterococcusfaecium from 

chicken and pork. T.L. Sorensen, M. Blom, D.L. Monnet, N. Frimodt-Moller, R.L. Poulsen and F. 

Espersen. New England Journal of Medicine. 2009. 345(16): 1161-1166. 

Summary: Reports on a study designed to test the ability of Enterococci from various meat 

sources to have sustained viability in the human intestine. Twelve volunteers ingested a 

suspension of Enterococci that originated from either a pig or chicken source that was resistant to 

at least one antibiotic. None of the 12 volunteers was colonized with resistant Enterococci at the 

onset of the experiment; however, eight of the 12 had antibiotic-resistant Enterococci isolated at 

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six days following ingestion, and one had resistant Enterococci at 14 days' post ingestion. 

Concludes that ingestion of resistant Enterococci of animal origin leads to detectable 

concentrations of the same resistant strain in stools for up to 14 days. 

Methicillin-resistant Staphylococcus aureus in food products: Cause for concern or complacency? J. 

A. J. W. Kluytmans. Clinical Microbiology and Infection, 2010.16(1): 11-15. 

Summary: A review on an emerging sequence type of MRS A ST398, which has been isolated 

from various food animals. A recent study in the U.S. observed a contamination rate of39.2 

percent for S. aI/reus on retail meats and in that group 5 percent was MRSA. Studies abroad have 

shown rates of MRS A contaminating retail meats as high as 11.9 percent. The author suggests 

that even though ST398 does not appear to spread easily among humans this assumption needs to 

be confirmed in well-designed studies. The spread of ST398 from animals to humans needs to be 

monitored as the potential threat from the retail food reservoir has widespread potential 

implications on human health. 

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MRSA 

The impacts of methicillin-resistant Staphylococcus aureus (MRSA) on certain areas across the country, 

veterinarians, health care employees and farmers. 

Methicillin-resistant Staphylococcus aurellS in pig farming. A. Voss, F. Loeffen, J. Bakker, C. 

Klaassen and M. Wulf. Emerging Infectious Diseases, 2005. 11(12): 1965-1966. 

Summary: Examines cases of MRS A colonization resulting from farmers' contact with pigs, 

how it moved though their families and was transmitted between a hospital patient and nurse. 

Reports that the frequency of MRS A among the group of regional pig farmers is more than 760 

times higher than that among the general Dutch population. 

Methicillin-resistant Staphylococcus aureus colonization in veterinary personnel. B.A. Hanselman, 

S.A. Kruth, J. Rousseau, D.E. Low, B.A. Willey, A. McGeer and J.S. Weese. Emerging Infectious 

Diseases, 2006. 12(12): 1933-1938. 

Summary: Reports a comprehensive evaluation of veterinary personnel for carriage ofMRSA. 

Samples were taken from participants who resided in 19 different countries and rates of 

colonization were determined. Of the volunteers, 6.5 percent were positive for MRSA; those 

working with larger animals showed higher carriage rates (15.6 percent). 

Hospitalizations and deaths caused by methicillin-resistant Staphylococcus au reus, United States, 

1999-2005. E. Klein, D.L. Smith and R. Laxminarayan. Emerging Infectious Diseases. 2007. 13(12): 

1840-1846. 

Summary: Reports on trends in MRS A infections between 1999 and 2005. The estimated rise in 

hospitalizations due to Staphylococcus aureus infections during this time was 62 percent, while 

the rate of MRS A infections more than doubled. 

Invasive methicillin-resistant Staphylococcus aureus infections in the United States. R.M. Klevens, 

M.A. Morrison, J. Nadle, S. Petit, K. Gershman, S. Ray, L.H. Harisson, R. Lynfield, G. Dumyati, J.M. 

Townes, A.S. Craig, E.R. Zell, G.E. Fosheim, L.K. McDougal, R.B. Carey and S.K. Fridkin. Journal of 

the American Medical Association, 2007. 285(15): 1763-1771. 

Summary: Finds that MRS A affects certain populations disproportionately, particularly African 

Americans. After researching invasive MRSA infections reported in hospitals in eight U.S. cities 

and the state of Connecticut, the authors estimate that in 2005 more than 94,000 cases of such 

infections occllrred, 18,650 of which were fatal. 

Emergence of methicillin-resistant Staphylococcus aurells of animal origin in humans. l. van Loo, X. 

Huijsdens, E. Tuemersma, A. de Neeling, N. van de Sande-Bruinsma, D. Beaujean, A. Voss and J. 

Kluytmans. Emerging Infectious Diseases, 2007. 13(12): 1834-1839. 

Summary: Reports that a new type of MRS A from an animal reservoir (pigs in the Netherlands) 

has recently entered the human popUlation and is now responsible for greater than 20 percent of 

all MRSA in the Netherlands. As most nontypable MRSA isolates are resistant to doxycycline, 

the spread of MRSA may be facilitated by the abllndant use of tetracyclines in pig and cattle 

farming. 

Methicillin-resistant StaphylococClls allrells ST398 in humans and animals, Central Europe. W. 

Witte, B. Strommenger, C. Stanek and C. Cuny. Emerging Infectious Diseases, 2007. 13(2): 255-258. 

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Summary: Studies recent human colonization by MRSA ST398, which in previous years had not 

been seen in humans. Animal-to-human transmission may occur with this strain; for example, a 

dog being treated for a wound infection transmitted ST398 to the staff of the veterinary practice 

where the dog was treated. Concludes that "MRS A exhibiting ST398 may colonize and cause 

infections in humans and in certain animal species such as dogs, horses and pigs." 

Methicillin-resistant Staphylococcus aureus colonization in pigs and pig farmers. T. Khanna, R. 

Friendship, D. Dewey and I.S. Weese. Veterinary Microbiology, 2008. 128:298-303. 

Summary: This study, the first of MRSA and pig farms in Canada, found that the prevalence of 

MRSA colonization on pig farms was 45 percent; prevalence in pig farmers was 20 percent. 

Humans residing on farms where pigs were free of MRS A also tested negative for MRSA. The 

authors note another study in which MRSA was identified in food products intended for human 

consumption, but none originated in pigs. This study adds support to the hypothesis that MRSA 

can be transmitted between pigs and humans. 

Pigs as source of methicillin-resistant Staphylococcu.f au reus CC398 infections in humans, 

Denmark. H.C. Lewis, K. Molbak, C. Reese, F.M. Aarestrup, M. Selchau, M. Sorum and R.L. Skov. 

Emerging Infectious Diseases. 2008. 14(9): 1383-1389. 

Summary: Provides evidence that persons exposed to animals on farms in Denmark, particularly 

pig farms, have an increased chance of being colonized or infected with MRSA CC398. 

Methicillin-resistant and -susceptible Staphylococcus aureus sequence type 398 in pigs and humans. 

A.van Belkum, D.C. Melles, I.K. Peeters, W.B. van Leeuwen, E. van Duijkeren, X.W. Huijsdens, E. 

Spalburg, A.I. de Neeling and H.A. Verbrugh. Emerging Infectiolls Diseases, 2008. 14(3):479-483. 

Summary: Reports that MRS A ST398, primarily a pathogen of pigs, appears to be quite virulent 

and can cause bacteremia in humans. States that if MRS A ST398 obtains this pathogenicity, care 

should be taken not to introduce this strain into humans. 

Transmission of methicillin-resistant Staphylococcus aureus strains between different kinds of pig 

farms. E. van Duijkeren, R. lkawaty, M.I. Broekhuizen-Stins, M.D. Iansen, E.C. Spalburg, AJ. de 

Neeling, I.G. Allaart, A.van Nes, I.A.Wagenaar and A.C. Fluit. Veterinary Microbiology, 2008. 126: 

383-389. 

Summary: MRSA strains were found in 23 percent of the farms tested. States that the use of 

standard antimicrobials "seems to be a risk factor for finding MRS A-positive pigs on a farm. Pig 

farms on which the pigs were treated with antimicrobials as group medication had a higher risk of 

being MRSA positive, 'whereas farms on which antimicrobials were used restrictively had a much 

lower chance of being MRSA positive." 

Increase in a Dutch hospital of methicillin-resistant Staphylococcus aureus related to animal 

farming. M.M.L. van Rijen, P.H. Van Keulen and I.A. Kluytmans. Clinical InfectiollS Diseases, 2008. 

16:261-263. 

Summary: Reports on a study 2002-2006 in the Netherlands involving hospital patients who 

had MRSA. Patients exposed to pigs or veal calves were shown to be at higher risk for MRS A as 

there was an emergence of nontypable MRSA during this time. Nontypable MRSA is assumed to 

stem from pigs and calves. 

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Methicillin-resistant Staphylococcus au reus (MRSA) strain ST398 is present in Midwestern U.S. 

swine and swine workers. T.C. Smith, MJ. Male, A.L. Harper, J.S. Kroeger, G.P. Tinkler, E.D. Moritz, 

A.W. Capuano, L.A. Herwaldt and D.J. Diekema. PLoS ONE. 2009. 4(1): e4258. 

Summary: Investigates MRS A in the Midwestern U.S. Samples were taken from swine and 

production workers in two commercial operations. MRS A prevalence was 49 percent in swine 

and 45 percent in workers. Results show that MRSA is common in swine production in the U.S. 

and that these animals could be harboring the bacterium. 

Methicillin-resistant Staphylococcus aureus: A new zoonotic agent? B. Springer, U. Orendi, P. Much, 

G. Hoger, W. Ruppitsch, K. Krziwanek, S. Metz-Gercek and H. Mittermayer. The Middle Ellropean 

Journal of Medicine, 2009. 121: 86-90. 

Summary: Discusses changes in MRS A over the past decade. Once known almost completely 

as a hospital pathogen, MRSA is now emerging in the community in persons without hospitalrelated risk factors. Recent evidence also has shown a link between livestock colonization and 

MRS A infections in persons working with these animals. Identifies three potential transmission 

routes of MRS A: from animal origin into the population; human-to-human contact from farm 

workers to the community; via food or by environmental contamination. 

Methicillin resistant Staphylococcus aurues ST398 in veal calf farming: Human MRSA carriage 

related with animal antimicrobial usage and farm hygiene. H. Graveland, J.A. Wagenaar, H. 

Heesterbeek, D. Mevius, E. van Duijkeren, D. Heederik. PLoS One, 2010.5(6): 1-6. 

Summary: Studies MRSA ST398 carriage in veal calves, farmers, their family members and 

employees. A large sampling size of veal calf farms in the Netherlands was selected at random to 

be screened for ST398. All participants were given a questionnaire to fill in describing their 

contact and role on the farm as well as how farm operations were conducted. Samples from both 

humans and veal calves were cultured and categorized using molecular techniques. The data 

presented show that direct associations between human and animal carriage of MRS A ST398 

exist and that carriage was shown to increase in calves as antibiotic use on the farm increased. 

Duration of contact to veal calves showed a highly elevated risk of MRS A ST398 carriage in 

humans and a decrease in MRSA was seen in farms with better hygiene practices (ie cleaning of 

stables before new claves were brought on the farm). Disinfection was applied in less than 20 

percent of the farms in the study and was not associated with prevalence of MRSA carriage in 

calves. Overall the prevalence of MRS A was 15.9 percent in participants who lived or worked on 

veal calf farms, which is far greater than the general population carriage rate in the Netherlands 

estimated to be below I percent. 

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ANTIMICROBIAL-RESISTANT INFECTIONS 

Injections arising with implications toward the use of antimicrobials in food animal production. 

Widespread distribution of urinary tract infections caused by a muItidrug-resistant Escherichia 

coli clonal group. A.R. Manges, J.R. Johnson, B. Foxman, T.T. O'Bryan, K.E. Fullerton and L.W. Riley. 

New England Journal of Medicine, 200 L 345(14): 1007-10 13. 

Summary: Studies urinary tract infections (UTls) in the u.S. caused by E coli resistant to 

trimethoprim-sulfamethoxazole as well as other antibiotics. Concludes that UTls may be caused 

by contaminated foods, as the outbreaks appear to follow a pattern similar to that of E coli 0157 

as they spread throughout a community. 

Fluoroquinolone resistance in Camplyobacter absent from isolates, Australia. L. Unicomb, J. 

Ferguson, T.V. Riley and P. Collignon. Emerging Infectious Diseases, 2003. 9(11): 1482-1483. 

Summary: Reports on a study offluoroquinolone resistance in New South Wales, Australia, 

over a three-year period. Only 12 Campylobacter isolates were found to be resistant to 

f1uoroquinolones. Ten of these were related to travel; travel status of the other two is unknown. 

Australia has never allowed the use offluoroquinolones in food animal production, a policy that 

may have impacts on human health for countries with f1uoroquinolone-resistant cases of 

Campylobacter. 

Possible animal origin of human-associated, multidrug-resistant, uropathogenic Escherichia coli. 

M. Ramchandi, et aL Clinical Infectious Disease, 2005.40: 251-257. 

Summary: Reviews a collection of 495 animal and environmental E. coli isolates collected by 

the Gastroenteric Disease Center and determines that 26 percent had indistinguishable 

characteristics from human isolates. Concludes that the data suggest that drug-resistant, 

uropathogenic, human-associated E coli strains may have an animal origin and that drug-resistant 

urinary tract infections in humans could be derived from foodborne illnesses. 

Tbe rising influx of multidrug-resistant gram-negative bacilli into a tertiary care hospital. A.E. 

Pop-Vicas, E. M. C. D'Agata. Clinical Injectiolls Diseases, 2005. 40: 1792-8. 

Summary: Studies multi-drug resistant (MDR) E coli, Klebsiella species, Enterobacter cloacae, 

and Pseudomonas aemginosa isolates from patients harboring these bacteria upon entering a 

hospital in Israel (within 48 hours of admittance). Finds that between 1998 and 2003 the 

prevalence of MDR isolates of all listed species increased significantly except Pseudomonas 

aeruginosa. Of the 464 isolates collected 12 percent, 35 percent and 53 percent were resistant to 

5, 4 and 3 antimicrobial groups, respectively. 

Analysis of a uropathogenic Escherichia coli clonal group by multilocus sequence typing. SY. 

Tartof, 0.0. Solberg, A.R. Manges, L.W. Riley. Journal of Clinical Microbiology, 2005.5860-5864. 

Summary: Forty-five strains of uropathogenic E coli were analyzed by a molecular typing 

method called multi-locus sequence typing (MLST). The research shows that one sample from a 

cow grouped with other human isolates collected from urinary tract infections and bacteremia. 

This shows that E coli from animals may be a cause of UTls and bactermia in humans. 

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Low-level fluoroquinolone resistance among Campfyobacter jejuni isolates in Australia. L. Unicomb, 

J. Ferguson, R.J. Stafford, R. Ashbolt, M.D. Kirk, N.O. Becker, M.S. Patel, 0.0. Oilbert, M. Valcanis 

and L. Mickan. Clinical Infectious Diseases. 2006. 42: 1368-1374. 

Summary: Reports a study from five Australian states between 200 I and 2002 that looked into 

the susceptibility patterns of Campylobacter jejuni. Only two percent of isolates from locally 

acquired infections were resistant to ciprofloxacin, likely reflecting Australia's policy of 

restricting the use of fluoroquinolones in food production animals. 

First report of the emergence of CTX-M-type extended spectrum S-Lactamases (ESBLs) as the 

predominant ESBL isolated in a U.S. health care system. J. S. Lewis II, M. Herrena, B. Wickes, lE. 

Patterson, J. H. Jorgensen. Antimicrobial Agents and Chemotherapy, 2007.51(11): 4015-4021. 

Summary: A study on Extended spectrum beta-Iactamases (ESBLs) from a clinic in San 

Antonio Texas. ESBLs are enzymes produced by bacteria that can negate the use of certain 

newer antibiotics used in treating infections of E. coli or similar bacteria. The new ESBL enzyme 

described here as seen for the first time in the U.S. is located on a plasmid (a mobile element of 

DNA) within the bacterium. As plasmids can be readily passed between bacteria this new finding 

could have a wide health impact. The authors state "a worrisome trend with the emergence of 

these enzymes has been an increasing frequency of E. coli isolates from outpatients or patients 

hospitalized for a very brief period, suggesting community acquisition of these strains." 

Endemic and epidemic lineages of Escherichia coli that cause urinary tract infections. A.R. Manges, 

H. Tabor, P. Tellis, C. Vincent and P. Tellier. Emerging [nfectious Diseases, 2008. 14(10): 1575-1583. 

Summary: Studies urinary tract infections (UTI) in women from California and Canada. 

Relatedness of the infections is apparent, as the profiles of the bacteria are identical. Multidrugresistant E. coli outbreaks are the causative agent of the disease, and how these bacteria are 

acquired by the gut is unclear; however, the authors cite a previous study indicating that poultry 

and pork consumption may lead to the development of drug-resistant UTIs. 

Temporal changes in the prevalence of community-acquired antimicrobial-resistant urinary tract 

infection affected by Escherichia coli clonal group composition. S.P. Smith, A.R. Manges, L.W. 

Riley. Clinical Infectious Diseases, 2008. 46: 689-695. 

Summary: Reports on urinary tract infections (UTIs) from 1,667 patients over the course of6 

years. E. coli specimens were collected and characterized by molecular methods. Twelve percent 

of human UTI samples collected were found to be from a specific group, which from previous 

work has been shown to include E. coli that had been collected from food animals or retail poultry 

products. The collected human isolates were also shown to be resistant to trimethoprimsulfamethoxazole at a rate of 49 percent. The authors suggest that contaminated food products 

may be a source 0 f drug resistant UTIs. 

Hospital and societal costs of antimicrobial-resistant infections in a Chicago teaching hospital: 

Implications for antibiotic stewardship. R.R. Roberts, B. Hota, l. Ahmad, R.D. Scott II, S.D. Foster, F. 

Abbasi, S. Schabowski, L.M. Kampe, 0.0. Ciavarella, M. Supino, J. Naples, R. Cordell, S.B. Levy and 

R.A. Weinstein. Clinical [nfectiolls Diseases, 2009. 49: 1175-1184. 

Summary: Assesses the attributable cost associated with antimicrobial-resistant infections 

(ARl). Data were collected from patients admitted to a public teaching hospital in the Chicago 

area in the year 2000. Of 188 patients that met eligibility of ARl, the attributable medical cost of 

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treatment ranged from $18,588 to $29,069 per patient. Social costs were $10.7 to $15.0 million, 

and total cost corrected to 2008 dollars was $ 13.35 million. 

Antibiotic management of Staphylococcus aureus infections in US children's hospitals, 1999-2008. 

J.C. Herigon, A.L Hersh, J.S. Gerber, T.E. Zaoutis, J.G. Newland. Pediatrics, 2010. l25:eI294-e1300. 

Summary: This study focuses on the rates of S. aureus infection in children under the age of 18 

from 1999 until 2008. The authors also track the trend of antimicrobial use during that time 

period. Finds that S. at/reus infections increased by a rate of more than IO-fold over the course of 

10 years from 14.8 per 1000 admissions in 1999 to 35.7 per 1000 admissions in 2008. MRSA 

infections also increased I O-fold during the same period from 2.0 cases per 1000 admissions in 

1999 to 20.7 cases per 1000 admissions in 2008. Increased use of c!indamycin was most 

substantial (21 percent in 1999 to 63 percent in 2008) while linezolid also saw increased use 

between 2001 (when it became available) and 2008. The substantial use of clindamycin may lead 

to greater resistance and ineffective treatment of future s. at/reus infections. The authors note that 

continuous monitoring of local S. aureus susceptibility patterns is needed as treatment patterns 

have changed over the past decade due to the emergence of community-associated MRSA. 

Genetic identity of aminoglycoside-resistance genes in Escherichia coli isolates from human and 

animal sources. P. Ho, R.C. Wong, S.W. Lo, K. Chow, S.S. Wong, T. Que. Journal of Medical 

Microbiology, 2010. 59: 702-707. 

Summary: A study in Hong Kong on E. coli isolates collected from food producing animals and 

humans (most from urinary tract infections). The group looked at the aminoglycocide 

(gentamicin) resistance characteristics of these isolates and found the main source of resistance 

was due to a gene called aacC2. The aacC2 gene was shown to exist in both human and animal E. 

coli. This suggests that gentamicin resistance in human E. coli urinary isolates can be attributed 

to resistance genes that are present in food-producing animals. Study illustrates when humans are 

in close contact with contaminated food, there is a risk of picking up antibiotic resistant E. coli 

that could lead to UTIs that are more difficult to treat. 

Food reservoir for Escherichia coli causing urinary tract infections. C. Vincent, P. Boerlin, D. 

Daignault, C.M. Dozois, L. Dutil, C. Galanakis, RJ. Reid-Smith, P-P. Tellier, P.A. Tellis, K. Ziebell, 

A.R. Manges. Emerging Infectious Diseases, 2010.16(1):88-95. 

Summary: The design of this study was to see if a food reservoir exists for E. coli that may 

cause urinary tract infections. Sampling for E. coli was completed between 2005 and 2007 

comprising clinical UTI samples, retail meats and restaurantiready-to-eat foods. Upon 

comparison of these collected isolates by molecular methods the author's report that E. coli 

identified from retail chicken and other food sources are identical or nearly the same as those 

from human UTIs. 

For additional information on the Pew Campaign 011 Human Health and Industrial Farming, or on any 

o(these studies. please contact Laura Rogers. Project Director, Pew Health Group. at (202) 552-2018 or 

lrogers@pewtrusts.org. 

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163 

Ms. SCHAKOWSKY. [Presiding] Thank you. 

Dr. Hoang. 

STATEMENT OF CHRISTINE HOANG 

Dr. HOANG. Thank you for the opportunity to speak about antimicrobial resistance and the use of antimicrobials in animal agriculture. My name is Dr. Christine Hoang and I represent the 

American Veterinary Medical Association. 

As a veterinarian with a dual degree in veterinary medicine and 

public health, and additionally certified in public health, my work 

is largely focused on scientific evaluations to inform the decisionmaking process both domestically and abroad through the AVMA, 

the Codex Alimentarius Commission and prior to that the Food and 

Agricultural Organization of the United Nations. 

The AVMA’s 80,000 members are engaged in every aspect of veterinary medicine and public health. As veterinarians, our oath ethically charges us with promoting public health and protecting animal health and welfare. With that also comes the responsibility to 

be cognizant of the potential health impacts in humans that may 

occur as a result of any decision that we make. The veterinarian 

must always the consider individual animal, other animals and humans in contact with that animal, and if it is a food animal, we 

must ultimately consider the people who consume the end product. 

The decisions of the veterinarian go far beyond a single animal or 

person and an entire herd or flock and potentially hundreds of 

thousands of people that are affected by the many foods that are 

produced by a single animal. Therefore, as veterinarians, we carry 

a heavy burden but we do willingly with the knowledge, education 

and ability to make the right decision and to use the tools that are 

available to us appropriately and judiciously. Our members share 

the same concerns as our human health counterparts but yet we 

have additional concerns that must be considered: impacts on animal health and welfare and even negative impacts on human 

health that are often unrealized. 

Two decades ago, a study concluded that human health hazards 

from growth-promoting uses could not be proven nor disproven. 

The debate continues today for that very same reason. A direct epidemiologic investigation still cannot be completed. Furthermore, 

there are divergent opinions due to differing levels of acceptable 

risk. For example, a person might find risk associate with food unacceptable, any risk would be unacceptable, but risks associated 

with high-speed driving perfectly permissible. 

As veterinarians, we must consider many risks, risk to the animal, risk to ourselves, risk to our clients, risk to public health, risk 

of action and risk of inaction, and the accepting of some of those 

risks in order to minimize others. Whenever antibiotics are used, 

there is some risk of resistance developing. That risk resistance can 

be transmitted to humans yet systems are in place that can trigger 

further investigation to determine the level of those associated 

risks. Risk analyses that evaluate only risk report adverse effects 

ranging anywhere from one in 32,000 to seven in 100 million. Risk 

analyses that also consider benefits indicate an increase in thousands of sensitive strained human cases for a reduction of a fracVerDate Mar 14 2013 09:19 Mar 20, 2013 Jkt 077921 PO 00000 Frm 00171 Fmt 6633 Sfmt 6633 E:\HR\OC\A921.XXX A921

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tion of a single resistant case. Therefore, the greater risk of 

foodborne illness must be weighed against the many other factors. 

We caution against preemptive bans based on the following observations in other countries: significant increases in therapeutic 

use as a substitution for growth promoters. The need for increased 

therapeutic uses are indicative of a decline in animal health and 

welfare associated with disease and no clear evidence of a significant human health benefit. Veterinarians are trained medical professionals with the ability to predict disease conditions and recommend appropriate therapy. Those uses should not be considered 

injudicious nor banned as routine use. If a disease is predictable 

and can be prevented, it is incumbent upon the veterinarian to initiate appropriate therapy to prevent animal pain and suffering. Although over-the-counter antibiotic are available for such therapies, 

they are not unregulated. If a drug is not used according to the approved label indications for the dose, duration, disease or species 

or within extra-label drug use regulations, it is illegal. 

The AVMA’s antimicrobial use task force recently concluded that 

veterinarians should be involved in the decision-making process for 

the use of all antimicrobials in animals regardless of the distribution channel through which it was obtained. This would encompass 

prescription products, veterinary feed directives and over-thecounter antibiotics. Without exception, the AVMA is supportive of 

measures to mitigate risk to human health. To avoid potential diversion of resources away from more appropriate disease control 

measures, we encourage a regulatory strategy that is based on 

science, risk and benefit analysis, risk management that is commensurate with the level of risk, and cooperation with all relevant 

stakeholders. The AVMA is committed to providing consumers with 

the safest food possible and to protect human health against the 

current risk without compromising the health of food animals. 

Thank you for the opportunity to appear before you today. 

[The prepared statement of Dr. Hoang follows:] 


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TESTIMONY OF 

Christine Hoang, DVM, MPH, CPH 

Assistant Director 

American Veterinary Medical Association 

Concerning 

Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture 

Before the U.S. House of Representatives, 

Committee on Energy and Commerce, 

Subcommittee on Health 

July 14, 2010 
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Thank you, Mister Chairman and members of the Subcommittee on Health, for providing the American 

Veterinary Medical Association (AVMA) with the opportunity to speak about antimicrobial resistance and 

the use of antimicrobials in animal agriculture. 

My name is Dr. Christine Hoang, and I am an Assistant Director in the Scientific Activities Division of the 

American Veterinary Medical Association. In addition to a doctorate in veterinary medicine, I also hold a 

master of public health degree with concentrations in veterinary public health policy, both national and 

international, as well as epidemiology' and am additionally certified in public health. My work focuses 

upon science based policy for food safety, zoonotic diseaseb

, and antimicrobial resistance on behalf of 

the veterinary profession. Not only are these topics of public interest, but these are topics that require a 

great deal of intensive research and careful evaluation. 

Established in 1863, the AVMA is a not for profit association representing more than 80,000 U.S. 

veterinarians engaged in every aspect of veterinary medicine and public health private and corporate 

practice, government, industry, academia, and uniformed services. As veterinarians, our oath ethically 

charges us with promoting public health and protecting animal health and welfare. With that also comes 

the responsibility to be cognizant of the potential human impacts that may occur as a result of any 

decision we make. When a veterinarian makes the decision to use a drug, any drug, especially in a food 

animal, that person must consider the individual animal; other animals that may come into contact with 

that animal; humans who may come into contact with that animal; and if it is a food animal, we must 

ultimately consider the people who consume the end product. In today's world, the decisions of a 

veterinarian affect far beyond a single animal or person - it is an entire herd or flock and potentially 

hundreds or thousands of people affected by the many foods that are produced from a single animal. 

Therefore, as veterinarians, we carry a heavy burden, but we do so willingly with the knowledge, 

education, and ability to make the right decisions and to use the tools that are available to us 

appropriately and judiciously. With respect to antimicrobial resistance, our members share the same 

concerns as our human health counterparts. Yet, we also have additional concerns that must be 

considered such as negative impacts on animal health and welfare or even negative impacts on human 

health that are often unrealized. 

Risk - Benefit Assessments and Human Health Impact 

Two decades ago, at the request of the Food and Drug Administration (FDA), a committee of the National 

Research Council was charged with evaluating the effects of penicillin, chlortetracycline, and 

oxytetracyline at levels for growth promotion or disease prevention on human health. The committee 

concluded that human health hazards could not be proven or disproven because it is impossible to 

determine antimicrobial exposures of individual animal sources of meat products '. The debate continues 

today for the very same reason. While there have been technological advances such as DNA 

fingerprinting that can identify clonal isolates, a direct epidemiologic investigation still cannot be 

completed. Therefore, antimicrobial resistance and the role of animal agriculture continue to be debated. 

As the debate continues, it is important to understand that much of the varying opinions is due to differing 

levels of acceptable risks. For example, as an individual, a person may not accept any risks associated 

with food and yet be extremely tolerant of risks associated with driving at high speeds. As veterinarians, 

we must consider many risks risks to the animal, risks to ourselves, risks to our clients, risks to public 

health, risks of action, and risks of inaction - and be accepting of some of those risks in order to minimize 

other risks. 

a Epidemiology is a medical discipline that i" the study of the causes, distribution, and control of di~ease in populations and serves ao; the 

foundation and tQ£h: of interventions made in the interest ofj2nhEffi~.alfu and n.rc\'\.'!ljiv~ nJe5Ji9n~. 

b Zoonotic dis!.!ases are diseases d:1.:1t can be transmitted trom animals to humans. CDC estimates at lea'>t 60 percent of all human diseao;cs and 

75 pen::ent of all newly em..'Tging diseases are zoonotic. 

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Whenever antimicrobials are used, there is some risk of resistance developing. Therefore, similar to 

human medicine, clinical infections do occur and resistance in food animals does develop. That 

resistance can be transmitted to humans, however multiple monitoring and surveillance systems are in 

place that can recognize impactful events and trigger further investigation to determine the level of 

associated risks. One of those systems is the FDA adverse event reporting system which should include 

treatment failure as a result of resistance. Another system is the National Antimicrobial Resistance 

Monitoring System (NARMS) that monitors resistance in foodborne human enteric pathogens as well as 

resistance in animals. The retail meat NARMS surveys and the animal arm of NARMS, provide a more 

comprehensive view of antimicrobial sub-populations than the NARMS human data that are collected. 

Furthermore, resistance is closely monitored through diagnostic samples and retail meats with an 

overrepresentation in sampling. The NARMS sample collection design ensures that resistant animal 

isolates are overrepresented. 

Recognizing that food is the most likely route of transmission of resistance from food animals to humans', 

the AVMA supports the use of multidisciplinary and multi-hurdle' approaches' to safeguard our food 

supply and minimize the potential for any adverse impacts on human health. For instance, on the farm, 

we encourage the continued improvement of animal husbandry and management practices, the 

development of new technologies to advance animal health, and the continued availability and judicious 

use of antimicrobials. Post-harvest, we support the on-going improvements of Hazards Analysis and 

Critical Control Points (HACCP) based pathogen reduction programs - all of which to ensure a safe, 

healthy, and wholesome food supply. Some data suggest post harvest interventions, such as 

hyperthermia and disinfection can influence the survival of resistant bacteria, and should be further 

investigated. 4 

To minimize risks to human health, the FDA requires antimicrobial manufacturers to provide information 

to show that a proposed animal drug will not harm public health. The procedure ensures zero-risk for 

human safety because drugs that pose risks beyond "a reasonable certainty of no harm" to human health 

are rejected or the use of the antimicrobial may be limited in order to mitigate the adverse effect. 

Antimicrobials approved since the implementation of the FDA Guidance for Industry #152 (a risk analysis 

process) in 2003, have undergone a comprehensive, evidence-based approach to prevent the 

emergence and selection of antimicrobial resistant bacteria that may adversely affect human health. 

Because the extent-of-use limitations table in GFI #152 assigns a high ranking for intended administration 

to flocks or herds of animals, it is extremely difficult or impossible for FDA to approve antibiotics for use in 

feed or water for treatment of groups of animals, if those same antibiotics are also used in humans. 

Unfortunately, few new antimicrobials are currently being developed. While several drugs are developed 

and reserved for human use, only one new drug (tiamulin) has been made available for treating animal 

disease in recent years. Therefore, the antimicrobials that were approved decades ago (and in the same 

classes as some human use antimicrobials) may be the only antimicrobials available for use in herds and 

flocks to combat infectious diseases and safeguard the food supply. 

Given the pre-approval safety measures taken by FDA, further action to restrict antimicrobial use in 

animals should only occur if there is an imminent threat to human health or if the data clearly show that 

there is a threat developing following an accurate scientific risk assessment. The risk assessment must 

be conducted to facilitate risk-based decisions concerning the appropriate and judicious use of 

antimicrobials. Risk analyses should continue to evaluate the risks and benefits to animal health and 

welfare, in addition to the risks and benefits to human health attributed to uses in food animals. Risk 

analyses include risk assessment, risk communication, and risk management actions that are 

commensurate with the level of risk that is determined through risk assessment. Following a risk 

assessment, the risk management action may simply be to allow continued availability of the product with 

no changes because the level of risk has been determined to be insignificant, or the action may be to 

withdraw approval of the drug product. Other actions by the FDA can also include review by the 

2 ]1l<.~ multi-hurdle conc<qJ1 refers to the interaction offadors that affect mii..':rohial behavior in foods. t.'nder some cin::umstances these effects 

are additive. ender others. the implication is that s)llcrgistic interactions lead to a combined effect of greater magnitude than the SlUn of 

constraints applied individually. 

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Veterinary Medicine Advisory Committee or limitations of use such as use only for certain indications. 

Several antimicrobial risk assessments have been performed demonstrating varying risks to humans 

depending on the drug and the specific use of the drug. This further emphasizes the need to ensure 

science based risk assessments on a drug by drug basis to fully inform the regulatory process. One of 

FDA's risk assessments concluded that an unacceptable level of risk (1 in 34,945 people estimated to be 

affected in 1998 and 1 in 32,912 in 1999) for ftouroquinolone resistant Campylobacter as a result of 

poultry consumption due to the use of enrofloxacin in poultry' resulting in withdrawal of the product in 

2005. Yet, the desired outcome of minimizing fluoroquinolone resistant Campylobacter in humans 

remains questionable as human cases continue to rise'-

Another risk assessment by FDA in 20047 could not form conclusions as to whether the use of 

streptogramins (virginiamycin, an antimicrobial growth promoter) in food animals contributes to the 

occurrence of streptogramin-resistant E. faecium (SREF) infections in humans via a foodborne pathway. 

In fact, the FDA found the different Minimum Inhibitory Concentration (MIC) distribution and the dissimilar 

pattern of resistance genes between animal and human isolates to be inconsistent with an attribution of 

human streptogramin resistance to animal sources, meaning the resistance did not come from an animal 

source. Regardless, if it were to occur, the average risk to a random member of the US population of 

having SREF and impaired Synercid® (a streptogramin used to treat bacterial infections in humans) 

therapy as a result of animal uses of virginiamycin ranges from 7 in 1 billion to 14 in 100 million per yeaL 

In Denmark, where virginiamycin has been banned since 1998, resistance to Synercid® is much greater 

than what is seen in the USB 

In 1987, at the request of the FDA, an Institute of Medicine study was conducted to evaluate the risks 

associated with penicillin and tetracyclines at growth promotion and prevention levels. The study 

estimated approximately 6 deaths per year attributable to the use of penicillin and/or tetracyclines for 

growth promotion and disease prevention. When only used for growth promotion, that number decreased 

to 2 deaths per yeaL" When compared to estimated risks from the use of enroftoxacin for treatment1O , 

this data is contrary to the assumption that growth promotion uses are inherently stronger drivers of 

resistance than treatment uses and therefore cause human health hazards. 

Other risk assessments also demonstrate a very low risk to human health from the use of antimicrobials 

in food animals. With an approximate probability of less than 1 in 10 million per year for macrolide 

resistant Campylobacter infections and approximately 1 in 3 billion for E. faecium infections, a unique 

farm-to-patient risk assessment demonstrates that the use of tylosin and tilmicosin (macrolides) in food 

animals presents a very low risk of human treatment failure. 11 

Another risk assessment examines the impact of the use of penicillin-based drugs in food animals on 

penicillin/ aminopenicillin resistant enterococcal infections. The conclusion indicated that no more than 

0.04 - 0.18 excess mortalities per year would be prevented in the entire U.S. population by discontinuing 

current use of penicillin-based drugs in food animals. The true risk could be as low as zero.'2 This 

equates to one potentially preventable mortality in the U.S. population approximately every 7-25 years. 

Similarly, another risk assessment concluded that veterinary use of macrolides in Danish pigs resulted in 

a low risk to human health'" 

Some of the models using a risks and benefits model predict an increased human health burden if the 

use is withdrawn. Utilizing that model, a risk assessment for virginiamycin evaluated benefits to humans 

in addition to the risks. That assessment found an increase of 0.27 cases per year of streptograminresistant and vancomycin-resistant E. faecium (VREF) potentially resulting from the use of virginiamycin. 

Yet, as a benefit of continued use, the assessment found a significant increased human health risk if 

virginiamycin use is withdrawn an additional 6,660 cases of campylobacteriosis per yeaL The benefit of 

continued use and preventing those additional 6,660 cases per year of campylobacteriosis would far 

outweigh the minimal risks of an increased 0.27 cases per year of streptogramin-resistant and 

vancomycin-resistant E. faecium (VREF).14 Another risks and benefits assessment concluded that 

withdrawal of macrolide and ftuoroquinolone use is estimated to cause significantly more illness days than 

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it would prevent.'5 

Others have estimated that risk management strategies focusing on eliminating resistance are expected 

to create < 1 % of the public health benefit of strategies that focus on reducing microbial loads in animals 

or on foods. '6 We must consider this information within the context of food safety, animal health and 

welfare benefits that are gained by focusing on pathogen reduction strategies, including judicious 

antimicrobial use. Another study agrees, concluding that, "antimicrobials that benefit animal health may 

benefit human health, while regulatory interventions that seek to reduce antimicrobial resistance in 

animals m~,~ unintentionally increase illness rates (and hence antimicrobial use and resistance rates) in 

humans"". 

Information derived from studies of organic or antibiotic-free production practices compared to traditional 

production practices is inconclusive, but there are indications that organically grown meat may have lessresistant organisms but greater prevalence and quantities of pathogens on the meat. 18.19.20.21 Therefore, 

the greater risk of foodborne illness derived from these products must be weighed against the many other 

factors such as the likelihood of treatment failure if treatment is necessary. 

The question of what the nature and magnitude of the risk to humans is can only be answered by 

performing systematic risk assessments. Such risk assessments must include identification of the 

endpoints of concern (e.g., increased illness or mortality caused by bacteria resistant to antibiotics used 

to treat the disease in humans), the nature of the treatment protocols in food animals, the potential routes 

of exposure, characterization of the population at risk, and the probability of occurrence. Furthermore, risk 

assessments that also consider benefits will provide a more balanced perspective and fully inform the 

decision making process. 

Antibiotics as a tool to prevent and control disease in animals and 

humans 

The use of drugs in animals is fundamental to animal health and well-being. Of the tools that are 

available to veterinarians, one of the most important tools that veterinarians use to protect human health 

and animal health is the judicious use of antimicrobials. Antibiotics are necessary to relieve pain and 

suffering associated with disease conditions in animals. For food animals, drugs additionally contribute to 

the public health by mitigating disease and thereby reducing the numbers of bacteria entering the food 

supply. Studies show that a reduction in the incidence of food animal illness will reduce bacterial 

contamination on meat, thereby reducing the risk of human illness.22.23.24.25.26,27,28,29 The continued 

availability of safe, effective antimicrobials for veterinary medicine, including the retention of currently 

approved drugs and future approvals of new drugs, are critical components of ensuring a safe food 

supply and essential to the improvement of animal health and welfare. 

Just as in humans, resistant bacteria can and do develop in animals. However, many of the important 

details regarding the transfer of that resistant bacteria, or even resistance genes - to the environment or 

humans - still remains in question. Simply because resistance exists in animals, it does not necessarily 

equate to a significant human health risk. First, the bacteria or its resistance determinants may not 

effectively transfer to humans through the food chain. Secondly, the resistant pathogen may not colonize 

in humans to create disease. Third, if a disease does occur, antimicrobial therapy may not be indicated, 

and the disease resulting from the resistant bacteria is in effect no different than any other bacteria. In 

the vast majority of cases, antimicrobial therapy is not needed. Supportive therapy, such as fluids, is the 

only treatment that is needed for most Salmonel/a, Campylobacter and E. coli infections. For non-typhi 

Salmonel/a, antimicrobial therapy is generally not indicated because it has no effect on clinical illness and 

prolongs carriage and excretion of the organism. For Campylobacter jejuni, antimicrobial therapy is 

unlikely to provide benefit. Treatment of enterohemorrhagic E. coli (E. Coli 0157) may increase the risk of 

developing hemolytic uremic syndrome. 30 Lastly, if antimicrobial therapy is needed, even if the pathogen 

is resistant to one drug or multiple drugs, it may be still be susceptible to the drug of choice. 

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Routes of Transmission 

There are several theorized mechanisms for the spread of resistance from animals to humans: 1) Via 

residues 2) Direct route - when an individual consumes resistant bacterium in food or by direct contact 

with an animal infected with a resistant organism 3) Indirect route - through a resistance reservoir where 

an individual acquires a resistance determinant from that resistance reservoir (the animal food product). 

Residues 

There is an extremely low risk of developing resistance as a result of antibiotic residues. Furthermore, 

that risk only exists if there are a series of flaws in the system that has been designed to protectthe 

public from drug residues in food products. Whenever drugs are used to treat sick animals or prevent 

disease or when animals are exposed to chemicals in the environment, there is the potential for remnants 

to remain in the meat or other animal products (often known as residues). The FDA establishes 

tolerances for drug residues to insure food safety. The FDA also establishes "withdrawal times" or 

"withholding periods" which are times after drug treatment when milk and eggs are not to be used for 

food, and during which animals are not to be slaughtered. This allows time for the animals to metabolize 

and eliminate the drugs that had been used for treatment. 

Maximum residue limits and tolerances for drug residues protect us from residues that may impact human 

health. If withdrawal times determined by the FDA are insufficient or are not adhered to, then there is the 

potential for violative residues. Also, if the tolerance levels are inadequate or ineffectively enforced, then 

again there is a possibility for a human health hazard. However, in addition to those systematic errors, 

two additional conditions must be met for the residue to pose a risk for the development of resistance: the 

drug residue must retain its efficacy through processing and/or cooking and remain as an active 

compound to affect human gut flora; and the drug residue remaining must be of a sufficient level to select 

for resistance in humans. 

Direct Route 

The direct route of transmission is also based on a series of events. There are many ways in which an 

animal can be infected with a resistant bacterium. Quantity of use is not necessarily the sole factor in 

selecting for resistance, nor is the dose or a particular purpose for antimicrobial use. Also of note, the 

use of a particular drug is not necessarily the cause of resistance to that same drug. The process of coselection remains unclear and there is an increasing amount of evidence that resistance acquisition 

mechanisms are far more complex than previously thought. Resistance is mediated by certain genes and 

for many genes it is still unclear what causes the resistance gene expression or even development. 

Therefore, it is important to recognize that the use of a drug itself should not be a focus or rationale for 

restrictions on antimicrobials, but rather factual outcomes that are far more informative must be 

considered. 

If an animal is infected with resistant bacteria at the time of slaughter and the carcass remains 

contaminated with the resistant bacteria through slaughter and processing, a sufficient microbial 

pathogen load must remain after processing and post harvest interventions (such as carcass rinses) to 

pose a threat to human health. The pathogen must then survive cooking in sufficient quantity to cause 

infection, or proper food hygiene procedures not followed. An individual must consume the contaminated 

food, become ill, seek medical attention, and in the worst case scenario, there is treatment failure as a 

result of the resistant pathogen. In most cases, medical attention is not sought and antimicrobial 

treatment is contraindicated. 

As an example providing a comparative perspective on risk through a direct route of resistance 

transmission, a study on fluoroquinolone use in beef cattle had estimated the likelihood of a 

fluoroquinolone resistant Campy/abaeter jejuni infection causing a human death to be approximatel¥ a 1-

in-250 million assuming the person had acquired the infection by eating contaminated ground beef. 1 In 

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comparison with this risk that may be associated with the consumption of contaminated beef, a person is 

567 times more likely to be killed in a plane crash and 14,284 times more likely to be killed in a car crash 

in any given year.'2 

Indirect Route 

The indirect route of transmission is theoretical, shown to be possible experimentally in vitro with no 

clear indication of what will occur in vivo. This route consists of many assumptions and a series of 

required events before a risk to human health can occur as a result of antimicrobial use in food 

producing animals. Resistance determinants are presumed to be present in a food producing animal as 

the resistance reservoir. Then the determinants must follow the same pathway as the direct route of 

transmission through the food chain: The animal food product must be contaminated with the 

determinant during slaughter; the determinant survives processing and cooking; is effectively transferred 

to an organism in the human; the human pathogen expresses the gene or passes it to yet another 

organism until there is gene expression; the organism causes human illness; the person seeks and 

needs medical attention; and in the worse case scenario, the person experiences treatment failure as a 

result of the resistance. 

An example of the indirect route of transmission and concept of resistance reservoirs can be illustrated 

through the extended spectrum beta-Iactamases (ESBLs). The concept of resistance reservoirs suggests 

that a pool of resistance genes is maintained within certain environments and poses a risk to public 

health. Scientists have detected similar, but not identical ESBL genes in both humans and animals in an 

isolated geographic region. 33 In Denmark, the initial cases of ESBL resistance had been detected in 

imported animals and food products prior to 2003. In 2005 and after, ESBL producing organisms were 

detected in domestic animals and animal products. In 2007, Denmark experienced the first major human 

outbreak with ESBLs. One interpretation of this series of events has been the application of the 

resistance reservoir concept. Based on the temporal sequence of events, many have theorized that 

animals, particularly those raised outside of Denmark with less stringent antimicrobial controls in animal 

agriculture, are serving as a reservoir for the ESBL resistance genes and transferring those mechanisms 

of resistance through the food chain. An alternative theory could suggest that ESBLs in animals and 

animal products have evolved and spread due to increased therapeutic antimicrobial use after the bans 

on growth-promoting antibiotics. Much of the increased use in animal agriculture has more often been in 

the same classes as human use antimicrobials and at greater doses. Since 1998, the consumption of [llactams in food producing animals in Denmark has nearly doubled. Likewise, the development and 

spread of ESBL resistance genes in humans may be due to increased antimicrobial use in human 

medicine. Since 1998, human consumption of ~-Iactams in Denmark has nearly quadrupled. Some 

experts speculate that this increase in human use may be due to shortened hospital stays and increased 

perioperative prophylactic use.34 Thus, it is plausible that ESBLs are transmitted through the food chain, 

but the probability, frequency, and efficiency of that transfer remains unknown. 

Not all antimicrobials or all their uses are equal in their probability of developing resistance or creating a 

risk to human health, further elucidating the need for individual risk assessments. Based upon risk 

assessments conducted and epidemiological evidence obtained thus far, the risk to people of resistant 

infections from consuming animal products appears to be very low, as the use of antimicrobials in animals 

is only one of the many factors that can impact antimicrobial efficacy in treating these infections. In terms 

of animal agriculture, the main goal of mitigating risks to human health should be to decrease the spread 

of foodborne pathogens, rather than focusing upon what is presumed to be the source of antimicrobial 

resistance. Moreover, prior attempts to decrease use of antimicrobials in animals in other countries have 

not been shown to significantly decrease resistant infections in people. Thus, broad-based bans and 

other limitations on antimicrobial treatments in food animals cannot be expected to produce the desired 

result of enhancing human health. In addition, many antimicrobials used in food animals have no 

medically important counterpart in human medicine, so the concept of reducing these uses bears no 

impact at all on human infections. 

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AVMA's Efforts 

The AVMA has maintained three primary objectives when considering antimicrobial use: 

1. Safeguarding public health, 

2. Safeguarding animal health, and the 

3. Continued availability of effective therapeutic agents, including antimicrobials for veterinary 

medicine and the retention of currently approved, safe drugs and biologics as well as future 

approvals of new therapeutic agents. 

The veterinary profession strives to promote optimal human health and public health through zoonotic 

disease prevention and control, which includes foodborne pathogens among other diseases. To achieve 

optimal animal health as well as animal welfare, and in turn, human health, the veterinary profession must 

practice the same fundamental principles of public heath - prevention and control of disease in food 

animal medicine and population medicine'. While the end goal is the same for all medical professionals -

good health veterinarians are severely limited in our tools for disease control and prevention. 

Regulations for drug approvals are more stringent for food animal drugs than human drugs, therapeutic 

agents can be more difficult to develop, and there are fewer treatments available. Thus, veterinarians 

must rely on their knowledge of clinical medicine to determine the best course oftreatmenl. Given the 

numbers of food animal species, in addition to the diversity of disease conditions that affect animals, a 

relative scarcity of labeled indications accompanying FDA approved drugs exists. Although the FDA, the 

AVMA and others have made and continue to make significant strides in enhancing drug availability, 

including legislative initiatives (such as the Minor Use and Minor Species Act, and the Animal Drug 

Availability Act), the numbers of FDA approved drugs are inadequate to meet veterinary medical needs, 

placing both animal health and welfare - and, potentially, human health - at significant risk. 

Other successes through collaborative efforts include a decline in foodborne illness from meat and poultry 

products35 as well as a decline in the prevalence of foodborne pathogens (including Salmonella) 

associated with meat and poultry36 and resistance of those organisms 3

? These are all a result of 

improvements in animal health and the joint efforts of stakeholders. 

The AVMA has also advocated for more research to support scientifically based therapeutic practices, 

such as epidemiological studies, that assess the effects of antimicrobial use. We support the scientifically 

valid and meaningful collection and review of data for all uses of antimicrobials and other pharmaceuticals 

used in humans and animals. We urge that such data be collected in concert with other data necessary 

to explain or inform fluctuations in use, e.g., disease prevalence, regional data, populations of animals, 

etc. An example is the USDA program, Collaboration for Animal Health, Food Safety and Epidemiology, 

that is attempting to study the use of antimicrobials on farms correlated with disease occurrence, and the 

effects of antimicrobial use on antimicrobial resistance as measured both on the farm and during 

processing of the meat from the specific farm. The AVMA also provided start-up funding for projects to 

create a nationally coordinated laboratory system to test for and report on resistance in animal pathogens 

and to create a decision support system to assist veterinarians when making antimicrobial use decisions. 

Unfortunately, while this project received follow-on funding by the FDA, it has not been sustained or 

completed. 

a Population mcdlcine is a medical discipline focusing on the concepts of public health and epidemiology. In yctcrinary medicine, these 

concepts are incorporated to make strategic decisions to advance animal and herd health. 

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Veterinary Oversight, Judicious Use, and VCPRs 

Since 1998, the AVMA has actively worked to mitigate the development of antimicrobial resistance 

related to the use of antimicrobials in food animals. The AVMA Guidelines for the Judicious Therapeutic 

Use of Antimicrobials were developed to safeguard public health by providing specific recommendations 

for responsible and prudent therapeutic use of antimicrobials. With support and input from the CDC, 

Infectious Diseases Society of America, the FDA, and the USDA, the guidelines were developed in 

collaboration with our species specific allied veterinary organizations. These guidelines were based upon 

carefully reviewed, scientifically sound research, and we believe that our members conscientiously 

adhere to the principles of judicious therapeutic use of antimicrobials to ensure the protection of human 

health, as well as animal health and welfare. 

We have actively encouraged and assisted our allied veterinary organizations to use the AVMA general 

principles as a template to develop more detailed guidelines appropriate to each species, disease and 

type of client. The AVMA also worked with these groups to develop and deliver a continuing education 

program to raise awareness within the profession and to encourage utilization of the principles. 

Fundamentally, the guidelines encourage scientifically based therapeutic practices, the use of 

antimicrobials only when needed, and compliance with all existing regulatory requirements when 

antimicrobials are used. For example, the American Association of Avian Pathologists (AAAP) Guidelines 

to Judicious Therapeutic Use of Antimicrobials in Poultry states, "Antimicrobials in Class III used at 

labeled instructions should be considered first if farm history, in vitro sensitivity and clinical judgment 

warrants." In the AAAP guidelines, Class III antimicrobials are identified individually and noted to be 

those of no or minimal importance to human medicine. The guideline further outlines disease specific 

diagnostics, non-antimicrobial interventions, and suggested antimicrobial interventions as a last resort. 

Much of the discussion on antimicrobial use in animal agriculture revolves around a category commonly 

known as growth promotion or a group of antimicrobial uses that are poorly categorized as "nontherapeutic" or "sub therapeutic." The terms "non-therapeutic," and "sub-therapeutic," have no consistent 

definition. The use of ill-defined or inconsistent definitions only serves to further confuse the issue. We 

caution against indiscriminate use of these terms. Alternatively, we advocate using the definitions of the 

Codex Alimentarius Commission (an organization of the World Health Organization and the Food and 

Agricultural Organization of the United Nations), the FDA, and AVMA. All three organizations classify 

treatment, prevention, and control of disease as therapeutic uses. Antimicrobials that are labeled for 

production uses such as increased rate of gain or feed efficiency are often referred to as growth 

promoters. 

Additionally, it is important to recognize that veterinarians are the trained professionals who know when 

antimicrobials are indicated in animals and when they are not. While some production systems can 

provide benefits in meeting an animal's behavioral needs, the costs can often be an increase in risk of 

disease.'8 Even in pristine conditions, at certain life stages, and under certain stressful circumstances, 

disease outbreaks can be predictable. In some of these cases, a veterinarian may choose to recommend 

the use of antimicrobials during those predictable stages to strategically prevent or control disease. The 

ability of a trained medical professional to predict a disease outbreak and recommend appropriate 

therapy should not be considered injudicious nor banned as "routine use." 

There is little debate on the use of antimicrobials for treatment of disease in animals showing obvious 

clinical signs. However, few understand the importance of disease control and prevention, and even 

fewer have a clear understanding of growth promotants. Prevention and control of disease are key 

elements in the practice of veterinary medicine, particularly in animal agriculture, where the focus is on 

population health. This concept of disease prevention and control through herd health is analogous to 

public health efforts. If a disease is predictable and can be prevented, it is prudent for the veterinarian to 

recommend therapy to prevent animal pain and suffering that would occur associated with the disease 

condition. Likewise, if an infectious disease condition has been established in a herd or flock, it is 

incumbent upon the veterinarian to initiate appropriate therapy to minimize further disease spread and 

alleviate associated pain and suffering. Additionally, some of the growth promoting antimicrobials have 

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no human health equivalent and thus no human health impact. In fact, studies show a potential health 

benefit from the use of growth promoting antimicrobials.3940 41,42,43,44,45,46 

While it may seem intuitive to some that healthy animals are critically important for safe food, there are 

few who understand the intricacies of why. As an example, it is fairly intuitive that an effective antibiotic 

will help decrease the bacterial load in food. What many do not understand is that it is extremely difficult 

to ascertain whether or not a particular animal is carrying certain bacteria, Animals can harbor types of 

bacteria in their intestinal tracts that have no effect on their health, but can cause illness in humans, 

Many bacteria such as Salmonella, are shed intermittently, can increase with physical stressors such as 

underlying infections, and cannot be easily detected by routine testing procedures. Thus, we must rely on 

the combination of many different types of interventions to protect our food supply. These interventions 

would range from prevention and control of disease before it occurs in animals, to post harvest 

interventions such as carcass rinsing to further minimize bacterial contamination in food. 

Another concept that is often misunderstood or overlooked is how a seemingly unrelated illness, such as 

respiratory disease in a food animal, can affect the presence of enteric bacterial pathogens in the meat 

and therefore food safety. The example of air sacculitis, a respiratory disease that affects poultry, 

illustrates how food can be safer by treating an animal that does not exhibit obvious symptoms. Air 

sacculitis is a fairly common disease that can spread rapidly and often go undetected until slaughter. The 

disease causes tissues to become more friable' and difficult to remove during food processing. The 

increased handling and difficulty in processing increases the potential for damaginp the intestines and 

contaminating the carcass with enteric pathogens that can be harmful to humans 4 . By controlling this 

disease through the use of antibiotics and/or other therapeutic agents, veterinarians assist producers in 

maintaining a healthy flock and a safe food supply. This example further illustrates the necessity to 

continually maintain and improve animal health in the preservation of food safety. 

The AVMA also strongly encourages a veterinarian-client-patient relationship (VCPR) and veterinary 

consultation when implementing any treatment regimen. Dispensing or prescribing a prescription product 

(including antimicrobials) requires a VCPR. The VCPR is the basis for interaction among veterinarians, 

their clients, and their patients. 

The veterinarian must have sufficient knowledge of the animal(s) to initiate at least a general or 

preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has 

recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an 

examination of the animal(s), or by medically appropriate and timely visits to the premises where the 

animal(s) are kept. 

Veterinarians making treatment decisions must use sound clinical judgment and current medical 

information and must be in compliance with federal, state, and local laws and regulations. The 

veterinarian must also include consideration of: judicious use principles; food safety and public health; 

and producer education as a part of the treatment plan. After considerations have been made for animal, 

human, and the environmental health impact, veterinary authorization is required prior to dispensing of 

the prescription product. 

There are older antimicrobials that are available in medicated feeds (over-the-counter or OTC drugs) that 

can be purchased without a veterinary prescription. However, this is not to say that these drugs are 

unregulated. In fact, there are greater restrictions on the use of antibiotics in animals than there are in 

humans. Feed mills that distribute medicated feeds are licensed to do so by the FDA. All FDA approved 

drug products are restricted to a very specific use, dose, and duration as indicated on the label. 

Veterinarians are strictly prohibited from using certain drugs in food animals. Veterinarians are also 

restricted by Extra Label Drug Use (ELDU) regulations. Therefore, if a drug is not used according to the 

label and FDA approved instructions or ELDU regulations, then it is illegal. 

a Friable is a term used in pathology to describe tissues that are brittle, fragile, and easily damaged. 

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To our knowledge, no new classes of antimicrobials have been approved by the FDA as an OTC drug 

since the 1980s. A newer category of drugs, the Veterinary Feed Directive (VFD) Drug category, was 

created by the Animal Drug Availability Act of 1996 to provide veterinary control for certain animal 

pharmaceuticals for use in feed that are not suitable for OTC status. Any animal feed bearing or 

containing a VFD drug shall be fed to animals only by or upon a lawful VFD issued by a licensed 

veterinarian in the course of the veterinarian's professional practice. 

The AVMA recently convened the Antimicrobial Use Task Force to evaluate the veterinarians' role in all 

uses of antimicrobials. The Task Force concluded that veterinarians should be involved in the decision 

making process for the use of all antimicrobials in animals regardless of the distribution channel through 

which it was obtained. This would encompass prescription products, VFDs, and OTC antimicrobials. 

In our unique role as the only profession that routinely operates at the interface of human and animal 

health, veterinarians must balance the need for animal health and welfare with the need of human health. 

Without exception, the AVMA is supportive of measures to mitigate risks to human health. Yet, we must 

emphasize the importance of science based risk analyses and risk management that is commensurate 

with the level of risk. Risk management measures can include any of the following: advisory committee 

review of an existing approval or application for a new animal drug approval; post-approval monitoring 

through systems such as the National Antimicrobial Resistance Monitoring System (NARMS); limitations 

on the extent of use (e.g., individual animals only for short duration of use); limited or broad extra-label 

use restrictions in some cases or all cases; and, finally, non-approval or withdrawal of a previously 

approved antimicrobial. 

Although there are critical shortages in the veterinary workforce, particularly in food supply veterinary 

medicine and veterinary public health, veterinarians provide oversight and advice on the use of 

medications, including OTC antimicrobials, on a significant percentage of animal operations. Feedlot '99 

reports that all large operations and nearly all (96.5%) small operations used the services of a 

veterinarian. Large operations were more likely to use a veterinarian that made routine visits or employ a 

full-time veterinarian on staff than small operations. Conversely, small operations were more likely to use 

a veterinarian when the need for one arose. Veterinarian recommendations had strong or moderate 

influence on selection of an antimicrobial for nearly 100% of feedlots. Laboratory test results influenced 

58.8% of feedlots strongly or moderately. Veterinarian recommendations and laboratory test results were 

more likely to strongly influence selection of antimicrobials on large feedlots than small feedlots. Almost 

three out offour feedlots provided formal training in areas related to antimicrobial use.'" 

The USDA Swine 2006 reports approximately seven of 10 sites (69.1 %) used a veterinarian during the 

previous year. A higher percentage of large and medium sites (88.1 and 85.0%, respectively) used a 

veterinarian during the previous year compared to small sites (60.8%). Nearly 5 of 1 0 large sites (46.8%) 

used an on-staff veterinarian. A similar percentage of large sites (42.5%) used a local practitioner. 

Overall, approximately half of the sites (49.5%) used a local veterinarian during the previous 12 months. 

About one of four sites (24.7%) was visited by a veterinarian five or more times. Producers used the 

services of a veterinarian for many purposes during the previous 12 months. A higher percentage of 

large sites used a veterinarian for blood testing, production record analysis, employee education, and 

quality assurance compared to small sites. For sites that had at least one veterinary visit during the 

previous 12 months, the highest percentage of sites used a veterinarian to treat individual pigs (63.8%) 

and to provide drugs or vaccines (62.6%). These are followed by vaccination consultation (48.6%), 

quality assurance (47.9%), blood testing (47.6%), nutritional consultation (19.8%), environmental 

consultation (19.0%), and employee training/education (18.0%).49 

We believe that these numbers can be improved through the resolution of the critical shortage of the 

veterinary workforce by identifying resources and developing solutions in collaboration with key 

stakeholders to ensure that veterinary needs are met. Further studies and proposals should appropriately 

address the availability of veterinary services. 

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Data Collection and Review; Monitoring and Surveillance Systems 

The AVMA believes that there is a critical need for improved, more robust monitoring and feedback 

systems for foodborne disease and antimicrobial resistance such as FoodNet and National Antimicrobial 

Resistance Monitoring System (NARMS). Since the mid-1990s, the FDA has coordinated the NARMS in 

cooperation with the CDC and the USDA. NARMS is a multi-agency program that includes monitoring for 

resistant bacteria in retail meats by the FDA, monitoring for resistant foodborne pathogens in humans by 

the CDC, and monitoring for resistant bacteria in animals on farms and animal products in slaughter and 

processing facilities by the USDA. The Foodborne Diseases Active Surveillance Network (FoodNet) is a 

collaborative project of the CDC, 10 states, the USDA, and the FDA to monitor trends of foodborne illness 

and attribute the illness to specific foods and settings. Veterinarians in both public and private practice 

actively participate in these national programs and AVMA has consistently advocated for funding to 

maintain and continually improve all of these programs. 

We are pleased that in recent years reporting by NARMS has been timelier. Yet, we still find gaps in data 

collection, lack of clarity in the interpretation of trends, and uncertainty as to how the data may be used to 

determine action. We also note that there remains a disconnect between data collection systems. For 

example, FoodNet provides data on foodborne infections, including resistant bacterial infections, but does 

not specify the proportion or incidence of resistant foodborne illness. In fact, only 2 outbreaks of resistant 

foodborne bacteria have been reported in the past decade. One of which was as a result of raw milk 

cheese consumption. Yet, NARMS data incongruously provides resistance trends and specifies a relative 

proportion of resistant bacteria but does not indicate how or if it may relate to food and human infections. 

Therefore, there is a clear dissociation between resistant foodborne infections and the source. Lastly, 

and most importantly, there is no system for monitoring how or how much antimicrobials are being used in 

humans or animals. Without this critical piece of information, it is impossible to understand how various 

uses can impact the resistance trends. 

The Netherlands 

The MARAN 2008 report indicates an increase in total antibiotic use from 1998-2008. Part of the 

increase is attributed to an increase in therapeutic use as a substitution for growth promoters. 

Therapeutic use has doubled in 2007 when compared to 1999. Although therapeutic use in 2008 has 

declined compared to 2007, the report indicates the reduction is due to veterinarians stockpiling drugs at 

the end of 20075

°, a puzzling explanation that questions why the stockpiling occurred and the potential 

impact on data interpretation. Important data reported from MARAN indicates: 

Increase in ciprofioxacin resistant Salmonella infections in humans in 2008 compared to 

200612007 with resistance to attributed to DT1 04. The source of increased incidence is unknown 

but not a Dutch animal source. 

Fluoroquinolone resistant Campylobacter continued to increase in humans and animals in 2008 

Resistance rates in E. coli continue to increase in pigs, broiler chickens, and dairy cows 

Resistance levels of Enterococcus remain high or increases in all animal species 

This data would suggest that the ban of antibiotic growth promoters in the Netherlands has not achieved 

a decrease in total use, a decrease in therapeutic use, or a decrease in resistance levels. 

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Danish Experience 

The Danish experience has taught us that there can be serious negative consequences in animal health 

and welfare following the withdrawal of growth promoting antimicrobials and few, if any, improvements or 

positive human health impact 

In the late 1990s, Denmark instituted a voluntary ban on the use of antimicrobials for growth promotion 

(AGPs). A complete ban of AGPs was initiated in 2000 and completed by the start of 2002. The following 

has been observed as a result of the ban on the use of antibiotics for growth promotion in Denmark: 

In animalsFrom 2001 to 2008, the overall consumption of antimicrobials in pigs increased by 19%. 

Consumption of tetracyclines increased by 118% per pig from 2003-2008. 

Consumption of all antimicrobials in food animals has gradually increased 110% from 1998-2008, 

while the meat production has increased 32%." 

There has been increased death and disease in the swine herds, especially at the weaning 

stage (information inferred from DAN MAP 2005 and other reports on pigs). According to 

published news reports, there was a relative increase of 25% in the number of pigs that died from 

illnesses from 1995to 2005. 

Nearly double the quantity of antimicrobials is used for therapeutic purposes as compared to 

years before the ban. The antimicrobials now used are classes such as tetracyclines that are 

also used in humans.51 

Resistance to some antibiotics has decreased in some animals while resistance to other 

antibiotics has increased. 

In humans35.6 % increase in Defined Daily Doses b from 1999-2008 

Vancomycin, qUinopristin/dalfopristin, avilamycin resistance still prevails more than a decade after 

banning the use of avoparcin, virginiamycin, and avilamycin for growth promotion. 

Resistance to virginiamycin (quinupristin/dalfopristin, e.g., Synercid) in humans had been steadil~ 

increasing (up to 25%) from 1997 to 2005 until the definition of resistance was changed in 20065 , 

bringing the level of resistance down to 0%.' 

When the definition of resistance is standardized to the United States definition used by 

CDC and the level of resistance in humans in Denmark to Synercid is compared to the 

United States, we find that the level is 10 times higher in Denmark in spite of the Danish 

ban in 1998 of use in animals and the continued use in the United States. 

"Tr.:nds in total consumption (kg active compotmd) ofpresl'rihcd antimkrobial" for production animals reported by DAI\~JA.P 2008: Table 5 

b Defined Daily Dose is a measure of antimicrohial use in human medicine in Denmark 

C 'Ib..:: rationale f()r this l'hange is unknown, but appears to introduce bias in repOl1ing. DA!\lJV1AP decided to use a preliminary European 

Conmlittec on A.ntimicrobial Susceptibility Testing breakpoint instead of the rreviollslyuscd breakpoint established by the Clinical and 

Laboratory Standards Institute. 

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In humans and animals -

A significant increasing trend of resistance to tetracycline, ampicillin, and sulfonamide in humans 

and pigs from 2001 - 2006 (2007 and 2008 decreases are related to in an increase in outbreaks 

of sensitive strains) 

There is little evidence to demonstrate a general decline in antimicrobial resistance in humans 

and there is no evidence of an improvement in clinical outcomes of antimicrobial treatment of 

humans, the desired consequence of the antibiotic ban in livestock. The results have been 

mixed. In fact, resistance in humans to some of the banned drugs has increased dramatically. 

This data indicates that the ban of antibiotic growth promoters in Denmark has not achieved a decrease 

in total use or a decrease in therapeutic use and mixed results in resistance levels in pigs (an increase in 

some resistance levels for some antibiotics and a decrease in resistance levels for others). 

The ban on antibiotic growth promoters in Denmark has not resulted in a significant reduction of antibiotic 

resistance patterns in humans. It has, however, resulted in an increase in disease and death in the swine 

herds and an increase in the use of antimicrobials for therapeutic uses in swine herds that discontinued 

the use of antibiotic growth promoters. 

Even though the results of the Danish experiment with antimicrobial growth promotant drug bans is very 

mixed, evidence shows that the Danish ban has caused animal health and welfare problems, without 

significantly improving human health. 

Based on the results of the bans enacted in Denmark and the Netherlands, we do not believe the public 

would significantly benefit from such limitations on the use of antimicrobials. The loss of approved uses 

of antimicrobials will negatively impact animal health and welfare without significantly or 

predictably improving public health. Non-science based, broad bans of preventive uses of antimicrobials 

have the potential to harm public health, such as through increased foodborne disease. 

Significant decisions regarding animal health need to be science- and risk-based decisions. Decisions 

made without the benefit of veterinary input as well as a thorough evaluation of risks and benefits have 

the potential to further divert resources away from more appropriate disease control measures. 

NARMS 

Important resistance trends' reported by NARMS53 (Isolates from humans with clinical disease) indicate 

substantial decreases in Salmonella resistance for some serotypes associated with animal sources and 

an increasing trend in resistance for the serotype associated with human reservoirs: 

Salmonella spp. (non-Typhi) - more than twice as likely to be resistant in 1996 as compared to 2007 

'Y a highly significantb improvement in susceptibility' (22.5% relative increase in susceptibility, from 

66.2% in 1996 to 81.1% in 2007) 

"-Odds ratios VI'ere cakulated hased upon available dat1. from NARMS assumlng the reported iSl){ates \vcre repreSentative orihe baderial 

population. 

o "MarginaUy significant" indicaks a p~value between 0.05 and 0.10: "significant"' indicates II p~value between 0.01 and 0.05; "highly 

significant" indicatel' a p-value ofkss than 0.0 t 

<: no resistance dekcted to any of 5 subcla<;ses of antibiotics 

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Salmonella Typhimurium - more than twice as likely to be resistant in 1996 as compared to 2007 

'Y a highly significant improvement in susceptibility (52% relative increase in susceptibility from 

37.9% in 1996 to 57.6% in 2007) 

Salmonella ser. Typhi (a human reservoir foodborne pathogen) more than 4 times as likely to be 

resistant 2007 as compared to 1999 

"r a highly significant ~ in susceptibility (50% relative increase in susceptibility from 71.3% in 

1999 to 35.4% in 2007) 

Most foodborne infections do not require treatment with antimicrobials. The data indicates that there is a 

decreasing trend offoodborne diseases, thereby decreasing the potential numbers of treatments. 54 

NARMs55 reports the following resistance percentages of non-typhi Salmonella to ftuoroquinolone 

(ciprofloxacin) - 0.1%; third-generation cephalosporin (ceftriaxone) - 0.4%; ampicillin -10.1%; and cotrimoxazole (trimethoprim-sulfamethoxazole) 1.5%. These resistance levels do not indicate a public 

health crisis associated with foodborne Salmonella. Resistance patterns from Campylobacter and E. coli 

do not mirror Salmonella on a drug by drug basis, but do show overall increases or stability in 

susceptibility levels. Of note, campylobacter resistance to ciprofloxacin (a ftuoroquinolone) has continued 

to increase following the ban on enroftoxacin. The trends of decreasing resistance (increasing 

susceptibility) mean more successful treatments when needed. This information would suggest that there 

is not a public health crisis related to foodborne pathogens. 

Conclusion 

The American Veterinary Medical Association is committed to ensuring a safe and healthy abundant food 

supply. Among other things, our profession is dedicated to improving animal health, further safeguarding 

public health and food safety, and to maintaining the long-term effectiveness of antibiotics. The AVMA 

established a profession-wide initiative to create and implement judicious use guidelines for the 

therapeutic use of antimicrobials by veterinarians, and we launched an educational campaign to raise the 

awareness of the profession to the issue. Today, we continue to review and update those guidelines to 

reflect current practices and actively encourage compliance. 

Foodborne illness and the spread of antibiotic resistance is a public and animal health concern. There is 

no question that the public demands a safe food supply and that the human medical profession is facing 

extreme challenges because of hospital- and community-acquired resistant human pathogens. The 

human medical problem with resistant nosocomial and community-acquired infections has increased the 

concern of development of resistant pathogens in animals that can be transferred to humans through the 

food supply or environment. Yet, we must not forget that animal health is food safety. 

The AVMA shares the concerns of the human medical community, the public health community, 

governmental agencies, and the public regarding resistance developing in animals and then being 

transferred to humans. However, we emphasize the importance and primacy of using these medicines to 

prevent and treat diseases before they enter our food supply. Preemptive bans of veterinary 

antimicrobials before science-based studies and risk-based evaluations are performed can be detrimental 

to animal and human health. Simple solutions may not solve such complex problems. Inappropriate 

reactions could have unknown and unintended consequences that negatively affect animal health and 

welfare, and ultimately, could create other public health risks, such as increased foodborne illness. 

The AVMA believes that a lack of availability of antimicrobials or other therapeutic agents in veterinary 

medicine and animal agriculture can put animal health and welfare and public health at risk. We 

encourage a regulatory strategy that is based on science, risks and benefits analyses, and cooperation 

with all relevant stakeholders. 

An analysis that compared the regulatory strategy of the European Union to broadly ban or restrict animal 

antibiotic uses with the United States' approach of continued prudent use to prevent and control animal 

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infections, together with measures to improve food safety, has some pertinent conclusions. Among 

these, prudent use of animal antibiotics may actually improve human health, while bans on animal 

antibiotics, may inadvertently harm human health.'6 

The AVMA supports the ongoing scientific efforts of monitoring and surveillance of foodborne disease and 

resistant foodborne pathogens; education; development of new antimicrobials, biologics, and other 

treatment options; and other research to better define the challenges presented by animal agriculture. 

Increased data collection and surveillance of disease, as well as continued veterinary input (including the 

appropriate use of pre- and post-harvest interventions, and compliance with judicious use guidelines for 

veterinarians and producers), may be sufficient to protect human health against the current small risks 

without compromising the health of food animals. 

We also support adequate funding for all efforts to improve animal health and food safety, including 

efforts to combat antimicrobial resistance. These efforts were high-priority tasks in the 2001 version of 

the Public Health Action Plan to Combat Antimicrobial Resistance that was created by a Federal 

Interagency Task Force on Antimicrobial Resistance. Of the original 13 Top Priority Action Items, few 

actions have targeted animal health or yielded results that can mitigate antimicrobial resistance in 

animals, and therefore transmission to humans. The Action Plan reflected a broad-based consensus of 

federal agencies and stakeholders on actions needed to address antimicrobial resistance and provided a 

blueprint for specific, coordinated federal actions that included the full spectrum of antimicrobial use: 

human medicine, veterinary medicine and animal agriculture. We are disappointed that the Action Plan 

was not adequately funded and prioritized by Congress. We are also concerned that recent versions of 

the Action Plan do not appear to not be as collaborative, broad-based, or acceptable to the diverse 

community of stakeholders. 

The AVMA is committed to working in concert with the CDC, FDA, and USDA to provide consumers - not 

only in the United States, but all over the world - with the safest food possible. The judicious use of 

antimicrobials is but one of the essential components of the process that enables animal agriculture to 

meet that demand. Other components include veterinary care, good management practices, biosecurity, 

proper nutrition and good husbandry. 

Thank you for the opportunity to appear before you today and speak on behalf of our profession. 

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Antimicrobial ReSistance ~ Implications for the Food System, Institute of Food Technologists Expert Report, ComprehensiVe ReVieWS In Food Sctence and Food safety, VOI5, 

2006 (Available at httpllmember§ 1ft omllFIIResearchllFJExpertReportsfantimicroblal report htrn) 

hurdle concept by modeling the bactenal growth! no growth interface 

in Denmark ISSN 1600-2032 

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Vrrgmiamycin nsf:. assessment Silver Spring, MD FDA Center for Veterinary MedICine, 2004 (Available at 

w,lMIJda gov/downioads/AmmaiVetermary/NewsEvenfs/CYMUpdates/UCM054722 pdf) Accessed Jui 7 2010 

ISSN 1600-2032 

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Genter iorVetennary Medicine, 2001. Available at:y~HW.fda govidownklads/AnlmalVetennarylSafetyHeafthfRecallsWlthdrawalS/UCM042038 pdf. Accessed Jul7 2010 

" Hurd S et al PubliC Heafth Consequellces of Macrolide Use III Food Animals' A Determlnlstlc Risk Assessment J Food Protecton 2004; 67 980-992 

': Cox LA. et 131. Human Health Risk Assessment of Penic!lIm/AmlnopenlClllm ReSistance in EnterococcI Due to PenICillin Use In Food Animals 2008. in Press 

A human heafth risk assessment for macrolide-reSistant Campylobacter associated with the use of macrolldes tn Danish pig production Prev Vet Med 2008, 

P Cox LA Potentl3i human health oonefrts of antibiotics used In food animals' a case study of virglnlamycin EnViron !nt 2005,31549-63 

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rsk to human health? A cntlcal reView of published data. J of Antlmlcrobl3l Chemotherapy 2004. Vol 53, pp 

17 Cox LA. et al. QuantifYlIlg Human Health Risks from Animal Antimicrobials Interfaces 2007,3722-38 

I' Antimicrobial Resistance _ Implications for the Food System, Institute of Food Technologists Expert Report, Comprehensive Revievvs in Food SCience and Food Safety. Vol 

5,2006 (Available at httpJlmemberslft orafifT/ResearchfiFTExoertReportsfantimicroblal report htm) 

et al Prevalence and antimicrobial suscephbility of thermophilIC Campylobacter 111 organic and conventional broiler flocks. letters In Applied Microbiology 2001; 

:" Bailey JS. Cosby DE Salmonella Prevalence In Free-Range and Certified Organic Chickens J of Food Protection 2005, 68.2451-2453 

:2 Smger RS. Modeling the Relationship between Food Animal Health and Human Foodbome Illness Prev Vet Med 2007, 79: 186-203 

The effect of air sa ccullt is on bird weights. uniformity, fecal contammatlon. processlllg errors, and populattons of Campylobacter spp and EschenchJa colt Poult 

21 Russell SM. Ban Antlbiotlcs In Poultry? !WhyThe Poiqmakers Have ItWrongj, WATT Poultry/USA, March 2003 

25 Dawe J. The Relatlonshlp be1.v>leen Poultry Health and Food Safety Poultry informed ProfeSSIOnal 2004, 77 1-6 

'" Cox LA. RtcCI P. Causal regulations vs. political will Why human zoonobc mfectlons mcrease despite precautionary bans on animal anlibiotlcs. Errviron Int 2008 (In press) 

F Cox LA, Popken DA QUantlfyll1g Potentll.1 Human Health Impacts of Ammal AntlblOtlc Use' Enrof]oxacll1 and Macrolides In Chickens RlskAnalys~ 2006,26.135-146 

7" Cox LA. Potentl3l human health benefits of antibiotiCS used 111 food ammals a case study ofvlIgmlamycm. EnViron Int 2005,31 549-63 

'0 Hurd S et al Potential HUman Health ImpllCatJons of Swme Hea~, Abstract of Oral Presentation, 2007 

8enmsh andW. Khan Therapy GUidelmes for Entenc InrectlOns~A 12-YearUpdate 2007 !n APUA Newsletter, Vol 25. No 3, pp 1~4 

RISk assessment of the impact on human health of resIStant Campylobacter JeJuni from fluoroqUinolone use 111 

:lcCervantes, H 2007 AntibiotiC Feed Additrves' PolitiCS and SCience. Proc U.S. Pou~ry & Egg Assocrabon Poultry Production and Health Seminar. September 19-20, Marriott 

Downtown Hotel MemphIS, TN 

clWlnokur Pl, Brueggemann DL, DeSalvo Dl, Hoffmann l, Ap!ey MD, Uhlenhopp EK, Pfaller MA, Doem GV Animal and Human MurtJdrug-Resistant, CephalosponnReslsbnt Salmonella Isolates Expressmg a Plasmid-Mediated CMY-2 AmpC Beta-Lactamase Antimicrobial Agents and Chemotherapy, 2000, 44 2777-2783 

Denmark ISSN 1600--2032 

'') CDC FoodNet Facts and Figures related to «Prelimmary FoodNet Data on the Incidence of Infecbon with Pathogens Transmitted Commonly Through Food-.--10 States, 

United States, 2009" published In the Morbldfty and Mortality Weekly Report (MMWR) on Apn116, 2010 (Available at http:!twww.cdc.gov/foodnetlfactsandf1gureshtm) 

3~ AVMA Welfare Implications of Laying Hen Housmg. (Available at httplfwwwavma orairefere[lce/backarolmders/laylng Il8n houslf,g bgnd pdD 

J) Singer RS. Modeling the Relationship between Food Animal Health and Human Foodborne Illness. Prey Vet Med 2007, 79 186-203 

uniformity, fecal contammatlon, processmg errors, and populations ofCampylobacter spp. and Escherichia coli. Poult 

'ij Russell 8M !3anAntlblotlcs In Poultry"? {Why The Po«cymakers Have It Wrong), WATT Poultry/USA, March 2003 

"e Dawe J The Relationship ootween Poultry Health and Food Safety Poultry Informed Professtonal2004, 77'1-6 

13 Cox LA, Ricci P Causa) regulationsvs political will Why human zoonotic IIlfections Increase despite precautionary bans on animal antibiotics Environ Int2008 (m press) 

",j Cox LA, Popken DA Quanbfying Potential Human Health Impacts of Animal Ant~jotlc Use" Enrofloxacln and Macmlides In Chickens Risk AnalySIS 2006, 26'135-146 

de COX LA Potential human health benefits of antibiotics used in food animals a case study ofvirglnlamycln EnViron Int 2005; 31.549-63 

I,e Hurd S et al Potential Human Health ImplicatIOns of Swine Health, Abstract of Oral Presentation, 2007 

F Russell SM. The effect of ansact:ulitls on bird weights, uniformity, fecal cont:tminatlon, processmg errors, and populations of Campylobacterspp. and Eschenchl<l coil. Poult 

SCI 2003 82" 1326-1331 

,,~ United states Department of Agriculture Animal end Plant Health Inspecbon Service (May 2000) feedlot '99 - Part I' Baseline Reference of Feedlot Management 

Practices 1999. (#N327 0500) Fort CollinS, CO USDAfAPHISNSICEAHINAHMS 

part 1 

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"CDC. NatlonalAntlmlcrobial Resistance MOnitoring System. Enteric Bacteria. 2007 Human Isolates Final Report (Available at 

httpllwwwcdc govrnanns/NARMSAnnualReoort2DD4 pdf) 

~e Cox LA, RiCCI P Causal regulations vs polrtlcal will Why human zoonotlc Infections Increase despite precautionary bans on animal antlbloDcs EnViron Int 2008 (in press) 

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183 

Ms. SCHAKOWSKY. Thank you, Dr. Hoang. 

Dr. Singer. 

STATEMENT OF RANDALL SINGER 

Dr. SINGER. Mr. Chairman and members of the subcommittee, I 

would like to thank you for giving me the opportunity to discuss 

the role of antibiotics in animal agriculture. My name is Dr. Randall Singer. I am an Associate Professor or epidemiology at the 

University of Minnesota, both in the College of Veterinary Medicine and in the School of Public Health. 

Antibiotic resistance continues to be a critical issue that affects 

human health, animal health and environmental health. All uses 

of antibiotics have the potential to select for resistant bacteria. 

What we are discussing here today, though, is risk and specifically 

the potential that the use of antibiotics in animal agriculture might 

result in more antibiotic-resistant bacteria that then lead to increased human health harm. 

One of the antibiotic uses that is of particular concern is the approved label claim of growth promotion. The fact is that this label 

claim is almost 50 years old. It is an unfortunate label whose name 

has never been changed. Unfortunate why? Because we now know 

that the reason these antibiotics help animals grow faster is because these antibiotics help animals maintain their health status. 

They prevent disease as well. And for evidence of this, we need to 

look no further than the Danish experience. It is a fact that following the removal of growth-promoting antibiotics in Denmark, 

the animals got sicker. Animal diseases that had been kept under 

control now appeared as a quote from their papers, epidemics, as 

stated by the Danish themselves. The unfortunate truth is that 

more than 15,000 swine producers in Denmark, over 60 percent of 

the total that existed before the ban, went out of business, most of 

these being the small and mid-sized farms. 

But let us not focus on productivity. When it comes to antibiotics, 

we should be thinking about impacts on health. The only documented health benefit of the ban in Denmark was a decrease in 

some resistance in some bacteria on farms and in the community. 

There was no real human health benefit related to fewer resistant 

infections, at least that I have seen reported from the Danish experience. 

Regardless, perhaps it is time to retire the outdated label claim 

of growth promotion. After all, its name implies a strictly production use of antibiotic. But let me ask you this. Since when it has 

become better to treat the sick than to prevent the disease in the 

first place? If we can give a lower dose of a second-tier antibiotic 

to animals to prevent a disease from occurring by, for instance, improving the gut health of that animal, isn’t this better than having 

to treat an entire population of sick animals with a high dose of 

a critically important antibiotic? The growth promotion doses give 

us that option. 

We need to take a holistic view of health that seeks to maintain 

the healthiest animal population possible. Healthier animals lead 

directly to a safer food supply. Nobody in the animal industry 

wants to continue, though, with the status quo. Changes in production are happening. Companies are voluntary reducing their uses 


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184 

of antibiotics. But we still need options for preventing and treating 

disease and these are disappearing as can be seen in the poultry 

industry. The only animal agricultural antibiotic banned from use 

in the United States remains the fluoroquinolones in poultry production. There is another antibiotic. It has no human counterpart 

and it still has not been approved for treating disease in poultry 

in the United States. Both of these antibiotics are available as 

treatment options in Europe. I will stress that again. 

Fluoroquinolones are available in Europe as a treatment option. 

In the absence of efficacious treatment options, the poultry industry at least needs the option of using antibiotics to prevent disease in the first place. What we should be doing is determining 

what antibiotic uses minimize risks to human health while maximizing animal health. How do we begin to quantify those risks and 

determine the antibiotic uses that pose the least risk? FDA’s Center for Veterinary Medicine has an approved risk assessment approach as described in Guidance for Industry Document number 

152. I was part of a team that used this approach to examine a 

specific antibiotic class, and we found that under the FDA’s own 

definition, there was reasonable certainty of no harm to human 

health associated with this use. That is a peer-reviewed publication. 

I am in full agreement with the many international reports and 

FDA statements that we need to continue to assess these risks but 

they need to be done a drug-by-drug basis in each animal species. 

All antibiotics that fall under the same usage category are not 

equal in terms of their impacts on resistance or their impacts on 

human and animal health. 

In conclusion, Mr. Chairman and members of the subcommittee, 

I thank you for the opportunity to speak today. Antibiotics are an 

integral component of animal health and healthier animals lead to 

healthier people. I would hope that decisions regarding antibiotics, 

their approval and removal from use will continue to rest with the 

FDA’s Center for Veterinary Medicine, who has in place a system 

for assessing the risks to human health associated with animal antibiotic use. I hope that those who make the final decisions about 

antibiotic use are truly interested in all health, human, animal and 

environment, and agree that preventing disease is always preferable to having to treat the sick. The best way to manage antibiotic uses in animal agriculture is through sound, rational, 

science-based policy that evaluates the risks and benefits of all antibiotic uses. Thank you. 

[The prepared statement of Dr. Singer follows:] 


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Testimony of Dr. Randall Singer 

Associate Professor of Epidemiology 

University of Minnesota 

Subcommittee on Health 

Committee on Energy and Commerce 

United States House of Representatives 

Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture 

July 14, 2010 

Mr. Chainnan and Members of the Subcommittee: 

Thank you for providing me with the opportunity to discuss the important topic of antibiotics in 

animal agriculture. I am an Associate Professor of Infectious Disease Epidemiology and 

Ecology at the University of Minnesota. I have a dual appointment at the university, both in the 

College of Veterinary Medicine and the School of Public Health. I am a veterinarian by training 

with a degree from the University of California at Davis. Following my veterinary degree, I 

obtained a PhD in epidemiology from the University of California at Davis. I have worked as a 

professor of epidemiology since 1999, first at the University of Illinois, Urbana-Champaign and 

now at the University of Minnesota. I have spent the past 12 years engaged in research, teaching 

and service activities related to antibiotic use and antibiotic resistance in human and animal 

health. I will focus my discussion on six questions that I think are critically important: 

1. What are antibiotics and how are they used in animal agriculture? 

2. What is antibiotic resistance and how does it develop? 

3. What are the impacts of antibiotic usage in animal agriculture? 

4. How do we assess the risks of antibiotic use in animal agriculture? 

5. How do we manage the risks of antibiotic use in animal agriculture? 

6. How does the One Health paradigm apply to antibiotic use in animal agriculture? 
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What are antibiotics and how are they used in animal agriculture? 

Although many people think of antibiotics as human-made compounds, antibiotics are actually 

small molecules that are naturally produced by microorganisms in the environment (30). 

Humans have created synthetic analogs to these naturally occurring compounds to improve their 

efficacy. The function of these molecules in nature is still not entirely understood. Because 

bacteria in the environment have been exposed to these antibiotics for eons, they have developed 

mechanisms for survival in the presence of these compounds. These mechanisms are what we 

refer to as antibiotic resistance -- a way for the bacterium to resist the action of these antibiotics. 

The presence of naturally produced antibiotics in the environment is rarely considered as a 

contributor to the degree of resistance that is found in bacteria around the world, and yet it is this 

environmental pool of resistance, recently termed the resistome (7), that is the basis for the 

resistance observed today. Antibiotic resistant microorganisms can be found in areas with little 

to no obvious human influence or impact, emphasizing that there is a large background reservoir 

of resistance that exists in the natural world. 

Antibiotics are used in animal agriculture in four major ways: disease treatmellf, disease control, 

disease prevention, and growth promotion. Briefly, disease treatment refers to the use of the 

antibiotic in an ill animal. Disease control refers to the use of the antibiotic in a population of 

animals during a time of illness. Not all of the animals receiving the antibiotic are necessarily ill 

at the time of antibiotic administration. Disease prevention refers to the use of the antibiotic in 

an animal or in a population of animals at a time when it is known that the animals are 

susceptible to disease and a disease risk is present. The importance of prevention should not be 

underestimated; it is always preferable to prevent disease than to treat a whole flock or herd of 

diseased and exposed animals once an outbreak has begun. In fact, one of the central tenants of 

medicine is to minimize health impacts by maintaining a healthy population in the first place. 

Finally, growth promotion refers to the use of the antibiotic in a low-dose fashion to improve the 

weight gain and feed efficiency of the animal. This type of use has been termed "production 

use" in the recent FDA Draft Guidance document #209 because production uses "are not directed 

at any identified disease, but rather are expressly indicated and used for the purpose of enhancing 

the production of animal-derived products (e.g. increasing rate of weight gain or improving feed 

efficiency)" (28). 

All four of these use categories result in an improved health of the animal receiving the 

antibiotic. Nonetheless, assumptions about these llses often lead to confusion. One area of 

confusion is related to the route of administration. Uses of antibiotics that are "in-feed" are often 

equated with growth promotion uses and are assumed to be long-term low-dose regimens of 

antibiotic administration for the sole purpose of improving weight gain. In fact, all four of these 

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uses can be applied via the feed or the water because the only realistic way to administer an 

antibiotic to populations of animals, such as a flock of chickens, is through the feed or the water. 

Further, antibiotics used for disease treatment and disease control are often given via the 

drinking water because sick animals may stop eating but often continue to consume water. 

Many of the antibiotics currently used in animal agriculture, particularly those used for 

"production" purposes, were approved in the 1960's. In general, there was a poor understanding 

of how these compounds worked, but because animals fed antibiotics for production purposes 

grew faster, the antibiotics were labeled for increased feed efficiency and average daily weight 

gain. The label claims for these antibiotics have not changed in almost 50 years. In a time when 

bacteria are becoming increasingly resistant to the action of antibiotics, it might seem injudicious 

to use an antibiotic solely to increase weight gain and feed efficiency, and this use might be 

interpreted as having a pure economic value. We now know that low-dose uses of antibiotics 

improve the overall health of the growing animal, and the outdated label claims of feed 

efficiency and growth promotion do not do justice to the "gut health" and "disease prevention" 

attributes that these low doses possess. In general, the improvements seen in feed efficiency and 

growth are the result of improved health and gut integrity due to disease prevention. 

When strictly considering the label claims of improved feed efficiency and average daily weight 

gain, the "production" uses of antibiotics do not appear to have the same importance they once 

had. For example, in a study by Dritz et al. (9), various antibiotic regimens were tested on 

growing pigs. Only the growth rate of nursery pigs was significantly improved by some of the 

regimens. The authors concluded that dramatic improvements in the health management of 

animals in intensive agricultural facilities as well as improved animal genetics likely led to a 

diminished need for "production" uses of antibiotics. 

A very recent study by Aarestrup et at. (2) analyzed antibiotic use and production data from 

swine raised in Denmark between 1992 and 2008. By January 2000, Denmark had stopped using 

any antibiotic for growth promotion in swine. The authors concluded that total antibiotic 

consumption per pound of pig produced decreased over the time span of the study, although the 

authors included approximately 6 years of data before the ban was even initiated. At the same 

time, the authors concluded that swine productivity, when analyzed as mean number of pigs per 

sow per year raised for slaughter and average daily weight gain increased during the time period 

of the study. Consequently, it would appear from this study that animals can be raised efficiently 

without the need for "production" uses of antibiotics. 

There are several troubling aspects of the data analysis in the paper by Aarestrup et aI., however, 

as well as a key take-home message that was not highlighted in the manuscript. First, according 

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to the Danish Agriculture and Food Council, the number of pig producers in Denmark dropped 

from approximately 25,000 in 1995 to less than 10,000 in 2005. Only those with the highest 

productivity and efficiency survived, and those producers that survived became larger operations 

and became more integrated and intensive. If more than half of the producers were lost during 

the timeframe of the study, and if these producers were the least efficient and productive, then 

estimates of overall productivity would have to increase over timefor no other reason than the 

fact that only the most productive producers survived. Unfortunately, information about specific 

producers and their productivity over time is not available, and therefore it is impossible to do an 

analysis to determine how much increase there was in productivity on an individual producer 

basis. Even with this information, though, the fact remains that increases in pig productivity 

were already being observed in Denmark prior to the bans due to improved animal genetics and 

improved health management systems. 

A final point that is critical to recognize from the paper by Aarestrup et al. is demonstrated in 

Figure 2 of the paper, as shown below: 

No saf4)!lJ. prd'rt 

I 

A1J'Qpat(:!I'II ba~ VI!)Jfl"i8mycin 

ban L$Jwsoo.i,a inimcaiJu/ans 

• 

Time 

PM\i\lS 

Figure 2 (from Aarestrup et aL 2010 (2) Consnmption of antimicrobials for use as AGPs (black bars) or for 

thcrapeutic administration (gray bars) [rom 1992 to 2007 by thc Danish swine production systcm. Notice thc 

ban on usc of avoparcin and on veterinary profits from the prescription and sale of antimicrobials, the ban on 

AGP use in finishing pigs and on nsc ofvirginiamycin in all pigs that was instituted in 1998, and the ban on 

AGP use in weaning pigs that was instituted in January 2000. Outbreaks ofPRRS (1996 to 2000). discase 

attributable to Lm1'sonia intracellularis (1998 to 2002), and PMWS (2001 to 2(06) are indicated (arrows). 

Weaning and finishing pigs weighed < 35 kg and> 35 kg, respectively. 

Over time, and particularly following the ban on growth promoting antibiotics (AGP), there was 

a steady increase in the use of therapeutic antibiotics. The antibiotics approved for therapy in 

animal agriculture are often those that would also be considered medically-important in humans. 

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The authors attempted to explain these increases in therapeutic antibiotic uses by events like an 

outbreak of Lawsonia intercel1ularis in the period of 1998 through 2002. This is misleading 

because Lawsonia il1tercel1ularis is always present on most swine operations and can be kept in 

check by the administration of disease prevention doses of antibiotics. A take-home message of 

this paper is the fact that this disease appeared following the removal of "production" uses of 

antibiotics and should indicate that these uses do have health-related functions far beyond the 

labeled feed efficiency and average daily weight gain claims. Such uses might include disease 

prevention doses of antibiotics that would be targeted at specific pathogens typically found on 

farms, such as Lawsonia intracel1ularis, and would be given to swine at ages when they are most 

susceptible (i.e. at weaning). 

What is antibiotic resistance and how does it develop? 

Antibiotic resistance refers to the ability of a microorganism to survive the effects of an 

antibiotic. As stated previously, antibiotics are naturally produced by environmental 

microorganisms, and as a result, many microorganisms possess mechanisms that enable them to 

resist the action of these antibiotics. The two major mechanisms by which the microorganism 

can acquire resistance are through random changes in the genetic makeup, known as mutation, or 

through the sharing of genetic material with other microorganisms. 

When an antibiotic is applied to a population of bacteria, those bacteria that are not intrinsically 

resistant to its action must find a way to survive. The antibiotic will either kill or suppress the 

bacteria that are susceptible to the antibiotic. For this reason, the antibiotic is said to 'select' for 

resistant bacteria because only the resistant ones can survive despite the pressure imposed by the 

antibiotic. During the course of the antibiotic, the rates at which bacteria can acquire resistance 

might increase. Consequently, the use of the antibiotic may pose a risk to human and animal 

health through the selection of a more resistant bacterial popUlation. 

Whereas FDA Guidance Document #209 (28) states in the Executive Summary that "Misuse and 

overuse of antimicrobial drugs creates selective evolutionary pressure that enables antimicrobial 

resistant bacteria to increase in numbers more rapidly than antimicrobial susceptible bacteria and 

thus increases the opportunity for individuals to become infected by resistant bacteria," it is 

important to recognize that ALL uses of antibiotics select for resistance to some degree in 

specific bacteria. The question, stated simply, is how to ensure that public health and 

environmental health are maximized while maintaining animal health. To address this type of 

holistic question, we must first assess how different uses of antibiotics impact antibiotic 

resistance. 

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What are the impacts of antibiotic usage in animal agriculture? 

To begin this section on the potential impacts of antibiotic use, it is critical to distinguish 

between antibiotic resistance and food safety. Nobody should be questioning the fact that 

bacteria from animals can move through the food chain and cause disease in people. This is the 

basis of food safety and control programs designed to reduce the burden of illness associated 

with foodborne disease. Efforts are often focused on controlling the contamination of food 

products and educating the consumer about the proper ways for handling food products. 

Foodborne bacteria can cause disease regardless of whether they are susceptible or resistant to 

antibiotics. The relevant question for this hearing is why are some of these bacteria resistant to 

antibiotics in the first place, and did the use of antibiotics in animals cause the resistance 

observed in these bacteria? Unfortunately, many individuals have linked the two issues, leading 

to the assumption that antibiotic resistant bacteria that infect people through the consumption of 

food are resistant BECAUSE of the use of antibiotics in animals. This linking of two separate 

issues has been incorporated into many reports that are being used to set policy, and because 

many of these reports cite prior reports rather than citing the original research on which the 

reports are based, these misconceptions have been propagated over time. Two key examples are 

described below: 

One study that was published in 1999 out of Denmark reported on a multi-drug resistant bacterial 

isolate of Salmonella Typhimurium definitive phage type 104 that caused morbidity and 

mortality in people (20). This bacterium was of particular concern not only because it was multidrug resistant but also because it was resistant to a very important class of antibiotic, the 

fluoroquinolones. The authors of this paper concluded in the Abstract that "because of this 

increase in quinolone resistance in Salmonella, the use offluoroquinolones in food animals 

should be restricted." If one reads beyond the Abstract of this paper, the authors admit that 

"There was no indication offluroquinolone use in the implicated [swine] herds" (p. 1424). They 

continue to say that it is impossible to determine if this multi-drug resistant Salmonella strain 

"was introduced by pigs from outside Denmark, was introduced by environmental spread (e.g., 

from wild animals or equipment), or was related to the use offluoroquinolones at the suspected 

farms before 1998" (p. 1424). Consequently, this paper is an unfortunate story of severe illness 

caused by Salmonella that potentially originated in swine, but it says nothing about the impacts 

of the agricultural use of antibiotics. It should be noted that fluoroquinolones, when used in 

animal agriculture, are used as a therapeutic antibiotic for treating sick animals; they are not 

"production use" antibiotics. To include this paper in discussions of the potential risks of 

agricultural uses of antibiotics and in discussions regarding "production use" antibiotics, as has 

been done in many of the governmental and non-governmental reports on antibiotics in 

agriculture, seems inappropriate. 

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A second paper worth noting was published in 2000 and discussed a ceftiofur resistant 

Salmonella strain that was acquired by a child possibly from cattle (11). Ceftiofur is a thirdgeneration cephalosporin related to ceftriaxone, a medically-important antibiotic. Tn the 

Abstract, the authors conclude that "This study provides additional evidence that antibioticresistant strains of salmonella in the United States evolve primarily in livestock." A statement 

this strong would suggest that the authors had data demonstrating that ceftiofur was used in the 

implicated cattle herd, that susceptible Salmonella strains were isolated, and that they could 

document the emergence of a ceftiofur-resistant strain on the implicated farm due to the use of 

the antibiotic on that farm. The authors state on page 1247 that "It is probable that the use of 

antimicrobial agents in cattle led to the selection of the ceftriaxone-resistant strain that was 

subsequently transmitted to the child. Although we were unable to establish its use in these 

herds, an expanded-spectrum cephalosporin (ceftiofur) is approved for use and is widely used in 

domestic animals, including cattle." This paper documents an unfortunate severe illness but says 

nothing about the impacts of antibiotic use in animal agriculture. Once again, the antibiotic 

addressed in this study, ceftiofur, is a therapeutic antibiotic and should not be included in 

discussions of "production use" antibiotics. Nonetheless, it remains one of the central citations 

used to set policy 

Studies that have been conducted on the effects of antibiotic administrations in agricultural 

animals are not numerous. There are more studies on the effects of treatment dose 

administrations than on the effects of disease prevention and "production" dose administrations. 

More studies need to be performed in animals in various settings meeting rigorous study design 

requirements. Dosing regimens need to be evaluated to determine how they impact selection of 

resistant bacteria. A brief summary of several studies that have evaluated antibiotic 

administrations are described below. 

A series of studies has been conducted in dairy and beef cattle to explore the effects of 

therapeutic ceftiofur administration on the appearance of cefti ofur-resi stant E coli. In one study, 

treated dairy cows showed a significant decrease in the total E. coli population when fecal 

samples were analyzed (24). There appeared to be a complete decimation of the susceptible E. 

coli population. Animals that possessed E. coli with ceftiofur resistance could be detected in 

some of these samples. Although animals not treated with ceftiofur were confirmed to possess 

ceftiofur resistant E. coli using molecular methods, these animals never had resistant E. coli 

isolated from their fecal samples. Within a week of the cessation of treatment, the susceptible 

population of E coli returned, and resistant isolates were not recovered again for the remainder 

of the 30-day study period. The antibiotic treatment provided a window to detect the presence of 

ceftiofur-resistant E. coli but did not cause its emergence or result in its amplification. In a trial 

with ceftiofur in beef cattle, similar findings were observed (17). In this study, the susceptible E. 

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coli population returned within 28-days, indicating that the effect in this study was somewhat 

longer lasting. Another study in dairy cattle found that treated animals continued to shed 

resistant strains 17 days after the initial treatment (16). In an investigation of dairy farms, those 

dairies that used ceftiofur were significantly more likely to have cows shedding E. coli with 

reduced susceptibility to cephalosporins (26). 

These studies and others not mentioned demonstrate a consistent point: high dose therapeutic 

antibiotic administration can eliminate susceptible populations of bacteria. This effect can lead 

to a selection of resistant strains. Furthermore, many of the antibiotics used for therapeutic 

purposes in animals would be considered medically-important to humans, and consequently, 

their use could be selecting for bacteria that are resistant to the same antibiotics used in human 

medicine. Further research is needed to determine how to minimize this risk and also how to 

control the release of resistant bacteria from the farm. 

Studies on antibiotic uses at "production" and disease prevention doses can also show a higher 

rate of resistance in the treated animals versus the control animals. For example, in pigs treated 

with apramycin (an antibiotic no longer marketed in the US), apramycin resistant E. coli levels 

were higher in the treated versus the control groups but quickly returned to baseline levels as in 

the previously cited treatment dose studies (18,19). Effects such as these are not always 

observed, as evidenced by a recent study of feeding trials in finishing pigs with tylosin or 

chlortetracycline under different dosing regimes (29). This study found no difference in 

resistance in either Salmonella or E. coli between the treatment and control b>roups. Another 

effect occasionally assessed in these studies is the potential for the low-dose antibiotics to 

decrease shedding of important foodborne bacteria such as Salmonella. This effect has been 

suggested by studies that have observed lower levels of Salmonella shedding in pigs that have 

been fed antibiotics (10,12,19). One recent study observed a decrease in Salmonella shedding 

over time in the antibiotic-treated groups, but the effect was not statistically significant (29). 

Perhaps the best place to look for some of the impacts that "production" uses of agricultural 

antibiotics have is in Denmark and the European Union. It is often reported that levels of 

antibiotic resistance in bacteria isolated from animals and people in Denmark declined following 

the complete ban of "production uses" of antibiotics in the late 1990's. Furthermore, it is often 

stated that antibiotic use levels also declined. Both of these statements, however, depend on how 

the data are analyzed. 

Figure 27 from the 2008 DANMAP report (8), shown below, shows that the prevalence of 

resistance to certain antibiotics in Salmonella Typhimurium has actually increased over time. 

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This is important because of the public health relevance and burden of illness associated with 

this bacterium. 

Pigs Pori<; 

Danlsl)") 

~.~.' ~ .. '.""'I! .. 

. . ~ 

27. Trends in resistance to selected antimicrobials among SalmoneHa Typhimun'um isolated from pigs, pork 

cases,. Denmark 

Figure 28 from the 2008 DANMAP report (8), shown below, demonstrates increasing 

prevalences in antibiotic resistant Campylobacterjejzmi, another important human pathogen. 

Danish 

broilers 

Danish broiler 

meat 

imported broiler Domestically 

meat acquiredJ ) 

I I 

I !

I 

, I 

t. 1\1 

j / 

Figure 28. Trend C jejum. Trends in re.sl$tance to selected amm!corblals among Campyiobacter jejuni isolates 

""Om broilers. broifer meat and human cases, Denmark 

Together, these figures demonstrate that the removal of antibiotics from animal production will 

not necessarily result in a decline in antibiotic resistance. Fib'ures 9 and 10 from the 2008 

DANMAP report (8), shown below, highlight a critical concern when setting antibiotic use 

policy. When the antibiotic administrations are recorded as the number of doses given to 

animals, the number of doses has steadily risen in Denmark since the ban of "production use" 

antibiotics. These Figures, when combined with Figure 2 from Aarestrup et al. as shown 

previously (2), clearly demonstrate that following the removal of the "production use" 

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antibiotics, considerably more therapeutic administrations were required. This is due to the 

increased animal illness that has been observed in Denmark since the ban. 

DANMAP 2008- DANf\lAP 2008 

Given that over ten years ago the removal of the "production use" antibiotics in Denmark was 

implemented to improve human health, one would expect to have seen human health 

improvements by this point in time. The major impacts that are cited are a reduction in resistant 

bacteria in animals and in people within the community; no clear-cut human health 

improvements (i.e. decreased incidence of disease caused by resistant bacteria) are even 

mentioned. As shown previously, even the reports of decreased antibiotic resistance in bacteria 

from animals and humans depends on which bacteria and which antibiotics are being considered. 

On the contrary, the 2008 DANMAP report (8) documents the dramatic increase in multi drugresistant Klebsiella pneumoniae isolates in hospitals. This bacterium can cause serious blood 

infections in people, and the multi drug-resistant strains are particularly difficult to treat. One 

hypothesis for the dramatic increase is the increased consumption of broad spectrum antibiotics, 

especially tbe 2nd and 3rd generation cephalosporins. Much of this consumption is occurring in 

human hospitals, but some of this consumption could also be occurring as a consequence of the 

increased use of therapeutic antibiotics on farms to treat the increasing numbers of ill animals. 

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How do we assess the risks of antibiotic use? 

There are two primary approaches for assessing and managing the potential risks associated with 

antibiotic use in animal agriculture. One approach is to employ the precautionary principle. In 

this argument, the precise public health risks associated with animal antibiotic use might not be 

known. Because there is a perceived potential for serious negative consequences, it is deemed 

better to avoid the action entirely rather than to suffer the potential consequences. Europe has 

used this principle to withdraw certain antibiotic uses from animal agriculture (3). One reason 

why this approach is often relied upon, especially in the case of antibiotic use and resistance, is 

the belief that antibiotic use is negatively impacting human health. It is extremely difficult to 

design, implement and analyze the decisive study that will prove or disprove this theory. 

Caution would dictate that by the time such a study is complete, any negative effects associated 

with continued antibiotic use might be irreversible. Therefore, the precautionary principle 

approach to managing antibiotic use in animal agriculture has only one real option: withdraw the 

antibiotic use that might result in a negative human health consequence. The problem is that it is 

very difficult if not impossible to predict the negative unintended consequences associated with a 

precautionary measure (6). 

A more objective way to evaluate the potential consequences of antibiotic use in livestock and 

poultry is to develop scientifically-based predictions, and through these models, evaluate 

interventions that reduce potential human and animal health risks associated with certain 

antibiotic uses in animal agriculture. This approach includes the methodology known as risk 

assessment. Throughout many governmental and non-governmental reports, including those 

cited in FDA Draft Guidance #209 (28), there have been repeated calls for the use of risk 

assessment approaches. In 2003 the FDA Center for Veterinary Medicine (FDA-CVM), which 

uses a scientific approach to regulatory decisions, issued Guidance for Industry document #152 

that described a qualitative risk assessment process that is utilized in the approval of all 

applications for new animal antibiotics and the reassessment of existing animal antibiotics (27). 

FDA Guidance Document #209 makes a clear distinction between the use of#152 in the preapproval process of a new animal drug and a safety review of a currently-approved product. 

Regardless, the risk assessment approach is a science-based approach to evaluating the potential 

risks to human health associated with the use of antibiotics in animal agriculture. A major 

challenge to this approach, though, is related to the definition of risk and an acceptable level of 

risk. In FDA Guidance Document #209, it is stated on page 13 that "FDA considers an 

antimicrobial new animal drug to be "safe" if the agency concludes that there is "reasonable 

certainty of no harm to human health" from the proposed use of the drug in food-producing 

animals" (28). This is a vague definition that has traditionally been used for toxicological 

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assessments. With respect to antibiotic resistance, it is unclear what is implied by "reasonable 

certainty of no harm." 

If the risk assessment approach is to be utilized, it should be expected that each antibiotic or class 

of antibiotic that is approved or that is seeking approval would be evaluated separately, and that 

an assessment would be conducted in each animal species separately. To assume that all 

antibiotics that are used in the same way pose the same risk to human health seems to defeat the 

purpose of a scientifically-sound risk assessment process. Performing a risk assessment that is 

drug-host-microbe specific is feasible, and there is at least one peer-reviewed and published risk 

assessment that did this while following the GFI #152 approach. The published model assessed 

the risk that the agricultural use of a family of antibiotics known as macrolide antibiotics poses to 

human health (14). The concern is that macrolide antibiotics are also used in human medicine, 

and therefore, the use of macrolide antibiotics in animal agriculture could compromise the 

efficacy of these antibiotics in human medicine and potentially increase the number of 

macrolide-resistant bacterial infections in people. A semi-quantitative risk assessment model 

following the format ofGFT #152 was developed and found that all macrolide antibiotic uses in 

animal agriculture in the U.S. pose a very low risk to human health. The Table below shows the 

results of the model. The risk is expressed as the probability that macrolide use in the animal 

species will result in macrolide resistance in a specific bacterium, that this bacterium will make it 

through the food chain and infect a person, that this person will seek medical care, and that 

treatment of the infection with macrolides will fail due to the macrolide resistance. The highest 

risk was associated with macrolide-resistant Campy/ahaete,. infections acquired from poultry, 

but this risk was still estimated to be less than I in lO million and would thus meet the standard 

of"reasonable certainty of no harm" employed by FDA-CVM. 

Animal Macrolide-Resistant Quantified Risk to Humans of Treatment Failure Due 

Product Bacteria to a Resistant Infection 

Beef Campy/ohaeter < 1 in 236 million per person per yr 

Efaeeium < 1 in 29 billion per person per yr 

Poultry Campylabacter < I in 14 million per person per yr 

Efaeeium < 1 in 3 billion per person per yr 

Pork Campylahacter < 1 in 53 million per person per yr 

Efaeciul11 < 1 in 21 billion per person per yr 

Results from Hurd et aI., 2004, J Food Prot, 67:980-992 

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How can we manage the risks of antibiotic use in animal agriculture? 

Most risk assessment models conducted to date in antibiotic resistance that have been used for 

regulatory purposes have not included specific interventions that can be implemented to reduce 

the human and animal health risks. Instead, the assessments seem to have been designed for the 

sole purpose of making the dichotomous decision of whether or not to withdraw an antibiotic 

from use. For risk assessments to be useful, they should include evaluations of potential 

interventions for reducing the risks to human and animal health. In the U.S. FDA-CVM risk 

assessment offluoroquinolone use in chickens (4), the model only estimated the potential human 

health impact of this antibiotic use and did not evaluate ways for minimizing the risk associated 

with fluoroquinolone use in poultry. For example, the model could have examined the 

possibility of processing chickens from treated poultry flocks separately from chickens from 

untreated flocks as a potential risk reduction strategy. This separated processing could help 

reduce the chance of cross-contamination of chicken meat from non-treated poultry flocks with 

the bacteria from treated flocks. The model could have examined a potential intervention in 

which farms that have received fluoroquinolones are cleaned in a more intensive manner than the 

normal cleaning, and all litter from these flocks is sterilized. Finally, the model could have 

assessed an intervention in which flocks that have been treated with antibiotics would have to 

wait for a longer period of time before processing. This type of approach would resemble the 

mandatory withdrawal times associated with antibiotic residues. Guidelines could then be 

developed to determine when specific antibiotic uses should be ceased in flocks before they go to 

processing in order to reduce the amount of antibiotic resistant bacteria in the birds. 

Consideration of such risk mitigation interventions rather than complete withdrawal of these 

drugs would have been very important to poultry veterinarians. 

These types of interventions might sound labor-intensive and costly. They are, and that is the 

point. Under certain circumstances, it might be cost-effective and ethical for a veterinarian to 

use a powerful antibiotic to control a severe disease in the herd or flock, but this use would then 

have major repercussions on how the herd or flock as well as the farm are subsequently 

managed. Producers might not opt for this intensive measure, but at least they would have a 

choice that is accepted as scientifically-sound for reducing both the human and animal health 

risks associated with the antibiotic use on their farm. As we begin to gain a better understanding 

of the ecology of resistance and its relation to animal and human health, we will need these 

scientifically-based strategies for minimizing the impacts of antibiotic use on animal, human and 

environmental health. 

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How does the One Health paradigm apply to antibiotic use in animal agriculture? 

The health of humans, animals and the environment are intricately related. Many of the 

challenges we face today, including emerging infectious diseases, antibiotic resistance, food 

safety and security, and sustainable living exemplify this holistic view of health. The notion of 

One Health incorporates this holistic view and aims to bring a multidisciplinary approach to 

addressing these complex health issues. The issue of antibiotic resistance serves as an exemplary 

model for a One Health approach. We cannot possibly grasp how microbes are impacted by 

exposure to antibiotics without an understanding of the dynamics of microbes in the 

environment, animals, and people (25). Further, we cannot understand the implications of 

human exposure to bacteria carrying resistance genes without understanding how exposure 

occurs, how resistance develops, and what the risks of such exposure are. 

When we consider the complex issue of antibiotic resistance, we must begin to take a more 

holistic view of health into consideration. Every action and every policy decision we make that 

is intended to slow or stop the development and spread of resistance has the potential to have 

serious unintended consequences. As an example, the removal of growth promoting antibiotics 

from use in food animals in Denmark resulted in an increased reliance on therapeutic doses of 

medically-important antibiotics to treat the ill animals. The Figure below shows a schematic of 

this relationship in which animals that are given antibiotics for growth or disease prevention are 

healthier, leading to a longer term improvement in animal health. This improvement leads to a 

safer food supply and therefore improved human health. However, these antibiotics can also 

select for resistance, which can lead to a decline in human health. If antibiotics used for growth 

or disease prevention are removed, there will be a decrease in antibiotic resistance, which could 

lead to improved human health. There will also be a decline in animal health, as seen in 

Denmark and other countries, which will then lead to an increased use of therapeutic antibiotics 

to treat the sick animals. This leads to increased antibiotic resistance and a decline in human 

health. Furthermore, a decline in animal health can lead to a decline in human health through 

more contaminated meat entering the food supply. 

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Improvement in Increase in Decline in Decrease in 

Animal Health Resistance 

r"'~' 1 Resistance 

~ 1 Health 

Improvement in Decline in 

Increase in ~ Therapeutic Decline in Improvement in 

Human Health Human Health Antibiotic Use Human Health Human Health 

L='~I,J Resistance 

In this schematic, the solid black arrows denote negative impacts on human health while 

solid white arrows denote positive impacts on human health. AGP represents antibiotics 

used as for growth promotion, but because the effect of these antibiotics is also to improve 

animal health, AGP could be substituted with Disease Prevention doses. 

The scenario described above has a basis in the published scientific literature. The health status 

of animals that are processed for meat can potentially affect food safety in two major ways. 

First, animals that are less healthy may shed higher levels of harmful bacteria, such as 

Salmonella and Campylobacter. Second, groups of animals that have experienced illness, either 

clinically or subclinically, can be smaller in size and more variable in size. Their gastrointestinal 

tracts can have weaker walls. During processing, these factors can contribute to an increased 

likelihood of the gastrointestinal tract being ruptured, and this processing error can lead to 

increased contamination and cross-contamination of the meat and thus increase the risk of human 

foodbome illness. Reducing animal illness likely plays a critical role in reducing the chances of 

contamination during processing (13,22)' A recent mathematical model was developed to 

address this relationship shown in the figure above (23). The model demonstrated a large 

increase in human illness associated with small increases in animal illness, suggesting that 

agricultural management strategies may have significant impacts on human health. The model 

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showed that the potential benefits to human health associated with the use of antibiotics in 

animal agriculture can far outweigh the potential risks. This finding has now been validated by 

additional studies (5,13,15). 

Another example of a potential unintended consequence of antibiotic use policy relates to 

methicillin-resistant Staphylococcus aurcus (MRSA). An observation was made that tetracycline 

resistance was among the resistance carried by MRSA isolates from animals. The concern was 

that any continued use of tetracycline was selecting for MRSA. A recent study from Denmark 

found that both MRSA and MSSA (susceptible strains) were resistant to tetracycline, but only 

the MRSA strains were resistant to zinc (1). Zinc chloride has been used in Denmark as a nonantibiotic alternative following the antibiotic bans, and now it appears that zinc compounds may 

have selected for the emergence and dissemination of MRSA strains in Denmark. 

Summary 

In summary, Mr. Chairman and Members of the Subcommittee, thank you again for the 

opportunity to discuss the role of antibiotics in animal agriculture. Antibiotics are an integral 

component of animal health. All uses of antibiotics improve animal health, and these 

improvements in animal health can substantially improve human health. Even "production" 

uses of antibiotics, which have the unfortunate, decades-old label claim of improving feed 

efficiency and average daily weight gain, have the clear and documented effect of improving 

animal health. All uses of antibiotics may also pose a risk, mainly associated with increases in 

antibiotic resistance. The key is to assess the ability of interventions to maximize the benefits 

and minimize the risks associated with the agricultural use of antibiotics. Simply removing 

antibiotics from use in animal agriculture may help reduce some of the antibiotic resistance 

circulating today, but it might also have severe unintended consequences. The best way to 

manage antibiotic uses in animal agriculture is through sound, rational, science-based policy. A 

successful management strategy is one that will optimize human, animal and environmental 

health. Success should not be measured by implementation of the policy itself (21) but rather 

through documented health improvements. 

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References 

1. Aarestrup, P. M., L. Cavaco, and H. Hasman. 2010. Decreased susceptibility to zinc 

chloride is associated with methicillin resistant Staphylococcus aureus CC398 in Danish 

swine. Vet. Microbiol. 142455-457. 

2. Aarestrup, F. M., V. F. Jensen, H. D. Emborg, E. Jacobsen, and H. C. Wegener. 2010. 

Changes in the use of antimicrobials and the effects on productivity of swine farms in 

Denmark. Am. J. Vet. Res. 71:726-733. 

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714. 

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F. 1. Angulo, and S. H. Hinrichs. 2000. Ceftriaxone-resistant Safmone11a infection 

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13. Hurd, H. S., J. Brudvig, J. Dickson, J. Mirceta, M. Polovinski, N. Matthews, and R. 

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N. Jones. 2004. Public health consequences of macrolide use in food animals: a 

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16. Jiang, x., H. Yang, B. Dettman, and M. P. Doyle. 2006. Analysis of fecal microbial flora 

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17. Lowrance, T. c., G. H. Loneragan, D. 1. Kunze, T. M. Platt, S. E. Ives, H. M. Scott, B. 

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18. Mathew, A G., K N. Gamer, P. D. Ebner, A M. Saxton, R. E. Clift, and S. Liamthong. 

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Typhimurium in their offspring. Foodborne. Pathog. Dis. 2:212-220. 

19. Mathew, A G., S. Rattanatabtimtong, C. M. Nyachoti, and L. Fang. 2009. Effects of infeed egg yolk antibodies on Salmonel/a shedding, bacterial antibiotic resistance, and 

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20. Molbak, K, D. L. Baggesen, F. M. Aarestrup, J. M. Ebbesen, J. Engberg, K Frydendahl, 

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22. Russell, S. M. 2003. The effect of airsacculitis on bird weights, uniformity, fecal 

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Escherichia coli. Poult. Sci. 82:1326-1331. 

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Modeling the relationship between food animal health and human foodborne illness. 

Prevo Vet. Med. In Press. 

24. Singer, R. S., S. K. Patterson, and R. L. Wallace. 2008. Effects of therapeutic ceftiofur 

administration in dairy cattle on Escherichia coli dynamics in the intestinal tract. Appl. 

Environ. Microbiol. 

25. Singer, R. S., M. P. Ward, and G. Maldonado. 2006. Can landscape ecology untangle the 

complexity of antibiotic resistance? Nat. Rev. Microbiol. 4:943-952. 

26. Tragesser, L. A., T. E. Wittum, J. A. Funk, P. L. Winokur, and P. J. Rajala-Schultz. 2006. 

Association between ceftiofur use and isolation of Escherichia coli with reduced 

susceptibility to ceftriaxone from fecal samples of dairy cows. Am. 1. Vet. Res. 67: 1696-

1700. 

27. U.S.Food and Drug Administration Center for Veterinary Medicine. Guidance for 

Industry: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to 

Their Microbiological Effects on Bacteria of Human Health Concern. Document No. 152 

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28. U.S.Food and Drug Administration Center for Veterinary Medicine. Draft Guidance: The 

Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. 

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29. Wagner, B. A., B. E. Straw, P. 1. Fedorka-Cray, and D. A. Dargatz. 2008. Effect of 

antimicrobial dosage regimen on Salmonella and Escherichia coli isolates from feeder 

swine. Appl. Environ. Microbiol. 74: 1731-1739. 

30. Waksman, S. 1961. The role of antibiotics in nature. Perspectives in Biology and 

Medicine 4:271-287. 

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Ms. SCHAKOWSKY. Thank you. 

Dr. Carnevale. 

STATEMENT OF RICHARD CARNEVALE 

Dr. CARNEVALE. Chairman Pallone, Ms. Schakowsky and Ranking Member Shimkus and members of the subcommittee, thank 

you for the opportunity to appear before you today. I appeared before this committee some time back during the Animal Drug User 

Fee hearings, and I want to thank the committee for moving that 

piece of legislation through. We greatly appreciate it. 

My name is Dr. Richard Carnevale. I am a veterinarian and Vice 

President at the Animal Health Institute. AHI is an industry trade 

association representing companies that make medicines for animals. Before AHI, I spent nearly 20 years at the FDA and USDA 

working on animal drugs and food supply. 

While I submitted more thorough comments for the record, I 

would like to talk to you today about one simple truth: animals 

need medicines including antimicrobials. Without safe and effective 

medications to treat, control and prevent diseases, animal welfare 

would suffer and deaths would increase. Additionally, as Dr. Singer 

pointed out, healthy farm animals are critical to safe food. Animal 

health companies invest in the development of new medicines to 

provide veterinarians and producers the tools to keep food animals 

healthy and must be able to rely on a predictable science-based 

regulatory process. 

There has been much debate, as we all know, over the contribution of animal antimicrobial use to resistant bacterial infections in 

humans. Antimicrobial resistance is a serious public health threat 

but resistance is not a single problem. It is a problem comprised 

of several different bacteria/drug combinations that must be examined individually to ascertain risks. For example, some of the most 

widely recognized resistance problems in humans are in respiratory 

tract infections and venereal diseases like gonorrhea. In neither of 

these cases is there any evidence that antimicrobial use in animals 

is associated with these problems. 

Both antimicrobial-resistant and susceptible bacteria can contaminate foods, our food safety system is comprised of multiple layers of protection to reduce their presence. The first layer of protection is a stringent regulatory review process at FDA. Animal 

antimicrobials must meet all the same requirements as 

antimicrobials used in humans with two additional requirements. 

First, sponsors must show that drug residues left in foods are safe 

for human consumption. Second, the FDA Guidance for Industry 

152, which Dr. Sharfstein spoke of, outlines a qualitative risk assessment process for new antimicrobials. This process is designed 

to estimate and manage the risk of antimicrobial-resistant bacteria 

that could be transferred from animals to humans. 

Quantitative risk assessments have also been conducted and 

published on key antimicrobials, particularly those used in animal 

feed. A quantitative assessment is a more detailed review of each 

step along the food production continuum from farm to table that 

could contribute to or reduce the presence of foodborne bacteria. 

These studies have routinely reported extremely low levels of risk. 


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As Dr. Sharfstein discussed, FDA has announced two new initiatives relative to antibiotics used in food animals. These actions illustrate that the agency has broad authority to take actions it 

deems necessary to protect public health. AHI welcomes these initiatives and understands the reasons for their concerns. We will, of 

course, comment in detail to both publications. 

A second layer of protection and one of the most important, in 

my opinion, is reducing bacterial contamination in slaughter and 

processing plants. Improved hygienic and pathogen-reduction measure in meat and poultry plants under the USDA HACCP pathogenic reduction regulation has significantly reduced bacterial contamination and therefore antimicrobial-resistant bacteria as well. 

A third layer is in the multi-agency National Residue Program 

and National Antimicrobial Resistance Monitoring System to assure antimicrobials are being used properly and according to labels. 

Judicious-use guidelines which the AVMA representative has spoken about help to ensure that antimicrobials are being used responsibly in food and companion animals. 

Finally, USDA has mandated safe food handling labels, and 

there are extensive food safety education programs that instruct 

consumers how to properly handle and cook foods to avoid 

foodborne illness. 

Before I close, I want to note that Congress in the last 2 years 

passed legislation dealing with the use of antimicrobials in animals. The 2008 Farm Bill included a mandate for additional research on antibiotic resistance in food animals and the 2008 Animal Drug User Fee Amendments required FDA to collect antibiotic 

use data from sponsors by March of 2010. We expect the report 

from the agency later this year. 

Mr. Chairman and members of the subcommittee, there are clear 

benefits to using antimicrobials to keep animals healthy including 

attending to animal welfare and assuring food safety. FDA has a 

stringent review process to ensure that antimicrobials are safe and 

effective. Monitoring data from the NARMS program as well as 

public and private risk assessments have shown the process is 

working. With that said, FDA has recently articulated concerns 

with the way certain antibiotics are currently labeled and used. 

The animal health industry is committed to working collaboratively 

with the agency to address those issues while assuring that important animal health products continue to be available to prevent, 

control and treat animal disease. 

Thank you for the opportunity to appear today and I welcome 

any questions. 

[The prepared statement of Dr. Carnevale follows:] 


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Testimony of Dr. Richard Carnevale 

Vice President, Scientific, Regulatory and International Affairs 

Animal Health Institute 

Committee on Energy & Commerce 

Subcommittee Health 

Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture 

July 14, 2010 

Chairman Pallone, Ranking Member Shimkus, and members of the Subcommittee: 

Thank you for holding this hearing on antibiotic resistance and the use of antibiotics in animal 

agriculture. I am Dr. Richard Carnevale. I am a veterinarian by training with a degree from the 

University of Pennsylvania, and I am here today on behalf of the Animal Health Institute, a trade 

association that represents companies that make medicines for animals. Prior to joiningAHI about 

15 years ago, I served as Deputy Director for the Office of New Animal Drug Evaluation at FDA's 

Center for Veterinary Medicine and later as Assistant Deputy Administrator for the Office of Science 

at USDA's Food Safety & Inspection Service. AHI companies work to provide products to livestock 

and poultry producers that help keep their animals healthy. By doing this, companies contribute to 

public health and food safety. Research shows that the first link in the chain of producing safe 

meat, milk and eggs is keeping animals free from disease. AHI companies also develop products 

that are used for the health and welfare of our companion animals, but today my remarks are 

focused on the objective of this hearing and animal agriculture. 

Food safety starts on the farm, and our companies spend millions of research and development 

dollars to find new and innovative products to keep farm animals healthy. Some animal health 

products are used to treat and prevent or control disease in animals while others are used for 

nutritional efficiency. More recently, products are being developed that will contribute to food 

safety by reducing bacteria that do not make animals sick but have the potential to make people 

sick. 

Animal health products are subject to stringent, science-based review processes at three federal 

agencies: pharmaceutical and feed additive products are reviewed by the Food and Drug 

Administration (FDA) under the Federal Food, Drug and Cosmetic Act, biologic products, or 

vaccines, are regulated by United States Department of Agriculture (USDA) under the Virus, Serum, 

Toxins and Analogous Products Act, and animal pesticides are regulated by the Environmental 

Protection Agency (EPA) under the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA). All 

products are reviewed for safety and efficacy: efficacy, which protects producers by ensuring the 

products deliver the benefits they promise; and safety, to ensure the products are safe for the 

animal being administered the drug or vaccine and to ensure the meat from the animal is safe for 

human consumption and safe for the environment 

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One class of products important to the health of food animals is antibiotics. Antibiotics are used by 

livestock producers, poultry producers, and the veterinarians who work with them to prevent, 

control and treat often fatal bacterial infections. There are many benefits to animals, producers and 

consumers that come from the use of antibiotics in animal agriculture: 

Healthy animals reduce the need for greater, more involved disease interventions, and 

limit the spread of disease and illness that can impact the people that care for animals. 

Animal welfare is improved as a result of veterinarians and producers having the tools 

to be able to maintain the animal's health. 

Producers are more efficient because they can produce more food from fewer animals. 

Without antibiotics to treat, prevent, and control diseases, more animals get sick and die 

with producers losing not only the animal but all the input costs, including feed, that 

have gone into the animal. 

There are ecologic benefits. Young animals that have their diseases controlled through 

the use of antibiotics grow faster and more efficiently, thereby using less land and feed 

to maintain the same herd and flock sizes. Moreover, some studies have shown that 

certain antimicrobials used in cattle feeds reduce levels of methane emissions. 

Benefits to global food markets. With the concern over food costs and availability in 

today's economic climate, antimicrobials and other animal drugs that improve animal 

health and productivity are critical to American agriculture's ability to feed the world's 

growing population. The Food and Agriculture Organization (FAO) ofthe United Nations 

estimates that more than 1 billion people worldwide do not have enough to eat They 

propose that one solution is to help producers to raise their output 

Consumers benefit because healthy animals are needed to produce safe food. Over the 

past five years, published, peer-reviewed studies have indicated that carcasses from 

chickens without subclinical diseases are more likely to be free of human foodborne 

pathogens.1.'.3,4 Research shows this is due in part to more standardized carcass size, 

reducing the potential for intestinal breakage during mechanical evisceration. 

The FDA approves antibiotics to treat specific diseases or conditions at specific dosages rates. There 

are four specific efficacy claims that FDA approves antibiotics for use in food animals: disease 

treatment, disease prevention, disease control and growth promotion - as measured by the amount 

of feed needed to produce a pound of animal weight or increased rate of weight gain. 

The first three uses - disease treatment, prevention and control- are considered to be therapeutic 

uses by FDA, the American Veterinary Medical Association (AVMA) and such international bodies as 

Codex Alimentarius and the World Health Organization (OlE). While critics of antibiotic use like to 

use the term "nontherapeutic" to refer to disease prevention, disease control and growth 

promotion, this term is not used nor recognized in national or international regulation. 

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Many assume in-feed uses equate to growth promotion, but this confuses the use with the route of 

administration. In fact, any of the four uses, including therapeutic, can be administered via feed or 

water, as that is under certain circumstances the only practical way to administer medication to 

large flocks or herds. In most cases, a veterinarian is involved in this process, recommending feed 

that is specifically formulated for the health management system used for the flock or herd. 

How Antibiotics are Regulated 

Veterinarians, Producers, and Animal health companies rely on a rigorous, efficient, predictable and 

science-based review process at the Food and Drug Administration's Center for Veterinary 

Medicine (CVM) to provide these products. The standard for the approval of antibiotics used in 

animals is the same as that for antibiotics used in human medicine: they must be shown to be safe 

and effective. 

FDA Approval Process 

Potential for resistance selection to 

impaot human he.lth through food 

The rigorous review process and post approval monitoring systems in place are at the heart of a 

broad system of protections that ensure that all medicines, including antibiotics, are safe for 

animals and humans. Antibiotics for use in animals must meet all the same requirements as 

antibiotics used in humans, with two additional requirements: first, sponsors must show the meat, 

edible tissues, milk and or eggs from animals in which the medicine is used is safe for human 

consumption. Product sponsors have the burden of proof upon them to demonstrate the safety to 

the Agency. Second, beginning in 2003, CVM instituted Guidance for Industry (GFI) # 152, which 

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outlines a qualitative risk assessment process that is applied to all antibiotics approved for use in 

animals, This gUidance process is designed to measure the risk of antibiotic resistant bacteria being 

transferred from animals to humans ifthe product is approved, Based on this risk, FDA makes 

decisions to either deny or approve the drug with certain restrictions to significantly reduce risk 

Restrictions can include requiring a veterinary prescription, prohibiting extra-label use in certain 

species or restricting the antibiotic to individual animals, In most cases antimicrobial resistance 

monitoring is required post approvaL The methodology is very conservative - meaning it is very 

difficult to get an antibiotic approved, Further, the guidance is sufficiently broad so that if new, 

previously unidentified or undescribed, resistant organisms or genes were to become of concern, 

the Agency can act swiftly to take this information into account The existing gUidance allows the 

Agency sufficient flexibility to allocate resources appropriately to changing issues of safety related 

to resistance emergence, 

In response to concerns raised in the 1970's, FDA required sponsors to conduct tests to determine 

the potential for resistance to be selected in the animals and to be transferred to bacteria that could 

cause human disease, While the standards and science may have changed over the years, the safety 

of these products has been continually demonstrated as an ongoing exercise at FDA Since there 

has been a greater availability of susceptibility data on marketed products, we believe that 

quantitative risk assessment is now the proper tool for making policy decisions about the safety of 

currently approved antimicrobials and is more appropriate than simply applying the tenets 

contained in Guidance 152, Published quantitative risk assessments, performed by both the Agency 

and individual product sponsors, have affirmed that the risks to human health from these 

antibiotics in animal feed under approved conditions of use are very low, 

Recent FDA Actions 

The FDA has proposed two initiatives to ensure the judicious use of animal antibiotics, In March, 

the Agency issued an Advance Notice of Proposed Rulemaking regarding the modernization of the 

VeterinalY Feed Directive, which requires veterinarian involvement when antibiotics are 

administered in animal feed, And on June 28, the FDA issued draft guidance on the use of medicallyimportant antibiotics in food-producing animals, Draft Guidance 209, The Judicious Use a/Medically 

Important Antimicrobial Drugs in Food-Producing Animals, had two specific recommendations: 1) 

the use of medically-important antibiotics in food-producing animals should be limited to uses 

necessary for assuring animal health, and the use for growth promotion are not judicious uses and 

2) that the use of medically-important antibiotics in food-producing animals should be limited to 

uses that include veterinary oversight 

We look forward to collaborating with the Agency to help ensure that the process envisioned by 

these new initiatives will result in animal producers and veterinarians having access to the tools 

they need to protect the health offood producing animals, We appreciate that FDA has reached 

out to stakeholders for input on how to achieve their objectives, It is critical that stakeholders 

are involved to ensure that changes to the judicious use guidelines and the regulatory framework 

are carefully considered, 

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These recent initiatives further illustrate that FDA already has a great deal of authority to regulate 

the labeling and use of antimicrobials, and that it is willing to use it to ensure safe and judicious use 

of antibiotics in food producing animals. 

In addition to the rigorous review process and the additional public and private risk assessments 

that have been conducted, there are other post-approval layers of protection to ensure the safe use 

of antibiotics. 

Monitoring programs 

USDA's Food Safety and Inspection Service monitor meat samples for the presence of antibiotic 

residues as a check on the observance of the withdrawal times set by FDA. It is very uncommon for 

FSIS to find an unsafe residue, an indication that products are being used according to label 

directions. 

The National Antibiotic Resistance Monitoring System (NARMS) is a mUlti-agency program 

coordinated by FDA to monitor antibiotic resistant bacteria and allow for implementation of 

management and control measures if needed. The three agencies involved are: 

The USDA Agricultural Research Service (ARS), which analyzes Salmonella and 

Campylobacter isolates collected from carcasses and meat samples in the USDA FSIS 

HACCP jPathogen Reduction Program for antibiotic resistance; 

The FDA, which monitors for resistant bacteria in retail meats; 

The Centers for Disease Control and Prevention (CDC), which collects isolates from 

pu blic health laboratories to monitor for the emergence of antibiotic resistant 

enteric pathogens in humans. 

To date, the animal and human arms of the program have produced eleven years of data 

representing over 19,000 Salmonella isolates from livestock and poultry carcasses and meats and 

12,000 human Salmonella isolates, while retail meat testing was added later. Most bacterial species 

isolated from humans and tested for resistance against drug classes potentially related to animal 

usage have shown stable or declining resistance to most antimicrobials. Most of the multiple-drug 

resistance types, such as Salmonella typhimurium DT104 show stable or declining prevalence in 

both food animals and humans since 1996, according to an expert report issued in 2006 by the 

Institute of Food Technologists entitled "Antibiotic Resistance: Implications for the Food System." 

While AHI strongly supports continued funding of the NARMS program, we would point out that 

there are inherent weaknesses in the sampling strategies that prevent the data from estimating a 

true national prevalence of resistance and yearly trends. The FDA Science Board has identified 

these weaknesses as well and has encouraged the agencies involved in NARMS to work to improve 

the data.s 

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Judicious Use Guidelines 

Responsible or judicious use programs that are specific to different livestock species give 

veterinarians and producers specific guidelines to help them safely and properly use of antibiotics 

in their health management systems. Generally, these guidelines have been prepared 

collaboratively by FDA, CDC and veterinary groups. These guidelines help ensure there is no 

unnecessary use of antibiotics in animal agriculture. Others testifying today will provide additional 

detail on how these principles are used by veterinarians and producers. 

International Guidelines 

Codex Alimentarius is responsible for protecting the health of consumers and ensuring fair 

practices in food trade. In 2007, Codex established an ad hoc Intergovernmental Task Force on 

Antimicrobial Resistance to develop guidelines for food safety risk analysis of antibiotics used in 

animals. The Codex Commission just last week, advanced draft guidelines to Step 5, meaning that 

the Task Force will likely be finalizing guidance in October 2010 for adoption as a Codex standard 

in 2011. International standards are important, because bacteria knows no borders and actions 

taken within the U.S. may not be as effective if there is not concerted international action. It is also 

important that the international community establishes a sound scientific basis for countries to 

assess the risk of antibiotic use. Otherwise, government regulators are left open to outside 

pressure to take overly zealous precautionary measures that may be unjustified and in the long 

term harmful to animal health and food safety. 

Correlation Between Use of Antibiotics in Animals and Human Antibiotic Resistance 

There is no question that antibiotic resistance is a serious public health threat But resistance is not 

a single problem: it is a problem comprised of several different bacteria-drug combinations that 

must be examined individually to ascertain risk. For instance, some of the most widely recognized 

antibiotic resistance problems in humans are in respiratory tract infections and venereal diseases 

like gonorrhea. In neither of these cases is there any evidence that antibiotics used in animals are 

associated with these problems. In fact, in a survey published in 2000 a group of medical experts 

estimated the animal contribution to the overall human resistance problem is less than 4 percent" 

That small contribution was attributed to the potential for antibiotics used in food animals to 

contribute to resistance in certain bacteria which can be transferred from animal food products to 

humans. However, there is a chain of events from the "farm to the fork" that must be traversed by 

bacteria that develop resistance in animals as outlined in the accompanying chart: 

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Antibiotic Us.e in anilnals 

Dev~IQpn,ent of resistant animal bacterial strain 

Survival through food prepardtion 

Resistance tran'j,fer to humans 

Colonization in human 

In order for resistance to happen, the antibiotic must be used in the animal, resulting in the 

selection of resistant bacteria in the animal. Those bacteria then must survive the slaughtering and 

processing of the animal. Remember, we have successfully reduced the number of bacteria -- both 

resistant and not resistant - that survive this process through the implementation of controls like 

HACCP. The bacteria must then survive the normal cooking process. If enough resistant bacteria 

survive to this point and are ingested in a large enough quantity, they can make an individual sick 

with a common foodborne illness. As you know, most foodborne illnesses are self-limiting - they 

resolve themselves in most cases without antibiotics being necessary. In the event that an 

antibiotic is necessary, the illness could be treated with the antibiotic that the bacteria is resistant 

to, and the treatment could fail, prolonging the illness. 

While we know this can happen, the question becomes, how often does this happen and how severe 

are the consequences? The answer to this much-studied question is that it does not happen enough 

that we can find it and measure it So, scientifically, we cannot say it does not happen, but we can 

say it is uncommon. 

Danish Experience 

The Danish experience provides a real world example of what happens when producers lose access 

to antibiotics. In the late 1990s, the European Union phased out one particular use --the use of 

antibiotics for growth promotion. Data from the Danish government, which you see on the 

accompanying chart, shows that use of antibiotics to treat disease has doubled since the ban. 

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140000 

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This data, along with the discussion in the Danish report, clearly indicates the ban led to additional 

animal disease and death. The important question is: what impact did it have on public health? 

There is some evidence to indicate resistance declined in the animals and human s in certain 

bacteria. However, there is no evidence that this has resulted in reducing the public health burden 

of resistant bacterial infections in humans. The list of references at the end of my testimony 

includes published papers on the results of the ban. 

Antibiotics Data 

Critics have charged that we don't know how big the problem is because we don't have reliable data 

about the use of antibiotics in animal agriculture. However, it is important to note, that levels of 

antibiotic resistance are not correlated to the amount of use. Nonetheless, Congress has addressed 

the lack of data issue by requiring antimicrobial sales and distribution data to be reported to FDA 

under the Animal Drug User Fee Amendments of 2008. The ADUFA data collection requirements 

commenced this year, and our companies have complied. The FDA has indicated they will publish a 

report later this year. 

Furthermore, Congress acted on this issue in the 2008 Farm Bill. That legislation contained an 

authorization for USDA's Agriculture Research Service to conduct additional research to study the 

development of antibiotic resistant bacteria in livestock on how judicious use principles can help 

producers use these products to protect both human and animal health. 

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Summary 

In conclusion, antibiotics are vitally important to the health of our nation's livestock and poultry 

herds and flocks. Antibiotics are highly regulated and are used carefully by veterinarians and 

livestock and poultty producers. The many regulatory layers of protection that have been put in 

place allow us to safely use antibiotics to protect both animal and human health. The FDA 

regulatory process and risk assessment are the proper tools for making decisions about the use of 

these products. FDA has recently expressed concerns with antibiotic use in food animals; the 

industry is committed to working collaboratively with the Agency to address these concerns while 

assuring the availability of important animal health products to prevent, control, and treat animal 

disease. 

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'Russell SM, The effect of airsacculitis on bird weights, uniformity, fecal contamination, processing 

errors and populations of Campylobacter spp, And Escherichia coli. Poult Sci 2003; 82:1326-31. 

2COX Jr LA Potential human health benefits of antibiotics used in food animals: a case study of 

virginiamycin. Environ Int 2005;31:549-63, 

'Hurd HS, et aL Swine Health Impact on Carcass Contamination and Human Foodborne Risk Public 

Health Reports, May-June 2008; 123: 343-351. 

4Berrang ME, et aL Subtherapeutic Tylosin Phosphate in Broiler Feed Affects Campylobacter on 

Carcasses During Processing, Poult, Sci. 2007;86:1229-1233, 

5http://wwwJda,gov/cvm/Documents/NARMSExecSum03,pdf, 

6Bywater, RJ and Casewell M, An assessment of the impact of antibiotic resistance in different 

bacterial species and of the contribution of animal sources to resistance in human infections, J 

Antimicrob Chemother 2000;46:643-635, 

ADDITIONAL REFERENCES 

Phillips l, Case well M, Cox T, et aL Does the use of antibiotics in food animals pose a risk to human 

health? A critical review of the published data, J Antimicrob Chemother 2004;53:28-52, 

Antibiotic Resistance: Implications for the Food System. An Expert Report, Funded by the 1FT 

Foundation, Comprehensive Reviews in Food Science and Food Safety 5 (3),71-137 

doi: 1 0, 1111jj,1541-433 7,2006,00 004,x 

Hurd HS, Assessing Risks to Human health from Antibiotic Use in Food Animals, Microbe 

2006;1:115-119, 

Hurd HS, S DOOl'es, D Hayes, et aL The public health consequences of macrolide use in food animals: 

a deterministic risk assessment J Food Protect 67:2369-2374, 

Wassenaar, TM, Use of Antibiotic Agents in Veterinary Medicine and Implications for Human 

Health, Critical Reviews in Microbiology; 31:1155-169, 2005, 

10 
216 

Ms. SCHAKOWSKY. Thank you. 

Dr. Levy. 

STATEMENT OF STUART LEVY 

Dr. LEVY. Thank you. Mr. Chairman and members of the subcommittee, thank you for inviting me to testify on this crucial subject of antibiotic use in animal husbandry. I am Stuart Levy, a physician, research scientist and Professor of Molecular Biology, Microbiology and of Medicine at Tufts University School of Medicine in 

Boston. I also serve as President of the Alliance for Prudent Use 

of Antibiotics. 

For more than 3 decades, I have been studying antibiotic use in 

animal husbandry and its effect on bacteria associated with animals, farm workers and their families and the environment in general. Throughout my career, I have noted the paradoxical nature of 

human engagement with antibiotics, hence the title of my book, the 

Antibiotic Paradox. On one hand, antibiotics cure disease, are miraculous. On the other hand, they select among their targets those 

which are resistant and make these drugs not effective. 

My own research stretching back to the early 1970s has confirmed the broad environmental impact of antibiotic use, and I 

stress that. We performed the first and only prospective study of 

the effect of introducing antibiotic-, in this case, tetracycline-laced 

feed for chickens on a farm. By one week, almost all E. coli bacteria 

in the intestinal tracts of chickens were tetracycline resistant. By 

3 months, the chickens and most of the farm dwellers were excreting E. coli not only resistant to tetracycline but to other antibiotics 

as well. We also demonstrated that low-dose non-therapeutic 

amounts of tetracyclines can in fact propagate bacteria resistant to 

the drug and other antibiotics at high levels. Resistant bacteria 

were found to move among animals and from animals to people. 

Antibiotics are unique. They are societal and ecological drugs. 

Each individual taking an antibiotic whether animal or person becomes a factory producing antibiotic-resistant bacteria. Thus, there 

is a difference in the environmental impact when the same amount 

of antibiotic is given to one as opposed to a number of animals 

sharing that particular environment. In principle, fewer animals 

will be given antibiotics and for less time when antibiotics are used 

prophylactically as compared to growth promotion. 

Mr. Chairman, we are not gaining ground in the struggle against 

antibiotic resistance. Antibiotics are continually misused and overused in both human medicine and animal medicine at great cost to 

our society in terms of human health and cost of health care. It is 

estimated that antibiotic resistance leads to more than $20 billion 

in hospital costs and up to $35 billion when society costs are included. Some progress has been made in encouraging more judicious use of antibiotics in human medicine but there has been precious little progress with respect to stemming the spigot of antibiotics flowing into animal agriculture. 

In contrast, other industrialized nations have come to the same 

conclusion that many public health organizations around the world 

have, and that is that the use of antibiotics for growth promotion 

and feed efficiency must be curtailed. We can take some encouragement in the FDA’s recent release of a draft guidance. We need to 


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move with greater urgency to stem the use of antibiotics in industrial animal production. Because most antibiotics currently approved for growth promotion are also approved for routine disease 

prevention, I have great concern that feeding large quantities of 

antibiotics non-therapeutically will continue, rendering meaningless any FDA guidance on eliminating antibiotic use for growth 

promotion. 

Mr. Chairman and committee members, in view of the certainty 

in my opinion of the public health threat, the history of regulatory 

inaction and unyielding nature of the relevant industry, it is now 

clear that even a well-intentioned FDA is unable to overcome the 

influence of agribusiness. We have given moral persuasion, medical 

urgency, scientific study and voluntary guidance a chance and the 

situation has not changed. We can’t wait any longer. 

Legislation pending in this session of Congress, the Preservation 

of Antibiotics for Medical Treatment Act, would withdraw the use 

of seven classes of antibiotics vitally important in human health 

from food production unless animals are sick with disease or the 

use is needed for disease prevention without threat to human 

health. I urge this committee to move expeditiously to consider and 

approve this important legislation. 

Thank you for giving me the opportunity to testify, and I will answer any questions. 

[The prepared statement of Dr. Levy follows:] 


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Stuart B. Levy 

TESTIMONY OF DR. STUART B. LEVY 

President, Alliance for the Prudent Use of Antibiotics 

Distinguished Professor of Molecular Biology & Microbiology and of Medicine 

Tufts University School of Medicine 

Before the Subcommittee ou Health of the 

U.S. House Committee ou Energy and Commerce 

July 14,2010 

Me Chairman, I want to express my appreciation to the House Energy and Commerce 

Committee for convening today's hearing, for its ongoing work to help stem the crisis of 

antibiotic resistant bacteria and for inviting me to share my thoughts on these issues. 

By way of background, my name is Dr. Stuart B Levy and I am Distinguished Professor of 

Molecular Biology and Microbiology and of Medicine, as well as the Director of the Center for 

Adaptation Genetics and Drug Resistance at Tufts University School of Medicine and Staff 

Physician at Tufts Medical Center. I also serve as President of the Alliance for the Prudent Use 

of Antibiotics (APUA), an international organization with members in over 100 countries and am 

Chief Scientific Officer ofParatek Pharmaceuticals. I am a Fellow of the American College of 

Physicians, Infectious Disease Society of America, the American Academy of Microbiology, and 

the American Association for the Advancement of Science. I am a past President of the 40,000-

member American Society for Microbiology. 

For more than three decades, I have been studying and following the issue of antibiotic use in 

animal husbandry and its effect on bacteria associated with the animals, on the farm workers and 

families, and the environment in general. Throughout my career, I have been happy to appear 

before Congressional panels like this one to share my views on the science and solutions 

surrounding these issues. I vividly recall testifying in December 1984 before the House 

Subcommittee on Investigation and Oversight of the Committee on Science and Technology on 

antibacterial resistance and the data showing spread of resistant bacteria among animals and 

among animals and people. 

In that testimony and throughout my career, I have noted the paradoxical nature of human 

engagement with antibiotics (1). On the one hand, these miraculous drugs are pillars of modern 

medicine, helping us to manage and prevent dangerous bacterial infections and save lives. On the 

other hand, the widespread use and misuse - of antibiotic drugs has spawned the evolution of 

life-threatening bacteria that render our current antibiotics useless. 

In 1975-76, my research group performed the first, and I believe only, prospective study of the 

effect of introducing antibiotic-laced feed on a farm (2). We established a family farm about 40 

miles West of Boston. We introduced chickens, hatching from eggs laid from pathogen-free 

hens, and separated them into two groups of 150 chickens each. One group received low dose 

antibiotic-laced feed (oxytetracycline (100g/909kg», and one did not. 

The findings were striking. Within 24-48 hours, the chickens given the oxytetracycline-laced 

feed began to excrete tetracycline-resistant E coli, a common bacterium in the feces of chickens, 

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Stuart B. Levy 

people and other mammals. The control group did not. By one week, almost all E. coli in the 

intestinal tracts of the antibiotic-treated chickens were tetracycline-resistant. 

As time continued on this single low-dose antibiotic, the bacteria in the feces of the chickens 

began to acquire more and more resistances. By 3 months, the chickens were excreting E. coli 

resistant not only to tetracycline, but also to sulfonamides, ampicillin, streptomycin and 

carbenacillin. 

Most striking was that the farm family, as compared to the control group of neighborhood farm 

dwellers none using antibiotics also showed an increasing number of fecal E. coli resistant to 

multiple antibiotics. 

This study demonstrated the ecologic and environmental impact of an antibiotic, in this case lowdose antibiotics, on the animals housed in the fann and on the fann dwellers themselves. it 

answered one principal question at that time: that low-dose nontheraputic amounts of antibiotics 

can, in fact, select for, and help propagate, bacteria resistant to the drug at high levels. 

The study also resulted in other important findings. There were increased numbers of multi drug 

resistant bacteria among people on the farm, even though they were not taking antibiotics. Of 

note, transfer of E. coli from the chickens to the farm workers was also observed (3). 

In subsequent studies, we haved demonstrated that even in the absence of an antibiotic, resistant 

bacteria will move tl-om animal to animal, in this case from bull to calt~ to pigs to chickens, 

presumably through the air (4). Additionally, we demonstrated the presence of resistant bacteria 

on t1ies_ In the study, it was clear that farm workers could pick up the biochemically-marked E_ 

coli that was initially put into the bull, where it remained in their intestinal tracts at a detectible 

level for several weeks_ Thus, there is no containment of antibiotic or antibiotic resistant bacteria 

in the farm environment. 

As you can see, Mr. Chairman, much of my personal energy and professional endeavors have 

been given to better understanding the causes of antibiotic resistance and advancing solutions to 

this growing threat to human health. 

Drawing on that experience, I regret to report to this Committee that we are not gaining ground 

in the struggle against antibiotic resistance and all of us ~ you, me and your constituents are at 

ever greater risk of contracting a resistant bacterial infection and even one that is untreatable. 

Antibiotics continue to be misused and overused on a massive scale in both human 

medicine and animal agriculture; and 

There is a dearth of activity in large pharmaceutical firms to develop new drugs that can 

best antibiotic resistant bacteria_ FOliunately, the void has been filled by work performed 

in small biopharmaceutical companies like the one I co-founded, Paratek 

Pharmaceuticals_ 

Some progress has been made in developing protocols and encouraging more judicious use of 

antibiotics in human medicine. There is awareness of the crisis and our public health agencies 

have developed protocols for promoting proper use of antibiotics by doctors and patients alike. 

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Stuart B. Levy 

But there has been precious little progress with regard to stemming the spigot of antibiotics 

flowing into animal agriculture. Indeed, the Food and Drug Administration has attempted on 

several occasions to initiate prudent steps for curtailing the misuse of antibiotics in industrial 

agriculture, only to be thwarted by powerful industry interests, which have questioned the 

science and mobilized Congressional allies at every step of the way. 

These efforts have been undertaken despite a mountain of domestic and international scientific 

evidence demonstrating the linkages between the use of antibiotics in animal agriculture and the 

emergence of bacteria resistant to antibiotics of critical importance to human health and to the 

frequency of resistant strains of bacteria in human beings. 

There are a number of common concepts in the antibiotic resistance field that we have learned 

over the years, which I think are relevant when in evaluating the nontheraputic use of antibiotics 

in animal husbandry (5). 

One, antibiotics are "societal drugs." Their use in one individual can affect the level of resistance 

and the presence of resistant organisms in other individuals sharing the same environment. An 

excellent demonstration of the concept came from Dr. William CunlitTe's dermatologic group in 

London, which showed that those sharing the household with patients treated for acne picked up 

and began to shed staphylococci from their skin that were multi drug-resistant, as were the 

bacteria found on treated patients. This was not true among households where an antibiotic was 

not used (6). 

Secondly, as discussed earlier, antibiotics have an environmental impact. They are ecologic 

agents - they can change the bacterial environment, largely from drug-susceptible organisms to 

resistant ones (7). Moreover, these do not have to be therapeutic amounts of antibiotics; 

nontheraputic low-dose antibiotics have a similar profound ecologic effect Furthennore, an 

important finding was that the length of time on the antibiotic (tetracycline) selected bacteria 

with resistances to more than the tetracyclines. In animals, long term use of the single antibiotic 

led to multidrug resistant bacteria. This phenomenon has been seen among women taking 

tetracycline for treating urinary tract infections. In these patients, I-to-2-week-use led to 

multidrug resistant E. coli in their intestinal tracts (8). This is critical when we begin to discuss 

the total time of antibacterial treatment of animals whether it is for growth promotion, for disease 

prophylaxis, or for therapy. The amount of time on the antibiotic can influence the numbers of 

resistances that appear in the bacteria associated with these animals. 

Third, a point that I think is missed often, is that the total amount of antibiotic does not tell us 

enough about what is happening in that environment. We need to know about the distribution of 

the antibiotic. For example: You have toO grams of antibiotic, and you give all of it to one 

animal. That animal becomes the single producer of resistant bacteria, which it can shed to the 

environment. On the other hand, if you give those 100 grams to toO different animals, you now 

have 100 times more "factories" of resistant bacteria that are being propagated by the selection 

of the antibiotic. This point, T stress, is critically important in evaluating the data when amounts 

are only presented in total numbers, in grams, in kilograms. We need to know how many animals 

are being affected. There is no doubt that with billions of animals being treated with antibiotics 

in our country, as opposed to millions of people sporadically, that there are many more 

"factories" of antibiotic resistant organisms among the animals, then the people, and especially 

in those instances where the therapy is prolonged for weeks and at less-than-therapeutic amounts. 

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Stuart B. Levy 

APUA has been following this issue for some time. We have looked at the different routes of 

transfer of antibiotics and antibiotic resistant bacteria, as shown in the attached figure. At each 

step of the way, there are data demonstrating the means of transfer of either the antibiotic or the 

resistant bacteria, or both. Water downstream from fanns has been found contaminated with 

antibiotics leeching through the ground. It is critically important to look at how the drug and the 

amount of the drug is being given in water or by injections. Ifit is given in a way that is not 

contained, there is much more environmental contamination. So if one can focus on the amount 

of drug, how it's being delivered, and how it's being distributed that is, the vehicle and how 

many individuals (animals, people, plants) are being given tbe antibiotic, one can appreciate 

better how to control the unwanted consequences of antibiotic use (9). 

Several years ago, APUA put together a stakeholders' group that came up witb recommendations 

for improving antibiotic use in the raising of fann animals. It was concluded that antibiotics for 

nontheraputic use sbould be eliminated, since the benefit was unclear and did not merit the 

practice. On this point it is noteworthy that there are no current studies to show tbat a growth 

promotion effect still exists. 

Other industrialized nations, most notably in Europe, bave come to similar conclusions and have 

taken steps to curtail the use of antibiotics for the purpose of growth promotion and feed 

efficiency. But the United States lags behind and bas done almost nothing to curtail nontherapeutic uses. 

In view of this bistory, it was velY encouraging that the FDA announced on June 28, 2010 its 

draft guidance to industry on the use of antimicrobial drugs in food-producing animals. 

The FDA is to be applauded for stating boldly and accurately that: "Overall, the weight of 

evidence to date supports the conclusion that using medically important antimicrobial drugs for 

production purposes is not in the interest of protecting and promoting the public health." 

Tbe FDA's draft guidance establishes a number of key foundations for the future: first, that there 

is broad agreement that antibiotics should be deployed under the guidance of veterinarians to 

treat sick animals; second, that antibiotic use for growth promotion and feed efficiency is not 

judicious, is contrary to human health and should be stopped; and third, that antibiotics may be 

used on a prophylactic basis for short-durations with at-risk animal populations under the 

direction of a veterinarian. These are important building blocks for forging consensus between 

public health and agriculture interests in the future. 

There is less consensus around the use of antibiotics in generalized prevention, where antibiotics 

are used in the absence of specitic animal health risks to guard against infections that might 

otherwise be prevented with additional sanitation measures and less crowded conditions. There is 

an absence of studies to show the scientific basis for prophylaxis and the time and dose required. 

Such studies have improved prophylaxis use in human medicine, most notably in surgery. 

The FDA's draft guidance is a welcome step and reflects the kind offoresight and wisdom I've 

waited years, even decades to hear from this institutional guardian of animal and public welfare. 

Nonetheless, the FDA's recent action represents only voluntary guidelines that would take many 

months, perhaps years to finalize. Even if finalized as voluntary guidance to industry, the reality 

is that aglibusiness has fought etforts to curtail overuse of antibiotics every step of the way and 

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Stuart B. Levy 

there is no basis for confidence that industry will do anything but dodge and challenge the FDA's 

guidance. Because most antibiotics currently approved for grow1h promotion are also approved 

for routine disease prevention, I have great concerns that industry will continue feeding massive 

quantities of antibiotics non-therapeutically, rendering meaningless the FDA guidance on 

eliminating antibiotic us as growth agents. 

Me. Chairman and Committee Members, in view of the urgency of the public health threat, the 

history of regulatory inaction, and the unyielding nature of the relevant industry, it is now clear 

that even a well-intentioned FDA is unable to overcome the power and influence of agribusiness. 

We've given moral suasion, medical urgency, scientific study and voluntary guidance its chance 

and the problem has only grown worse. We can't wait any longer. Congress must act 

1 applaud you for convening today's hearing and for developing a Congressional record on the 

evidence of this significant challenge. But the evidence is clear and compelling and it is time to 

move from educational hearings to legislative mark-ups. 

Legislation pending in this session of Congress, the Preservation of Antibiotics for Medical 

Treatment Act (PAMTA, H.R. 1549, S. 619), would withdraw the use of seven classes of 

antibiotics vitally important to human health from food animal production unless animals or 

herds are sick with disease or unless drug companies can prove that their nontherapeutic use is 

needed for disease prevention and only at high risk times in their rearing and does not represent 

the threat to human health. This is a sensible and etfective approach toward curtailing the use of 

antibiotics in industrial farming and 1 urge this Committee to move expeditiously to consider and 

approve this important legislation. 

Thank you for your consideration of my testimony and I would be happy to answer any questions 

you may have. 

1 - Lc·vy, S.B. (2002) lhe Antibiotic Paradox: How misuse (!f antibiotics destroys their curative plYWers. 

Perseus Books, Boston 

2 - Lev,., S.B., G.B. FitzGerald and A.B. Macone (1976) Changes in intestinal flora offaml 

personnel after introduction of tetracycline-supplemented feed on a Hum. Nc\v Eng. 1. 

Med. 295:583-588. 

3- Lev,.. S.B., G.B. FitzGerald. and A.B. Macone (1976) Spread of antibiotic resistance 

plasmids from chicken to chicken and from chicken to man. Nature 260:40-42. 

4 - Marshall, B.M., D. Petrowski and S.B. Levy (1990) Inter and intraspecies spread of E. coli in a farm 

environment in the absence of antibiotic usage. Proc, Nat'1 AcacL Sci (USA) 87:6609-6613. 

5- Levy, S.B. & B. Marshall (2004) Antibacterial resistance worldwide: Causes, challeuges and 

responses. Nature Med. I O:SI22-S 129 

6 - Cunliffe, W.J.. Miller, Y.W .. et al: (1996) Sequential antibiotic therap)' for acne promotes the carriage 

ofrcsista.nt staphylococci on the skin ofeontacts. 1. Antimicrob. Chemother. 38:829-837. 

7 - Levy, S.B. (1984) Playing antibiotic pool: time to tally the score. New England J. Mod. 

11:663-665. 

8 - Datta N, Faiers Me. Reeves DS, ct al: (1971) R factors in Escherichia coli in faeces after oral 

chemotherapy in general practice. Lancet J :312-315. 

9 - Barza, M .. Gorbach, S .. (cds.) (2002) 111e Need to Improve Antimicrobial Use in Agriculture. Report 

from the Alliance for the Pmdcnt Usc of Antibiotics. Clin.lnfect. Dis. 34:Sup.3. 

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Stuart B. Levy 

Figure: 

The Flow of Antibiotic Resistant Bacteria 

ANTIBIOTICS 

Page 6 
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Ms. SCHAKOWSKY. I want to thank all of our witnesses. As is obvious, I guess, Mr. Pallone had to go to yet another committee that 

he is on where they are voting and so he won’t be able to return. 

I have some questions that I want to ask but I also want to let 

you know that we have a whole bunch of questions that I fear will 

not be asked and therefore we will get them to all of you and would 

appreciate very much your answers in writing later. 

Mr. SHIMKUS. Madam Chairman, can we also ask, it wasn’t done, 

I think, a UC that all members’ statements can be submitted for 

the record? 

Ms. SCHAKOWSKY. That all members’ statements can be submitted for the record, without objection so ordered. 

Mr. SHIMKUS. Thank you. 

Ms. SCHAKOWSKY. I want to give a special thank you to Dr. 

Henriksen for coming from Denmark, and I wanted to give him the 

opportunity at this hearing to answer some questions, because 

there has been a lot of discussion about the Danish experience. We 

have seen articles and heard testimony claiming that even though 

you eliminated the use of antibiotics for growth promotion, you 

ended up using more antibiotic than you had before because all the 

animals got sick. That is what we are hearing. And in fact, in the 

testimony of the American Veterinary Medicine Association, Dr. 

Hoang states and Dr. Singer as well that antibiotic use went up 

between 1998 and 2008. So can you clarify for us exactly what the 

situation has been with regard to antibiotic use in Denmark? And 

as part of that, can you tell us what steps you took to reduce antibiotic use and what impact each step has had on the use of antibiotics? 

Dr. HENRIKSEN. Yes, I will try to answer your questions, all your 

questions. It is correct that after the ban the consumption of therapeutic antibiotics has been increased but in the same period the pig 

production has been increased too, and if you see my fact sheets 

on page 10, you can see figure 1 which both has the antibiotic 

usage in all types of animals and the number of pigs produced, and 

in that period from 1998 to 2008, you can see an increase in the 

therapeutic use of antibiotics but an almost similar increase in the 

number of pigs produced in Denmark. You can put it another way, 

that is to calculate how many milligrams per kilo pig produced in 

Denmark, and you can have the data before the ban. Before the 

ban in 1994, the total use of antibiotic growth promoters and for 

therapeutics were 99 milligrams per kilogram of pig produced, and 

even in 2008 the total consumption was 49 milligrams per kilogram 

pig produced. That is, we have reduced the total usage of antibiotic 

per kilogram pig produced from 99 to 49 milligrams. That is a 50 

percent reduction. 

It is correct as stated by many U.S. observers that the disease 

situation has changed in Denmark. Diseases come and go in humans and animals, but if you look at the fact sheet on page 14, you 

can see the mortality in weaners, the mortality since 1993 to 2003, 

2004 has been increasing from about 2 percent to almost 5 percent, 

but since 2004 the mortality in weaners has decreased almost to 

the level from 1992–1993. So in that respect to mortality in 

weaners, the more focus of disease in Danish pig production cannot 

be released by the mortality figures. If you compare to the morVerDate Mar 14 2013 09:19 Mar 20, 2013 Jkt 077921 PO 00000 Frm 00232 Fmt 6633 Sfmt 6633 E:\HR\OC\A921.XXX A921

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tality in finishers in figure 7 on page 14, you can see that the mortality has been varying little during the 1992 to 1997, 1992 to 

2007, but the mortality is between 3 and 4 percent. So there has 

not been any significant impacts on mortality neither in weaners 

nor in finishers. 

I would like to add on the previous page on the fact sheet, page 

13, figure 4, this is the productivity as we express it in Denmark, 

number of pigs produced per sow per year, and you can see from 

1992 to 2006, 2007, the number of pigs per sow per year has been 

increasing from 20 to more than 22 pigs per sow per year. That 

means that during this phasing out of growth promoters has been 

increasing production, but I would of course admit in some farms 

you see severe disease problems, and this is the task for a trained 

veterinarian to deal with the specific problem in specific farms 

whether it should be a vaccination schedule, prophylactic changes 

in the environment, new ventilation system, better feed quality and 

so on, maybe prolonged weaning age from 3 weeks to 4 weeks, or 

treatment with antibiotic. So that I think most of the questions I 

answered. 

Ms. SCHAKOWSKY. Let me just then underscore and make sure 

that this is correct, that the total antibiotic consumption in foodproducing animals has been reduced by about 40 percent from the 

mid 1990s until today. So we are talking about total consumption 

is just almost in half or about 40 percent. Is that correct? 

Dr. HENRIKSEN. That is correct when you compare the total use 

of antibiotic growth promoters and therapeutic use in the end of 

1997–98 to 2008, yes, that’s correct. 

Ms. SCHAKOWSKY. Thank you. I appreciate your being here and 

I appreciate your testimony. 

Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Madam Chairman. 

But I will say from ban until now, therapeutic use has gone up, 

and that—and you are shaking your head, which I think that 

means yes. We do appreciate you coming a long way. 

Madam Chairman, and this has been addressed with the staff for 

submission to the record a statement from the pork producer, if you 

would—— 

Ms. SCHAKOWSKY. Without objection, so ordered. 

[The information was unavailable at the time of printing.] 

Mr. SHIMKUS. Thank you, Madam Chairman. 

The other thing I want to—I need to highlight some stuff going 

back to the previous panel and the third chart I didn’t get a chance 

to talk about. I think the issue—I just want to get it on the record 

that the United States and Canada had pathogen reduction regulations during this time and the issues of voluntary withdrawal too. 

So there is more to be said by charts that unfortunately we didn’t 

have time to pursue that with the previous panel because of time. 

Another thing I want to make sure to put on the record, and this 

is from the D.C. area, that there is a huge price discrepancy between food products that are antibiotic-free and conventional price, 

and there is a list of 10 products here and it goes from anything 

from 141 percent to 20 percent change in retail prices. So another 

thing to place on the table is the cost of basic food products from 

beef to eggs to you name some of the issues. 


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Also, the reduction in Danish swine farms from the passage of 

legislation from 12,500 to 3,500, and for my friend from Denmark, 

the United States is the number 1 pork-producing country in the 

world. He knows that. I think it is a percentage of what is exported 

based upon what is consumed. But I would say second is the EU 

followed by, I don’t know if it is Canada or Brazil, but this is a 

major industry in the United States. It is a major industry in my 

Congressional district, and that is why we want to make sure that 

science is addressed because we are concerned about antibiotic 

issues. We have had hearings. But we want to make sure that 

again that we don’t do more harm than good. And I appreciate the 

various opinions and the issues on risk because healthy animals 

should grow bigger. I mean, if you are sick, you are not going to 

grow. If you are healthy, you do grow. 

We just passed a health care bill that said preventative—let us 

make sure we keep Americans healthy because of the high cost in 

taking care of sick people, but here we are going to flip the charts. 

We are going to turn it upside down. We are going to say let us 

don’t keep the animals healthy, let us do therapeutic antibiotics 

when they are sick. 

Dr. Carnevale, I have two questions, because we heard from a lot 

of the panelists both here and then also on the first panel that 

there is unequivocal evidence, and it reminds me of the climate 

change debate, that the science is settled. Well, I think the American public understands that the science is not settled. Is there unequivocal evidence that there is a connection between the use of 

antibiotics in animals and connect them to human health? 

Dr. CARNEVALE. Well, as many have said today, this is a very 

complicated issue. I would say there is not unequivocal evidence 

that the use of antibiotics in animals, particularly those used in 

animal feed, are directly responsible for human health impacts, 

and human health impacts has been kind of loosely defined here, 

but I would certainly think that the most key human health impact 

would be failure of the treatment of a disease. 

Mr. SHIMKUS. Yes, and let me—my time is very limited and I 

want to be respectful of my colleagues. And the animal feed issue 

is different than what the Danish experience was in the use of 

antibiotics. I don’t want you to elaborate. 

I want to follow up. My second question is, the FDA role. The 

FDA role is to make sure they approve drugs for animals and for 

humans. Now, when they say this antibiotic is good for use in animals, do they also look at its possible risk for human consumption 

through the process? Do they have to consider the effect on human 

health? 

Dr. CARNEVALE. Yes. 

Mr. SHIMKUS. So when the FDA says it is OK, it is not only saying it for the animal, it is saying it for human health and consumption? 

Dr. CARNEVALE. Absolutely. They have a mandate to approve 

drugs safe and effective, which means safe to the animal, safe to 

humans and safe to the environment. 

Mr. SHIMKUS. My time is expired. Thank you, Madam Chairman. 

Ms. SCHAKOWSKY. Thank you. 


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I wonder if you would mind if I just follow up with Dr. 

Henriksen, just find out what the Danish experience was on the 

cost of production after the ban. I don’t know if—— 

Mr. SHIMKUS. No, we talked and I will be happy as long as our 

colleague down there is fine. 

Ms. SCHAKOWSKY. Just a quick question. Was there any impact 

on the cost of production after the ban or the cost to the consumer 

after the ban? 

Dr. HENRIKSEN. The prices in the shops have not been increased 

due to this ban. I don’t have any data available with me about the 

production costs for the farmer. 

Ms. SCHAKOWSKY. Thank you. 

Dr. HENRIKSEN. I can present it to you if you want. 

Ms. SCHAKOWSKY. Thank you. 

Congresswoman Christensen. 

Mrs. CHRISTENSEN. Thank you, Madam Chair, just a few questions. 

Dr. Hoang, the AVMA, I understand, suggests that the current 

FDA approval process for antibiotic use in food animals is sufficiently strict to protect human health but the FDA doesn’t apply 

a standard regarding antibiotic resistance retroactively to drugs 

that were approved maybe decades ago. So what is the AVMA’s position? Should we reevaluate the safety or not of already approved 

drugs? 

Dr. HOANG. The AVMA is supportive of reevaluation of the drugs 

that have been previously approved, but I might also add that the 

FDA does have the authority to withdraw a drug if they find that 

there is an imminent human health hazard, which they have not 

done so. 

Mrs. CHRISTENSEN. Thank you. 

Dr. Levy, why do you think the United States has yet to follow 

the example of other industrialized nations in limiting antibiotic 

use in meat production? Is it because the scientific basis for action 

is questionable? It seems to me there is a lot of evidence. I don’t 

think the bacteria behave much differently here than in Europe, so 

what do you think the reason is? 

Dr. LEVY. That is exactly what I was thinking. It has bothered 

me a lot as I go out to teach about how to use antibiotics that Europe, I think, is ahead of us by eliminating this major source of resistant emergence. Why? It is much more difficult in this country 

to get this ban. I had preferred all along in my career that it would 

be more voluntary and that you wouldn’t need a legislative ban, 

but I have been disappointed. 

But anyway, all that being said, as we know, the Europeans 

looked at the data and with one fell swoop they said precautionary 

principle, we eliminate this use. I think the scientific data is clear, 

and I am a scientist and I have looked at the data, and the APUA 

has actually put out a few years ago an evaluation of this whole 

prospect with stakeholders and all agreed that this is no longer 

needed. First of all, we don’t even know if growth promotion is 

really working. If it is prophylactic, let us call it prophylactic. And 

as I said in my statement, there is a big difference in terms of the 

selection of the numbers of animals that we get for growth promotion, which is everyone, whether healthy or not, versus prophyVerDate Mar 14 2013 09:19 Mar 20, 2013 Jkt 077921 PO 00000 Frm 00235 Fmt 6633 Sfmt 6633 E:\HR\OC\A921.XXX A921

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laxis, which in human medicine, look at what we do with surgery. 

We eliminated all that extra antibiotic and we gave a dose before 

and a dose or two after. Why aren’t we doing that with animals? 

Where are the studies? If we call it prophylaxis, show me that it 

is prophylaxis. Show me what—I mean, a spade a spade. What is 

it? And so I think it is a different, should I say culture, but I don’t 

think that anyone—there are plenty of us in the United States that 

agree with the European decision. 

Mrs. CHRISTENSEN. And I noted Dr. Hansen in her statement— 

I don’t have a question for you but I know that you said that even 

in 1977, that is where I got the point I made in my opening statement, that the evidence was significant but we did not allow FDA 

to apply a ban. Is that correct? 

Dr. HANSEN. Yes, ma’am. I would certainly agree with that. I 

think that we certainly don’t lack the science at all. We certainly 

have—this is just a representative portion of the science that we 

have. We may lack or we may have at least up until this point with 

all these hearings may have lacked some of the political will. 

Mrs. CHRISTENSEN. Thank you. 

Dr. Carnevale, how does AHI justify opposing significant reductions in antibiotic use in food animals when such overuse ultimately helps to contribute to the demise in your products’ ability 

to treat both human and animal disease? Aren’t you sacrificing 

long-term financial well-being, not to mention public health, in 

favor of short-term profit in this case? 

Dr. CARNEVALE. If I understand the question, you are saying why 

do we oppose reducing antimicrobial use. I don’t think AHI has 

ever said that. I think what our position is is that these products 

have been approved as safe and effective by the FDA 

Mrs. CHRISTENSEN. Safe and effective for treatment. 

Dr. CARNEVALE. Safe and effective for all the claims on the label. 

Mrs. CHRISTENSEN. From growth—— 

Dr. CARNEVALE. They have been approved as safe and effective 

for growth promotion, disease prevention, disease treatment and 

disease control, whatever is on the label. 

Mrs. CHRISTENSEN. Well, FDA has issued some guidelines now 

regarding—— 

Dr. CARNEVALE. Yes. 

Mrs. CHRISTENSEN. Does AHI support the guidelines that 

FDA—— 

Dr. CARNEVALE. We welcome the opportunity to work with the 

agency on their concerns about it. We clearly understand that they 

do have a concern about the way these products have been marketed for many years over the counter. We do understand they 

have a concern for the growth promotion claims. I don’t want to 

prejudge the situation. I simply want to say that our companies are 

committed to working with the agency to try to address those concerns, and if there are alternatives that we can come up with for 

growth promotion claims, I am sure our companies will be more 

than happy to pursue that track. 

Mrs. CHRISTENSEN. And are your companies—— 

Dr. CARNEVALE. Yes, we really want to work with the agency on 

this. 


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Mrs. CHRISTENSEN. Are your companies willing to report on the 

sale of medicines, drugs for animal use? 

Dr. CARNEVALE. In fact, they are required to now under the Animal Drug User Fee Act. In fact, our companies have all submitted 

those reports to the FDA as of the end of March 2010. So yes. 

Mrs. CHRISTENSEN. Thank you, Madam Chair. 

Ms. SCHAKOWSKY. Well, that concludes all the questioning. I 

really thank you for your patience today, for staying with us all 

afternoon. In closing, I want to remind members that you may submit additional questions for the record to be answered by the relevant witnesses. The questions should be submitted to the committee clerk within the next 10 days. The clerk will notify your offices of the procedures. 

And without objection, this meeting of the Subcommittee is adjourned. Thank you. 

[Whereupon, at 5:55 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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U.S. Representative Kathy Castor 

Committee on Energy and Commerce - Subcommittee on Health 

Hearing: "Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture" 

July 13, 2010 

• Thank you Mr. Chairman for convening the third hearing in 

our antibiotic resistance series. 

• This afternoon's focus is critical looking at ways to reduce 

antibiotic resistance by cutting down on non-judicious use of 

antibiotics in farm animals may prove to be vital to 

combating the growing problem of antimicrobial resistance in 

humans. 

• It is clear that we need a comprehensive strategy to address 

antimicrobial resistance in humans, as resistant infections 

cause approximately 90,000 deaths each year and account for 

up to $26 billion a year in additional health care costs 

including hospitalization of infected patients for weeks or 

even months at a time. 

• Our strategy must include an assessment of the use of 

antibiotics in farm animals. 

• We must also take a closer look at the reasons that we are 

light years behind other nations, such as Denmark, in our 

effort to cut back on non-judicious use of antibiotics in 

animals. 

• Here in the U.S., Salmonella bacteria are considered a norm 

for uncooked chicken and raw eggs. 

• We promote the need to use everyday household 

disinfectants to keep families safe from bacteria frequently 

found in two of the most common foods. 
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• But, most Americans would be surprised to learn that 

Salmonella bacteria incidence in chickens can be prevented 

and is not innate. In Denmark, the incidence of Salmonella 

bacteria in poultry is 0-2%. Ironically, a problem that is so 

common in the U.S. that it is rarely considered a problem is 

almost non-existent in Denmark. 

• Further, Norway is now the most infection-free country in the 

world after the implementation of an aggressive program to 

cut back on overuse of antibiotics in humans. 

• Again, other nations are light years ahead when it comes to 

addressing this issue - one that we could have taken seriously 

many years ago. 

• The notion that pumping farm animals with antibiotics can 

lead to overexposure to certain drugs during human food 

consumption is nothing new - it has been asserted for 

decades - yet there has yet to be a concerted effort to put a 

stop to it. It's time to get to the bottom of it. 

• I am proud cosponsor of HR 1549, the Preservation of 

Antibiotics for Medical Treatment Act, which many other 

members of this Committee support. This legislation, 

introduced by Congresswoman Louise Slaughter of New 

York, would ban farm use of drugs that are critical to fighting 

human infection unless the animals are ill. 

• I hope that today we can look closely at the concerns 

addressed in H.R. 1549. 

• Again, thank you Mr. Chairman, and I look forward to 

hearing from our witnesses. 
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Opening Statement 

Honorable Ranking Member Joe Barton 

Subcommittee on Health 

Hearing on "Antibiotic Resistance and the Use of 

Antibiotics in Animal Agriculture" 

Wednesday, July 14,2010 - 2:00 PM 

Mr. Chairman, I would like to welcome the witnesses 

to the hearing and thank them for testifying today. 

This is the third hearing we are having on the subject 

of antibiotics. Today, we will discuss the use of antibiotics 

in animal agriculture. In reviewing the testimony, it is clear 

that the federal government, veterinarians and producers 

are doing a great deal to ensure that antibiotics are being 

used safely. 

The Food and Drug Administration, the Centers for 

Disease Control, and the Department of Agriculture are 
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conducting monitoring programs to track the development 

of antibiotic resistance. Veterinarians and producers have 

adopted and implemented judicious use programs to ensure 

that antibiotics are safely and properly used. The FDA has 

implemented a stringent approval process for animal drugs. 

I understand that the FDA recently released a new 

guidance document in which it indicated that it would like 

to ban certain uses of antibiotics in animals. From what I 

understand, this ban could have some serious consequences 

for both public health and jobs. I would like to know more 

about why the FDA has proposed this major action at this 

time and what data serve as the scientific foundation for 

taking the proposed action. 

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I also want to note that this is our third hearing on 

antibiotics even though the Majority has yet to hold one 

hearing on how the President's new health care law is being 

applied to the American people. Last week, President 

Obama decided to appoint a new Administrator of the 

Centers for Medicare and Medicaid Services (CMS) 

through a recess appointment, thereby bypassing the 

constitutionally prescribed process of Senate confirmation. 

I think the President's surprise decision to avoid the 

normal public examination of a nominee is another problem 

on top of the problems being generated almost daily by his 

health care law. Dr. Berwick has now taken an important 

jobwithout Congressional approval. The American people 

do not even know how Dr. Berwick intends to implement 

Obamacare, and this is wrong. For example, Congress and 

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the people have every right to know how Dr. Berwick will 

implement the $575.1 billion in Medicare cuts before he 

begins the cutting. People also have a right to know how 

Dr. Berwick will cut $145 billion from the Medicare 

Advantage program and who will lose their plans because 

of his decisions. 

Dr. Berwick also will be in charge of implementing an 

unprecedented expansion of the Medicaid welfare program. 

Obamacare expands enrollment in this welfare program to 

more than 90 million people, and there will be an increase 

in spending of nearly 90% during the 2014-2019 period 

alone. Dr. Berwick and the Obama Administration owe the 

country an explanation of what they're up to. 

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Dr. Berwick's previous public statements suggest that 

he believes that the government should be the ultimate 

arbiter on the medical care that patients receive and that 

rationing is a legitimate function of government-supervised 

health care. Given the power of the Medicare and 

Medicaid Administrator and the concern regarding Dr. 

Berwick's seemingly radical opinions, this Committee 

needs to invite Dr. Berwick to testify at the earliest 

opportunity so he can speak for himself and clear the air. 

We need to know the direction Dr. Berwick intends to take 

his new agency and our nation's health care system. 

Thank you, Mr. Chairman. I yield back the balance 

of my time. 

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BLUNT STATEMENT FOR E&C SUBCOMMITTEE ON HEALTH 

July 14,2010 

Mr. Chainnan, 

Thank you for holding this hearing regarding antibiotics and animal 

agriculture. 

As we have discussed in previous hearings, antibiotic resistance is a 

major concern for both human and animal health. Both doctors and 

veterinarians should always prescribe only what is essential to ensure that 

antibiotics are not used unnecessarily. I have met and spoken with many 

fanners and animal producers in my district on a regular basis. I know they 

have the utmost respect for antibiotics and seek to use them only when 

necessary to help maintain the health of their animals. They work in close 

consultation with their veterinarians because healthy animals are the first 

step in food safety. 

Currently, the FDA must approve all medications administered to 

food-producing animals. These antibiotics undergo a stringent approval 

process. Recently, the FDA released new draft guidance regarding the 

judicious use of antibiotic drugs in food-producing animals. I hope the FDA 

will work closely with all stakeholders and listen to their comments, as they 
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move forward with finalizing Guidance 209. We should not restrict or 

reduce access to the tools that our farmers need to keep their animal 

populations healthy, as this would have a direct effect on human health. 

We should also make sure to take into account the experiences of 

other countries when determining new guidelines. In 2000, Denmark put 

into place a ban on the use of antibiotics for growth promotion for cattle, 

pigs and broilers. Since then, the country has seen an increase in the 

instance of death and disease in their swine herds. Their producers have also 

had to use increased amounts of antibiotics used to treat their animals. As 

we consider policies that govern the use of antibiotics in animal agriculture, 

we must rely on science-based findings to make sound determinations. 

I look forward to working with the chairman and my colleagues on the 

subcommittee regarding this issue. 
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Opening Statement 

Congressman John Sullivan 

Subcommittee on Health 

House Energy and Commerce Committee 

Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture 

July 14,2010 . 

2123 RHOB 

Thank you for holding this hearing today to examining antibiotic 

resistance and the use of antibiotics in animal agriculture. 

Antimicrobial drugs have been used in medicine for over 50 years and 

they have yielded tremendous benefits for public health and animal 

health. 

In June, the FDA released new draft guidance about antimicrobial drugs 

and their use in food producing animals indicating that use of such 

antimicrobials for "production purposes" such as promoting growth and 

improving "feed efficiency" represents an injudicious use of such drugs. 

There is much debate about whether antibiotic resistance bacteria can 

develop in animals and transfer to humans. As we examine this issue, it 

is important to note that there are no conclusive U.S. peer-reviewed 

studies indicating a link between animal antibiotic use and human 
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health. Further study is necessary and I fear that the FDA is going too far 

and too fast on this critical economic and food safety issue. It is vital 

that we challenge the scientific rational for the FDA's guidance and I am 

concerned that federal public health regulators are starting down a road 

that will inevitably lead to restricting the antibiotics that farmers and 

ranchers can use without evidence to support increased federal 

regulation in this area. 

In addition to the FDA guidance, legislation has been introduced this 

Congress mirroring the FDA guidance that will ban the use of anti 

microbial drugs in animals. We need to be careful because such a ban 

could have serious economic and food safety consequences for our 

nation. I've heard that adopting such a ban would cost U.S. pork 

producers $1.1 billion alone, which would undoubtedly raise the cost of 

food while doing little to benefit public health. 

I look forward to hearing the testimony from our witnesses today and I 

yield back the balance of my time. 
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U.S. DEPARTMENT OF HEALlH AND HUMAN SERVICES 

July 13, 2010 

The Honorable Frank Pallone, Jr. 

Chairman 

Subcommittee on Health 

House Committee on Energy and Commerce 

Washington, D.C. 20515 

Dear Chairman Pallone: 

Public Health Service 

Centers for Disease Control 

and Prevention (CDC) 

Atlanta GA 30333 

Please find attached written responses to questions for the record from the Subcommittee's April 

28 hearing on antimicrobial resistance. These responses provide additional detail on the strong 

scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in 

humans. 

There are multiple North American studies describing how: 

• Use of antibiotics in animals results in resistant bacteria in food animals 

• Resistant bacteria are present in the food supply and transmitted to humans 

• Resistant bacteria result in adverse human health consequences (such as increased 

hospitalizations) 

In addition, a strong body of evidence from Europe demonstrates that antibiotic use in animals is 

linked with antibiotic resistance in humans. Multiple studies looked at the effects of the Danish 

ban on non-therapeutic use of antibiotics in food animals. We have thoroughly reviewed these 

studies and have found them to be well-designed and rigorous, and to establish a clear link 

between antibiotic use in animals and antibiotic resistance in humans. 

I appreciate this opportunity to restate my conclusions from the April hearing, and provide you 

additional detail. This opportunity is particularly important because some discussion at the 

hearing has been mischaracterized. To be clear, the Centers for Disease Control and Prevention 

(CDC) finds that there is a compelling body of evidence to demonstrate this link, as summarized 

above, in my April testimony, and in the attached responses to questions for the record. I am 

pleased that the Subcommittee is holding another hearing in its series on this important issue, and 

that Dr. Ali Khan will be able to represent CDC to further elaborate on this evidence regarding 

the relationship between antibiotic use in food animals and antibiotic resistance in humans. 
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Page 2 - The Honorable Frank Pallone Jr. 

CDC remains committed to working with Congress and our colleagues at the Department of 

Health and Human Services and the U.S. Department of Agriculture to identify the best ways to 

address the health risks posed by antibiotic resistance. 

Cc: Rep. John Shimkus, Ranking Member 

Anthony Fauci, NIH 

Margaret Hamburg, FDA 

Josh Sharfstein, FDA 

Ali Khan, CDC 

Sincerely, 

Thomas R. Frieden, M.D., M.P.H. 

Director, CDC, and 

Administrator, Agency for Toxic Substances 

and Disease Registry 
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QUESTIONS SUBMITTED FOR THE RECORD 

HEARING ENTITLED, 

"ANTIBIOTIC RESISTANCE AND THE THREAT TO PUBLIC HEALTH" 

SUBCOMMiTTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

UNITED STATES HOUSE OF REPRESENTATIVES 

APRIL 28, 2010 

Thomas Frieden, M.D., M.P.H. 

Director 

Centers for Disease Control and Prevention 

U.S. Department of Health and Human Services 

Representative Henry A. Waxman 

Ql. You mentioned data from Europe demonstrating the link between animal antibiotic 

use and antibiotic-resistant microbes in people, in particular the example of avoparcin and 

vancomycin-resistant enterococcus. You also mentioned the data from Denmark, where 

antibiotics were banned for growth promotion uses for animals. Please evaluate the lessons 

from these European data and provide your views on any relevant lessons for the United 

States. 

A. The Danish studies have focused on non-therapeutic use of antimicrobial agents in foodproducing animals, particularly swine and broiler chickens. Non-therapeutic uses include 

promoting growth and improving feed efficiency; drugs for these purposes are typically given in 

feed. 

• In 1995, the Danish government banned the non-therapeutic use of avoparcin for growth 

promotion in Denmark. In 1997, the commission of the European Union (EU) countries 

adopted the same ban for all of its member states. 

• In 1998, Denmark banned use ofvirginiamycin for growth promotion. Also in 1998, the 

agriculture ministers in the EU voted to ban use ofvirginiamycin, bacitracin, tylosin, and 

spiramycin for growth promotion; this ban became effective for EU member states in 

1999. 

• The Danish cattle and broiler industries voluntarily stopped the non-therapeutic use of all 

antibiotics for growth promotion in February 1998. 

The Danish swine industry through voluntary and regulatory action stopped all nontherapeutic use of antibiotics for growth promotion in swine above 35 kg by February 

1998 and for all age groups by December 1999. 

• In 2002, the EU voted to phase out all non-therapeutic use of antibiotics for growth 

promotion (AGPs, i.e., all non-prescription use) beginning in 2006. 

1 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark: The WHO 

international review panel's evaluation of the termination of the use of antimicrobial growth promoters in 

Denmark.Available at http://www.who.int/saimsurv/en/Expertsreportgrowthpromoterdenmark. pdf. 

2 DAN MAP. 2008. Use of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from food 

animals, foods and humans in Denmark. Available at: http://www.danmap.org/pdfFiles/Danmap 2008.pdf. 

1 
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• While there has been an increase in therapeutic use of antimicrobials in animals, total 

antimicrobial consumption in animals in Denmark has decreased by over 50%. From 

1998 to 2008, total antimicrobial consumption reduced from 100 to 49 milligrams of 

antimicrobials per kilogram of meat produced. 

• Stopping the use of various non-therapeutic antibiotic growth promoters (e.g., 

avilamycin, avoparcin, spiramycin, tylosin, virginiamycin) has resulted in a major 

reduction in antimicrobial resistance as measured among several different bacterial 

species in food animals and food. This has been thoroughly documented in scientific 

publications from Denmark. 

• Denmark measured total consumption of antimicrobial agents by food animals and 

resistance to those drugs among Enterococcus isolated from food animals and the foods 

derived from them. 

• Resistance to these drugs among Enterococclls isolated from broilers, swine, and the 

meat from these animals decreased after AGPs were discontinued. However, in 2003, the 

World Health Organization (WHO) could not determine the ban's direct and total effect 

on antimicrobial resistance in humans because oflimited data. Newer monitoring data 

available since then show that human resistance trends appear to be mirroring the decline 

in on-farm use of antibiotics; however, newer monitoring data on human resistance must 

be considered carefully. The trend must first be determined to be sustainable. Second, 

although the trend may mirror decreases in resistance in animals, more needs to be 

known about the potential causes for decrease in humans. If present, the trend toward 

decreased resistance is likely due to many factors including those aimed specifically at 

human antimicrobial usage and transmission of resistant bacteria. 

• Weaner (swine) mortality increased several years before as well as a few years after nontherapeutic use stopped, but has drastically decreased in recent years, indicating that the 

termination had no effect on swine mortality. 

• Production and economic impacts are described in a 2003 WHO report. The WHO 

reports that: "Overall, total volume of pork production in Denmark continued to increase 

in the period following the termination of antimicrobial growth promoters ... The net costs 

associated with productivity losses incurred by removing antimicrobial growth promoters 

from pig and poultry production were estimated at 7.75 DKK (1.04 €) per pig produced 

3 Aarestrup, F.M., A.M. Seyfarth, H.D. Emborg, K. Pedersen, R.S. Hendriksen, and F. Bager. July 2001. "Effect of 

Abolishment of the Use of Antimicrobial Agents for Growth Promotion on Occurrence of Antimicrobial Resistance 

in Fecal Enterococci from Food Animals in Denmark," Antimicrobial Agents and Chemotherapy 45(7): 2054-2059. 

Available at: http://aac.asm.org/cgi/reprint/45/7/2054. 

4 Boerlin, P., A. Wissing, F. M. Aarestrup, J. Frey, and J. Nicolet. 2001. "Antimicrobial Growth Promoter Ban and 

Resistance to Macrolides and Vancomycin in Enterococci from Pigs," lournal of Clinical Microbiology 39(11): 4193-

4195. Available at: http://jcm.asm.org/cgi/reprint/39/11/4193. 

5 Evans, M.e. and H.e. Wegener. 2003. "Antimicrobial Growth Promoters and Salmonella spp., Campylobacter 

spp. In Poultry and Swine, Denmark," Emerging Infectious Diseases 9(4): 489-492. Available at: 

http://www.cdc.gov/ncidod/eid/voI9n04/pdfs/02-0325.pdf 

6 Gravea, K" V,F. Jensen, K. Odensvik, M, Wierup, and M. Bangen. 2006. "Usage of veterinary therapeutic 

antimicrobials in Denmark, Norway and Sweden following termination of antimicrobial growth promoter use," 

Preventive Veterinary Medicine 75(1-2): 123-132. 

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and no net cost for poultry. This translates into an increase in pig production costs of just 

over 1%.,,7 

In general, subtherapeutic use has been shown to lead to an increase in resistant strains in 

animals. The European experience demonstrates that it is possible to stop these uses, reduce 

overall use of antibiotics in animals, reduce resistant circulating bacteria that can infect humans, 

and not have industry or consumers affected by decreased production or increased costs. 

Additional information, such as reliable data on quantities of antibiotics used in animals for 

various purposes and comprehensive on-farm studies of the relationship between use and 

resistance, would be needed to study the same effects in the United States. 

Q2. The rates of food borne illnesses-particularly those generated by antibiotic resistant 

organisms-have risen in this country. Ms. Capps asked about the National Antimicrobial 

Resistance Monitoring System data and suggested that much of the nation's meat and 

poultry products are tainted with some kind of antibiotic resistant bacteria. There are a 

number of studies, both in Europe and in the United States, suggesting a link between the 

use of certain antibiotics in animals and bacteria resistant to those antibiotics in food 

products and humans. For example, a study in Minnesota and Wisconsin found evidence 

indicating that antibiotic-resistant E. coli in people were likely to have came from poultry, 

while antibiotic-sensitive E. coli in people likely did not come from poultry (J.R Johnson et 

aI., Antimicrobial Drug-Resistant Escherichia coli from Humans and Poultry Products, 

Minnesota and Wisconsin, 2()()2-2()()4, Emerging Infectious Diseases (June 2007) (online at 

http://www.cdc.govIEID/content/13/6/838.htm). Can you expand on this information, and 

comment on whether CDC believes such antibiotic resistant bacteria from animals and 

their meat have been transmitted to people? 

A 

• CDC is familiar with the J.R.Johnson article referenced and concurs with the conclusions 

described in the study. Johnson et al analyzed the distribution and virulence genotypes of 

drug-susceptible and drug-resistant E. coli isolates from human volunteers and poultry 

products. They found that drug resistant E coli isolates from humans were more similar 

to drug resistant isolates from poultry then they were from drug susceptible isolates from 

humans. This work as well as other work from Johnson's group has contributed to the 

evidence that drug resistant E coli found in humans is most similar to that found in 

poultry. 

• The National Antimicrobial Resistance Monitoring System (NARMS)R has demonstrated 

a steady and statistically significant increase in the prevalence of resistance to the two 

7 World Health Organization. 2003. Impacts of antimicrobial growth promoter termination in Denmark: The WHO 

international review panel's evaluation of the termination of the use of antimicrobial growth promoters in 

Den m a rk.A va ila ble at: IillJl.:LLwww. wh o. inti sa I ms urv I en!Experts repo rtgrowth promoterd en marJs&<jf. 

B NARMS is a collaboration among CDC (human samples), FDA's Center for Veterinary Medicine (retail meats and 

animal feeds), and USDA's Food Safety and Inspection Service and Agricultural Research Services (animal samples). 

Participating health departments forward every twentieth non-Typhi Salmonella isolate, every Salmonella Typhi, 

every twentieth Shigella isolate, and every twentieth E. coli 0157 isolate received at their public health 

laboratories to CDC for susceptibility testing. NARMS investigates outbreaks involving these bacteria and conducts 

research on resistance mechanisms. 

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most clinically important antimicrobial agents, ciprofloxacin and ceftriaxone, in 

Salmonella strains isolated from ill humans in the United States. 

• A multi drug resistant (MDR) Salmonella Typhimurium emerged in the 1990s in cattle 

and in people, and has persisted since then (associated with ground beef). 

• MDR Salmonella Newport emerged in 1998 in cattle and humans and has persisted since 

then (associated with ground beef). 

• Resistance to ciprofloxacin in Campylobaeter in poultry and people emerged in the late 

1990s and steadily increased (associated with chicken and turkey). 

• In 2005, FDA withdrew approval for fluoroquinolone use in poultry due to evidence it 

might be associated with resistant human infections. 

• Although it has not been demonstrated conclusively in a single study that use of 

antimicrobial agents in food animals results in adverse human health consequences, 

numerous studies have demonstrated the movement of resistant pathogens through the 

food supply. Studies related to Salmonella, including many studies in the United States, 

have demonstrated that (I) use of antimicrobial agents in food animals results in 

antimicrobial resistance in food animals, (2) resistance strains are present in the food 

supply and commonly transmitted to humans, and (3) increases in resistant strains results 

in adverse human health consequences (e.g., increased hospitalization)9, 10 

Q3. Mr. Dingell asked that you provide the level of your request for financial support for 

antimicrohial programs in the President's budget, the amount CDC has been given for 

these programs during each of the last 3 years, and the amount anticipated for the next 3 

years. Please provide such information, including your professional judgment budget for 

the appropriate level of funding for antibiotic resistance programs at CDC. 

A. 

• In FY 2008, FY 2009, and FY 2010, antimicrobial resistance was funded ($16.9 million per 

year), either through specific Congressional appropriations or agency allocations. 

• The FY 2011 President's Budget includes $8.7 million available to fund AR activities. The 

FY 2011 Budget also includes an increase of $19.6 million for the Emerging Infections 

program, which supports antimicrobial resistance activities, such as surveillance, technical 

assistance, and epidemiological and laboratory support. 

CDC is committed to maintaining a strong AR program and is exploring the high value 

investments moving forward. CDC will work to prioritize funding through the Emerging 

infections program and antimicrobial resistance program to combat AR. 

In CDC's professional judgment, to fully combat the growing problem of antimicrobial 

resistance, and to fully implement the CDC-coordinated sections of the Federal Inter-Agency 

Task Force on Antimicrobial Resistance Action Plan (surveillance, prevention and control), CDC 

requires an annual budget of $50 million phased in over a three year period (i.e. $30 million in 

FY 2012, $40 million in FY 2013, and $50 million in FY 2014). An incremental increase in the 

annual budget will allow for a stepwise expansion of surveillance, prevention and control 

9 Dutil et ai., Emerg Infect Dis 2010 

10 Foister et ai., Foodborne Pathog Dis 2010 and Zhao et ai., Appl Environ Microbial 2008. 

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activities described in the Action Plan. This does not include funding of antimicrobial resistance 

activities for specific diseases (such as tuberculosis and gonorrhea) funded through other CDC 

budget lines. This represents the professional judgment estimates of CDC staff on the size and 

scope of the AR activities, and is provided without regard to the competing priorities that the 

agency, the President, must consider to develop the Budget. 

CDC would use this increase in funding to continue its antimicrobial resistance activities and add 

new applied research grants and demonstration projects; 75% of the division projects would be 

funded extramurally (both domestic and international) and 100% of the applied research grants 

and demonstration projects would be funded extramurally to domestic grantees. This increase in 

funding would also allow states via the Emerging Infections Program (EIP) and the 

Epidemiology and Laboratory Capacity (ELC) program to expand surveillance activities (e.g., to 

include antimicrobial resistance in healthcare-associated infections) and to increase state 

laboratory capacity to detect new and emerging resistance. CDC would also hire personnel to 

coordinate new surveillance activities and coordinate projects at state levels. This professional 

judgment budget also includes funding for capital expenses to reinforce select CDC reference 

laboratories and to develop and implement rapid diagnostic methods to determine the 

susceptibility of select microorganisms to new anti-infective agents. Funding would support an 

expansion of current databases of both antimicrobial use and antimicrobial resistance patterns, 

and expand web based reporting capabilities. Finally, the increase in funding would provide 

continued support for the Antimicrobial Resistance Task Force and allow CDC to plan and hold 

an antimicrobial resistance conference that will bring together scientists and consultants to 

update the Action Plan and discuss the latest scientifIC trends and developments in the field of 

antimicrobial resistance. 

Professional Judgment Annual Budget for Antimicrobial Resistance Activities 

Category Explanation Cost 

(in millions) 

FY12 FY13 FY14 

Continuing & new 75% extramural, both domestic and $7 $10 $12 

division projects international, Interagency Agreements 

Continuing & new 100% extramural applied research grants and $5.5 $8.5 $15.5 

research grants demonstration projects; educational activities 

Ongoing and new ElP and ELC funding to increase State-level $9 $10 $12 

State-based AR capacity for surveillance, prevention 

activities activities, and reference laboratory services 

CDC Support for on- CDC funding for FTEs, laboratory supplies, $8 $11 $10 

going and new AR 

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activities laboratory equipment, and software 

Task Force Support Antimicrobial Resistance meeting, conference $0.5 $0.5 $0.5 

planning, Antimicrobial Resistance Task 

Force, consultants' meetings 

Total $30 $40 $50 

Q4. Your testimony before the Committee cited the theoretical risk of the use of antibiotics 

in animal feed. You also stated that you supported further action to ensure judicious use of 

antibiotics. Do you consider the use of antibiotics in animal feed for growth promotion or 

feed efficiency a judicioIls use of antibiotics, given these risks to public health? 

A. CDC believes that the use of antimicrobials should be limited to protecting human and animal 

health. Purposes other than for the advancement of animal or human health should not be 

considered judicious use. 

Q5. You spoke in yonr testimony about the need to judiciously prescribe antibiotics for 

humans. All antibiotics for humans in this country are prescribed under the oversight of a 

physician. In your view, should antibiotics used for animals be under the oversight of a 

veterinarian? 

A. Yes, the use of medications for the prevention, treatment, and control of disease in animals 

should be under the supervision of a veterinarian. CDC supports the WHO's principles on 

containment of antimicrobial resistance in animals intended for food. Veterinarian oversight is a 

key principle in the "WHO Global Principles for Containment of Antimicrobial Resistance in 

Animals intended for Food" which is available at 

http!/whglibdoc.who.intlhq/2000/WHO CDS CSR APH 2000.4.pdf 

Q6. [ understand that the CDC's National Nosocomial Infections Surveillance (NNIS) does 

not track infections in long term care facilities or ambulatory surgical centers. 

Can you explain why that is? [n your view, would it be useful for the system to encompass 

long term care facilities and ambulatory surgical centers? 

A. CDC agrees that it would be useful to expand health care-associated infection (HAl) 

surveillance and prevention activities to non-hospital settings. The National Healthcare Safety 

Network (NHSN - formerly NNIS) is successfully used by healthcare facilities in all 50 states 

(with 21 states using NHSN to fulfill their public reporting mandates) to collect and use HAl 

data for prevention activities, determine which practices help prevent HAls, and to share data 

with other facilities within a healthcare system and/or public health agencies for collaborative 

prevention activities. Participation in NHSN has grown significantly in the past few years. As 

of March 20, 2009, over half of the approximately 5,000 U.S. hospitals are enrolled in and 

utilizing NHSN. Some states are already using NHSN for HAl surveillance and prevention 

activities in non-hospital settings. In October 2008, Colorado used American Recovery and 

Reinvestment Act funds awarded by CDC to extend its NHS N reporting of HAls from 

ambulatory surgical centers. Additionally, there are 122 long-term acute care facilities, 51 

outpatient surgical centers, and 109 hemodialysis facilities enrolled in NHSN. 

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Nationally, there are about 26,000 non-hospital facilities, including ambulatory surgical centers, 

dialysis centers, and long term care facilities where complex procedures are increasingly 

performed. CDC does currently have surveillance in these settings, though only a small portion 

of these non-hospital facilities are enrolled in NHSN because we are still refining the best way to 

capture surveillance data and modifying surveillance definitions for use in these settings. 

Currently, CDC's long-term care work group is using and modifying existing long-term care 

infection surveillance definitions in order to decrease surveillance burden on facilities. The FY 

2011 Budget included an increase of $12.3 million for NHSN to support the expansion to 2,500 

additional hospitals, and facilitate the implementation of prevention activities to achieve HHS 

HAl goals and targets. 

Representative Jim Matheson 

Q1. It is my understanding that in December 2007, the federal Interagency Task Force on 

Antimicrobial Resistance held a consultation in Atlanta bringing in 60 external consultants 

to help the task force revise the 2001 Action Plan on Antimicrobial Resistance. A draft 

revision was promised in 2008. We are now in 2010 and are waiting to see a product. a. 

Can you provide the committee with an update on the status of this action plan? Will this 

revised action plan contain benchmarks, as would be required by legislation that I 

introduced -the STAAR Act- to measure progress including for CDC, FDA and NIH? b. 

If no, then why not? 

A The Action Plan is currently under development and is expected to be released this year. This 

Action Plan includes benchmarks and timelines and will be made available for public comments 

upon release when it is published in the Federal Register. The Action Plan identifies four 

focused areas and each one has an agency coordinator and timeline: 

• Surveillance: CDC is coordinating most action items 

• Prevention and Control: CDC is coordinating most action items 

• Research: NIH is coordinating most action items 

• Product Development: FDA is coordinating most action items 

CDC plans to regularly update the Action Plan with specific project and implementation steps at least 

every 2 years so that it becomes an even more informative and useful document. 

Q2. In November of last year, President Obama, along with our European partners, 

announced the creation of a Transatlantic Task Force on Antibiotic Resistance to 

strengthen the antibiotic pipeline, develop interventions to address resistant infections in 

hospitals and communities, and opportunities to eliminate inappropriate uses in human 

and veterinary medicine. I am aware that it takes time to set up such an entity, but we are 

approaching 6 months from the announcement and I am not aware of word from the 

Administration on how this gronp is going to operate, what its charge will be, and whether 

it will include nongovernment experts. Including external experts to advise the government 

is a critical component of the Strategies to Address Antimicrobial Resistance (STAAR) Act, 

which I sponsored. a. What is the statns of this international gronp and what is the charge 

of the transatlantic task force? b. Please provide the Committee with the list of 

participants, both domestic and international. 

A The Transatlantic Task Force on Antibiotic Resistance (Task Force) EU-US planning group 

has had a series of video conferences and a kickoff meeting of the Task Force is scheduled for 

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June 20 I o. The Task Force will develop an action plan focused on the areas defined by the 2009 

EU-US Summit declaration: 

• Developing appropriate therapeutic use of antimicrobial drugs in the medical and 

veterinary communities 

• Preventing both healthcare- and community-associated drug-resistant infections 

• Developing strategies to improve the pipeline of new antimicrobial drugs 

The Task Force is composed of experts and officials from the European Union and the United 

States. The United States is represented by the following individuals and agencies of the 

Department of Health and Human Services: 

US Department of Health and Human Services (HHS)' Office of the Secretary 

Nils Daulaire, Director, Office of Global Health Affairs 

Mary Lisa Madell, Director, Europe and Eurasia, Office of Global Health Affairs 

Centers for Disease Control and Prevention (CDC) 

Denise Cardo, Director, Division of Healthcare Quality Promotion, National Center for 

Emerging and Zoonotic Infectious Diseases (proposed) 

1. Todd Weber, CDC Liaison to the European Centre for Disease Prevention and Control, 

National Center for Immunization and Respiratory Diseases 

Jean Patel, Deputy Director, Office of Antimicrobial Resistance 

National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health 

Dennis Dixon, Chief, Bacteriology and Mycology Branch, Division of Microbiology and 

Infectious Disease 

Jane Knisely, Scientific Program Analyst, Bacteriology and Mycology Branch, Division of 

Microbiology and Infectious Disease 

Food and Drug Administration 

Edward Cox, Director, Office of Antimicrobial Products, CDER Drug Shortage Coordinator 

Linda Tollefson, Director, FDA Europe Office 

The European Union will be represented as follows: 

European Commission (EC) 

Andrzej Rye, Public Health Director, Directorate General Health and Consumers 

Martinue Nagtzaam, Policy Officer, Directorate General Health and Consumers 

Anna Lonnroth Sjoden, Deputy Head of Unit, Directorate General Research, Health-Infectious 

Diseases 

European Centre for Disease Prevention and Control (ECDC) 

Dominique Monnet, Senior Expert and Programme Coordinator, Scientific Advice Unit 

European Medicines Agency (EMEA) 

David Mackay, Head of Unit, Veterinary Medicines and Product Data Management 

European Food Safety Authority (EFSA) 

Marta Hugas, Scientific Coordinator, Head of Unit, Biological Hazard 

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Council of the European Union will be represented by the TRIO Presidency: Spain Belgium 

and Hungary 

Jose Campos, Head of Unit, Antibiotic Laboratory, lnstituto de Salud Carlos III 

Nathalie Denecker, Clinical Assessor, Federal Agency for Medicines and Health Products 

Karolina Borocz, Head of Department, National Centre for Epidemiology 

Q3. In the STAAR Act, I have suggested a holistic approach to the problem of antibiotic 

resistance and establish a network of experts across the country to conduct regional 

monitoring of resistant organisms as they occur-which would be like a real time snapshot 

to pick up on problems early. Would you agree that there is importance in augmenting 

CDC's current surveillance system with some sort of expert surveillance network system? 

A: CDC thinks it is important that legislative provisions enhance and complement CDC's 

existing surveillance systems, research and prevention efforts in order to avoid duplication of 

efforts. Surveillance is part of CDC's core mission and CDC agrees surveillance of resistant 

organisms is important. CDC's current surveillance system for antimicrobial resistance, the 

Emerging Infections Program (EIP), is a network of 10 state health departments working with 

collaborators in laboratories, healthcare facilities, and academic institutions to conduct 

population-based surveillance. Through this surveillance system, CDC provides national 

estimates of disease burden and tracks changes in disease burden over time for both resistant 

community-associated and healthcare-associated bacterial infections. 

CDC also has other surveillance networks for bacterial resistance because surveillance strategies, 

goals and objectives vary for different problems: the National Healthcare Safety Network 

(NHSN) and the National Antimicrobial Resistance Monitoring System (NARMS). These 

surveillance systems complement EIP and are used to assess and monitor the scope, magnitude 

and trends ofthe antibiotic resistance problems and also to drive and direct prevention efforts, 

determine treatment recommendations, guide new drug development, and evaluate the 

effectiveness of prevention programs. 

The National Healthcare Surveillance Network (NHSN) is a web-based surveillance tool for 

hospitals and state health departments to monitor healthcare-associated infection (HAl) rates, 

such as those caused by MRSA, Clostridium difficiTe, and multi-drug resistant gram-negative 

bacteria. Approximately half of U.S. hospitals (over 2,500) are currently enrolled in NHSN. 

The National Antimicrobial Resistance Monitoring System (NARMS) is a lab-based surveillance 

system between CDC, the Food and Drug Administration (FDA), the U.S. Department of 

Agriculture (USDA), and all 50 states. NARMS is used to detect resistance in enteric bacteria 

that are commonly transmitted from animals to humans through food, such as Sa1monella, 

Campy1obacter, and E. co1i and monitors trends in the prevalence of resistance among bacteria 

isolated from humans, retail meats, and livestock. 

CDC is taking steps to connect these systems including developing and launching networks of 

acute care facilities reporting HAl data through NHSN within the EIP, building an infrastructure 

to link pathogen-based evaluation, developing innovative surveillance methodologies, and 

translating surveillance data between population-based and hospital-based systems. 

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Q4. In your written testimony (p. 7) you reference that the VA reduced their rate of MRSA 

infections by 60% in part by implementing universal screening of all ICU and high-risk 

patients for MRSA (VA MRSA Initiative 2007). As part of the recommended test methods 

to identify patients colonized with resistant bacteria to prevent transmission, would CDC 

consider studying the effectiveness of rapid pre-surgical screening? 

A. The subject of pre-surgical screening has been studied in the past and a recently published, 

well-conducted trial suggested that this may be an effective approach in select settings and for 

select surgical procedures (Bode LGM, Kluytmans JAJW, Wertheim HFL, et al. Preventing 

surgical site infections in nasal carriers of Staphylococcus aureus. New EnglandJournal of 

Medicine 2010;362:9-17). CDC agrees that prevention research is needed to define the optimal 

strategy for using rapid pre-surgical screening, and we have much to offer in making sure such 

research is aligned with public health goals. CDC is currently providing technical assistance for 

a national survey of infectious disease physicians to assess the prevalence of pre-surgical S. 

aurells screening in the US. 

CDC guidelines recommend that hospitals tailor their MRSA prevention strategies to their 

individual institution. CDC recommends that hospitals consider active surveillance as part of a 

comprehensive strategy to reduce MRSA infections if initial measures are not effective in 

reducing MRSA infections. CDC guidelines point out that the current science shows that active 

surveillance for MRSA might have an impact in reducing MRSA infections but only as part of a 

comprehensive strategy. What matters are the steps a hospital takes after it has identified 

colonized or infected patients and what subsequent prevention measure it uses. CDC guidelines 

recommend that hospitals achieve a reduction in MRSA using a comprehensive approach to 

prevention. For hospitals not showing a reduction using CDC's initial or first tier 

recommendations, CDC directs them to add additional measures, including screening of high risk 

patients for MRSA colonization, until success is demonstrated. 

Q5. As you may know, The Infectious Diseases Society of America (lDSA) has urged the 

Administration and Congress to adopt the goal of developing 10 new antibiotics by 2020. 

Obviously, this is a large undertaking considering how few novel antibiotics there are 

currently in the pipeline. Has the Administration reviewed IDSA's 10 x '20 Initiative? 

What policies do you think this Committee should take into consideration to spur antibiotic 

development - especially for gram negative bacteria which has little, if anything in the 

pipeline? 

[Please note that the response to this question was prepared by the National Institutes of Health, 

in response to the same question. We defer to NIH's expertise on this particular issue.] 

The National Institute of Allergy and Infectious Diseases (NIAID), the lead component of the 

National Institutes of Health (NIH) for research on infectious diseases, is aware of the IDSA's 

initiative and supports its intent of bringing attention to the need for new antibiotic drug 

development. While there may be a number of policies that may provide incentives for the 

pharmaceutical and biotechnology industries to further engage in antibiotic drug development, 

the key to spurring antibiotic drug development is continued support of the drug development 

pipeline from the earliest stages through advanced development. NIAID recognizes the need to 

develop new antibiotic drugs and has a longstanding commitment to facilitate such development. 

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NIAID plays a critical role in the federal government's comprehensive efforts to combat the 

problem of antimicrobial resistance, with a particular emphasis on the issue of drug 

development. NIAID conducts and supports basic research to identify new antimicrobial targets 

and translational research to apply this information to the development of therapeutics; to 

advance the development of new and improved diagnostic tools for infections; and to create safe 

and effective vaccines to control infectious diseases and thereby limit the need for antimicrobial 

drugs. NIAID supports research and development of diverse products through a variety of 

mechanisms, including grants and contracts to academic laboratories, non-profit organizations, 

and small and large companies. Research and development of novel agents with activity against 

Gram-negative pathogens is being supported via all of these mechanisms. 

Since 2002, NIAID has supported translational research efforts through its Challenge 

GrantlPartnerships Program, which was created to stimulate collaborative efforts and 

multidisciplinary approaches to rapidly advance promising candidate products for infectious 

diseases through the product development pathway. This program has uniquely fostered many 

new research collaborations between experts from different disciplines of academia and industry 

and has significantly accelerated the development of numerous new or improved 

countermeasures against many pathogens and toxins. Each year, the initiative targets different 

pathogens based on scientific needs and priorities, and selected Gram-negative pathogens have 

frequently been the focus of this program. Drug-resistant Gram-negative pathogens of concern 

were specitically targeted in the 2009 initiative. 

To complement these collaborative research efforts, NIAID provides a broad array of pre-clinical 

and clinical research resources and services to researchers in academia and industry designed to 

facilitate the movement of a product from bench to bedside. By providing these critical services 

to the research community, NIALD can help to bridge gaps in the product development pipeline 

and lower the financial risks incurred by industry to develop novel antimicrobials. Importantly, 

development activities for several therapeutics with activity against Gram-negative bacteria are 

being carried out through these mechanisms. 

Through an initiative initially introduced in 2007, NfAID has made a sustained effort to support 

clinical trials aimed at prolonging the effectiveness of currently available antibacterial drugs. 

The contracts awarded under this initiative support studies designed to help answer key questions 

about proper antimicrobial dose, treatment duration and whether antimicrobial treatment is 

necessary in all cases. The contracts provide for the design and conduct of Phase III and/or 

Phase IV clinical trials to test different therapeutic approaches and regimens that will reduce 

overexposure to antimicrobial drugs, thereby decreasing the likelihood of antimicrobial drug 

resistance and preserving the effectiveness of existing antimicrobials. For example, one of these 

clinical trials is focused on evaluating the optimal duration of therapy for urinary tract infections 

in children. Since urinary tract infections are caused primarily by Gram-negative organisms, the 

potential to decrease antibiotic use in this area would help to alleviate the selective pressure that 

drives the development of resistance in Gram-negative bacteria. This initiative will continue 

with new trials this year aimed at pneumonia, Gram-negative hacteremia, acute otitis media and 

pulmonary tuberculosis. 

In late July, NIAID will co-sponsor, along with IDSA and FDA, a public workshop on antibiotic 

resistance. Topics for discussion will include an overview of the scale of the current bacterial 

resistance problem; the current understanding of the science and mechanisms of bacterial 

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resistance; the use of rapid diagnostics in diagnosis and management of bacterial infections; and 

the science of antibacterial drug development. 

Representative Marsha Blackburn 

Ql. On November 3rd of last year, President Obama, along with our European partners, 

announced the creation of a Transatlantic Task Force on Antibiotic Resistance [to 

streugthen the antibiotic pipeline, develop interventions to address resistant infections in 

hospitals and communities, and find opportunities to eliminate inappropriate uses in 

human and veterinary medicine]. Obviously, it takes time to set up such an entity, but now 

6 months later, there has been no word from the Administration on how this group is going 

to operate, what its charge will be, and whether it will inclnde non-government experts. 

Can you give us the status of this international group? Also, can you please provide the 

Committee with the list of participants, both domestic aud international? 

A. The Transatlantic Task Force on Antibiotic Resistance (Task Force) EU-US planning group 

has had a series of video conferences and a kickoff meeting of the Task Force is scheduled for 

June 2010. The Task Force will develop an action plan focused on the areas defined by the 2009 

EU-US Summit declaration: 

• Developing appropriate therapeutic use of antimicrobial drugs in the medical and 

veterinary communities 

• Preventing both healthcare- and community-associated drug-resistant infections 

• Developing strategies to improve the pipeline of new antimicrobial drugs 

The Task Force is composed of experts and officials from the European Union and the United 

States. The United States is represented by the following individuals and agencies of the 

Department of Health and Human Services: 

US Department of Health and Human Services (HHS)' Office of the Secretary 

Nils Daulaire, Director, Office of Global Health Affairs 

Mary Lisa Madell, Director, Europe and Eurasia, Office of Global Health Affairs 

Centers for Disease Control and Prevention (CDC) 

Denise Cardo, Director, Division of Health care Quality Promotion, National Center for 

Emerging and Zoonotic Infectious Diseases (proposed) 

J. Todd Weber, CDC Liaison to the European Centre for Disease Prevention and Control, 

National Center for Immunization and Respiratory Diseases 

Jean Patel, Deputy Director, Office of Antimicrobial Resistance 

National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health 

Dennis Dixon, Chief, Bacteriology and Mycology Branch, Division of Microbiology and 

Infectious Disease 

Jane Knisely, Scientific Program Analyst, Bacteriology and Mycology Branch, Division of 

Microbiology and Infectious Disease 

Food and Drug Administration 

Edward Cox, Director, Office of Antimicrobial Products, CDER Drug Shortage Coordinator 

Linda Tollefson, Director, FDA Europe Office 

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The European Union will be represented as follows: 

European Commission (EC) 

Andrzej Rye, Public Health Director, Directorate General Health and Consumers 

Martinue Nagtzaam, Policy Officer, Directorate General Health and Consumers 

Anna Lonnroth Sjoden, Deputy Head of Unit, Directorate General Research, Health-Infectious 

Diseases 

European Centre for Disease Prevention and Control (ECDC) 

Dominique Monnet, Senior Expert and Programme Coordinator, Scientific Advice Unit 

European Medicines Agency (EMEA) 

David Mackay, Head of Unit, Veterinary Medicines and Product Data Management 

European Food Safety Authority (EFSA) 

Marta Hugas, Scientific Coordinator, Head of Unit, Biological Hazard 

Council of the European Union will be represented by the TRIO Presidency: Spain, Belgium, 

and Hungary 

Jose Campos, Head of Unit, Antibiotic Laboratory, Instituto de Salud Carlos III 

Nathalie Denecker, Clinical Assessor, Federal Agency for Medicines and Health Products 

Karolina Borocz, Head of Department, National Centre for Epidemiology 

Q2. In its Fiscal Yea,' 2011 Congressional Justification, CDC calls antimicrobial resistance 

"one of the world's most pressing public health problems." However, within the 

Preparedness, Detection, and Control of Infectious Diseases program's proposed budget, 

CDC's already severely strapped Antimicrobial Resistance budget would be cut 

dramatically by $8.6 million-just over 50 percent! The FY2011 budget would allow only 

20 stateilocal health departments and health care systems to be funded for surveillance, 

prevention, and control of antimicrobial resistance, down from 48 this past year. Can you 

tell us which states will no longer receive funding under the Antimicrobial Resistance 

program at CDC? 

A. The FY2011 budget request would allow 20 stateilocal health departments and health care 

systems to be funded for surveillance, prevention, and control of antimicrobial resistance. It is 

not possible at this time to determine which states would receive funding. Its possible that more 

state and local health departments could be funded through the $ 19 .6 million increase in the 

emerging infections program. 

Q3. Additionally, in the budget justification, CDC states that the num ber of states to 

receive funds under the Get Smart in the Community program will go from 12 to zero. Can 

you give us the rationale for your decision to cut back so drastically on this important 

program given the dire health implications of antimicrobial resistance? 

A.. The program has contributed to a 25 percent reduction in antimicrobial use per outpatient 

visit for presumed viral infections. In addition, more than 959 campaign partners and 166 

funded state-based programs collaborate with the Get Smart campaign. Given competing 

priorities, CDC is looking for ways to efficiently use funding and make difficult decisions based 

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on available funds. Activities will continue on a prioritized basis, as funding exists through the 

Emerging Infections program. 

Q4. For the past 18 months or more, there has been no full-time director for the 

Antimicrobial Resistance program, since the departure of the most recent permanent 

director. What is the status of appointing a new director to oversee the Antimicrobial 

Resistance programs at CDC? 

A. CDC's Director of the Office of Antimicrobial Resistance (OAR) retired in April 2010. An 

acting director has been appointed and will remain in place until CDC hires a new permanent 

director. CDC is conducting a national search for an individual who is a recognized leader in 

the field of infectious diseases and antimicrobial resistance. 

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STATEMENT FOR THE RECORD 

Subcommittee on Health. Committee on Energy & Cummcn::c 

United States House ofRe-presentatives 

Fur the Hearing On AnUblotic Resistance And The Use or Antibiotics In Animal 

Agriculture 

July 14, 2010 

RE: H,R, 1549/S. 619, The Preservation of Medical Treatment Act 

The San Francisco Medical Sodety is in full support for H,R. 1549, the:': 

"Preserviltion of Antihiotics for Medical Tr1'3tment Act" (PAMTA- H.R. 1549/5. 

619). 

As a 140-year old organization of over 1,000 physicians in practice and .f€search, we 

have been following and advocating for more rational and healthy practice and policy 

OIl this topic for a deca.de, The California Medical Association and American Medical 

Association both adopteu our polk")' resolutinn urging curtailment of the nOHtherapeutic use of antibiotics in agriculture, and scientlfic research conducted since that 

time has made it increasingly clear that the polici(;'s embodied by PAMTA are urgently 

needed. 

Medical ex.pert.~ across the globe increasingly agree that the growth of drug resistant 

bacterial infections is a looming public ~ealth crisis and acknowledge that the wide 

scale use or antibiotics in food animal productIon is a significant (ontributor to the 

problem. 

By reducing the use of antibioti(s where they are belng applied most inappropriately 

and In the greatest numbers, PAMTA would represent a crucial step fbrward in the fight 

against antimicrobial resistance. We urge Congress to swifUypass this legislation tel 

ensure the health of our citizens. 

Sincerely, 

Michael Rokeach, MD 

President 

Steve Heilig, MPH 

Director 

San Francisco Medical Society 

1003A O'Reilly Avenue 

San Francisco, CA 94129 

(415)561-0050x270 

http'! /WVlW.Srm~.{lU!. 
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Physicians for Social Responsibility-Los Angeles 

Board of 

Directon 

Itartt:}' G1m.ls, 

Pnn\6€'~t 

JIl"",yflara, I'D 

'ilee Pr€,~HI~"! of 

"lerl1\>llrslllP 

I(cnLevy. 

Rirnan.! Sal<rm, Mi}, 

(merlt!,s 

Sollcnd€"l'!D, 

'i1qrleytlagldson, 

Ementll 

CongrellSfllatllknry Waxman 

2204 Raybum lIou~e UffiC0 Building 

Washinglon. D.C. 205 i5 

Td('phollc L:!{i2) 225<\97(> Fax t2(2) 225~4049 

On behalf of the uver 4,OOG physicians: nnd h~lIlth professionals of tile l~by5icians f(lr Social ResponsibililyLos Angeles (PSR~LA). I am writing tI'l C'''rr~ss support for H.R, 1549, the "'Preservation (If Antibioli-cs fot 

Meukal Tre~lt1llcnl Act" (PAMTA~ H-K 1549!S. 619). Antibiotics lirc one oflhe most usdul amI imp()rlan! 

medical udnmces in r,,"Cenl hislory. Their eftecliv(!'(]CRS. ho\vever. is being compromised by I.lacteriu! 

r('~is!allC~, arising in part from c~cessivc use ofunlibiotles in animal agrkullurc. 

Up to 7() percenl of!lll<llllibiotic& sold in lh~ \,!.S. ara used on indu:'itrial farms in healthy rood ltnimats. 

accor.ding to Th~ Union of COliC em cd Scientists. This mnkCh the United States one ofdlC biggest users or 

antibiotics in food ;mimat prudut:tto!l on a pound per pound bUllis. Many of the antibiolil;;:$ used m food 

!1;tl, animal pmduclion are identical or from the 5111n..: fml'li!y liS drugs ll~cd in human medicinl' to cur" serious 

diseuse. Whik bacteria a.rc killed through 11K proper usc of andbi,lllc!'t, improper liSt:' on thc (ann allows. 

bactt'ria to become res..istant. Rcsist::\nt germs are le!1to gruw anJ multiply, promoting the development of 

antibiotic-resistant bacteria {hat can spread to hUUltlll$. Resblnnt bacteria! infections are !J:lfder 10 treat, 

rC4uin~ Jon}!er tlOspital stays and possibly other interycntiOll';'" generatc Sl6.6 billion to S2r'i billion per ye,1r in 

('Xliii. co;;15 to Ihe United Stutes health e~re system, and Icad to over 90,000 dertlhs peryellr nationwide. 

Congress has befon.· it [1 common sensc solutilln that would address the gmwing humm1 ht"Olltl tn-reat pos~d 

hy antibiotic resistance. lfpas:.cd into lnw, l'AMTA wonk! withdnnv St:'VCll classes of;lt1tibiotics vit<lUy 

!!nportanllO human health from routine u.~e in food animal pmJuctioll unless Ililimais or herds arc sick with 

diseasi:' or unlcS$ drug co.)!TlflWlics can prove thai their usc uocs not l13nn human health. 

PAMTA is suppork~d by Nlr n~ti()nlll organization, Physjcian,~ for Sodal Rcspo.n:;.ibility (PSR), and by 

k~l(li!lg ml,.'Clkal organizations including the American Medical Association, tbe Anwricllll Iltlblic Health 

Association, the fnfcctiotls Diseases Sociel)' (If America, the World HC<lhh Organizatio(l, ami the American 

AcadelUy of Pediatrics. The Food lind Drug Administration recently recolllllu:udeJ lhat the u~c llfmcdical!y 

impmtaill tl(tmau anli\lioilcs in food l!nimlll produCtion ~ShollJu be limitt:d to those u.<;cs that arc eonl-iucrcd 

neccssllry for Msuring anilllllJ health." While this is ~iq~ in tht.' right din.'Ction, It is ckar that It:'gislathc ac1ion 

will be nec~'),l>ary iflhisurgcut public health threat is 10 be addressed. 

!\\lvlTA would repr.:s~nt:l crucial Shop rom ani in 11lc fight ag,ainst;)ntimicrobia! r~istnncc by redudllg the 

Ul>C ofamibiotics where they being applied mt~st inappropriately and in the greatest number;,. On b(.'h1l1fof 

PSR-LA, J urge Congress to swi1Uy pass this legislatilHl tll ensure the health of our citi.lens. 

Sillcerely, 

Martha Dina Arguello 

Ex~cutive Director, 

Physicians for Soda! Rcsponsibilily-Los Angeles 
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Without Harm 

the campaign for 

environmentally responSible 

health care 

The Honorable Henry A. Waxman 

Chairman 

Committee on Energy and Commerce 

U.s. House of Representatives 

2125 Rayburn House Office Building 

Washington, DC 20515 

July 12, 2010 

Dear Representative Waxman: 

CAMPAIGN HEADQUARTERS 

12355 SUNRISE VALLEY DRIVE 

SUiTE 680 

RESTON, VA 20191 

T. 703.860 9790 

F: 703.860 9795 

EMAIL·INFO@HCWH.ORG 

VVII'IW.NOHARM ORG 

Health Care Without Harm is pleased to submit the attached documents for the Record on the hearing 

"Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture" of the House Committee on 

Energy and Commerce Health Subcommittee, July 13, 2010. We will submit through Representative 

Schakowsky. 

Since the introduction of the "Preservation of Antibiotics for Medical Treatment Act," HCWH has 

gathered information from the health care sector in support of the legislation. We are submitting more 

than 1000 names of physicians and other health care practitioners who have written to support 

legislation that would reduce or prohibit the non-therapeutic use of antibiotics in food animals. We are 

also submitting a list of more than 70 hospitals that have indicated their support for such legislation by 

Signing a petition. 

In addition, more than 300 hospitals have signed the Health Care Without Harm Healthy Food in Health 

Care Pledge, which, among other commitments, seeks to purchase foods produced without the use of 

non-therapeutic antibiotics for the hospital food service, for patients and staff. 

We believe that legislation is necessary to preserve the effectiveness of our existing antibiotics. 

Antibiotic resistant bacterial infections are a serious concern for individuals, communities and our health 

care delivery system. Patients suffer longer illnesses and pay higher medical costs, and health 

practitioners are left with little means to protect their patients or themselves from bacterial infection. 

The Centers for Disease Control and Prevention estimates that 60,000 Americans die annually from 

resistant infections. The American College of Physicians estimates that $30 billion is spent on the 

cumulative effects of antimicrobial resistance each year (including multiple drug regimens, extra 

hospital days, additional medical care and lost productivity). 

Despite the rising rates and immense medical costs of antibiotic resistance, antibiotics and related drugs 

are routinely added to the feed of livestock and poultry not to treat diagnosed disease, but to promote 

faster growth and compensate for unsanitary living conditions. In 2003, the U.S. Institute of Medicine/ 

National Academy of Science stated that "substantial efforts must be made to decrease inappropriate 
260 


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overuse [of antibiotics] in animals and agriculture" and that decreasing "antimicrobial use in human 

medicine alone will have little effect on the current [antibiotic-resistant] situation." 

Health Care Without Harm is an international coalition of more than 430 organizations in 52 countries, 

working to transform the health care industry worldwide, without compromising patient safety or care, 

so that it is ecologically sustainable and no longer a source of harm to public health and the 

environment. For more information on HCWH, see www.noharm.org. 

Thank you for the opportunity to submit these documents for the record. 

Sincerely, 

Jamie Harvie 

Chair, Healthy Food Initiative 

HCWH 

Cc: The Honorable Janice D. Schakowsky 
261 


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Without Harm 

July 12,2010 

the compoign for 

environmentolly re$ponsible 

heal1h core 

Dear Senator or Representative: 

On behalf of Health Care Without Harm and the undersigned hospitals and health systems, we urge you 

to support the Preservation of Antibiotics for Medical Treatment Act (S. 6191H.R. 1549). This 

legislation is necessary to keep our precious antibiotics working for people when they are faced with 

potentially life-threatening illnesses. In addition to the hospitals and health systems listed below. 

PAMTA is supported by a growing number of medical and public health organizations including the 

American Medical Association, American Nurses Association, American Public Health Association, and 

the American Academy of Pediatrics. 

Antibiotics were one of the greatest medical innovations of the last century. But today, physicians are 

seeing more and more patients with more expensive, more threatening infections that are resistant to 

mUltiple antibiotics. The Centers for Disease control estimates that 60,000 Americans die annually from 

resistant infections. The American College of Physicians estimates that $30 billion is spent on the 

cumulative effects of antimicrobial resistance cach year (including multiple drug regimens, extra 

hospital days, additional medical care and lost productivity). 

The Institute of MedicinefNational Academy of Science has stated that, "Clearly, a decrease in 

antimicrobial use in human medicine alone will have little effect on the current [antibiotic-resistant] 

situation. Substantial efforts must be made to decrease inappropriate overuse in animals and agriculture 

as well." Nevertheless, medically important antibiotics and related drugs continue to be routinely added 

to the feed of livestock and poultry that are not sick, to promote faster growth and compensate for 

unsanitary living conditions. This unnecessary overuse of antibiotics promotes the development of 

resistance and as well, undercuts their effectiveness for treatment of sick animals. 

The Preservation of Antibiotics for Medical Treatment Act "'ill protect public health by requiring 

automatic phase out of the use of seven classes of antibiotics designated as "critically important" or 

"highly important" in human medicine as agricultural feed additives unless FDA concludes within two 

years that their use does not contribute to antibiotic resistance affecting humans. Passage of this bill 

would be an important step in addressing the very real threat of antibiotic resistance and preserving the 

effectiveness of existing antibiotics for treatment of both human and animal diseases. 

We urge you to support the Preservation of Antibiotics for Medical Treatment Act and undertake 

all measures necessary to ensure its ultimate enactment. 
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Sincerely, 

Health Care Without Harm 

Fletcher Allen Health Care, VT 

Porter Medical Center, VT 

Fairview Hospital, MA 

Covenant Health Systems, New England (14 facilities) 

Regis Care Center, NY 

Swedish Covenant. IL 

St Luke's, MN 

Sacred Heart Hospital, Vv1 

Mercy Medical Center, Baltimore, MD 

Oregon Health and Science University, OR 

Catholic Healthcare West, AZ, NV, CA (40 facilities) 

Sl. Joseph Health System - Sonoma County, CA (7 facilities) 
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Dear Senator or Representative: 

CAMPAIGN HEADQUARTERS 

, 2355 SUNRISE VALLEY DRIVE 

SUITE 680 

RESTON, VA 20191 

T. 703 860.9790 

F" 703 860.9795 

EMA1L"INFO@HCWH ORG 

\IIMf\IV.NOHARM ORG 

We, the undersigned nurses, doctors, dietitians and other health practitioners are writing to urge you to 

support the Preservation of Antibiotics for Medical Treatment Act (S. 619/H. R. 1549). We believe that this 

legislation is necessary to preserve the effectiveness of our existing antibiotics. 

Antibiotic resistant bacterial infections are a serious concern for individuals, communities and our health 

care delivery system. Patients suffer longer illnesses and pay higher medical costs, and health 

practitioners are left with little means to protect their patients or themselves from bacterial infection. The 

Centers for Disease Control and Prevention estimates that 60,000 Americans die annually from resistant 

infections. The American College of Physicians estimates that $30 billion is spent on the cumulative 

effects of antimicrobial resistance each year (including multiple drug regimens, extra hospital days, 

additional medical care and lost productivity). 

Despite the rising rates and immense medical costs of antibiotic resistance, antibiotics and related drugs 

are routinely added to the feed of livestock and poultry not to treat diagnosed disease, but to promote 

faster growth and compensate for unsanitary living conditions. In 2003, the U.S. Institute of Medicinel 

National Academy of Science stated that "substantial efforts must be made to decrease inappropriate 

overuse [of antibiotics] in animals and agriculture" and that decreasing "antimicrobial use in human 

medicine alone will have little effect on the current [antibiotic-resistant] situation." Delaying action only 

exacerbates the problem. 

As individuals, we join with the American Medical Association, the American Academy of Pediatrics, the 

American Nurses Association and many other public health organizations. Please support the 

Preservation of Antibiotics for Medical Treatment Act and undertake all measures necessary to ensure its 

ultimate enactment. 

Sincerely, 
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Health Care Without Petitio" Signers to Date (1098 total) luly 12, 2010 

ALABAMA 

Paula Gasser, RN; Birmingham, AL 

Elisa Mejia, RN BSN/BA Infection Preventionist; 

Birmingham, AL 

Mary Pate, RN, DSN; Birmingham, AL 

Mariann Schmitz, MPH, (IC; Birmingham, AL 

Arlene Morris, RN, MSN, EdD, CNE; 

Montgomery, AL 

charlene roberson, RN; montgomery, AL 

Thomas Hodges, CHMM; Opelika, AL 

Helen Wilson, RN, MSN; Wetumpka, AL 

ARIZONA 

Diane Gold, RN, MSN, CSN; Clarkdale, AZ 

Gary Spivey, MD; Douglas, AZ 

Sara Gibson, MD; Flagstaff, AZ 

April Laliberte, ; Flagstaff, AZ 

Chandy Leverance, ; Globe, AZ 

Donna Farney, RD, MS; Goodyear, AZ 

Michelle Dorsey, MD; Mesa, AZ 

Carl Nichols, CDM CFPP; Peoria, AZ 

Julie Spelman, RD MBAi peoria, AZ 

Caleb laieski, i Phoenix, AZ 

Karen Peterson,; Phoenix, AZ 

Christopher Jentoft, MD; Scottsdale, AZ 

Carolyn Maxon,; Scottsdale, AZ 

Bonnie Roil!, RD, MA; Scottsdale, AZ 

marlene bluestein, md; tucson, AZ 

Klara Dannar, RN; Tucson, AZ 

Raymond Graap, M.D.; Tucson, AZ 

Schuyler Hilts, MD, FACP, FACNP; Tucson, AZ 

Janet Hughes, RN; Tucson, AZ 

Sharon MCDonough-Means, MD; Tucson, AZ 

Fayana Richards, ; Tucson, AZ 

Eve Shapiro, MD; tucson, AZ 

Linda Taylor, ; Tucson, AZ 

Barbara Warren, MD, MPH; Tucson, AZ 

CALIFORNIA 

Joyce Lashof, MD,FACPM; Alameda, CA 

george chang, DO; arcadia, CA 

ena valikov, dvm; bellflower, CA 

Joel Kreisberg, DC; Berekely, CA 

David Dresser,; Berkeley, CA 

Todd Jailer,; Berkeley, CA 

Hercules Morphopoulos, DDS; Berkeley, CA 

Sanghyuk Shin, MSc; Carlsbad, CA 

Bruce Burdick, MD; Carmichael, CA 

Lucinda Crawford, ; Chino Hills, CA 

Carla Jackson, MPH; Claremont, CA 

Virginia & William Corzine,; Cloverdale, CA 

alison negrin, ; concord, CA 

Robert Grisnak, RN; Daly City, CA 

Terrie Kurrasch, MPH, FACHE; Emeryville, CA 

Karen Arnold, RD; Fairfax, CA 

Angel Lee,; Fremont, CA 

Mike Starry, MLS; Fresno, CA 

Arthur Smith, PhD; Garden Grove, CA 

Sanford Newmark, md; Half Moon Bay, CA 

Tesds Lusher, MD; Healdsburg, CA 

Lorraine Moriarity, RN; Hemet, CA 

Robert Rosenberg, DDS, DScD; Kentfield, CA 

Pedro Sun, ; la mesa, CA 

Pejman Katiraei, DO; Lama Linda, CA 

Amy Blomquist,; Lama Mar, CA 

Robert Frcek, CPA; Los Angeles, CA 

Dawn Lee,; Los Angeles, CA 

Lenard Lesser, MD; Los Angeles, CA 

Bruce Hyman, MD; los gatos, CA 

Steven Freedman, MD; Martinez, CA 

Oscar Firschein,; Menlo Park, CA 

David Chittenden, ; Mill Valley, CA 

stephen pardys, MD; mill valley, CA 

JESSIE MULLEN, NONE; MONTEREY, CA 

Kathi Randall, RN, MSN, Neonatal CNS &NP- BC; 

moreno valley, CA 

Jerry Abajian, MD; Napa, CA 

Kathleen Young, ; Northridge, CA 

scan AMUNDSON,; OAKLAND, CA 

Emily Cronbach, MD; Oakland, CA 

Arthur D'Harlingue, MD; Oakland, CA 

J. Huston, CEC, CDM, CFPP; Oakland, CA 

Jennifer Jackson, MA; Oakland, CA 

Jeffrey Johns, MD; Oakland, CA 

Eleanor Luce, MD; Oakland, CA 

laurence Platt, MD, MPH; Oakland, CA 

Charles Rath, MD; Oakland, CA 

Kimi Schell,; Oakland, CA 

Kathryn Williams, MD; Orinda, CA 

David Campen, MD; Palo Alto, CA 

Ivan Gend,el, MD; Palo Alto, CA 

John Mark, MD; Palo Alto, CA 

Daniel Asimus MD, MD; Pasadena, CA 

Mary Henriques, MPH; Pasadena, CA 

John Tsai, MD; Pomona, CA 

marianne gerson, MD; portola Valley, CA 

Jack Kabak, MD; Portola Valley, CA 

Judith Murphy, MD; Portola Valley, CA 

Anthony DeRiggi, MD; Sacramento, CA 

Alan Moritz, MD; Sacramento, CA 

Harry Wang, MD; Sacramento, CA 

Lee Lipsenthal, MD; San Anselmo, CA 

Jerri Smith, RDCS; San Bernardino, CA 

Thomas Newman, MO, MPH; San Carlos, CA 
265 


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Health Care Without Harm Petition Signers to Date !1 098 total) July 12, 2010 

Anthony Earthen, ; San Diego, CA 

Caroline Frederick, MBA, MS; San Diego, CA 

Karmyn Garcia, LEED AP; San Diego, CA 

Michael Mae, ; San Diego, CA 

Dana Riccio, RD; San Diego, CA 

cathy wise,; san fran, CA 

Erin Amerson, MD; San Francisco, CA 

Helen Chang, MD; San Francisco, CA 

Karen Duderstadt, PhD, RN, CPNP; 

San Francisco, CA 

Robert Gould, MD; San FranciSCO, CA 

Lisa Hartmayer, B5, RN; San Francisco, CA 

Sarah Janssen, MD, PhD, MPH; San Francisco, CA 

Cathlin Milligan, MD; San Francisco, CA 

Zeljko Milovanovic:, MD; San Francisco, CA 

judith ostapik, ; san francisco, CA 

Kelly Pfeifer, MD; San Francisco, CA 

Joan Saxton, M.D.; San Francisco, CA 

Joseph Spaulding, MD; San Francisco, CA 

George P. Susens, MO, MD; San Francisco, CA 

Susan Vickers,; San Mateo, CA 

Lee FitzGerald, Registered Nurse; San Rafael, CA 

Douglas Gerstein, MD; San Rafael, CA 

joseph gutstadt, MD-Ret.; san rafael, CA 

Susan Clarke, RN; Santa Barbara, CA 

John La Puma, MD; Santa Barbara, CA 

Janet Lengsfelder, RN; Santa Barbara, CA 

Patricia Rupel, RN; Santa Clara, CA 

Deane Bussiere,; santa cruz, CA 

lisa segnitz, md; Santa Cruz, CA 

Stephanie Singer, RD; Santa Cruz, CA 

Sister Janet Corcoran, ; Santa Maria, CA 

Linda Hansen, COM; Santa Rosa, CA 

Marsha Nunley MD, MD; Sausalito, CA 

Laura Dick, PhD, RD; South Lake Tahoe, CA 

Trisha Reece, ; Studio City, CA 

Gerri French, RD; Summerland, CA 

Evelyn C Lundstrom, ; Sunnyvale" CA 

Alicia Bright, CNS, RN; Tiburon, CA 

Andy Coren, MD; Ukiah, CA 

Andrea McCullough, MD; Ukiah, CA 

Marilyn Klakovich, RN; Upland, CA 

Susan Zabo, ; Valencia, CA 

Ronald Bieselin, MD; Vallejo, CA 

Sandra Rigney,; Walnut Creek, CA 

Martin Bronk,; Woodside, CA 

COLORADO 

JEANNE REISIG, MA; Aurora, CO 

Michael Vasil, Ph.D.; Aurora, CO 

Sarit Schneider, CNM; Boulder, CO 

Richard Steinberg, MD; Boulder, CO 

David Howard, ; colorado springs, CO 

Carolyn Coker Ross, MD, MPH, MD, MPH; 

Denver, CO 

Roberta M Richardson, MD; Evergreen, CO 

Lisa Henbest, RN; Highlands Ranch, CO 

Kristi Ennis,; Lafayette, CO 

Francis Babineau, PE; Littleton, CO 

MICHELLE HOSACK, RD; Rifle, CO 

CONNECTICUT 

Constance Byam, RN; Andover, (T 

Bethany Hricu, RD; Avon, CT 

Evelyn Angry-Smith, ; Bloomfield, CT 

Ana Chambers,; Canton, CT 

Sharon Riccardi, ; East Hartford, CT 

lorraine barker, ; goshen, CT 

Mary Cobb, RN; Guilford, CT 

Susan Pinkham, RD; Hartford, CT 

Natalia Piende!, ; Manchester, CT 

william whitehead, ; new canaan, CT 

Mary Cranley, RN/NP; Oakland, CT 

Nick DeDominicis, ; Old Saybrook, CT 

Lisa Burch, LCSW; South Windsor, CT 

Maureen Clinton, NCCMHC; Tolland, CT 

kathleen McLaughlin, ; Tolland, CT 

Gabrielle Riola, RD; Tolland, CT 

Anne Gallagher,; washington depot, CT 

Shellie Jones, ; Willimantic, CT 

Heidi Krajewski,; Windsor Locks, CT 

kathy murphy, RN/MSN; Wolcott, CT 

DISTRICT OF COLUMBIA 

Matt Aleshire, ; Washington, DC 

Helen Hagerty, ; Washington, DC 

Elizabeth Ide, MA; Washington, DC 

Tamar Klaiman,; Washington, DC 

Marjorie McKnight, MD; Washington, DC 

Shannon Pryor, MDi Washington, DC 

DELAWARE 

Ann Darwicki, RN; Bear, DE 

Sarah Bucic, MSN, APRN-BC; Delaware City, DE 

Kelly Rossi, MS, RD; Frankford, DE 

Tish Gallagher, RN, PhD, CNE; New Castle, DE 

Joyce Linus, NCSN, RN; New Castle, DE 

Michelle Lauer, RN, MSN, BC; Wilmington, DE 

christine madden, Ph.D. (ABD); Wilmington, DE 

Catherine Maguire, RN, MSN; wilmington, DE 

Sheila Sharbaugh, RN; Wilmington, DE 

FLORIDA 

Adam LIPKIN, MD; ENGLEWOOD, FL 

Noelle Lipkin, ARNP; Englewood, FL 

Carol OBrien, RN MA CNAA; Fort Lauderdale, FL 

susan Milette, RN; Ft. Pierce, FL 
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Health Care Without Harm Petition Signers to Date (1098 total) luly 12, 2010 

Betty Finnk, RN, CIC; Hollywood, FL 

Brittany Marshall,; Lake Mary, FL 

susan luck, R N; Miami, FL 

HILDA WONG,; MIAMI, FL 

Thomas Perez, R.Ph.; Mims, FL 

linda miHllo wilson, rn,clc; pbg, FL 

Karen Boothe, RN; pembroke pines, FL 

connie sheri, RN; Pembroke Pines! FL 

Molly Dodge, MD; St.Petersburg, FL 

GEORGIA 

Emily Moore, MS, RD, LD; Albany, GA 

Hannah Jacskon, ; Athens, GA 

Tiffany Barrett,; Atlanta, GA 

Erin Bradley, ; Atlanta, GA 

Jessica Enders, RD/LD; Atla nta, GA 

jessica johnson, MS, RD, LD; atianta, GA 

Francoise Maillet, RD,LD;Atlanta,GA 

liz McGovern,; Atlanta, GA 

Lynne Ometer, RO; Atlanta, GA 

Jessica Principe, MS, RD, LD; Atlanta, GA 

Kip Slaughter, RD, LD; Atlanta, GA 

Patti Willard, citizen; Atlanta, GA 

Lisa Byrns, RN; Brunswick, GA 

Elizabeth Gilchrist, ; Decatur, GA 

GUAM 

Leonora Urbano, RN; Hagatna, GU 

HAWAII 

Kawika Liu, MD, PhD, JD; Honolulu, HI 

IOWA 

Cathy Chenard, RD; Coralville, IA 

patricia fuller, RN; Council Bluffs, IA 

Angie Tagtow, MS, RD, LD; Elkhart, IA 

Kristin Breitbach, BSN; Iowa City, IA 

Julia Buchkina, MD; Iowa City, IA 

Veronika Kolder, MO, MD; Iowa City, IA 

christine ziebold, MD PhD MPH; Iowa City, IA 

Colleen Clopton,; Jefferson, IA 

Diane Foster, ; Jefferson, IA 

Hayley Hegland, ; North Liberty, IA 

Maureen McCue, MD PhD; Oxford, IA 

John Rachow, PhD, MD; Oxford, IA 

IDAHO 

Robin E Pattillo, PhD, RN, CNL; Blackfoot, ID 

ILLINOIS 

Debra Bergander, ; Chicago, IL 

Martha Bergren, RN; Chicago, IL 

henry buehler,; chicago, IL 

Jose Cuevas, Advocate; Chicago, IL 

Danielle Dupuy, MPH; Chicago, IL 

Donna Nelson, MS, RD; Chicago, IL 

Danielle Thomas, MD candidate, class of 2013; 

Chicago, IL 

Matthew Turner,; Chicago, !L 

Steven Verzi, ; Chicago, fL 

Judith Gibbs, b.s.n.; Decatur, IL 

Cindy Ferguson, CHMM; downers grove, IL 

Rachel Greeley, LCSW; Evanston, IL 

Alvin Paden, Retired; Evanston, IL 

Lynnette Jones, RD; Glen Ellyn, IL 

Kay Butier, CDM, CFPP; Highland, IL 

Maureen Anger, RN; LAke forest, IL 

Amy Switzer, RN, MS, CPHO; Paris, IL 

Rebecca Crane, RN, MSN, CIC; Quincy, IL 

elizabeth holland, MD; river forest, IL 

Laura Wenger, RN; Schaumburg, IL 

Sue Schleyhahn, RN; Springfield, IL 

Mary Johnson, RN; Wheaton, IL 

Maria Schnaper, RN; Wilmette, IL 

Marta Keane, ; Yorkville, IL 

INDIANA 

Stephen Ashkin, ; Bloomington, IN 

Christine Carver, RD, CD; Bloomington, IN 

Joyce, ; Bloomington, IN 

SHARON RICKETIS WILLIAMS, Recycling Coor; 

Covington, IN 

Anne E Belcher,; Indianapolis, IN 

Alan Berry,; Indianapolis, IN 

Mary Lou Hulseman, MD; Indianapolis, IN 

Eugene Justus, DO; Indianapolis, IN 

Maria Madar, BS Health Education; 

Indianapolis, IN 

Charles Platz, MD; Indianapolis, IN 

Heather Woods, RRT; Indianapolis, IN 

arlene shannon, ; laGrange, IN 

CHERYL CORBIN, RN; LINTON, IN 

Joseph Vasta, ; South Bend, IN 

Fredric Salstrom, ; St. Mary of the Woods, IN 

Rhonda Blevins, MT(ASCP), Infection Preventionist; 

Waterloo, IN 

KANSAS 

AMI RUGHANI, Medical Student; Kansas City, KS 

Nicole Tichenor, ; Lawrence, KS 

Jill Pettis, ; Merria m, KS 

Jasmine Thompson,; Wichita, KS 

KENTUCKY 

Wanda Vanlandingham, ; Falmouth, KY 

James Roach, MD; Midway, KY 

LOUISIANA 

Alex Choi, ; New Orleans, LA 

Wendy Hounsel, ; New Orleans, LA 

Ann Hsieh, MD Candidate 2013; New Orleans, LA 

krisztian magyar,; new orleans, LA 
267 


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Health Care Without Harm Pcti tion Signers to Date (1 OWl tolal) July 12, 2010 

Peggy Verret, RN, MA, BC-NH; Slidell, LA 

MASSACHUSETTS 

Marianne Pappaceno, RD, LDN; Abington, MA 

Jennifer Taylor, ASCP; Acton, MA 

Jennifer Stinson, RD, LDN; Amesbury, MA 

samuel gladstone, md; amherst, MA 

Pamela Sierra, OTR; Andover, MA 

Cynthia Sauer, RN; Attleboro, MA 

Deborah Boudrow, RD LDN; boston, MA 

Kerri Hawkins, MS, RD, LDN; Boston, MA 

lynn Larsen, RD, LDN; Boston, MA 

Sean Palfrey, MD; Boston, MA 

julie rollins, MA; boston, MA 

Nicholas Sambuco,; Boston, MA 

Kate Speach, ; Boston, MA 

Julie Thayer, MPH; Boston, MA 

Katherine Villers, M.A.; Boston, MA 

James Warth,M.D., M.D.; Boston, MA 

lisa Ferreira, MS, RD, LDN; Brighton, MA 

Vanessa Kane, RD, LDN; Brighton, MA 

Emily McPhee, RD, LDN; Brighton, MA 

Margaret Scholl, ; Brockton, MA 

Colleen Caldwell, B.A; Brookline, MA 

Perrine Marcenac, ; Brookline, MA 

Lauren Oliver, Ms, RD, LDN; Brookline, MA 

Janel Ovrut, RD, LDN; Brookline, MA 

Tara Nelson, MS, RD, LDN; cambridge, MA 

Sara Valverde, ; Cambridge, MA 

Josefine Wendel, MS, RD, LON; Cambridge, MA 

Aaron Manders, RD; Cambridge MA, MA 

Kristen Pufahl, MS, RD, LDN; Charlestown, MA 

Deborah Woods,; Cheshire, MA 

mark richards, MSW, LlCSW; chester, MA 

Jonathan Ginzberg, Lic.Ac.; Cummington, MA 

lisa Harvey, MD; Cummington, MA 

Elizabeth Quinn, ; Dracut, MA 

Stephanie Freitas,; East Freetown, MA 

SHARON SOUZA, RN; FAIRHAVEN, MA 

Melissa Cabral, ; Fall River, MA 

regina brady, ; feeding hills, MA 

Louise Bendel, MS, RD, LDN; Framingham, MA 

alice Ng, RD; Framingham, MA 

Colleen Brannelly, RN; Franklin, MA 

Peter Antalek, CTS; Grafton, MA 

Stephanie Chalupka, EdD, RN, PHNCNS-BC, FAAOHN; 

Grafton, MA 

Jane Griffin, RDMEd,CDE; hingham, MA 

Barbara Casaceli, RD, LDN; Hudson, MA 

Bridget Lee, MD; Jamaica Plain, MA 

Bronwyn Williams, ; Jamaica Plain, MA 

Lydia Bonilla, LPN; Lawrence, MA 

Tony Leroka, LPN; Lawrence, MA 

David Ndungu, RN; Lawrence, MA 

Siobhan McNally, MD, MPH; Lenox, MA 

Bill Ravanesi, MA,MPH; Longmeadow, MA 

Sharon Berkley, LPN; Lowell, MA 

Misty Mahoney, LPN; Lowell, MA 

Linda Sullivan, RD, LDN; Lynn, MA 

Alisa Himelfarb, RD; Marlborough, MA 

Jessica Prohn, RD, LDN; Marlborough, MA 

Christine Rymsha, MS, RD, LDN.; Marlborough, MA 

Claudia Mills, RN; Mattapoisett, MA 

Jacquie Higgins, RD; Newburyport, MA 

Maria Morales, CNA; North Andover, MA 

Martha Nathan, MD; Northampton, MA 

Robert Rechtschaffen, MD; northampton, MA 

Kathleen Benjaminsen, RD, LDN.; Norton, MA 

Marcia Difronzo, RD, LDN; Peaboday, MA 

Henry Mack,; Pembroke, MA 

Roger Knysh, CDM, CFPP; Pittsfield, MA 

Richard Rosenfeld, M.D., MD; Pittsfield, MA 

gary shalan, md; pittsfield, MA 

Lisa VanDusen, MS, RD, LDN.; princeton, MA 

Rita Buhlraja, RD, LDN; Rehoboth, MA 

Ja mes Perry, ; Rockport, MA 

Erica Stevens, RD, LDN; Salemi MA 

Carole Vecchry, RD, LDN; Salem, MA 

christine gadbois, RNBC, BSN; seekonk, MA 

Suman Kohlin, RD, CNSD; Shrewsbury, MA 

Melanie Beach, RD; Somerville, MA 

Yosefa Ehrlich,; Somerville, MA 

Andrew Smith, MD; somerville, MA 

Sarah Trist, RD, LD; somverville, MA 

KUMARA SIDHARTHA, MD; SOUTH DENNIS, MA 

Christopher Blesso,; Southbridge, MA 

Susan Gilbert, ; Springfield, MA 

Hermine Levey Weston, RN; Springfield, MA 

Gabrielle Riola, RD; Springfield, MA 

Erik Deede, MD; Sudbury, MA 

Donna Jones, RD; Sudbury, MA 

Brian Weitze, ; Tewksbury, MA 

Stacia Clinton, RD; Townsend, MA 

Glenn Morash, CDM, CFPP; Townsend, MA 

Kathryn Butler, MEd, RD, LDN; Wakefield, MA 

Irene Sedlacko, RD, LDN; Wakefield, MA 

Lauren Orlando, SLP; Waltham, MA 

Sara Henry, RD; Watertown, MA 

Rebecca Tipton, MD; Wayland, MA 

Amy Collins, MD; Wellesley, MA 

Laura Winig, MBA; Wellesley, MA 

Julianne Ferro,; West Roxbury, MA 

Sherrill Canna, MD retired; Westboro, MA 
268 


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Health Care Without Harm Petition Signers to Date (1098 total) July 12, 2010 

Katherine Sargent, ; Westborough, MA 

Deborah Burkhalter, LlCsW; Westhampton, MA 

Paula Murphy, LlCsW; Westhampton, MA 

Kelly Balcourt, RD, LDN, CNsD; worcester, MA 

Kristen Baskerville, RD, LDN; Worcester, MA 

Kristen McEvoy, RD, LDN; Worcester, MA 

Erica Weston,; Worcester, MA 

Wendy Allard, MPH, RD, LDN; Wrentham, MA 

MARYLAND 

Carol Heckman, RN; Annapolis, MD 

Rebecca Shelley, RN, Ms; Annapolis, MD 

Brenda At,al, RN, Ms; Baltimore, MD 

Dr. Steven Bond,; Baltimore, MD 

Marjorie Buchanan,; Baltimore, MD 

Denise Choiniere, RN; Baltimore, MD 

Melanie Coffman, RN; Baltimore, MD 

Ryan Coffman, MPH, CHEs, CTIS; Baltimore, MD 

Rachel DeMunda, HEM, CHMM; Baltimore, MD 

Jennifer Harrington, ; Baltimore, MD 

Patrick Holmes, i Baltimore, MD 

Joan Kanner,; Baltimore, MD 

Rebecca Kanter,; Baltimore, MD 

Jeffrey Kaplan, MD; Baltimore, MD 

Michaela Lindahl, Ns; Baltimore, MD 

Louise Mitchell, P.T.; Baltimore, MD 

Keith Molesworth, ; Baltimore, MD 

Lela Osbourne, BSN, RN; Baltimore, MD 

Lela Osbow, RN; Baltimore, MD 

Linda Pierce, LPN; Baltimore, MD 

A R,; Baltimore, MD 

Rebecca Ruggles, MBA; Baltimore, MD 

Jaimie Sagoskin,; Baltimore, MD 

Barbara Sattler, RN, DrPH; Baltimore, MD 

Claudia Smith, PhD, MPH, RN-BC; Baltimore, MD 

Deborah Smith,; Baltimore, MD 

Katherine Smith,; Baltimore, MD 

Robin Spence, RD, LONi Baltimore, MD 

Susan Woodman,; Baltimore, MD 

Frank Weinberg, ; Bel Air, MD 

Marilyn Guterman, RN; Bowie, MO 

Idayert Saidfashina,; Bowie, MD 

Lindie McDonough,; Catonsville, MD 

Penelope Paul, RN; Catonsville, MD 

Kim Rencewicz,; Catonsville, MD 

Rob Rencewicz,; Catonsville, MD 

Denise Pudinski,; Chester, MD 

carol bowman, md; churchville, MD 

Laura Evans, RN, MPH; Columbia, MD 

Katherine McCune, RN, CNM, Ms; 

Dickerson, MD 

jane rhule, RN; edgewater, MD 

Jane Rhule,; Edgewater, MD 

Hannelore Bloom, CRNP; Eldersburg, MD 

Marian Condon, RN, Ms; Ellicott City, MD 

Marcea Cotter, RD, LDN; Ellicott City, MD 

Kristi Johnson, RNC; Ellicott City, MD 

Alec Anders, MD; Germantown, MD 

Amanda Buchhalter, RD; Greenbelt, MD 

Melissa Douglas,; Greenbelt, MD 

Ronald Keyser, MD; Hagerstown, MD 

Molly Hauck, ; Kensington, MD 

Diane Blakely, Manager; Laurel, MD 

Corrine Mohnasky,; laurel, MD 

Debra Roy,; Laurel, MD 

Anthony Bollino, MD; LaVale, MD 

Sheila Joy, CDM, CFPP; Mt. Airy, MD 

Tim,; Owings Mills, MD 

Jodi Rosenberg, ; Pikesville, MD 

Mohammed Razvi, i Potomac, MD 

Pamela Charles, i Rockville, MD 

Anjana solaiman, RNC, Ms, I BCLC; Rockville, MD 

Richard Stoner, GRI; Rockville, MD 

Alexis Hodge, RN, RN; Rosedale, MD 

Kathleen McPhaul, RN; Severna Park, MD 

Betty Schweitzer, Retired; Severna Park, MD 

Jamie LaRue, RN; Silver Spring, MD 

Sara McCullough, j Silver Spring, MD 

Andrew Wong, MD; Silver Spring, MD 

Diane Harves, RN; Sparks, MD 

Gaylord Cia rk, RN; Stevenson, M D 

Margery Clark, ; Stevenson, MD 

Pat Holobaugh, ; Takoma Park, MD 

Darrell McCartney,; Takoma Park, MD 

Chris D1Adamo, PhD Candidate; Timonium, MD 

Heather Keller, RN, BsN, CPFI; Towson, MD 

Natalie Hanold,;, MD 

MAINE 

Peter Kirbach, DO; Bangor, ME 

Alison Watson,; Belfast, ME 

Kathy Hally,; Blue Hill, ME 

Bettie Kettell, RN; Durham, ME 

Renee Page, MPH, ClC; Farmingdale, ME 

Nicole Marquis, SN; Fort Kent, ME 

susan bickford,; newcastle, ME 

Alex Drew, ; Portland, ME 

Tyson Weems, RD; Portland, ME 

Jeffrey Space,; Rockport, ME 

Nancy Tarr, RN, MsN; Vassalboro, ME 

MICHIGAN 

Kelly Bakulski, ; Ann Arbor, MI 

Marsha Benz, MPH; Ann Arbor, MI 

Anne G. Berggren,; Ann Arbor, MI 
269 


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Health Can:' Without Harm Petition Signers to Date (1098 total) july 12, 2010 

Martha Boggs, ; Ann Arbor, MI 

Elizabeth Burt, ; Ann Arbor, MI 

Bruce Cadwallender, ; Ann Arbor, MI 

Susan Hope Dundas, EMT-B; Ann Arbor, MI 

Diana Dyer, MS, RD; Ann Arbor, MI 

Laurie Fort/age, MS, RD; Ann Arbor, MI 

Susan Garetz, MD; Ann Arbor, MI 

Aileen Glaves, ; Ann Arbor, MI 

roger gorlewski, professor; ann arbor, Ml 

Larry Junek, MD; Ann Arbor, MI 

Nancy Kurtz, R.N.; Ann Arbor, MI 

LEV LlNKNER, MD; ANN ARBOR, MI 

Sally Lusk, RN, PhD; Ann Arbor, MI 

jennifer marenghi,; ann arbor, M! 

Brittany Marino,; Ann Arbor, MI 

robert oneal, MD; ann arbor, MI 

Malcolm Sickels, MD; Ann Arbor, MI 

Susan Webb, CRNA, MS.; Ann Arbor, MI 

Stacy Witthoff, RD; Ann Arbor, MI 

Noah Canvasser, MO; Ann Arnar, MI 

Carole Jacobs, ; Brighton, MI 

Timothy Morris, MS; Brighton, MI 

Lee Ann Farull,; Canton, MI 

Cynthia Mulkey, RN; Chesterfield, MI 

Dennis Wideman, BS; Clawson, MI 

Joan Wideman, MS, (IC; Clawson, M! 

Julie Knowles,; Climax, MI 

Gigi Kelm, RN, CIC; Clinton Township, MI 

Dustin Costa,; Commerce, M! 

Emley Navarro,; Davison, MI 

Mary Bieniasz, NP; Dearborn, MI 

Carolyn Gutowski,; dearborn, MI 

Mary Serowoky, NP; Dearborn, MI 

Jonnie Hamilton, DNPc, PNP-BC, RN; Detroit, MI 

marion burgett,; dexter, M! 

Winnie Krieger,; Farmington Hills, MI 

Irwin Moyna, ARM CHSP; Farmington Hills, MI 

Karen Frahm, MPH; Frahkenmuth, MI 

Robert Soderstrom, M.D.; Grand Blanc, MI 

Courtney Gruner,; Grand Rapids, MI 

Wendy Popma, RN, BSN; Grand Rapids, MI 

Lara Webster,; Grand Rapids, MI 

shelly winney, CMT; Grand Rapids, MI 

kathy moloney, M.Ed; grosse pointe, MI 

Barbara Beesley,; Hamtramck, MI 

Kathryn Lawson,; Haslett, MI 

Marydale Casey, ; Hickery Corners, MI 

Karen Holman, ; Howell, MI 

Angela Poppe, RN; Howell, MI 

Donna McClurkan, MSHA; Kalamazoo, MI 

Marie Rogers, ; Kalamazoo, MI 

Michael Rowe,; Kalamazoo, MI 

Christa Betts, MA, RD; Lansing, MI 

Brenda Wideman,; Lexington, MI 

Walter Zetusky, PhD; Livonia, MI 

jennie hoffmann, CMT; marshall, MI 

tim hoffmann, md; marshall, M! 

Anne Cavanagh, MDi Mattawan, M! 

Ashley Peake, ; Middleville, MI 

Patricia Kosanovich, ; Monroe, M! 

Nicole Kasper, MPH; Northville, MI 

David Schwartz, RD; Northville, MI 

Jen Green, ND; Orchard Lake, MJ 

Helen Coverdale, retired teacher; Portage, Ml 

Deborah Russell, RN,FNP; Portage, MI 

Heather Snow,; Portage, MJ 

Miriam Scherrer, physician assistant (PA-C); 

Richland, MI 

patricia Butler, RN, CDE, PhD; Saline, MI 

diana Robison, rn,bsn; saline, MI 

Cheryl Wuttke, MT. ASCP, SLS; 

Sterling Heights, MI 

Margaret Smith, ; Tecumseh, MI 

patrick t, MD; Traverse City, MI 

Marjorie Polys, LMSW; Trenton, MI 

Darlene Wilson,; Ypsilanti, MI 

Jessica Butcher, RD; Zeeland, MI 

MINNESOTA 

Timothy (Tim) Power, ; Afton, MN 

Betty Chouinard,; Andover, MN 

Lezlie Rabine, CRA; Andover, MN 

Tori Payne,; Big Lake, MN 

Dana Slade, CHMM; Burnsville, MN 

Ben Anderson, PharmD; Carlton, MN 

Gregory Skalkog, DC; Chisholm, MN 

Paula I=ischer, ; Crystal, MN 

Pamela Bjorklund, RN, PhD, CS, PMHNP; 

Duluth, MN 

LeAnn Bollin, ; Duluth, MN 

Heather Buchholz, md; Duluth, MN 

Paula Bursch, RD., LD.; Duluth, MN 

Kim Dauner, PhD, MPH; Duluth, MN 

Lyndsay Guidinger, RN; Duluth, MN 

Faris Keeling, MD; Duluth, MN 

heather murphy, LMT; duluth, MN 

Sarah Nelson, MD; Duluth, MN 

Patricia Nielsen, Family Nurse Practitioner (FNP); 

Duluth, MN 

Emily Onelio, MD; Duluth, MN 

Anne Rogotzke, MD; Duluth, MN 

Anne Stephen, MD; Duluth, MN 

David Stephen,; Duluth, MN 
270 


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Health Care Without Harm Petition Signers to nate (1 098 total) july 12, 201{) 

nancy sudak, MD; duluth, MN 

Lorraine Turner, MD; Duluth, MN 

john wood, MD; duluth, MN 

Sarah Griffin, RN; Edina, MN 

Ramona Robinson-O'Brien, PhD, RD; Elk River, MN 

Tammi Brochman, RD; Hastings, MN 

Patricia Zander,; La Crescent, MN 

Heather Sutherland, RN; Little Canada, MN 

Melissa Adler, LlCSW; Minneapolis, MN 

joel albers, pharm.d. ph.d.; Minneapolis, MN 

Ann Blake,; Minneapolis, MN 

jody chrastek, RN MSN; minneapolis, MN 

Ellen Doherty, RN, BS, CPON; Minneapolis, MN 

cecelia Erickson, ; Minneapolis, MN 

rachelle hansen,; minneapolis, MN 

jeanne Harkness, RN, MSNi Minneapolis, MN 

john harkness, MD; minneapolis, MN 

Michelle Karsten, MD; Minneapolis, MN 

Marilyn Kennedy, PhD; Minneapolis, MN 

Julie Konrardy, Medical lab technician; 

Minneapolis, MN 

Marie Kulick, MSEL; Minneapolis, MN 

Tara Montgomery, MS, RD, LD; Minneapolis, MN 

nellie munn, RN; minneapolis, MN 

lisa Nadeau, RD; Minneapolis, MN 

Jawhar Rawwas, MD; Minneapolis, MN 

Crystal Sarie-Bevins,; Minneapolis, MN 

susan sencer, md; minneapolis, MN 

David Streitz, MD; Minneapolis, MN 

jenny su, Ph.D.; minneapolis, MN 

David Wallinga, MD; Minneapolis, MN 

lynn Mader, RD; Montevideo, MN 

Karen Renaud, Medical Laboratory SCientist; 

Mora, MN 

Cheryl Dornfeld, ; Mpls, MN 

Thomas Suit, MD; new london, MN 

Elise Whitehill, md; oak grove, MN 

Heidi Greenwaldt, MS, RD, LD, CNSD; 

plymouth, M N 

Kathleen Lenarz, RN; Richfield, MN 

Stephanie Heim, MPH, RD, LD; Rochester, MN 

Natalie lawrence, RN; Rochester, MN 

Nathan Arthur, BS, CHMM; Rose.ille, MN 

Lynell Hage, RN; Roseville, MN 

Cynthia Ford,; Saint Paul, MN 

Denise Marvinney, PhD, Licensed Psychologist; 

SAINT PAUL, MN 

Bob Power, MBA; Saint Paul, MN 

Elizabeth Soucy, RN; Saint Paul, MN 

Bonnie Carlson-Green, PhD; St Louis Park, MN 

dave councilman, MD; st louis park, MN 

Julie Chu, MD; St Paul, MN 

Catherine Zimmer, MS, BSMT; St Paul, MN 

Jayne Byrne, MS, RD; St. Cloud, MN 

ANdrew Bahn, MS Economics, organic gardener; 

St. Paul, MN 

Amy Gilbert, MD, MPH; St. Paul, MN 

Sheila Packwood, RD. LD.; St. Paul, MN 

Joanne Hewitt, RN; Wabasha, MN 

Carol Scott,; Wabasha, MN 

Loretta Boyer, CWOCN,CFCN; winona, MN 

Denise Erickson, RN; Winona, MN 

Terry Full, RPh; Winona, MN 

Rebecca McDonald, RN; winona, MN 

Marybeth Polus, RN; Winona, MN 

MISSOURI 

Jean Kuntz,; Ashland, MO 

alisa lau-sieckman, RN, BSN; ashland, MO 

Bill Rhodes, ; chaffee, MO 

Dee Dokken, RN; Columbia, MO 

Allison Kellenberger, RN; Columbia, MO 

Joe Kellenberger,; columbia, MO 

jan millen, rn; columbia, MO 

Ruthie Moccia, psychologist; columbia, MO 

Laura Nurnberg, RN; Columbia, MO 

Judy prewitt, ; Columbia, MO 

Dyanna Pursell, ; Columbia, MO 

Laura Wright, ; Columbia, MO 

Molly Wright, ; columbia, MO 

Amy Bearce,; Kansas Clty, MO 

Jill Robison, OTA/L; Kansas City, MO 

Tiffany Meller, RN; Lohman, MO 

Melanie Cheney, ; Rocheport, MO 

Mark Reed,; Saint Louis, MO 

Dani Kusner, ; st. Louis, MO 

MISSISSIPPI 

METRIC CLAY,; STARKVILLE, MS 

NORTH CAROLINA 

Carolyn Cole, MSW; Chapel Hill, NC 

marsha cadwallader, BSN, MSW, LCSW; 

Durham, NC 

Nancy Shakir, Educator; Fayetteville, NC 

Layth Awartani, ; greensboro, NC 

Amelia Mattocks, ; Greensboro, NC 

Marcy Williams, ; Greensboro, NC 

Donna Biederman, RN; Mebane, NC 

Kelly Velotta, MS, RD; Morrisville, NC 

Robin Brady, RT (R) (CT) (MR); Pittsboro, NC 

Beth Laman, ; Pittsboro, NC 

Pamela Chance, BS, LCCE, FACCE, HTR; 

Raleigh, NC 

Marjorie Nurnberg,; West End, NC 
271 


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Health Care Without Harm Petitioll Signers to Date (1 098 total) july 12, 2010 

ELSIE LARIVIERE, RN; WILM, NC 

NORTH DAKOTA 

Karen Ehrens, RD; Bismarck, ND 

NEW HAMPSHIRE 

Paul Lockwood,; Concord, NH 

Debbie Augustine,; Contoocook, NH 

Leah Fondeur, LPM; Derry, NH 

Peter Degnan, MD; Exeter, NH 

Kevin Keaveney,; exeter, NH 

Un Hill,; Grantham, NH 

Nancy Romano, MS, RD, CD; Grantham, NH 

Raymond Sebold, MEd; Greenfield, NH 

David Norton, ; Hampton, NH 

Jill Norton, RD, LON; Hampton, NH 

Cynthia Knipe, RD; Keene, NH 

john Leigh,; Lebanon, NH 

Rebecca Lockwood, i Manchester, NH 

karen chase, RN; new london, NH 

MARION ROMANOFF,; NEW LONDON, NH 

Cheryl Chrysostom, LPN; Newton, NH 

Kate Forbush, Work Comp adjuster; 

penacook, NH 

Sandra Horne,; Plainfield, NH 

Heather Fisherauer, ; Raymond, NH 

Kathleen Phair, LPN; Salem, NH 

Elke Melody, RD, LD; Warner, NH 

connie rieser, RD, lD, Registered Dietitian; 

Windham, NH 

Brenda Ventrlllo, HIM; Windham, NH 

NEW JERSEY 

Tracy Bradshaw, RN; Audubon, NJ 

Bonnie Wise, RN; Bogota, NJ 

Cynthia Carlin, RN; edsion, NJ 

Doreen Korn, AHNwBC; Glen Rockl NJ 

Suzen Heeley,; Hackensack, NJ 

martin cecire,; holmdel. NJ 

Caroline Edwards, CRNP; Linwood, NJ 

Sally Ringe, BSN, RN; Marlton, NJ 

Susan Williams, RNC; Mouint Laurel, NJ 

Andrea Racobaldo, RN; Pennsauken, NJ 

Oeepa Sannidhi, Medical Student; Piscataway, NJ 

Mary Ann Rollano, RN; Point Pleasant, NJ 

John McGowan, ; Ringwood, NJ 

David Barry,; Rutherford, NJ 

Sarah Muller, MPH, RN; Scotch Plains, NJ 

Regina Grazel, RN; Sewell, NJ 

sandra rousso, RN; tenafly, NJ 

Caroline Pope, BSN, RNC-NIC; Williamstown, NJ 

NEW MEXICO 

Karen Halderson, MPH, RD, CDE; Albuquerque, NM 

benjamin zimmerman,; Albuquerque, NM 

jessie emerson, RN, certified clinical herbalist; 

santa Cruz, NM 

NEVADA 

Heather Bowman,; Reno, NV 

Laurel Coats, ; Sparks, NV 

NEW YORK 

Paula Brewer, RD, CDN; Albany, NY 

helen Ruddy, NP; Astoria, NY 

Dorothy Wrase Hares, RD; Baldwinsville, NY 

Geraldine Dingman,; Ballston Lake, NY 

Kim Kalina, CCH; Berne, NY 

Rosa Parris, RN; Bronx, NY 

Alexandra Jamieson, Board Certified 

Holistic Health Counselor; Brooklyn, NY 

Maureen McGowan, CSW; Brooklyn, NY 

Jennifer Trotter,; Brooklyn, NY 

Erin Upton,; Brooklyn, NY 

Sanford Levy, MD; Buffalo, NY 

Carolyn Bova, MSED/CAS; Burt, NY 

Jean B Heady, RN; Clayton, NY 

Judith Hoffmann,; Corning, NY 

Suzanne Parton-Meeder, RD CON; Dale, NY 

Frances Crosby, EdD, RN; East Amherst, NY 

Carol Malley, MS; Farmingville, NY 

Cecilia Mulvey, RN,PhD; Fayetteville, NY 

Susan Moran, CDM, CFPP; Getzville, NY 

Tina Facteau, BSN,RN,CDE; Glens Falls, NY 

Kelly Moltzen, ; Harriman, NY 

Cathey Falvo, MD, MPH; Hastings on Hudson, NY 

William Griffin,; Ithaca, NY 

Maria Meoli,; Kerhonkson, NY 

diana orr, RN; Lagrangeville, NY 

Billie Hall,; Lake George, NY 

NYS NUrses AssOCiation,; Latham, NY 

Loretta Madia,; lewiston, NY 

Sara Hicks, APRN-BC (Nurse Practitioner); 

Long Beach, NY 

Cathryne A. Welch, RN, EdD; Loudonville, NY 

laurel Grey,; Martville, NY 

Karen Kassen, RN; Massapequa Park, NY 

Siby Thomas, RN; Nanuet, NY 

Karen A Ballard, MA, RN, FAAN; New York, NY 

Lolita Compas, RN; New York, NY 

claire fagin, RN; New York, NY 

Stephen Harnicar, Pharm.D, BCap; New York, NY 

Melaina Marion, ; New York, NY 

Sherry Mathew, Pharm.D.; new york, NY 

madeline naegle, ph.d rn; new york, NY 

lauren parsly, Dietetic Intern; New York, NY 

Lisa Yanowitz,; New York, NY 

Barbara Glickstein, RN, MPH, MS; New York, NY 
272 


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Health Care Without Harm P"tition Signers to Date (1 ()98 total) fUly 12, 2010 

Debbie Fritz, RN; Newburgh, NY 

Nicole Basso, RN; Ny, NY 

Thomas Lowe, RN, M~H; NYC, NY 

Joan Gussow, MEd, EdD, nutrition professor; 

Piermont, NY 

Lynn Moll, RD; ~ittsford, NY 

Cynthia Wallace, RD; ~ittsford, NY 

Usa Gengo, ND, ~AC; ~ort Chester, NY 

Suzette Smookler, MS RD; port jefferson, NY 

Wendy Harris, ; queens village, NY 

Sara Fagan, Student nurse; Rochester, NY 

~atricia Rochford, RN.C; Rockaway ~ark, NY 

Bernadette Curry, RN181555; Rockville Centre, NY 

nancy !ofaro,; saugerties" NY 

Susan Mantovani, RN; Sayville, NY 

gerri goerke, ; scarsdale, NY 

Kathleen CurtiS, L~N; Schenectady, NY 

E. Joyce Gould, RN, Rn, MSN; Schenectady, NY 

Joan Stollberger, RD, CDE; Smithtown, NY 

Jane Gengo,; So5alem, NY 

Merry Sam,; Spring Valley, NY 

terry podolak, RD; syracuse, NY 

Jeanne Finestone,; Tuxedo Park, NY 

Kelly Gaetz, RN; Upper Nyack, NY 

Aurora Tansiokhian, MD; Vestal, NY 

Carol Gburek, ; Warsaw, NY 

Krystal Sampson-Thomas, Student; 

white Plains, NY 

Maria Roche-Dean, MS,RNi Whitesboro, NY 

Mini Varghese, RN; Yonkers, NY 

OHIO 

Therese Dowd, PhD,. RN; Akron, OH 

Dorothy Marsh, RN< MSN; Akron, OH 

Anne Smith, ; Barnesville, OH 

Josefa Rangel, MD; Cincinnati, OH 

Kathleen Morris, RN; Columbus, OH 

Barbara Polivka, PhD, RN; Columbus, OH 

Clarence Dunn, ; Euclid, OH 

Rebecca McDermott, ASCP; Gibsonburg, OH 

bonnie wagner, RN,BSN,MSN-director of 

nursing public health; greenville, OH 

Rosemary Chaudry, RN, PhD, MPH; Marion, OH 

Ria Smeraldi, ; North Olmsted, OH 

Tari LaFountain, RPh; Oregon, OH 

Nand Shim man, ; Oregon, OH 

Susan Tullai-McGuinness, RN; Painesville, OH 

Lisa Lewis, RD, LD; Rocky River, OH 

Marcel Hesseling, ; Sylvania, OH 

Barbara Smykowski, R.N.; toledo, OH 

OKLAHOMA 

Dianne Miller-Boyle, N~; oklahoma city, OK 

OREGON 

Jenny Haag, RN; Aloha, OR 

Stephanie Potts, FNP; Astoria, OR 

Serena Kelly, FNP; Beaverton, OR 

Mark Petersen, ; Bend, OR 

david peter, md; canby, OR 

Julie Ahrendt, RN; Corvallis, OR 

Steve George, licensed Massage Therapist; 

Corvallis, OR 

John Helm, ; Corvallis, OR 

KIMBERLY HOLTER,; CORVALLIS, OR 

Cathy Law, PhD; Corvallis, OR 

Jan Spencer, LCSW; Corvallis, OR 

pauline billings, rn; dillard, OR 

Tracy Davis,; Dufur, OR 

Rosalie Hammond, RN, FNP, PhD; Eugene, OR 

Tracy Shepherd, RN; Eugene, OR 

Dee Tvedt, RN, BSN, CGRN; Eugene, OR 

Andrea Gough, MPH; Gresham, OR 

Duane Ray, PhD; Gresham, OR 

Cary Fardal, RD; Happy Valley, OR 

Carla Danley, RN; Hillsboro, OR 

Bonnie New, MD MPH; Hood River, OR 

martin donohoe, MD; Lake Oswego, OR 

Nancy Ellis, RD, LD; Lebanon, OR 

David Grant, MD; Medford, OR 

charlotte aborn, RN, BSN; portland, OR 

Kurt Beil, ND, MSOM, MPH; Portland, OR 

Robert Brookshire, Physician Assistant; 

Portland, OR 

Kevin Chatham-Stephens, MD; Portland, OR 

Eecole Copen, MS, RD; Portland, OR 

Erin Dawson, RD, LD; Portland, OR 

Jacque DeVore, RD, M~H; Portland, OR 

Aleta Dunne, ; Portland, OR 

Karen Erde, MD; Portland, OR 

Angela Gerrard, RN; Portland, OR 

Debora Goldstein, RN; Portland, OR 

Marceline H. Gearry, ; ~ortland, OR 

Donna Hammar, FNP, RN; Portland, OR 

Laura Hanks, PA-Ci portland, OR 

Mary lou Hennrich,; Portland, OR 

Susan Katz, MD; Portland, OR 

Teresa Keaane, NP; Portland, OR 

Jacob Klein, RN, BSN; Portland, OR 

Marc Lewis, RN; Portland, OR 

Barbara Martin, PA-C; Portland, OR 

Robert McFarlane, MD; Portland, OR 

Patricia Murphy, ND, LAc; Portland, OR 

Tania Neubauer, ND; Portland, OR 

Marylou Noble, Licensed Professional Counselor; 
273 


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Health Carl' Without Harm Petition Signers to Dale (1098 total) ruly 12,201 (I 

Portland, OR 

Carolyn Parchinsky, RN; Portland, OR 

john Pearson, MD Or 10935; Portland, OR 

Jenny Pompilio, MD, MPH; Portland, OR 

Jeanean Rauch, RN; Portland, OR 

Annie Robb, RN; Portland, OR 

Kellie Schenk, MD; Portland, OR 

Catherine Thomasson, MD; Portland, OR 

Maye Thompson, RN, PhD; Portland, OR 

Helen Turner, DNP, PCNS; Portland, OR 

Stacey Williams, MPH; Portland, OR 

kimberly amy ,eigenfuse, RN; portland, OR 

linda Pesanti, retired registered nurse; 

Saint Helens, OR 

James A. Auerbach, M.D., MD; Salem, OR 

Andrew Harris, MD; Salem, OR 

PENNSYLVANIA 

barsky andy, CDM; allentown, PA 

Ruth McDermott-Levy, PhD, RN; Berwyn, PA 

Danielle Hamilton,; broomall, PA 

Leah Berry, ; Chadds Ford, PA 

Nancy Berry, RN, MSN; Chadds Ford, PA 

Jennifer Conrad, RN, BSN; Dillsburg, PA 

Diane Oloughlin, RNC; Doylestown, PA 

Feargal Roche, ; Havertown, PA 

Jan Cingota,; Indiana, PA 

paulette schreiber, C.R.N.P.; kersey, PA 

Adele Spegman, PhD, RN; Lewisburg, PA 

Michele Ondeck, MEd, RN; McKeesport, PA 

Elizabeth Ann Gatti, RNC; Monroeville, PA 

Alexia Chororos,; Narberth, PA 

Diane Ferguson, RN, MSN; Ono, PA 

Lucille DiCampli,; Phila, PA 

Steven McCollick, ; Phila, PA 

Charles Mullin, ; Phila, PA 

Asher Barkan, CDM, CFPP; Philadelphia, PA 

Rebecca Brichta, ; Philadelphia, PA 

Shelley Chamberlain, RD,LDN; philadelphia, PA 

Heather Cowley,; PHILADELPHIA, PA 

Allegra Gordon, MPH; Philadelphia, PA 

patricia harner', MS; Philadelphia, PA 

Erin Kroll, as; Philadelphia, PA 

Myriah lipke, MA; Philadelphia, PA 

Sara lis, RN; Philadelphia, PA 

Dianne McChesney Moore, MS, MSW; 

Philadelphia, PA 

Kameela Miller, RNC; Philadelphia, PA 

Dianne Moore,; Philadelphia, PA 

Betty Nunnari, MBA; Philadelphia, PA 

Nathan Samras,; Philadelphia, PA 

Abbie Santana, MSPH; Philadelphia, PA 

Robert Stein,; Philadelphia, PA 

Howard SUdak, MD; Philadelphia, PA 

John Wierzbowski, MS, MPH; philadelphia, PA 

Judith Foeareta, RN, MEd; Pittsburgh, PA 

Marian Pokrywka, ClC; Pittsburgh, PA 

Mary Vandivier, BS EIEdjECEDirector; Pittsburgh, PA 

Christine Weinberger, MD; Pittsburgh, PA 

Stanley Weinberger, MD; Pittsburgh, PA 

Lynn Zakreski, Psychology, MA; 

Plymouth Meeting, PA 

Tamara Almquist, BS Biology; Pocono Summit, PA 

Amy Heins, RN, BSN, CIC; Reading, PA 

Renee Smith, RN, MS, CPAN, CAPA; Sunbury, PA 

Mallory Reed, ; West Reading, PA 

John Kosisky, Director / Nutritional Services; 

Wilkes-Barre, PA 

elizabeth keech, PhD,RN; Wynnewood, PA 

Donna Novak, RN, MSN, CRNP; Yardley, PA 

RHODE ISLAND 

Sandra Delack, RN; North Kingstown, RI 

Brian Nguyen, MA, MD; Providence, RI 

SOUTH CAROLINA 

William Eubanks, FASLA; Charleston, SC 

Cothran James, ; Charleston, SC 

Dena Howard, ; lexington, SC 

Tim James,; W. Cola, SC 

Veretta Campbell,; West Columbia, SC 

Michael Greeley, (MHA) - Hasp. Administrator; 

West Columbia, SC 

TENNESSEE 

Paul Thur de Koos, MD; Johnson City, TN 

David Marcovit" MD; Nashville, TN 

Jennifer Sterling, RN, BSN; Nashville, TN 

Lynn Wilson, M.Ed.; Nashville, TN 

TEXAS 

Karen Yaeger, i Allen, TX 

Sarah Buttrey, MD; Austin, TX 

Melissa Cline, MS, RD, lDi Austin, TX 

lacey Collins, ; Austin, TX 

STEVEN CONTI, MBA, RRT; AUSTIN, TX 

Dana Dose, RD; Austin, TX 

Mike Howe, ; Austin, TX 

heather murphy, ; austin, TX 

liza Sanchez, ; Austin, TX 

Shawta Sackett, ; Brya n, TX 

Carolyn Matthews, MD; dallas, TX 

Nuria Homedes,; EI Paso, TX 

brad beckman, md; houston, TX 

Francine Beckman,; Houston, TX 

Stephanie Smith, MPH, RD; Houston, TX 

Melody Young, RN,BSN; LaGrange, TX 
274 


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Health Care Without Harm Petition Signers to Dale (1098 total) July 12, 2010 

Linda Beeson, RN; Louise, TX 

Amber Smith, RD; Manor, TX 

wayne Hansen, PE; McKinney, TX 

Dion Turner, RD,LD; San Antonio, TX 

Anne Ruthstrom,; San Marcos, TX 

UTAH 

James Shaka, MD; HOLLADAY, UT 

VIRGINIA 

Laura Anderko, RN PhD; annandale, VA 

Stan Cahill,; Arlington, VA 

Anna Gilmore Hall, RN; Arlington, VA 

Ravie Kern, Pharm.D,; Arlington, VA 

Jeanne Shiffman, MD; Arlington, VA 

Robert McCandlish,; fairfax, VA 

Dee leggett, RD; Great falls, VA 

KJordan Chadwick,; Great falls" VA 

Linell Patterson, BSW; Harrisonburg, VA 

Steve Gohn, RO; Madison, VA 

Lauren DiPerna,; Manassas, VA 

Laura Erickson-Schroth, MD, MA; Reston, VA 

Cindy Schwalb,; Reston, VA 

Elizabeth Healy, ANCC; Springfield, VA 

VERMONT 

Annie harlow, ; Bristol, VT 

Barbara MacArthur, MS, MT, CIC; Burlington, VT 

Andrew Thompson, PhD; Burlington, VT 

Diane Imrie, RD; Colchester, VT 

Pete Gummere., M.S., M.A.; St Johnsbury, VT 

WASHINGTON 

Susan DuPuis, RD; Anacortes, WA 

Connie Campbell, ; Arlington, WA 

Jolene Naranjo, RN; Auburn, WA 

Ameera Hassen, ; Bellevue, WA 

Anna tyerusalimets, ; Bellevue, WA 

Oin Shen, ; Bellevue, WA 

Deborah Alley, ; Bothell, WA 

Nancy Boyer,; Bothell, WA 

Kim Griffin, RN, BSN, MNc; Bothell, WA 

Marcy Johnson, Dietetics graduate student; 

Bothell, WA 

Gail Richards,; Bothell, WA 

Steve Kohl, MD; Brush Prairie, WA 

Iris lefkowitz, MA; Chimacum, WA 

Andrea Wohlgemuth,; Duvall, WA 

Cynthia Meen,; Edmonds, WA 

Diane Skypeck, ; Edmonds, WA 

Stacey Sol emslie, ; Edmonds, WA 

Patsy Carmin,; Everett, WA 

Anne Dennis,; Everett, WA 

Peter Lar, ; Everett, WA 

Rosa Redondo,; Everett, WA 

Joseph Lamb, MD; Gig Harbor, WA 

Christa Bitner, ; Kenmore, WA 

Cindy Kuijper, RNC; Kenmore, WA 

Kavitha ,; Kenmore, WA 

DAvila, ; Kirkland, WA 

Alyssa Brin, ; Kirkla nd, WA 

Jocelyn Castro,; Kirkland, WA 

Alicia Corlew, ; Kirkland, WA 

Jacque Dooley,; Kirkland, WA 

Audrey Harvey,; Kirkland, WA 

Nga Ngo,; Kirkland, WA 

Susan Schandl,; Kirkland, WA 

Sarah Shoubridge, ; Kirkland, WA 

Renee Paden, ; Lacey, WA 

David J lash, ; Lake Stevens, WA 

Kenn Jones, RN; lynnwood, WA 

Melissa Nell Ewbank,; Lynnwood, WA 

Julie Negrin, MS; Mercer Island, WA 

Sue Dale, ; Monroe, WA 

Kellene Mart, RN, MNHP; Port Townsend, WA 

Denise Erechar, RN; Puyallup, WA 

C Gillum,; Redmond, WA 

Kelli Barber, RN; Seattle, WA 

Karen Bowman, MN, RN, COHN-S; Seattle, WA 

Mooda Burcheci,; Seattle, WA 

Anne Buzzelli, MS, RD; SEattle, WA 

Ashley Demaline, RN; Seattle, WA 

Leticia Descargar, ; Seattle, WA 

Rebecca Finkel/ i Seattle, WA 

Michelle forrest,; Seattle, WA 

Alethea Fournier, RN; Seattle, WA 

Risa Halford, RN; Seattle, WA 

David Hall, MD; Seattle, WA 

Laura Hart, MD; Seattle, WA 

Mary Susan Heffernan, RN-BC, MN; Seattle, WA 

Peter Jewell, BSN RN; Seattle, WA 

Candace Johnson, ; Seattle, WA 

Trina Kaufman, MS; Seattle, WA 

Amelie Mabbutt, RN; Seattle, WA 

Lily Y Pang, RN; Seattle, WA 

Marley Peale,; Seattle, WA 

Ofilia Poponut,; Seattle, WA 

Kirsten Rayor, RN; Seattle/ WA 

Cheryl Robinson, RN; Seattle, WA 

Teresa Sherwood,; Seattle, WA 

Travis Sherwood, ; Seattle/ WA 

Tamara Sullivan/; Seattle, WA 

Lana Tyer, Rn; Seattle, WA 

Catherine Webb,; Seattle, WA 

Jenna Umbriac, dietetic student; Shoreline, WA 

Maria Umbriac,; Shoreline, WA 
275 


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Health Ca,'e Without lIarm Petition Signers to Date !1 098 total) July 12, 20HI 

Melissa Murphy, RN, BSN; Spanaway, WA 

Julie Postma, PhD RN; Spokane, WA 

Nancy Picou, LPN; Tacoma, WA 

Bradley Thompson, RN; Tacoma, WA 

Mary DeVany, CSP, CHMM; Vancouver, WA 

stan freidberg, MD; Vancouver, WA 

linda Herbert, RN; Walla Walla, WA 

Paul Moyer, PA, RN, MPH.; White Salmon, WA 

Jean Mendoza, RN, BSN; White Swan, WA 

Barbara Bjarnason,; Woodinville, WA 

Andrea Sheahan,; Woodinville, WA 

Joan Beads,; , WA 

WISCONSIN 

Brenda leigh, MS,RD; Appleton, WI 

Shannon Meltz, RN; Appleton, WI 

Sandy Panzer, RN MSN; Appleton, WI 

Karlyn Raddatz, BA, RN-BSN; Appleton, WI 

Allison Weyenberg,; Appleton, WI 

Amy Miller, RD, CD; Black Earth, WI 

patricia Finder-Stone, RN,MS, RN, MS; De Pere, WI 

Tara Wood, PharmD; Fennimore, WI 

Judith Stadler, RD; Fitchburg, WI 

Jesse Charles, MD candidate; Green Bay, WI 

Lori Hartz, MS, RD; Greenvilie, WI 

lillian Nordin, FN P; Holmen, WI 

Patty Van Beek, RN, MS; Hortonville, WI 

Christine Immel, DTR.; Kewaskum, WI 

Kathryn lammers, MS, RN; laCrosse, WI 

Diane Cozzi, MSN, RN; Lake Geneva, WI 

Jenna Palosaari, RN; lodi, WI 

Ingrid Andersson, RN, CNM, MSN; Madison, WI 

Barb Bickford, ; Madison, WI 

deborah burns, ; Madison, WI 

Rachel Olson, RN; Madison, WI 

Rian Podein, MD; Madison, WI 

Patrice Udelhofen, NP; Madison, WI 

sherry grandaw, ; marinette, WI 

Sue Meyer, RN; Marshfield, WI 

Frances Stahl, MS, LCSW; Menasha, WI 

Mary Blakewell, ; Neenah, WI 

Betty Koepsel, RN, MSN; Oconomowoc, WI 

Belinda DeGoey, BSN; Oshkosh, WI 

patty Kandiko, Public Health Nurse; Oshkosh, WI 

mary viis, MS, ATC; oshkosh, WI 

Arlene McEntegart, Nurse Practitioner; Racine, WI 

Elien Martin, PT; Random lake, WI 

sue wright, rn; south range, WI 

Gail Baldwin, MD; Superior, WI 

lois Taylor, MA, RN; Trempealeau, WI 

Charlotte Smith, R. Ph. (Pharmacist); 

Wauwatosa, WI 

laura Grant, RNi West Bend, WI 

Donna Groth, RN; West Bend, WI 

Doug Petsch, sales; West Bend, WI 

Jan Path, RN BSN; Wilton, WI 

Paulette Stoltzmann, RN; Winnebago, WI 

Mary Jo Turner, RN, Public Health Nurse; 

Winnebago, WI 

WEST VIRGINIA 

Rebecca Foster, RD; Clarksburg, WV 

Barbara Hartman, MS, RD, LD; Kearneysville, WV 

Kendra Stoen, MS, RD; Morgantown, WV 

WYOMING 

Bonita Maddex, RD; Jackson, WY 
276 


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Healthy Food in 

Health Care Pledge This Healthy Food in Health Care Pledge is a framework that outlines steps to be taken by the health cafe industry 

to improve the health of patients, communities and the environment, 

As a responsible prOVider of health care services, we afe committed co the health of our patienrs, OUf staff and the 

local and global commumty, We are aware that food production and dL<;tribution methods can have adverse Impacts on 

public environmental health, As a result, we recognize that for the consumers who eat it, the workers who produce it 

and the t!co.system:, that sustain us, healthy food mmt be defined not only by nutntional quality, but equally by a food 

system that is economically viable, environmentally sustainable, and supportive of human dignity and justice. We are 

committed to the gOll! of providing local, nutritious and sustainable food. 

Specifically, we an: committed to the following healthy f(lod m ht!alth care measures for our im,titution. We plt!dge to: 

Increase our offering of fruit and vegetables, nutrition; 

ally dense and minimally processed, unrefined foods and 

reduce unhealthy (trans and saturated) fats and sweetened foods. 

Implement a stepwise progr8m to identify and adopt 

sustainable food procurement. Begin where fewer barriers 

exist and immediate sieps can be taken, such as the adop~ 

tion of rBGH free milk. fair trade coffee, or selections of 

organic and/or local fresh produce in the cafeteria. 

Work with local farmers, community-based org,lOizations 

and food suppliers to increase the availability of fresh, 

locally-produced food. 

Encourage our vcndors andlor fC)(ld management 

companies to supply us with food that is produced in 

systems that, among other attrib~He~, eliminate the 

use of toxic pesticides, prohibit the use of hormones 

and non-therapcmic antibiotics, suppOrt farmer and 

farm worker health and welfare, and ust! ecologically 

protective and restorative agriculture. 

Signed 

Communicate to our Group Purchflsing Organizations 

OUT imcrest in foods whose s.ource and production practices (i.e. protect biodiversity, antibiotic and hormone 

us!.!, loca!, pe!!ticide usc, etc) are identified, so that WI! 

may hl.1Ve informed consent and choice about the foods. 

we purcha:.e. 

Develop a program to promote and source from produc~ 

ers and processors which uphold the dignity offamHy, 

farmers, workers and their communities and support 

sustainahle and humane agnculture systems. 

Educate and communicate within our system and 

with our patients and community ahout our nutritious, 

sOciaHy just and eCQlogically sustainable healrhy food 

practices and proccdures. 

Minimize and hcneficiaJly reuse food waSle and support 

the use of food packaging and products that are ecologically prorective. 

Report annually on implementation of this Pledge. 

Date 

Without 

~ Harm , 
277 


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NORTHEAST 

Baystate Health, MA 

Berkshire Medical Center, MA 

Pledge 

Bon Secours Health System, Warwick, NY 

Bon Secours Charity Health System: 

Good Samaritan Hospital of Suffern, NY 

Community Hospital, Port Jervis, NY 

Boston Medical Center, Boston, MA 

Brattleboro Memorial Hospital, VT 

Bridgeport Hospital, Bridgeport, CT 

The Center for Discovery, NY 

Cheshire Medical Center, Dartmouth-Hitchcock, 

Keene, NH 

Cooley Dickinson Hospital, MA 

Covenant Health Systems: 

Maristhill Nursing & Rehabilitation Center, MA 

Mary Immaculate Health/Care Services, MA 

St. Mary's Health System, MA, including: 

st. Mary's Residences 

St. Mary's d'Youvilie Pavilion 

St. Mary's Regional Medical Center 

St. Andre Health Care Facility, ME 

st. Joseph Healthcare Nashua, NH 

St. Joseph Manor Health Care, MA 

St. Mary Health Care Center, MA 

St. Mary's Villa, PA 

Youville Hospital & Rehabilitation Center, MA 

Youville House, MA 

Youville Place Assisted Living Residence, MA 

Dartmouth-Hitchcock Medical Center, NH 

Fairview Hospital, MA 

Fletcher Allen Health Care, VT 

Lawrence and Memorial Hospital, CT 

Linco!n County Hea!thcare: 

St. Andrews Hospital & Healthcare Center, ME 

Miles Memorial Hospital, ME 

Littleton Regional Hospital, NH 

Memorial Sloan-Kettering Cancer Center, NY 

Metro West Medical Center: 

Framingham Union Hospital, MA 

Leonard Morse Hospital, MA 

Mid Coast Health Services: 

Mid Coast Hospital, ME 

Mid Coast Senior Health Center, ME 

Thornton Oaks Retirement Community, ME 

i:d\" 12. 20ll) 

Milford Regional Medical Center, MA 

Mt. Ascutney Hospital & Health Center, VT 

New Milford Hospital, CT 

Northeastern Vermont Regional Hospital, VT 

Olean General Hospital, NY 

The Orchard Nursing and Rehabilitation Centre, NY 

Parkview Adventist Medical Center, ME 

Porter Medical Center, VT 

Regeis Care Center, NY 

Rutland Regional Medical Center, VT 

Schervier Nursing Care Center, NY 

Shriners Hospital for Children, MA 

Southwestern Vermont Health Care, 

Bennington, VT 

Spaulding Rehabilitation Hospital, MA 

MID-ATLANTIC 

Abington Memorial Hospital, PA 

Anne Arundel Medical Center, MD 

Baltimore Washington Medical Center, MD 

Bon Secours Baltimore Hospital, MD 

Calvert Memorial Hospital, MD 

Carroll Hospital Center, MD 

Children's Hospital of Pittsburgh of UPMC, PA 

Christiana Care Health Systems: 

Christiana Hospital, DE 

Wilmington Hospital, DE 

Cooper University Hospital, NJ 

Geisinger Health System, PA 

Georgetown University Hospital, DC 

Hackensack University Medical Center, NJ 

Holy Redeemer Health System, PA 

Howard County General Hospital, MD 

LifeBridge Health: 

Courtland Gardens Nursing & Rehabilitation Home, MD 

levin dale Hebrew Geriatric Center and Hospital, MD 

Northwest Hospital, MD 

Sinai Hospital, MD 

Long View Nursing Home, MD 

Mercy Medical Center, MD 

Mt. Washington Pediatric Hospital, MD 

Northwest Health and Rehab Center, MD 

Shady Grove Adventist Hospital, MD 

Sinai Hospital, MD 

Thomas Jefferson University Hospital, PA 

Union Hospital of Cecil County, MD 
278 


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Food in 

University of Maryland Medical Center, MD 

Washington Adventist Hospital, MD 

SOUTHEAST 

Baptist Health South Florida: 

Baptist Hospital, FL 

Doctors Hospital, FL 

Homestead Hospital, FL 

Mariners Hospital, FL 

South Miami Hospita!, FL 

Bon Secours Hampton Roads: 

DePaul Medical Center, VA 

Mary Immaculate Medical Center, VA 

Maryview Medical Center, VA 

Bon Sewurs Richmond Health System: 

Bon Setours St. Marls Hospital, Richmond, VA 

Memorial Regional Medica! Center, Mechanicsville} VA 

Richmond Community Hospital, VA 

St. Francis Medical Center, Midlothian, VA 

Bon Secours St. Francis Health System: 

St. Francis Downtown, SC 

St. Francis Eastside, SC 

Children's Healthcare of Atlanta, GA 

INOVA Alexandria Hospital, VA 

Mission Hospitals, NC 

Reston Hospital Center, VA 

St. Mary's of Campbell County, LafolleUe, TN 

MIDWEST 

Adventist Bolingbrook Hospital, IL 

Advocate Christ, IL 

Advocate Health Care: 

Advocate Bethany Hospital, IL 

Advocate Christ Medical Center, IL 

Advocate Illinois Masonic Medical Center, IL 

Advocate Lutheran Genera! Hospital, IL 

Advocate South Suburban Hospital, IL 

Advocate Trinity Hospital, IL 

Good Samaritan Hospital, IL 

Good Shepherd Hospital, IL 

Altom Memorial Hospital, Il 

Aurora Health Care: 

Aurora BayCare Medical Center, WI 

Aurora Lakeland Medical Center, WI 

Aurora Medical Center, Hartford, WI 

Aurora Medical Center, Kenosha, WI 

Aurora Medical Center, OshKosh, WI 

)t;]y 12. :::010 

Aurora Medical Center, Two Rivers, WI 

Aurora Memorial Hospital of Burlington, WI 

Aurora Psychiatric Hospital. WI 

Aurora Sheboygan Memorial Medical Center, WI 

Aurora Sinai Medical Center, WI 

Aurora St. Luke's Medical Center, WI 

Aurora St. Luke!s South Shore, WI 

Aurora West Allis Medical Center, WI 

Bartels Lutheran Retirement Community, fA 

Bon Secours Kentucky Health System: 

Our Lady of Bellefonte Hospital, Ashland, KY 

Beaumont Hospital, Grosse Pointe, MI 

Borgess Medical Center, Kalamazoo, MI 

Bronson Methodist Hospital, MI 

Cancer Treatment Center of America at Midwestern 

Regional Medical Center, IL 

Cass County Memorial Hospital, IA 

Chelsea Community Hospital, MI 

Children's Hospitals and Clinics of Minnesota, MN 

Cleveland Clinic: 

Cleveland Clinic Main Campus, OH 

Euclid Hospital, OH 

Fairview Hospital, OH 

Hillcrest Hospital, OH 

Huron Hospital, OH 

Lakewood Hospital, OH 

Lutheran Hospital, OH 

Marymount Hospital, OH 

South Pointe Hospital, OH 

Drake Center, OH 

Galesburg Cottage Hospital, IL 

Hennepin County Medical Center, MN 

Henry Ford Health System, MI 

Henry Ford West Bloomfield, West Bloomfield, MI 

Hopedale Medical Complex, IL 

HospiceCare Inc., WI 

lIIini Community Hospital, IL 

Immaculate Heart of Mary, Monroe, MI 

Marquette General Hospital, MI 

Memorial Hospital of South Bend, IN 

Mercy Medical Center, IA 

Metro Health Hospital, MI 

Northern Michigan Regional Health System, 

Petoskey, MI 

Pana Community Hospital, IL 
279 


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Ridgeview Medical Center, Waconia, MN 

River Falls Area Hospital, WI 

Sacred Heart Hospital, Eau Claire, Wi 

Sparrow Health System, Lansing, MI 

Spectrum Health System, MI 

St. Elizabeth Healthcare: 

st. Elizabeth Covington, KY 

St. Elizabeth Medical Center, KY 

St. Elizabeth North, KY 

St. Elizabeth Florence, KY 

St. Elizabeth Ft. Thomas, KY 

St. Elizabeth Grant County, KY 

St. Joseph Mercy Health System, MI 

St. Luke's Hospital, MN 

St. Nicholas Hospital, WI 

St. Vincent Hospital, WI 

Swedish Covenant Hospital, Il 

Valley West Community Hospital, IL 

Waukesha Memorial Hospital, WI 

Weiss Memorial Hospital, Il 

West Hospital, IA 

Winona Health, MN 

NORTHWEST 

Cascade Healthcare Community; 

St. Charles Medical Center, Bend, OR 

St. Charles, Redmond, OR 

Children's Hospital and Regional Medical Center, WA 

Good Shepherd Medical Center, OR 

Island Hospital, WA 

Kaiser Atrium Cafe, OR 

Kaiser Sunnyside Medical Center, OR 

Kootenai Medical Center, ID 

Legacy Health System: 

Legacy Emanuel Hospital & Health Center, OR 

Legacy Emanuel Children's Hospital, OR 

Legacy Good Samaritan Hospital & 

Medical Center, OR 

Legacy Meridian Park Hospital, OR 

Legacy Mount Hood Medical Center, OR 

Legacy Salmon Creek Hospital, OR 

MultiCare Health System: 

Tacoma General Hospital, WA 

Mary Bridge Children's Hospital, WA 

Allenmore Hospital, WA 

Covington Outpatient Center, WA 

luly 12,20:JU 

Northwest Hospital & Medical Center, WA 

Oregon Health and Science University Hospital, OR 

Overlake Hospital Medical Center, WA 

Shriners Hospital for Children, OR 

St. Luke's Wood River Medical Center, ID 

St. Patrick Hospital and Health Sciences Center, MT 

Swedish Medical Center: 

Swedish Cherry Hill, WA 

Swedish First Hill, WA 

Swedish Ballard, WA 

University of Washington Medical Center, WA 

CALIFORNIA 

Bakersfield Memorial Hospital, CA 

Hoag Memorial Hospital Presbyterian, Newport Beach, 

CA 

John Muir Health System 

John Muir Health, Concord Campus, CA 

John Muir Health, Walnut Creek Campus, CA 

John Muir Behavioral Health Center, CA 

Kaiser Permanente, including 32 facilities in CA, CO, GA, 

HI, OH, OR, WA 

Sharp Coronado Hospital, CA 

st. Joseph Health System 

Santa Rosa Memorial Hospital (3 campuses), CA 

Petaluma Valley Hospital, CA 

St. Jude Medical Center, CA 

st. Joseph Hospital, CA 

St. Mary Medical Center, CA 

UCSF Medical Center, San Francisco, CA 

Washington Hospital Healthcare System, CA 

SOUTHWEST 

Catholic Healthcare West System Facilities including 40 

facilities in CA, NV, AZ 

Covenant Medical Center, st. Joseph Health System, TX 

Cypress Creek Hospital, TX 

Grand River Medical Center, CO 

Spring Branch Medical Center, TX 
280 


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JOINT STATEMENT FOR THE RECORD 

Subcommittee on Health, Committee on Energy & Commerce 

U.S. House of Representatives 

For the Hearing On Antibiotic Resistance And The Use Of Antibiotics 

In Animal Agriculture 

July 14,2010 

As organizations committed to protecting patients, public health, animal health, and food safety, we 

wish to submit this written testimony to express our concern about the misuse of antibiotics in 

agriculture and our strong support for policies, including the Preservation of Antibiotics for Medical 

Treatment Act (PAMTA, H.R. 1549, S. 619), that will institute a public health approach to 

antimicrobial use in animals. We commend the Subcommittee on Health for holding hearings to 

examine the growing public health threat of antibiotic resistance, including today's hearing 

specifically on the contribution of animal agriculture to the problem. We urge the Subcommittee to 

follow these hearings with prompt legislative action to greatly reduce or eliminate the non-judicious 

use of important antibiotics in animal feed and water. 

Our combined memberships include the country's foremost scientific and medical experts and 

represent more than nineteen million concerned Americans and health professionals. Our position is 

based on objective health interests and concerns that dangerous drug-resistant infections are rapidly 

increasing in hospitals and community settings, causing unnecessary human suffering and adding to 

the economic burden of U.S. healthcare costs as well as jeopardizing the effectiveness of treatments 

for sick animals. 

The development of antibiotics to treat life-threatening infections has been one of the most notable 

medical achievements of the past century. Physicians, healthcare professionals, and public health and 

food safety advocates are greatly concerned about the growing body of scientific evidence 

demonstrating that antimicrobial drug use in livestock and poultry contributes to the spread of drugresistant bacteria to people. Drug-resistant organisms are plaguing Americans, including otherwise 

healthy individuals, in healthcare settings and communities across the country. We are pleased that 

these concerns finally are being recognized and that Congress is poised to consider solutions to 

forestall epidemics of untreatable infections. 

Specifically, we support phasing out the use of antimicrobial drugs for growth promotion and feed 

efficiency, much more limited use for disease prevention, and requiring that all uses of these drugs be 

carried out under the supervision of a veterinarian and within the boundaries of a valid veterinarianclient-patient relationship - which we expect will end over-the-counter sales of tons of antimicrobial 

drugs annually. We support clearly defining the limited instances where antibiotics may be used 

judiciously in food animals for purposes of disease prevention and control and are eager to work with 

policymakers to ensure that any legislation considered is fully protective of public health. We urge 

Congress to enact a new antimicrobial policy that is mandatory, retroactive to already-approved 

drugs, and enforceable, in order to best guarantee a significant reduction in non-judicious antibiotic 

use. 
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While the U.S. Food and Drug Administration recently issued a draft guidance that suggests 

agreement with some of these principles, we are concerned that the agency has not clearly indicated 

to what extent preventative uses are encompassed in the guidance, nor has it laid out a timeline for 

action or a commitment to regulatory steps. It is therefore imperative that Congress act swiftly to 

protect public health. PAMTA is a sound science-based approach that is backed up by scores of 

scientific and medical publications and will protect the health of every American. 

By enacting P AMTA, Congress would eliminate non-judicious uses of antimicrobial drugs, including 

for purposes of growth promotion, feed efficiency and non-judicious disease prevention which have 

been practiced in animal agriCUlture for several decades. This would better protect the public against 

resistant infections and preserve the power of existing antibiotics. In addition, we urge Congress to 

ensure long-overdue veterinary supervision of all antibiotic uses in animals and end over-the-counter 

sale of antibiotics for animal agricultural uses. The sale of antibiotics for use in human medicine 

requires a prescription; there is no reason to permit a lower standard for agricultural purposes where 

considerably more antibiotic drugs are used annually. Finally, we would urge Congress to examine 

whether veterinarians should be permitted to sell antibiotics for a profit. Such a marketing pamdigm 

fosters inherent conflicts of interest that could lead to non-judicious uses of these precious drugs. In 

1995, Denmark put significant limits on the ability of veterinarians to profit from the sale of 

antibiotics in food animal production. This led directly to a reduction in total usage of antibiotics, 

especially tetracyclines. 

Adopting such policies would reflect the concerns of a broad consensus of the scientific, medical, 

public health and international health communities. Such consensus is buttressed by the actions of 

expert bodies and governments. For example: 

• Since 2002, the World Health Organization (WHO) has called upon all nations to terminate 

or rapidly phase out the use of antimicrobial growth promoters in food animals. 

• In 2003, the Institute of Medicine (lOM) of the National Academies of Science called on the 

FDA to ban the use of antimicrobials for growth promotion in animals, if those drugs were 

also used in human medicine. 

• In 2006, the European Union banned non-therapeutic use of antimicrobials, because such use 

was found to mise food safety concerns, and the ban was instituted to protect against further 

development of antimicrobial resistance. 

We recognize that phasing out of antibiotics for non-judicious uses in animals will require changes in 

the agricultural industry. But protection ofthe public's health must come first, and the phase-out can 

be conducted in a way that minimizes costs to the agriculture industry. Farmers in Europe have 

adapted to such a policy without undue disruption of production or increased consumer costs; the 

United States can learn from that experience while also protecting American lives. In addition, the 

U.S. Department of Agriculture has recognized that various production methods used in the United 

States today are viable alternatives to non-judicious antimicrobial uses and such alternatives are 

employed with little negative - or even with somewhat positive - economic impact to producers. 

We urge you to advance scientifically sound policies to phase out growth promotion and feed 

efficiency uses, and to strictly manage a narrow set of prophylactic uses while mandating veterinarypatient relationships and eliminating the over-the-counter sale of antibiotics for use in animals. 
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We remain committed to working with the members of the Energy and Commerce Committee to 

design these approaches in ways that will best protect the lives and health of both humans and 

animals. 

Alliance for the Prudent Use of Antibiotics 

American Academy of Pediatrics 

American Association of Critical-Care Nurses 

American Medical Association 

American Nurses Association 

American Public Health Association 

American Society of Health-System Pharmacists 

APIC-Association for Professionals in Infection Control and Epidemiology, Inc. 

Consumers Union 

Food Animal Concerns Trust 

Humane Society of the United States 

Infectious Diseases Society of America 

Institute for Agriculture and Trade Policy 

Keep Antibiotics Working 

Michigan Antimicrobial Resistance Reduction Coalition 

National Foundation for Infectious Diseases 

Society ofInfectious Disease Pharmacists 

The Pew Charitable Trusts 

Union of Concerned Scientists 
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KEEP 

ANTmIOTICS 

_~O~~ ______________________ _ www,KeepAntibloticsWorlllng,com 

STEERING COMMImE 

CenterforSt-iente 

in the Pubih: Interest 

Environmental Defense 

Food Animal 

Concerns Trust 

Humane Soci~ty 

ofthe United States 

IllstitutefprAgTicutture 

and Trade Policy 

lymphoma Foundation 

of America 

Nationat eathotic 

Rural LifeConferente 

Natura! Resoun::es 

Defense (ouncH 

Physicians- for Sodal 

Responsibility 

Safe Tables OUf Priority 

(5.T.0.P.) 

Sierra Club 

Union of ConcemGMI 

Scientists 

Waterk~r Alliam::e 

Keep Antibiotics Working 

Statement for the Record 

House of Representatives, 

Health Subcommittee to the Energy and Commerce Committee 

Hearing on the Public Health Risk from the Use of Antibiotics in 

Food-Producing Animals 

Wednesday, July 14,2010,2:00 PM 

Keep Antibiotics Working appreciates the attention that this committee is giving 

to the public health problem of antimicrobial resistance resulting from the use of 

antibiotics in food producing animals. Keep Antibiotics Working (KA W), a 

coalition of health, consumer, agricultural, environmental, humane and other 

advocacy groups, whose organizations have more than ten million members, 

is dedicated to eliminating this major cause of antibiotic resistance. 

Antibiotic resistance has long been considered by the Centers for Disease 

Control (CDC) one of the "most pressing public health problems.'" People 

already die from infections untreatable with existing antibiotics. More - perhaps 

many, many more - will die in years to come. This critical public health problem 

therefore requires a comprehensive approach that addresses all sources of 

resistance affecting human health. 

Summarizing four decades of scientific research, the U.S. Food and Drug Administration 

recently identified an important part of the problem: the injudicious use of antibiotics in food 

animal production". 

The age of miracle antibiotics may be coming to an end. Before even more people die of 

resistant infections, KA W therefore advocates that Congress at long last address this crisis, 

and, in particular, support the scientifically sound approach found in H.R. 1549, 

The Preservation of Antibiotics for Medical Treatment Act (P AMTA). 

PO Bo); 14590 ~ Chicago, Il60614-0590 

ptjONi, 773'S2Sw4952 "fr fAX' 773·5-25-5226 E·M41l, information@KeepAnt!biotic..sWorking.(om 
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Yes, the FDA has identified the need to act. But it has failed to take any action steps, or, even 

to identify what steps it intends to take to address this critical public health problem. Because 

of the FDA's historic failure to act, Congress must step in and assure by passing PAMTA that 

FDA moves forward to protect public health. 

Antihiotic-resistant infections: Major threats to food safety and public health 

As is well known to the medical community, we face an urgent crisis of antibiotic resistance. 

Once considered miracle drugs, antibiotics are becoming less and less effective at treating 

infections and disease. Many Americans have died or fallen seriously ill due to antibioticresistant bacteria. When initial antibiotics don't work, it can mean several days of unnecessary 

pain and suffering while doctors figure out another drug is needed. Treating a patient with an 

ineffective drug also can give infections the chance to progress to more serious illness. For 

cases where none of the available antibiotics work, resistance becomes a matter of life and 

death. In addition to rendering drugs ineffective, resistant strains are often more virulent than 

their susceptible counterparts - causing more serious disease, longer hospitalizations, and 

driving higher healthcare costs. 

Antibiotic resistance is particularly worrisome in terms of food safety. Half of all human 

Campylobacter infections are drug resistant, as are one in five Salmonella infectionsili. 

Salmonella and Campylobacter, the most common sources of food borne illnesses in the . 

United States, account for well over a million resistant infections in this country each yearlY. It 

is not unusual for Salmonella to be resistant to many drugs at once, as was the case for several 

outbreaks linked to ground beef last year. Getting sick with multi drug resistant strains of 

Salmonella can "increase the risk of hospitalization or possible treatment failure in infected 

individuals'''. 

Antibiotic resistance is not a problem only for humans. The bottom line of 

antibiotic resistance-harder to treat diseases and higher medical costs-is also true 

for veterinary medicine. 

Antihiotic resistance results from antihiotic use 

Microorganisms exist in an interconnected ecosystem and travel back and forth among 

humans, animals, and other elements in the environment. Exposure to antibiotics selects for 

those bacteria that can withstand the drug. Resistant organisms are most encouraged in settings 

where antibiotics are heavily used-primarily human medicine, veterinary medicine, and food 

animal production. But antibiotic-resistant microorganisms generated in the guts of pigs in the 

Iowa countryside, for example, don't stay on the farm. They can be transmitted to humans in at 

least three ways: carried on meat or poultry; colonizing farm workers who transmit them into 

the community; or moving through water and soil, which can lead to the contamination of fresh 

produce. 

When the antibiotics used in raising food animals such as pigs are the same (or more precisely, 

in the same classes) as those used in doctors' offices, bacteria from the pigs will be impervious 

to therapies based on the drugs vi. 
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The fundamental approach to prolonging the effectiveness of drugs is to curb unnecessary uses. 

Every sector needs to accept responsibility and curb its own unnecessary antibiotic use. 

The medical profession has stepped up to the plate and identified and attempted to address the 

issue by establishing guidelines against unnecessary uses, like treatment of viral diseases, and 

aggressively seeking to reduce prescriptions for those uses. Periodically, it evaluates the 

effectiveness of its initiatives. 

To date, the veterinary and industrial agriculture communities lag far behind the 

human medical community in taking similar steps to reduce unnecessary use. Instead it 

has spent its energies in minimizing or denying the problem. 

Production agriculture's contribution to tbe problem 

As it turns out, food animal production uses the lion's share of the antibiotics in the United 

States-about 70 percent of the total. The estimates include drugs used in only three livestock 

sectors-poultry, swine, and beef cattle-and only for purposes other than treating sick 

animals-nontherapeutic purposes like growth promotion and routine disease prevention. All 

of these antibiotics, among theIIl penicillins, tetracyclines, and erythromycin-are in classes of 

drugs used in human medicine vu Most of these drugs are delivered to animals mixed in their 

feed. 

Why do animal producers use such huge quantities of valuable drugs when most of 

the antibiotics are not used to treat disease? In part, because growth promotion and 

feed efficiency uses are thought to improve the bottom line even in healthy animals. But 

also because drugs are needed to compensate for crowded, stressful, and unhygienic conditions 

characteristic of many animal production operations. 

The link between animal production and reduced efficacy of human drugs 

In light of the enonnous use in production agriculture of exactly the same drugs used in human 

medicine, it is difficult to imagine a credible scenario under which resistant bacteria generated 

in the billions of animals we grow for food would not find their way to human populations and 

erode the effectiveness of our antibiotic arsenal. And indeed a mountain of scientific studies 

now demonstrates that that is the case. 

The list of antibiotic-resistant pathogens originating in animals is long. It includes 

the foodbome illnesses mentioned above, caused by Campylobacter and Salmonella. Resistant 

urinary tract infections, which can be caused by a number of different animal-associated 

bacteria, including E. coli, have also been linked to animal sources. Microorganisms 

originating in animals are also often associated with bloodstream infections that affect 

hospitalized patients. Resistance in Campylobacter and Salmonella is associated with increased 

bloodstream infections, increased hospitalization, and increased deathviii. And the list continues 

to grow. 
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We have only recently learned that livestock can be an important source of life-threatening 

methicillin-resistant Staphylococcus aureus (MRSA). In Europe, a strain of MRSA responsible 

for 20 percent of human MRSA infections in the Netherlandsi

' has been shown to be 

transmitted from pigs to farmers and their families, veterinarians, and hospital staff'. The pigassociated strain of MRSA has now been found in Canada'i and in the United Statesxii. 

hnportantly, the list of resistant bacteria themselves traceable to animals does not convey the 

full scope of the problem. Bacteria are promiscuous. They can acquire bits of DNA, including 

resistance traits, from unrelated bacteria. This means that the traits that originate in animal guts 

might move through the microbial ecosystem to confer resistance on bacteria not of animal 

origin. In addition, bacteria are known to harbor large circles of DNA that carry ten or more 

resistance traitsxiii. In these circumstances, the use of one antibiotic, say penicillin, can 

simultaneously drive up the levels of resistance to other antibiotics, like tetracycline, 

gentamicin, and cephalosporins. 

The literature in this arena is voluminous and the conclusion is clear: 

antibiotic overuse in agriculture-just as in human medicine-is undercutting the 

efficacy of important human therapies and generating more virulent pathogens. 

The recent FDA Draft Guidance Document #209 provides an overview of 40 years of studies 

on this topic'iv and finds that independent reviews of the data have consistently found a risk to 

public health and have repeatedly recommended reducing overuse. 

Reducing antibiotic use 

As long as the massive use of antibiotics continues, animals will remain an important source of 

resistant pathogens, dangerous to both animals and humans. The straightforward solution to the 

problem is to reduce the use of antibiotics in animal production and thereby diminish the pool 

of resistant organisms and traits. 

Fortunately, the largest amounts of antibiotics in food animal production are used for growth 

promotion, feed efficiency, and routine disease control, uses that can be eliminated without 

damage to animal health or unacceptable increases in animal production costs or consumer 

meat prices. 

As documented in the scientific literature, these uses can be reduced or eliminated with 

modern management practices. The viability of such practices has been demonstrated in a 

variety of different kinds of animal agricultural operations. On the more industrialized side, 

Tyson, Inc., a major poultry grower and retailer, was able to develop systems for all of its 

retail chicken that used no antibiotics at all. On the more niche side, cattle grown out-of-doors 

and fed primarily grass rarely need antibiotics at all. Many American producers, like 

Laura's Lean Beef, Niman Ranch, and Coleman Natural, are thriving in the marketplace 

selling beef and pork produced without antibiotics. 

A 2009 report from the USDA Economic Research Service looking at changes in 

U.S. agriculture supported the notion that antibiotic use in agriculture could be reduced without 
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significant costs to producers". The USDA confmned that large fanns are more likely than 

small fanns to use antibiotics in feed but noted that the benefits of this use is limited to certain 

stages of production, particularly pig nurseries. For other stages of production like finisher 

pigs, there were few benefits. The USDA also found that practices such as increased sanitation 

and vaccination could be substituted for antibiotics. 

Data from Europe also support the feasibility of reducing antibiotic use even in 

intensely industrial poultry and swine systems. In 1999, Denmark, the world's leading 

pork exporter, ended all use of antimicrobial growth promoters without reducing the 

productivity of its livestock sector'vi. 

Policy recommendation 

Because as mentioned above, reductions in the use of antibiotics can often be achieved by 

managing animals and their feeds better, production agriculture represents a golden 

opportunity to reduce the pressure driving up resistance traits in the microbial ecosystem. 

A sensible and protective two-part policy would: 

a) Reduce antibiotic use wherever possible in animal production by establishing and enforcing 

clinical practice guidelines in veterinary medicine 

b) Review, and where supported by the evidence, cancel the use of those antibiotics also used 

in human medicine (so-called medically important drugs) in animal agriculture for nontherapeutic purposes like growth promotion, feed efficiency, and routine disease prevention. 

The classes of medically important drugs are penicillins, tetracyclines, sulfonamides, 

lincosamides, streptograrnins, aminoglycosides, and macrolides. 

Such a policy would lead to substantial reductions in antibiotic use without 

depriving producers of antibiotics to treat sick animals. It is important to point out that a 

number of antibiotic-like drugs are not used in human medicine, and that, under this 

approach, these drugs would be available to producers for any purpose including feed 

efficiency or routine disease prevention. 

To accomplish public health and food safety goals, the policy needs to be effective across the 

board. A level playing field will force innovation in the industry and enable producers to resist 

temptation to fall back on antibiotics to compensate for sloppy management practices. 

Reduce through PAMTA 

The FDA has the authority to cancel antibiotics that are no longer safe from a resistance point 

of view, but so far has used it only in the case of fluoroquinolones in poultry. 

While FDA has correctly identified the problem of antibiotic overuse in its new Draft 

Guidance Document #209, the document gives no indication that FDA is taking steps to 

actually prohibit antibiotic overuse. There is nothing in the new draft policy by the FDA that 
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even suggests that the FDA has overcome the legal and institutional barriers that have long 

blocked action on thls important public health issue. The policy itself falls short because it only 

recommends reduction of antibiotics used for growth promotion. The FDA guidance does 

describe a vision of appropriate preventative use but the FDA has no authority to regulate 

veterinary practice to the extent that would be necessary to require that thls vision be followed 

{Once drugs are on the market, and there are many more existing approvals for disease 

prevention than growth promotion, the FDA has very little ability to change how they are being 

used.} 

So even if the current policy were to be implemented sometime in the future, the public health 

impact could be limited because it fails to recognize that drugs used for growth promotion can 

often be used in the exact same manner as drugs used for disease prevention. There is no 

benefit to be gained from continuing to use the same drugs in the same manner but calling it 

disease prevention instead of growth promotion. The FDA's push for voluntary changes by 

drug manufacturers is hlghly likely to result in only thls type of cosmetic change and is 

unlikely to lead to real reductions in use and the subsequent reductions in resistance. 

The failure of the FDA to move gave impetus to the Preservation of Antibiotics for Medical 

Treatment Act (PAMTA) and Draft Guidance #209 does nothlng to diminish the need for 

legislative action. Thls legislation would require the FDA to review antibiotics used in animal 

agriculture to determine whether they put public health at risk by leading to increased 

resistance and to withdraw from the market in a timely manner those drugs that cannot be 

shown to be safe. 

Thls legislation has been endorsed by over 350 organizations, including the American Medical 

Association, American Academy of Pediatrics, American Nurses Association, American Public 

Health Association, and Infectious Diseases Society of America. 

Delay on antibiotics: a disadvantage in the marketplace 

The European Union (EU) now has an EU-wide ban on non-therapeutic uses of antibiotics'';;. 

New Zealand"m, Thailand'"x, and Korean also have either enacted or will soon enact bans on 

certain non-therapeutic antibiotic use. 

As warned in a Government Accountability Office (GAO) report from 2004x>ci, these countries 

also represent potential challenges to U.S. products in the global marketplace. Under the trade 

rules, countries can restrict imports that do not conform to certain rules, provided they adhere 

to those rules themselves. For example, Korea could potentially restrict imports that relied on 

medicated feed not allowed in Korea. The greater the number of export partners that adopt 

such bans, the more vulnerable our meat exports in the global marketplace. As further noted in 

the GAO report, if a major importer were to restrict trade from the United States because of the 

use of nontherapeutic antibiotics, that action would override any economic benefits of 

thls practice. 

The U.S. animal agriculture industry is at risk of following the example of the U.S. 

auto industry and failing to see where the market is going. Increasingly, consumers are seeking 
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meat from animals raised without these antibiotics. International competitors are beginning to 

meet this demand. In addition to protecting public health, minimizing antibiotics use in 

livestock can help U.S. producers add consumer value to their products, and position 

themselves advantageously in the global marketplace. American producers should be supported 

in reducing their antibiotics use. 

Conclusion 

Antibiotic-resistant infections are making more people sick, and keeping them sick for longer. 

Longer hospital stays to treat these infections are also increasing the nation's health costs-by 

one recent estimate adding well over $24 billion per year to the health care tab in the United 

Statesxxii• And, of course, more time away from work is a drag on our economy. 

We have waited far too long for action to reduce the unnecessary uses of antibiotics in food 

animal production. While we have dithered, drugs have stopped working, new resistant 

diseases have emerged, old diseases have gotten worse, and people have died. 

Neither can we rely on the arrival of new drugs. The unhappy truth is that there are virtually no 

new classes of antibiotic drugs in the pipelinexxiii• The discovery of new classes of antibiotics, 

once almost a predictable occurrence, has become frustratingly difficult in recent decades. 

Even if we were able to develop a portfolio of new antibiotic drugs, we'd risk bacteria 

becoming resistant to them too, unless we take steps to assure they are used judiciously. We 

must act to preserve the continued effectiveness of today' s antibiotics, or risk the age of the 

miracle antibiotics coming to an end. 

While FDA in Guidance #209 has recognized the problem and the solution, there is nothing in 

the document that indicates it is ready to tackle this problem head on. 

There is simply no reason to continue the profligate use of valuable antibiotics for economic 

purposes or to compensate for the stressful, crowded anima! production facilities. The 

improved management practices necessary to reduce, if not avoid, antibiotic use are available 

and feasible. Yet, production agriculture has been unwilling to acknowledge, much less act on, 

this problem. We cannot tolerate this situation any longer. To protect our food supply and the 

public health, we must pass PAMTA. 

Centers lor Disease Control (CDC). 2004. Background on antibiotic resistance. Online at 

www.cdc.gov/getsmart. 

U Food and Drug Administration (FDA). Draft Guidance #209. The Judicious Use 01 Medically 

Important Antimicrobial Drugs in Food-Producing Animals. Online 

at:http://www.lda.gov/downloads/AnimaIVeterinary/GuidanceComplianceEnlorcement/Guidancel 

orlndustry/UCM216936.pdl 

m Centers lor Disease Control (CDC). 2009. National Antimicrobial Resistance Monitoring System 

(NARMS) lor Enteric Bacteria: Human Isolates. Final Report. 2007. Atlanta, GA: U.S. Department 01 

Health and Human Services, CDC. 
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I, Total number of illnesses from USDA (www.ers.usda.gov/Data/FoodBornelllness) is multiplied by 

data from footnote 3 to obtain totals for resistant illness 

UsDA/Fsls. 2009. California Firm Recalls Ground Beef Products Due to Possible Salmonella 

Contamination. Online at: 

http://www.fsis.usda.gov/News_&_Events/RecaIL041_2009_Release/index.asp 

,; McEwen 5, and Fedorka-Cray P. 2002. Antimicrobial use and resistance in animals. Clinical 

Infectious Diseases 34:593-106. 

,II Mellon M, Benbrook C, and Benbrook K. 2001. Hogging it!: Estimates of Antimicrobial Abuse in 

Livestock. Cambridge, MA: Union of Concerned Scientists. Online at 

www.ucsusa.orgffood_and_agriculture/science_and_impacts/impacts_industrial_agriculture/hoggi 

ng-itestimates-of.html 

vHi Helms M, et al. 2005. Adverse health events associated with antimicrobial drug resistance in 

Campylobacter species: a registry-based cohort study. Journal of Infectious Diseases 191:1050-5; 

Varma JK, et al. 2005. Antimicrobial-resistant nontyphoidal Salmonella is associated with excess 

bloodstream infections and hospitalizations. Journal of Infectious Diseases 192:554-61. 

;, van loo I, et al. 2007. Emergence of methicillin-resistant Staphylococcus aureus of animal origin in 

humans. Emerging Infectious Diseases [serial on the Internet] December. Online at 

www.cdc.gov/EID/content/13/12/1834.htm. 

, Huijsdens X, et al. 2006. Community-acquired MRsA and pig farming. Annals of Clinical 

Microbiology and Antimicrobials 5:26. Online at www.ann-clinmicrob.com/content/5/1/26.;Voss 

A, et al. 2005. Methicillin-resistant Staphylococcus aureus in pig farming. Emerging Infectious 

Diseases 11:196S-i;. 

,; Khanna T, et al. 200B. Methicillin resistant Staphylococcus aureus colonization in pigs and pig 

farmers. Veterinary Microbiolgy 128:298-303. 

,;; Smith T, et al. 2008. Paper presented at the International Conference on Emerging Infectious 

Diseasest Centers for Disease Control and Prevention, Council of State and Territorial 

Epidemiologists, Atlanta, GA, March, and personal communication. 

xIII Partridge SRI et al. 2009. Gene cassettes and cassette arrays in mobile resistance integrons. 

Federationof European Microbiological Societies (FEMs) Microbiological Reviews 33:757-84; Akwar 

HT, et al.2008. Associations of antimicrobial uses with antimicrobial resistance of fecal Escherichia 

coli from pigs on 47 farrow-to-finish farms in Ontario and British Columbia. Canadian Journal of 

Veterinary Research 72:202-10; Gillings M, et al. 2008. The evolution of class 1 integrons and the 

rise of antibiotic resistance. Journal of Bacteriology 190:5095-100. 

,I' Food and Drug Administration (FDA). Draft Guidance #209. The Judicious Use of Medically 

Important Antimicrobial Drugs in Food-Producing Animals. Online 

at:http://www . fda .gov/ downloads/ AnimalVeterinary/Gu ida nceCom plianceEnforcement/Guida ncef 

orlnd ustry /U CM 216936.pdf 

" USDA Economic Research Service. 2009.The Transformation of U.S. Livestock Agriculture: Scale, 

Efficiency, and Risks. Online at www.ers.usda.gov/Publications/EIB43/EIB43e.pdf. 

,,; Aarestrup, F et al. 2010. Changes in the use of antimicrobials and the effects on productivity of 

swine farms in Denmark. Am J Vet Res. 71(7):726-33. 

xvii European Commission. 2005. Ban on antibiotics as growth promoters in animal feed enters into effect, 

JP/05/1687. Online al: 

http://europa.euirapidipressReleasesAclion.do?reference=IP/05/1687&fonnal=HTML&aged=O&langnage 

=EN&guiLanguage=en. 
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.... n Government Accountability Office (GAO). 2004. Antibiotic Resistance: Federal Agencies Need to 

Better Focus Efforts to Address Risk to Humans from Antibiotic Use in Animals, GAO-04-490, April 

22. 

,', Brooks E. 2008. Reconciling scarcity and demand through innovation. Food Business Asia, Issue 21, 

July/August. Online at www.efeedlink.com/ShowDetai!/03c885e3-7852-439a-gefOa8aOb66a749c.html. 

" Pig Progress. 2008. Korea to ban antibiotics in feed. Online at: 

http://www.pigprogress.net/news/korea-to-ban-antibiotics-in-feed-id1914.html 

,,' GAO. 2004. Antibiotic Resistance. 

,," Foster. 2010. Economic Consequences of Antibiotic Resistance. Presented at 2010 Annual 

Conference on Antimicrobial Resistance. February 1-3. Bethesda, MD. 

"ill Infectious Diseases Society of America. 2003. Bad bugs, no drugs: Defining the antimicrobial 

availability problem. Backgrounder. Online at www.idsociety.org/badbugsnodrugs 
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STATEMENT FOR THE RECORD 

Subcommittee on Health, Committee on Energy & Commerce 

U.S. House of Representatives 

For the hearing, "Antibiotic Resistance and th~ Use of Antibiotics In Animal 

Agriculture" . 

July 14. 2010 

Jim Slama 

President 

FamllyFarmed.org 

Oak Park~IL 

Mr. Chairman and Members of the Committee, I am Jim Slama. President of 

Familyfarmed.org, an organization that assists small farmer access the food 

marketing and distribution system. I am writing to fully support the Preservation 

of Antibiotics for Medical Treatment Act (PAMTA). For the past decade, 

FamllyFanned.org has supported the development of local food systems. In this 

time, we have worked with many farmers who produce livestock, poultry, and 

dairy products and who do not use antibiotics for growth promotion. 

Many of these farmers and ranchers are highly successful. They have rapidly 

growing businesses fueled In part by consumers eager to purchase naturally 

raised meat and dairy products. In recent months, the demand for grass-fed beef 

products has been very strong and some producers have been unable to keep 

up with the demand. And, companies like Chlpotle, Whole Foods Market. Trader 

Joes, and others are furthering the market development for naturally raised meat 

and dairy products by purchasing them in high volumes. 

Grass-fed livestock production is an environmentally friendly system that 

provides consumerswlth healthy. great tasting food. PAMTAwill encourage 

even more produ~ to move into this nlche and meet tlie demand for these 

products. Thanks for your Interest In this topic. 
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Statement of 

Robert S. Lawrence, MD 

The Center for a Livable Future Professor·ofEnvironmental Health Sciences 

Johns Hopkins Bloomberg School of Public Health 

Director. Center for a Livable Future 

The Johns Hopkins University 

Hearing on 

Antibiotic Resistance and the Use of Antibiotics in Animal AgrIculture 

Subcommittee on Health 

Committee on Energy and Commerce 

U.s. House of Representatives 

July 14. 2010 
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The relationship between food animal production and antimicrobial resistance extends 

beyond one or two particular drugs; almost e'Very. major class of medically im'portant 

antimicrobials, from penicillin to third-generation cephalosporin compounds, has been 

approved for use In animal agriculture (Sarmah. et al., 2006). In some cases, new drugs 

were licensed for agricultural use before their approval In human medicine. Resistance to 

these drugs was then detected before they became available to physicians for treatment of 

human patients, further suggesting a causal relationship between animal agriculture and 

resistance (K1eke, et a\., 2006). Indeed, researchers have consistently found that using 

antimlcroblals'in food animal production shortens the "useful life" of existing drugs to treat 

both human and veterinary diseases (Smith,et aI., 2002). 

The current discussion of antimicrobial resistance has focused on the inapprQpriate 

prescription of drugs by physicians, and noncompliance with treatment regimens by 

patients. The animal agricultural Industry asserts these factors as the primary cause of 

resistance. However, it is estlmllted that food animals consume as much as 70 percent of 

antimicrobials administered in the United States - almost 2S million pounds per year 

(Mellon, j:!t al., 2001)., In North Carolina alone, the quantity of antl~lcrobials consumed by 

food animals exceeds the quantity utilized In human medicine throughout the United States 

(FIorini, eta!., 2005). The use of antimicrobials .inanlmal agriculture clearly exceeds their 

prescription in human medicine, suggesting the importance of food animal production's 

contribution to resistance. 

The use of antimicrobial drugs as growth promoters In food animal production is ofspeclaI 

concern. In these cases, drugs are typically added to feed and water at levels below those 

used to treat clinical.lnfection in animals. The exposure of bacteria til lower concentrations 

of antimicrobial agents selects for resistance. Under these condltionsj resistant strains. are 

more likely to survive and reproduce, and, given that most bacteria reproduce every 20-30. 

minutes, an entire population will quickly express resistance as the susceptible strains of 

the bacteria are eliminated by the low-dose antibiotics (Spellberg, et al., 2008). 

Furthermore, the industry asserts that, beyond growth promotion, antimicrobial drugs 

remain necessary for treatment, prevention, and control of pathogenic bacteria, often 

,confl.ating these pU.rl~oses.an,~ ~oIlecti ... elY.1abeJlng~em "t:I1erapeu* u.se.", YeryJew 

antimicrobials used in agriculture are administered as treatment for infection (Mellon, et 

al.,2001). Nevertheless, food animals should receive treatment for clinical disease. 

Furthermore, using antimicrobial drugs to control the outbreak of specific, diagnosable 

pathogens also merits consideration, with proper regulatory and veterinary oversight. 
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Environment: The excretion of resistant enteric bacteria In animal waste likewise creates 

exposure pathways between food animals and human populations. Each year, according to 

USDA, confined food animals produce 335 million dry tons ohvaste, more than 40 times 

the mass of human biosollds generated by publicly owned treatment works (7.6 million dry 

tons were generated In 2005. for example). 

When applied to farmland as fertilizer, typically without any pretreatment, animal waste 

contaminates surface and groundwater. Resistant E. coli and resistance genes have been 

detected in groundWater In North Carolina, Maryland, and Iowa (Anderson and Sobsey, 

2006; Stine, et al, 2007; Mackie, et aI., 2006). Resistant bacteria have also been isolated in 

air samples collected downwind of production facilities, while fewer bacteria were 

identified in samples collected upwind (Gibbs, et aI., 2006). 

Given the ability of bacteria to exchange resistance genes In the environment, and the 

numerous environmental pathways that connect food animal production with human. 

populations, no method of controlling the spread of pathogens can substitute for ending the 

practices that have accelerated the.development of antimicrobial resistance. Just one 

resistant bacterium that "escapesN 

can quickly reproduce, creating ~ountless opportunities 

for human exposure. 

Rural Communities: Rural communlHes and farmworkers face especially high risks of 

infection with antibiotic resistant bacteria and suffer dIsproportionately from. the use of 

antimicrobial drugs in food animal production. Resear«;hers have repeatedly documented 

this disproportionate risk {Van den Bogaard and Stobberlngh 1999; Price;.atal .. 2007; 

Olenlyl199B; Saenz 2006: Smith, et al., 200S; and KE Smith. eta\. 1999}. 

Policy Responses 

There Is consensus within public health and human medichte that the administration of 

antimicrobial drugs as growth promoters In food animal production should end; The 

American Public Health Association has called for banning non-therapeutic use of 

antimicrobials in food animal production (APHA, 2003). The World Health Organization, 

the American Medical Association, and the Infectious Diseases Society of America have 

made similar recommendations (WHO, 2003; Fryhofer, 2010: Spellberg, 200B). 

The WHO has stated, "In the absence of a publlc health safety evaluatlon, [governments 

should] terminate or rapidly phase out the use of antimicrobials for growth promotion if 
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treatment options, Increased health care costs, and hefghtenedvirulence of bacterial 

infections - more than offsets these supposed benefits. Nevertheless, producers and 

integrators ignore these health costs, which have been externalized to the larger society, 

and are not captured in the retail price of consumer meat products (Osterberg and 

Wallinga, 2004). 

Conclusion 

The Food & Drug Administration recen.tly released a draft Hguidance documen~ that 

reviewed the evidence linking antimicrobial resistance. to food animal production. FDA 

concludes, "Using medically important antimicrobial drugs for production purposes Is not 

In the interest of protecting and promoting public health" (FDA, 2010). FDA clearly 

supports the conclusions of public health researchers discussed here; and has begun taking 

action in response to antimicrobial resistance accelerated by animal agriculture. No 

scientific debate exists on these Issues - only political questions remain. 

I commend members for their leadership on this topic. and urge further action to fully 

prohlhlt using antimicrohial drugs for growth promotion and prophylaxis. Preserving the 

efficacy of antimicrobials in human medicine requires Immediate action, and I urge 

Congress to move quickly in taking steps to protect the public's health. 
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Kieke AL,Borchardt MA, Kieke BA, et al. .tJseQf streptogramln growth promoters in poultry 

and isolation of streptogramln-reslstant Enterococcus faeclum from humans. J Infect Dis' 

2006; 194:1200-8. 

Klare I, Badstubner D, Konstabel C, Bohme G. Claus H, Witte W. Decreased Incidence of 

VanA-type vancomycin-resistant enterococci Isolated from poultry meat and from fecal 

samples of humans In the community after discontinuation of avoparcin usage in animal. 

husbandry. Mlcrob Drug Resist 1999; 5:45-52. 

Luangtongkum T, Morishita TY, Ison AJ,Huang 5, McDermott PF, Zhang Q. Effect of 

conventional and organic production practices on the prevalence and antimicrobial 

resistance ofCampylobacter spp. in poUltry. Appl Environ Mlcrobiol2006: 72:3600-7. 

Mackie RI, Koike 5, Krapac L Chee-Sanford J. Maxwell 5, Aminov RI. Tetracycline residues 

and tetracycline resistance. genes In groundwater Impacted by SWine production facilities. 

Anim Biotechnol2006; 17:157-76. 

McEwan SA, Fedorka-Cray PJ. Antimicrobial use and resistance in animals. Clinical 

Infectious Diseases 2002; 34:593-5106. 

Mellon M, Benbrook C, Benbrook KL. Hogging It: Estimates of antimicrobial abuse in 

livestock. Cambridge, MA: Union of Concerned Scientists: Publications, 2001.· 

Miller GY, Algozln KA, McNamara PE, Bush EJ. Productivity and economic effectS of 

antibiotics use for growth promotion In U.s. pork production. Journal of Agricultural and 

Applied Economics 2003: 35:469·482. 

NWosu YC. Antibiotic resistance with particular reference to soil microorganisms. Res 

Microblol2001; 152:421-30. 

Ojenlyi AA. Direct transmission of Escherichia coif from poultry to humans. EpidemloI Infect 

1989; 103:513-22. 

Osterberg D, Wallinga D. Addressing externalities from·swine production to reduce public 

health and environmental impacts. American Journal of Public Health 2004: 94:1703·1708. 
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community from the Infectious Diseases Society of America. Clinical Infectious DIseases 

2008; 46:155-64. 

Stine OC, Johnson JA, Keefer-Norris A, et a!. Widespread distribution of tetracycline 

resistance genes in a confined animal feeding facUity. Int J Antimlcrob Agents 2007; 

29:348-52. 

Sunde M., Norstrom M. The prevalence of, associations between and conjugal transfer of 

antibiotic resistance genes in Escherichia coli isolated from Norwegian meat and meat 

products. J Antimicrobial Chemotherapy. 2006; 58:741-747. 

van den Bogaard AE, Stobberingh HE. Antibiotic usage in animals: impact on bacterial 

resistance and public health. Drugs 1999; 58:589-607. 

WHO (World Health Organization). Available at: 

httpi(/www,who,int/csr/resources/publications/dI'ijgresist/en/BGlobal Stratpdf 
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STATEMENT FOR THE RECORD 

Subcommittee on Health, Committee on Energy & Commerce 

U.s. House ofRepresentatlves 

For the hearing, "Antibiotic Resistance and the Use of Antibiotics in Animal 

Agriculture" 

July 14, 2010 

BUlKurtis, 

Chatnnan and Founder 

Tallgrass Beef Company (A grass-fed and grass-finished company) 

The Grass-fed Alternative 

If antibioticS were so important to raising beef, I often wonder how millions 

of cattle survived the cattle drives from Texas to Kansas and eventually to Chicago's 

stockyards in the 1800's. But they did survive, primarily on a diet of grass and 

forage' as they have evolved over thousands of years. 

Today, onlya few ranchers In the United States raise cattle on grass, start to 

finish, compared with more than 90 million head that support a vast beef Industry 

based on feeding com to the animals. This change in diet occurred nearly sixty 

years ago and leads directly to our problems with feeding antibiotics to livestock 

Why the system changed can be traced to NeW Deal polldesto save America's 

small farms during the Great Depression. Government price supports and direct 

subsidies made sure that corn, cotton, sugar, soybeans and wheat continued to feed 

us, even If all else failed. 

. Over the years, those farm policies would change but the subsidies, especially 

for corn, would never go away. 

In addition, the agricultural colleges started experimenting. with hybrid 

strains of agricultural crops to withstand changes in climate. and fight pests. The 

result would increase yields, especially for corn. 

And a third development would help revolutionize U.S. agriculture. A new 

fertillzer with ammonia nitrate could enhance the nItrogen content -of soil to 

dramatically Increase yields. 

These three developments came together during WWII with amazing results. 

Without Imowlng it, the U.S. had created the ability to grow more corn than 

anywhere else in the world-and we did. 

Corn was piled beside grain elevators and railroad tracks for lack of ran cars 

to transport it Farmers sought new markets for corn preferring to sell It rather 

than bUty:lt--

One alternative was to feed the corn to livestock The starch and sugar 

created extra Intramuscular fat that was promoted as "marbling'. It made the meat 

juicy and tender and allowed the animals to fatten quickly. 

By the early 1950's, large feeding operations began to concentrate thousands 

of animals into paddocks so they could be served by one feed truck The diet was 
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3 

Since grass-!ed and grass-jinished means no com or grain is used as feed, 

there are no -feedlots and hence, far fewer occasions to need antibiotics. My 

company, Tallgrass Beef, doesn't use any. No growth hormones are admln[stered. 

The environment Is better for it-the cattle graze the pastures and naturally fertilize 

it too, without producing an overabundance of waste In one concentrated location, 

as often occurs with feedlots. 

The cattle are treated humanely. 

The grass-fed movement is gaining momentum because the beef tastes 

richer, more like the original taste. And once the chemicals are removed, grass-fed 

beef, according to Clemson University researchers, contains twice the amount of a 

potent cancer fighting compound called conjugated linoleic add. They found the 

beef [s leaner and contains greater concentrations of desirable fatty adds and 

antioxidants. These benefits come from raising cattle without the use of any 

antibiotics. 

Grass-fed beefwill not replace the com-fed model overnight but the potential 

benefits offer an Intriguing alternative to the concentrated feeding operations and 

their need for antibIotics. Right now, it's a niche market in the scheme of things • 

But given a little help In the form of research and government Incentives-to expand 

the grass-fed, grass-finished program, I think It could provide valuable answers to 

the beefindusny's problems. 

bkurtis@ta1lgrassbeeicom 
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STATEMENT FOR THE RECORD· 

Subcommittee on Health, Committee on Energy & Commerce 

" U.S. House of Representatives 

For the hearing, "Antibiotic Resistance and the Use of Antibiotics In.AnimaI Agricultare" 

July 14, 2010 

Everly Maeario. SeD, MS, MEd ' 

Public Health Communlcatlons Research Consultant 

As a public health communications professional worlcing for the renowned MRSA Research Center at the 

University of Chicago, I am committed to protectiag human lives and educatiag the medical community and 

general public about ways to prevent deadly antibiotic-resistant infections. Those ofus working to promote.public 

health 8reatIyappreciate the Subcommittee on Health's recent attention to the growing public health !brest of 

anllmotic resistance, inCluding today's hesring specifically on the contribution of animal agriculture to the problem. 

I sincerely hope this interest does not fitde before solutions are found and acted upon. I wish to submit this written 

testimony to express my strong support for the Preservation of AntibiOtics for Medical Treallnent Act (P AMTA, 

H.R. 1549, S. 619), a key component of any comprehensive set of solutions, which would inStitute a public health 

approach to antimicrobial use in food animals. I urge the Subcommittee to follcwthese hearings with prompt 

legislative action to pass P AMTA to greatly reduce the non-thempeutic use of important antihiotics in animal feed 

and water. 

My interest in this issue is not purely professionsl, however. My beautiful curly reddish·haired cherub of a boy, 

Simon, is dead As short and cold as that sentence feels, that is how it happened. Hearty and healthy at 1 Y.. yesrs 

of age, ono random Friday morning six yearn ago, Simon woke not feeling well. By afternoon his face was cold 

and his breathing was labored. At nightliill he was bloated, covered in purple splotches and went into septio shock. 

He never woke up again. I need not dalv\! into the feelings of desperate, painful insanity that! felt, and still feel, 

about this un;fathomable experience. It is a parenfs worst nighllnare; 

It is not Possible for me to "wake up" ftom this nighIlnare. But we as a society must wake up and prevent other 

nightmares from ciccurrlng by preserving the efficacy of our antibiotics: 

At the tim" of Simon'. death, noone---really, no one, inclwllng the highly competent University of Chicago 

healtheare providers--koew why SimOo,had died. We learned only after an autopsy that Simon had contracted an 

antibiotio·resistsut bacterium called, MRSA, or methicillin·resistant StaphylOCOCCUlf aureus. And; it was the 

relatively new community-associated MRSA strain, not the morecommouly )mown health eare-assoclated· strain. 

You're asking, ''What is tha!?" That is what my husband and I (two PhJ)..level professional~, mine in public health) 

asked as well. My husband and I racked our brains endlessly wondering what we could have done to prevent 

Simon's death. To this day I do not know how Simon contracted this bug and why he was susceptible to it. 

-If-someone had asked me,befote'Simondied, whatlwould daifIlost II child; I know that I would have responded 

something to' the effect of not being able to go on with life. To myastonisliment, people that I have met arid would 

not have mat if Simon had not died, such as other paren1s who lost children and a slew of health care and media 

folks, have somehow kept me afloat by validating my feeling that loaing a child should not be allowed by the laws 

of nature.· Others at the University of Chicago helped me focus on a bigger cause and made it possible to found a 
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Everly MacariD's Story 

An Excerpt from Superbug: the Fatal Menace of MRSA, by Maryn McKenna, copyright 

2010, pages 53-56: 

"They were children like Simon Sparrow, son of Everly Macarlo and James Sparrow, who 

woke with a shriek on'Aprll16, 2004. 

Macarlo and Sparrow had lived in Chicago for about eight months, brought there by 

Sparrow's new job as an assistant professor of history atthe University of Chicago. It 

was a rare and precious tenure-track position at a school known for commltment,to the 

liberal arts, so Marario, who had been teaching at Harvard, ha~ been content to let her 

husband relocate them. Since the move at the start of the 2003 school year, she had 

been working from home as a consultant, a choice that let her raise seve'nteen-monthold Simon and his older sister Elena, who was four and a half. Macarfo's last degree had 

been a SeD, the PhD~equlvalent conferred by the Harvard Sehool of Public Health. Her ' 

specialty was public-health campaigns that persuaded people to use condoms and wear 

bike helmets and eat more vegetables. 

"thought we were done with infectious diseases,' she said ruefully. "thought what I 

was doing was what we needed to do next to improve our health.' 

In April 2004, the couple had just filed their taxes and signed the papersJor a Hyde Park 

condo. Sparrow's new job was gOing very well, and Everly had as much work as she 

wanted. 'Beautiful kids, dream jobs, a great neighborhood,' she said, looking back. 'We 

would hold each other and say, 'It's too good to be true.' 

Simon was big for his age and stUrdy except for a touch of asthma, With Maca rio's dark 

eyes and a mop of red-gold curls from his father. When he woke disoriented and 

feverish, they thought he might have a cold, or a retum ola throat Infection and· 

breathing problems that he had been diagnosed with two weeks earlier. Macarlohad 

taken him to the emergency room for that and brought him home with a prescrlptton' 

for antibiotics and steroids. It was 7:30 a.m. and Elena had a stomach virus that Macario 

was already handling, so she let her husband take Simon to the ER this time. A few 

hours later, with Elena tucked In at home and being minded by their nanny Marcarlo 

met Sparrow atthe hospital for a hand-off. He was due to drive to Peoria, three hours to 

the south, to give a speech. Simon was restless, squirming and wanting to be held but xrays and all his test results were unremarkable. The ER staff sent Macarlo homewlth 

hltn. 

On the way out of the ER, she noticed that his lips looked blue. At home, Elena was 

throwing up, and soon Simon was too, though he had not had anything all day but 

water. He rested on Macarlo's lap, and after an hour or so, she noticed that he was 

laboring to breathe, pushing out his chest and using the little muscles be):Ween his ribs 
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STATEMENT FOR THE RECORD 

Subcommittee on Health, Committee on Energy &; Commerce 

U.S. House of Representatives 

For the hearing, "Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture" 

July 14, 2010 

Raymond J. Tarpley, D.V.M., Ph.D • 

.. I am Raymond Tarpley, a veterinarian in College Station, TIC, with an interest in acquainting 

veterinary students, veterinarians and biologists with the emerging field of Conservation. 

Medicine,linking In:una\:l, animal and environmental health. I am retired from the veterinary 

faculty at Texas A&M University where I taught anatomy. and I am currently enrolled in the 

MPH program at the Johns Hopkins Bloomberg School of Public Health. 

I am writing to express my concern regarding the administration of low-dose antimicrobials to 

healthy animals for non-therapeutic ljseS in the animal production industry. Even as a veterinary 

student studying pharmacology many years ago, one of the bedrock concepts impressed upon me 

again and again was that if we as veterinarians chose to USe an antibiotic, it was essential that it 

be administered in sufficiently high doses fora long enough period of time to avoid what was considered malpractice - the selection for resistant bacteria that could harm antibiotic efficacy. 

To this day, I cannot use an antimicrobial without this sacrosanct priJiciple coming to mind. 

U.S. industrial animal agriculture routinely incorporatcs low-dose concentrations of 

anthnicrobials into the feed or water of htl!llthy production animals to promote growth and feed 

efficiency, an application cuttently permitted by the U.S. Food and Drug Administration (FDA). 

It is widely recognized that this Pmcticeselects for bacterial resistance to these antibiotiCS; and . 

there has been concern that such resistance could negatively impact public health. 

Considerable evidence has accumulated that these resistant organisms (and/or antimicrobial 

residues) move beyond the food animal production environment.via 1) food products, 2) soils . 

(upon which animal wastes. are applied), 3) wa~ (waste runoff into surface streams and seepage 

into underground aquifers, 4) crops (antimicrobial uptake from soil), 5) air (blown out of animal 

confinement facilities by industrial fans), 6) insect carriage (e.g., flies), 7) rodent carriage and 8) . 

human carriage (e.g., £ann personnel). 

During a time when bacterial resistance to an array of antimicrobials is increasing, renewed 

attention has been directed to\Vlll'd the threat that resistance erising from low-dose use of 

antimicrobials in food animals could pose for human and veterinary pharmaceuticallf, particularly 

with fewer novel antimicroJ>ials reaching the mat:k:et. We now know that resistance to 

antimicrobials can develop rapidly, ~ to other anthnicrobials in the same or a different 

class, and be shared among bacteria through multiple genetic exchange mechanisms within or 

. ..between genera,.cuhninating-in multi-drug·resistanoe·in·some organisms; 

While the FDA Center for Veterinary Medicine has acknowledged the threat of microbial 

resistance with their June 2010 draft guidance (#209) 011 the judicious use of antimicrobials in 

food animals, regulatory action has been slow to evolve on tl$ problem, particularly in an 

atmosphere of industry pushback. Nonetheless, discontinued use of antimicrobials for non-
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data from Scandinavian countries, ilwluding Denmark, Sweden, Finland and Norway, reveals 

that these disease spikes did not always occur, and when they <:lid, could be controlled by 

evidence-based management protocols, while reducing antimicrobial resistance. With feed 

formulations that lowered protein content, strict sanitation protocols, more humane treatment of 

production animals and the use of antimicrobials by prescription as needed for sick animals, 

animal production did not suffer following the bans, nor was there increased mortality. 

While fearing that animal health and welfare will be threatened by bans on low-dose 

antimicrobial use in feed and water, the A VMA nevertheless acknowledges that the Denmark 

data do "show that swine production, average annual number of piglets per sow, and weaned and 

fi1lishing (just prior to slaughter) pig average daily weight gains have increased and weaned pig 

mortality (death rate) hss drastically decreased in recent years". By encouraging industry toward 

more sophisticated, time-tested husbandry practices, combined with the use of antimicrobials as 

needed by veterinarians to treat sick animals, the animal production industry can operate 

efficiently while addressing root causes of disease and microbial resistance that will 

simultaneously eliminate the need fur antimicrobials as growth promoters or as deterrents to 

subclinical disease, while reducing public health risks. 

Currently there is a House bill, the Preservation of Antibiotics for Medical Treatment Act 

(P AMrA, H.R. 1549) that can begin to transition industIy and veterinarians toward a more 

controlled use of antimicrobials as supported by the best science over the past 20 years. I believe 

this bill holds promise for the nation, and I strongly hope that all professionals in the health field 

will endorse it with enthusiasm. Since the first objecti'Ve of medicine is to do no harm, this bill is 

reasonable in that it requires industry to prove the safety of itS practices, rather than have the 

public first prove itself to be harmed. . . 

Antimicrobials are critical for contemporary human and.veterinary medicine, and all 

interventions should be considered that protect and eonservetheir value. If the use of low-dose 

antimicrobials fur growth promotion can be safely discontinued by adopting improved strategies 

fur disease prevention, not only will the expense of these antimicrobials be recovered. by the 

producer, but the levels of resistant organisms escaping from the fiumenvironment will be 

mitigated. By making antimicrobials available fur farm 'USe only throughveterinaIy'prescription, 

prudent and transparent application of these valuable pharmaceuticals will be better assured, 

while the reduction of resistant bacteria achieved by withdrawing their low-dose use will help 

preserve their efficacy. 
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STATEMENT FOR THE RECORD 

Subcommittee on Health, Committee on Energy & Commerce 

U.S. House of Representatives 

For the hearing, "Antibiotic Resistance and the Use of Antibiotics in Animal 

Agriculture" 

. July 14,2010 

Patricia Whisnant, D.V.M. 

American Grassfed Beef . 

Rain Crow Ranch 

Doniphan, Missouri 

Use of Antibiotics In Livestock Production 

Has It only been. a generation since antibiotics represented the world's first 

miracle drugs? Prior to their discovery death could occur in what would seem to 

be very trivial injuries 'and diseases. What have we allowed to happen to this 

powerful gift of healing? Today antibIotic-resistant bacteria have become a . 

growing public health crisis that puts our health. our finances and even our lives 

at risk. MRSA; along with. resistant strains of salmonella, campylobacter, and 

E.coli have heightened our awareness of the risk we haveincun'ed In such a 

short time and alarmed us to a very real threat 

I recall the warnings of one of my professors in veterinary school that we, as 

veterinarians. werebemg given· a sacred trust and responsibility In the use of 

these drugs and they should be used wisely; As he was reaching retirement age 

our professor told us hoW as a young man coming home from WWII· he had _ 

contracted a lung disease caused by a bacterium similar to tuberculosis. They 

gave him little hope of survival but offered btry an experimental drug;·an 

antibiotic. Doomed to life in a sf.mitarium and early death, he gratefully chose to 

take part in the experiment. He fuUy recovered due to the new miracle drug •. His 

story and strong wamlng has. always made me consider the judicial use of 

antibiotics. Even then,in the beginning of my career, we understood that the 

overuse of antibiotics was already creating ·suPer'bugs· resistant to medication. 

It has been estimated that at least 18,000 Americans die every year from drugresistant Infeetlons. This does not take Into account the increase in health care 

cost and human suffering associated withantiblotlc-reslstant bacteria. 

Antibiotics probably single-handedly propelled my profession and that of human . 

physlclans-lnto-therespected.world of-scienGe-by-the·drarnatic.effects·of·thelr.~-.. 

administration in diseased animals and humans. Their judicious and therapeutic 

use Is stJII important for the health and recovery from disease of many. It Is not 

the therapeutic use of antibiotics with which I have an Issue. It is the non-
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principles of animal husbandry that allows fulfilling the natural behavlo~1 instincts 

of the animal in a clean natural environment allows for fewer pathogenic factors 

_ leading to disease and hence fewer drugs to tr9!llt disease. A pasture based 

system allows this to occur. In fact, that is how livestock was raised for 

thousands of years, right up until the mid-20th Century. It Is not something new 

but rather a return to basics, raising animals how they were Intended to be 

raised. The modem Jdea that the only way to feed the world is to raise animals in 

CAFO's using low dose antibiotics Is just wrong. ·Cheap foodv but at what cost? 

I am not sure society Is willing to pay the price to animal health. the environment 

and the effect on human health. 

Today. many small, sustainable farmers do not use antibiotics at all. in large part 

because they don't have to compensate for unhealthy conditions and are not 

trying to unnaturally increase growth rate. On sustainable farms. animals are 

raised In a clean environment that promotes their health. Other sustainable 

farmers use antibiotics, but only to treat sick animals. The practice of-feeding 

antibiotics to farm animals to promote faster growth Is being phased out In 

countrtes around the world to protect the publlc's health. Given the lack of 

demonstrable benefits. the U.S. meat Industry should heed the call of the U.S. 

public health community and global authorities to fOllow this lead. 

-The key to stopping non-therapeutIc use of antibiotics as well as reducing the 

need for therapeutic doSes is to consider agricultural models that promote 

we/lness. What we need to do-Is encourage farming systems-In which we are 

actively managing animals so they can develop strong natural immune systems -

a concept sometimes called ·positive health.- We should not raise animals In an 

environment of streSs that challenges the animal's capability to flghta Pathogen 

without the use of low dose antIbiotics. 

Research shows that animals that are under stress have reduced immunity. 

And, if animals are kept-on farms where they are not overcrowded. where they 

have access to pasture and space to move around, where they are fed a diet that 

matches their natural needs, and where they are managed to promote healthan~ 

well-being, then the levels of stress and the incidence of disease - and the need 

for antibiotics -Is m!Jch, much lower. Speaking from my personal experience I 

cannot recall the last time I had to use therapeutic antibiotics on an animal from 

our farm. It is that simple. 

The solution lies in looking at the causes of antibiotic-resistant Infections -

Including Intensive farming that relies on excessive amounts of low-dose 

antibiotics - and putting a stop to the continued non-therapeutic use of these vital 

medLclnes on-Whlch these farming systems-are so dependent .. -·Antlbiotics 

themselves are -not the problem. The irrespOnsible use of antibiotics Is the 

problem. And, it's not the farmers that are at fault; it Is the farming systems 

which result In the need for indiscriminate antibiotic use. 
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Coundf of State and Territorial Epidemiologists 

U I I IJ nil 

CSTE posrnON STA~ 1999-ID 7 

COMMITrEE: Infectious Diseases 

TITLE: Discontinuation of antimicrobials used to promote growth of food animals if they are used in or select 

for croos resistance to antimicrobials used in human therapy 

ISSUE: C~mpelling scientific evidence indioates that use of antimicrobials in food animals results in 

antimicrobial resistance which can be transmitted to humans through the food supply and lead to advme health 

consequences. An area of particuIsr public health concern has been the feeding of antimicrobials in 

subthl5l1lpe1ltic doses to animals to promole growth. The World Health Organization recommends that 

antimicrobials not be used as growth promotants if they are used for or select for croos-resistance to 

antimicrobials used in human medicine. Discontinuing thesllbtherapeutic uses of these antimicrobials in food 

lmimals is needed in the United States as part of a comprehensive plan to reduce antimicrobial usage and 

ultimately protect the public health. 

PosmON TO BE ADOPTED: 

CSTB sad NASPHV recommends the discontiriuation of antimicrobials used 10 promote the growth of food 

animals if they are also used in human medicine. These uses may increase antimicrobial resistance. and no 

longer meet the food safety criteria of reasonable certainty ofllO harm. 

BACKGROUND AND JUSTIFICATION: 

Antimicrobials are used for the treatment of sick animals, the prevention of selected animal production diseases. 

Subtherapentic use of antimicrobials provide an economic advantage to the producer by decreasing the amount 

of feed needed. However, these antimicrobials are not essential for food production animals to reach their full 

genetic potential. The World Health Organization (WHO) recommends that antimicrobial. not be used as 

growth promotants if they are used in or select for cross-resistance to antimicrobials used in human medicine. 

Consistent with the WHO recommendstiona, the European Union prohioited the use of the four such 

antimicrobials used in humans which were still used as growth promotants in Europe (virginiamycin, bacitracin, 

tylosiri, and spiramycin). 

FOr eXample. iJiei-e iseVidence th~i ~e ofav()pafcln;-a glyocopeptide, to pro~ote growth of food animals in 

Europe resulted in a large reservoir of vancomycin-resistant ente~ (VRE) in food animals, which were 

transferred to humans through meat and poultry, resulting in carriage in humans. The public health concern is 

that these colonized humans could introduce VRE to hospitals. Because of documented community carriage of 

vancomycin resistanl enterococci in humans and the importance of vancomycin as a therapeutic agent to treat 

hospital acquired enterococci infections, the European Union banned avoparcin use in food animals. Following 
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the ban on avoparcin use, there was a decline in prevalence ofVRE in food animals, meat and poultry, and humans in 

Europe. 

In the United States, seven of 17 FDA licensed antimicrobials currently used subtherapeutically in food animals to 

promote growth or enhance feed efficiency are also used in or select for crossresistance to antimicrobials in human therapy. These are bacitracin, lincomycin (selects for cross-resistance to 

clindarnycin), oxytetracycline, penicillin, tetracycline, tylosin (selects for cross-resistance to erythromycin), and 

virginiarnycin (selects for cross-resistance to quinupristinldalfopristin). The sUbtherapeutic use ofvirginiarnycin to 

promote growth in food animals in the United States threatens the effectiveness of quinopristinldalfopristin (Synercid), 

which will soon be approved in the United States for the treatment of multidrug-resistant VRE; such isolates are often 

resistant to all other available antimicrobials. Virginiarnycin, which is only used at subtherapeutic levels, has resulted in 

a reservoir of Synercid-resistant E. faecium in food animals. A preliminary survey of retail chicken products by CDC 

and four state health departments has found Synercid-resistant E. faecium in over half of the culture-positive chickens. 

Furthermore, preliminary data indicates that between 1-2% of persons in the general community may be carrying 

Synercid-resistant E. faecium. It appears likely that the use ofvirginiarnycin to promote growth in food animals has 

resulted in Synercid-resistant E. faecium which is of concern because Synercid will likely be the drug of choice to treat 

multi-drug resistant VRE in infected patients. 

The US Food and Drug Administration is responsible for ensuring the food safety criteria of a "reasonable certainty of 

no harm" with all approved antimicrobial uses in food animals. There is sufficient scientific evidence that 

subtherapeutic use of antimicrobials in food animals can select for antimicrobial resistance and do not meet this food 

safety criteria. In December 1998, US Food and Drug Administration proposed a new framework for evaluation of 

antimicrobials used in food animals. Although the proposed framework may be used to evaluate the existing approvals 

for subtherapeutic uses of antimicrobials in food animals, the details of how the proposal would be implemented remain 

to be determined, making it unlikely that the sUbtherapeutic use of these antimicrobials would be addressed for several 

years. More timely action is necessary to protect the public health. Antimicrobials which are Ilsed in human medicine, 

or which select for resistance to antimicrobials which are used in human medicine, should not be used to promote the 

growth of food animals. 
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July 12, 2010 

To the House Energy and Commerce Health Subcommittee: 

When the American Medical Association, American Academy of Pediatrics, World 

Health Organization, and American Public Health Association all agree on a health care 

poliey issue it's worth taking notice. Each of these leading organizations. has forcefully 

urged an end to the rampant overuse of antibiotics in the poultry and livestock industries. 

Why? Because ail estimated 70 percent of the antibiotics used in the United States are 

fed to animals that are not even sick, making germs drug resistant, and jeopardizing the 

, ability to effectively treat serious diseases in both humans and animals. 

When antIoioties were introduced in the 1940s and 19508 they were celebrated as 

revolutionaty. Indeed, many heralded them as ending the terrifymgera when disease 

plagues swept through nations. In 1969, the Surgeon General, in a message to Congress, 

stated "It is time to close the book on infectious diseases. The war against pestilence is 

over." 

But no one is saying that these days. With each passing year, research indicates that 

many commoninfectious diseases are developing new and mote problematic resistance 

to many common an!l'biotics. The ltlfectious Diseases Society of America now estimates .. 

that 90,000 people die every year of hospital-acquired infectious disease and that 70 percent 

have infections that are resistant to' at least one antibiotic drug. Antibiotic reSistant infections 

are estimated to cost the United States health care system as much as $26 billion annually, 

according'to a Cook County,IDinois hospital study. 

Using these drugs in livestock feed and water at low levels (subtberapeutically) is an 

especially foolhardy practice. It suppresses only the weak germs while allowing the strongest 

to live and'multiply. Yat this is precisely the way most antibiotics are used at industrial 

animal operations. Rather than a therapeutic dose that would kill all of the illness-causing 

germs, the drugs are added at lower levels to daily feed or water of chickens, turkeys, pigs 

and other food animals. This is done both to stave off disease in crowded, unsanitary 

conditions, and to trigger faster growth. 

:But this common practice puts the public at risk. F~ animals shed resistant bacteria in their 

feces, breath, and m their skin. Research by the Department of Agriculture and Johns 

Hopkins School of Public Health has shown that manure contaminated with resistant 

pathogens can migrate around a fann, in slaughter and meat processing (thus contaminating 

food), into neighboring farms and the environment, and even travel long distances in the air. 

After a two and half year process of research and deUberation, the Pew Commission on 

Industrial Farm Animal Production (of which Bill was a member) concluded that curbiqg 

ri6n~therapeutic mitibioucuse iit md\isirial anitDiil. farinS was CssentiaItri protectirig public 

health. The Commission's Chair, former Kansas governor John Carlin, recently stated, 

"More than three decades of research have shown that overuse of antibiotics in food-animal 

production contributes to antibiotic resistance in humans. " 
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-Crawford Stewardship Project 

Crawford Stewardsblp Project 

PO Box 184 

Gays MlIIs, WI 54631 

July 8, 2010 

RE: the use of human Antibiotics in farming 

aawfordstewardshlpproject.org 

esp.couuty@gmalLoom 

608-735-4277 

I am writing on behalf of the 680 supporters of Crawford Stewardship Project. As 

advocates for farm families in Western Wisconsin, we are highly concerned about the 

current us of human antibiotics in agriculture. 

It is estimated that up to 70 percent of all antibiotics sold in the U.S. are given to 

healthy food animals. As doctors have always warned, administering low doses of 

antibiotics over long periods of time is exactly the wrong way to treat these life saving 

drugs, but that is precisely what is happening. On many industrial farms across our 

nation, human antibiotics are being administered to healthy animals in low dosages 

over long periods of time, not to treat any illness w~tsoever. 

Taking action on the use of human antibiotics industrial farms would benefit 

Wisconsin in the following ways. First, by protecting people from potential life 

threatening diseases that are bomon industrial farms. Second, by upholding the 

efficacy of antibiotics for patient use, esPecially when a life is on the line, or in elderly 

folks. The AMA and many medical groups support a c4ange because it is doctors that 

oependdaiWoifthese live -savmgarugs to-dotheirjoos:Atid lastly; bYhelpmgfo 

encourage and improve our iJ8ricultural system. Wisconsin is home to tens of 

thousands of family farms who use antibiotics wisely, they let their cows out to 

pasture, and they actually care about the lives of each animal on the farm. Upholding 

those values is important, and at the same time we need to send a message to 

industrial farms that they should consider a more ethical way to raise and take care of 
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Wisconsin Association of School Nurses 

July 12, 2010 

Honorable Congresswoman Tammy Baldwin 

2446 Rayburn Building 

Washington DC 20515 

Dear Rep. Baldwin, 

The WiscoDSin Association of School Nurses supports the belief that the use of antlbiotics in 

agriculture should be therapeutic only - and that non-therapeutic use should be prohibited. Human 

antlbiotics are tar too critical to human life to simply be used preventatively or to encourage growth 

in fuod animals. Othor countries have proven that farming can be done without the use of nontherapeutic antibiotics, and the Wisconsin Association of School Nurses strongly encourages 

Congress to pass .similar Ineasmes. 

While we believe that limited antibiotic use to treat sick animals is necessary and advisable, the 

consequences of antibiotics misuse are unjustified. 

W ASN supports this change because the current practice undermines the medical treatment of 

significant and often life-threatening infections. This change will be best fur all people. for animals 

and especially fur those who need antlbiotics to be effective because their lives depend upon it. 

Please consider taking action on this issue - and accept our thanks fur your service and work. 

Sincerely, 

Ann Riojas, President 

Wisconsin Association of School Nurses 

riojasak@milwaukee.kI2.wi.us 
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July 9, 2010 

Honorable Congresswoman Tammy Baldwin 

2446 Rayburn BUUdilig 

Washington DC 20$15 

R.egarding: Non-therapeutic IUltibloties use in flll'll1ing 

Dear Rep. Ba1.dwin, 

_ .. _-------

The Wi8con&in Farmers Union represents thoUBimds of farms across the state of Wisconsin - and has 

been closely following the issue of antibiotic use in agriculture. 

The Wisconsin Farmers Union Policy on antibiotic use on farms is: 

Most anIlDiotios in anhnal husbandry aro used for th§ prevention of siokness and to ~letate 

growth. In ordet to ensure human health and consumer confidence, WFU supports policies that 

require independent mooitering of data on iIle use of antibiotics at food and feed companies, 

encourage USDA to increase testing for pathogens in processing plants, limit the use of 

IIIltibiotics to the treatment of disease in livestock and not to compensate for inadequate anhnal 

husbandry, environment or gllJletics. 

We believe that the use of antt'biotics in agriculture should only be thetapeutic. Human antl'biotics 

are far too critical to human life to simply be used preventatively or to encourage growth in food 

animals. Other countries have proven that farming can be done widlout the use arnon-therapeutic 

antibiotics, and the WlSCOnsin Faaners Union encourages Congress to pass similar measures. 

While we believe limited antibiotic use to treat sick animals is nec'essa:ry and advisable. the 

consequences of antJ'biotics misuse is wholly Ulljustified. P1esse consider taking action on this issue 

. - and accept our thanks for your service and work. 

~y. 

~Scltultz ExecutiveD 
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Testimony for the record 

Congressman Leonard L. Boswell 

Before the House Committee on Energy and Commerce, Health Subcommittee 

Hearing on antibiotics resistance and the use of antibiotics in animal agriculture 

JUly 14,2010 

2 p.m •. 

Chainnan Pallone, Ranking Member Shimkus and members of the Health Subcommittee, 

I would like to thank you for allowing me the opportunity to submit my testimony for the record 

today. I have spent most of my life involved in animal agriculture and have seen first-hand the 

responsible use of antibiotics. 

I understand the issues that affect the livestock, dairy and poultry industries having spent 

most of my youth working in livestock production, and I still have a hand in managing a cowcalf operation on my fann in Lamoni, Iowa today. After I retired from 20 years in the Anny, I 

moved back to Iowa to begin fanning. Part of my preparation included a consultation with my 

local veterinarian to discuss the use of antibiotics to treat sick animals and prevent future illness. 

From my experience with producers and veterinarians, the thoughtful use of antibiotics is not the 

exception, it's the rule. 

During the 11 Oth Congress, it was my privilege to serve as Chainnan of the Agriculture 

Subcommittee on Livestock, Dairy and Poultry. On September 25th oflast year, we held a 

hearing to review the advances in animal health within the livestock industry. We were 

specifically looking at how antibiotics are used on America's livestock fanns. Our witnesses 

included veterinarians from USDA's Animal Health and Plant Inspection Service and FDA's 

Center for Veterinary Medicine (CVM), producers, veterinary practitioners and academics from 

across the country. I believe that we heard from a good cross-section of the users of the animal 

health products, the doctors responsible for the use of antibiotics, and the experts studying the 

resistance trends from use of antibiotics in animals. 

As the Subcommittee members listened to the witnesses, it became very clear that 

America's livestock, dairy and poultry producers have a responsibility to safeguard animal and 

public health. This is a responsibility they take very seriously. They are committed to using 

antibiotics responsibly and have developed responsible-use guidelines for each of their 

respective industries. They didn't develop these guidelines because Congress told them to do so; 

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they developed the guidelines because it was the right thing to do for their animals and their 

consumers. 

Much has been discussed about the Denmark antibiotic ban. However, I believe that 

experience has been often mischaracterized. 

In the mid-1990's the European Union made a decision to phase out the use of antibiotics 

as growth promoters. Denmark, which had a pork industry roughly equivalent to the size of the 

pork herd in Iowa (which is the largest pork producing state in the country), instituted a full, 

voluntary ban in 1998 which became mandatory in 2000. Many proponents of restricting the use 

of certain animal antibiotics as a model often point to this ban instituted in Denmark, citing a 

drop in total tons of antibiotics used in pork production in that country. Interestingly, what the 

proponents never seem to discuss are the other effects of that ban. After the ban became fully 

implemented in 1999, Danish pork producers saw an immediate increase in post-weaning 

diarrhea and an increase in piglet mortality, which has had long-lasting effects on the Danish pig 

industry. The increase in piglet deaths and the overall impact on animal well-being might be 

acceptable if it resulted in improvements to public health, but such improvements have not 

materialized. And while overall use of antibiotics in Denmark declined, there has been a marked 

increase in the therapeutic use of antibiotics - those used to treat and control diseases. Today, the 

use of therapeutic antibiotics in Danish pigs now surpasses what was used to prevent disease and 

promote growth prior to the ban in 1999 and continues to rise each year. 

I had the opportunity to travel to Denmark in September 2009. During that trip I met 

with a large cross-section of the Denmark livestock industry. I found out that because of the ban 

they have lost over 80 percent of their producers - going from approximately 28,000 to 5,000-

and pork processors went from 67 to two. In my experience, less food production capacity is a 

greater threat to food security. 

Also, during that trip I had the opportunity to meet with several farmers. During informal 

conversations one producer stated that they thought the United States should implement a similar 

ban as well because it would make them more competitive. We must ask ourselves why we are 

pushing for this ban. Is it to reduce antimicrobial resistance of humans? There has been no 

decisive scientific data to support this to date. Is it to make Denmark more competitive with 

U.S. livestock producers? I certainly hope not. 

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A ban similar to Denmark's will also have a huge impact on the cost to produce meat 

products. A 2009 Iowa State University study estimated that the effect of a ban in the United 

States similar to Denmark's would raise the cost of production by $6 per pig in the fIrst year after 

such a prohibition; 10 years after the ban, the cumulative cost to the U.S. pork industry would 

exceed $1 billion. 

A recent study by Dr. Scott Hurd, associate professor at Iowa State University's College 

of Veterinary Medicine and former U.S. Department of Agriculture Deputy Under Secretary for 

Food Safety, demonstrated that when pigs have been sick during their life, those pigs will have a 

greater presence offood-safety pathogens on their carcasses. This is a serious implication that 

must be considered when looking at the costs and benefIts of antibiotic use in livestock. 

Protecting human health and providing safe food are paramount concerns of America's 

livestock producers. 

If policy decisions are going to be made regarding antibiotic use, we must ensure that we 

are using all of the science out there and not just looking at Denmark through a limited lens. 

Again I would like to thank you for allowing me the opportunity to submit my testimony 

for the record. I hope as a farmer and user of antibiotics I have offered you some insight into the 

livestock industry's perspective. In the United States we are very blessed to have the safest, 

most plentiful, and most affordable food supply in the world. As policymakers we must take a 

hard look at how our decisions affect human health and our ability to feed ourselves and the 

world. 

Thank you. 
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The Honorable Henry A. Waxman 

Cbainl1an 

Committee 011 Energy and Commerce 

House of Representative.s 

Washington, D,C. 20515-6115 

Deal' Mr, Chainmm; 

In the enclosed docllment, we have restated each question in bold type, followed by 

FDA's responses, 

opportunity to 

01' 

issues, If you 

Enclosure 

Sincerely, 

Jeanne Ireland 

Assistant Commissioner 

for Legislation 
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1, Doctor Shart~~tt'in, you cite significant medical literature in YOllr proposed 

guidelines stating the link between over-use and antibiotic resistance, yet tbe 

FDA's voluntary guidelines only address nou-therapeutic use, I've heard that 

poultry farmers have recently stated that, from egg to slaughter, chickens and 

turkeys AI, WAYS need antibiotics to prevent disea<;e. How do you 

addressing non-therapeutic usc, and what is to prevent. farms from recategorizing the purpose of the antibiotics they give to altimals, instead of 

actually ending oyer-use'! 

FDA has focused on non-therapeutic uses (e.g., uses intended to enhance growth or 

hnprove feed because we believe such uses are concern. Drugs 

used for this purpose: are not used to address any identified animal 

health concern, 2) are typically being administered to herds of flocks 

continuously in their feed, and 3) are being administered without any involvement of II 

veterinarian (I.e.. are currently marketed as Qver-the-t,mnter products). However. 

some of the same drugs that are approved for such production purposes 

are also approved for purposes as well. In contrast to the production uses, 

these therapeutic useS are directed at identified diseases and are administered 

in a more targeted way to certain animals for limited durations_ 

We aclmowledge the of maintaining the availability of ;.mtimicrobial drugs 

for therapeutic purp<)scs in food·producing animals. Although wc do not agree with the 

statement that poultry need antibiotics on a continuous basis f1'Om egg to slaughter, we 

acknowledge the need to administer antibiotics to poultry or other food-producing 

animals to address animal health issues (i.e., to treat, control. or prevent diseases) 

As discussed in Draft Guidance #.209 

necessary and judicious. 

The draft guidance uses to be considered necessary 

and judicious. When delemoinim! of use, impo11ant 

factors such as: 1) evidence of "n"'N'W'l1P", 2) evidence snch a preventive use is 

3) evidence that the use is linked 10 a 

vU"""IS'" agem, 4) evidence that the use is appropriately and 5) 

,'v,rlp",,"'" thai no reasonable ahematives for intervention exist, should be considered. 

As described in the draft that imponanrdrugs 

be limited to uses in food-producing animals that: are necessary for ensuring animal 

health. and 2) involve veterinary or consultation. The implementation of these 

recommendations would practically mean that marketed for 

production (non-therapeutic) uses would no be labeled and marketed for that 

purpose. and such products could now be dispensed only under the order of a veterinnri(lII 

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We believe requiring such veterinary involvement is a significant factor in mitigating the 

concern that fanns would simply ''re-categorize the purpose of the antibiotics." 

An additiop.al deterrent to such re-categorization is the fact that current law does not 

permit the extra-label use of drugs in feeds. Therefore, once relabeled, producers and . 

veterinarians would be required by law to use the drugs only for the labeled therapeutic 

uses. 

2. Doctor Sharf stein, the FDA's new Guidance Document identifies certain uses of 

antimicrobials as creating a public health risk. 

a. Why did you opt for voluntary guidelines as opposed to regulatory 

options that offer real enforcement? 

The draft guidance is a document that frames FDA's thinking as we move forward. FDA 

is keep~g all options on the table for addressing this issue. We think it is important to 

pursue all available pathways for implementing the principles outlined in Guidance 209, 

including working collaboratively with the animal phaImaceutical industry and exploring 

other options, such as potential regulatory action. 

b. Since no regulatory action has yet been annonnced, should we assume 

you are focusing on voluntary approaches first? If so how long are you going 

to give this approach? 

We are supportive of voluntary actions to address antimicrobial resistance. FDA has 

been actively seeking input from all of its stakeholders on approaches for addressing this 

issue and is encouraged that opportunities exist to make significant progress forward 

through the guidance process. 

c. Does the FDA believe that drug manufacturers and farmers will 

voluntarily make changes that go against their financial interest? 

FDA's Center for Veterinary Medicine has been activelY reaching out to all stakeholders 

on this issue, including drug manufacturers,. producers, and veterinarians. With regard to 

the animal pharmaceutical industry in particular, we are encouraged by the reaction of the 

Animal Health Institute that "welcomed" the recent publication of our draft guidance. 

We are also encouraged by the engagement of the animal pharmaceutical industry to date 

in substantive discussions on approaches for implementing FDA's recommendations. 

3. In July 200S, the FDA proposed banning in the fall of200S the extra-label use of 

all cephalosporin antibiotics in food producing animals. In November 2008, the 

FDA said it would not implement the ban and would review the public 

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comments it had received on its July 2008 proposal Dr. Sharfstein, you 

indicated in a letter dated December 16, 2009, that "FDA shares your concerns 

about the public health risks associated with the development of resistance to 

important antimicrobial drugs such as the cephalosporins. As the agency has 

indicated previously, we intend to issue another order of prohibition addressing 

the extra-label use of the cephalosporin class of drugs. The Center for 

Veterinary Medicine has completed its analysis of the public comments and has 

prepared a revised order. This document is currently undergoing review." 

Could you please indicate the status of the review and when the draft prohibition 

order can be expected? 

This issue remains a priority for the Agency. 'While we cannot provide a specific 

timeline for publication, we are targeting the end of 20 10 for completion of the revised 

order. We believe this is an achievable goal for an Agency draft prohibition order. 

The Honorable John Shimkus 

1. Have all antibiotics available for livestock production been approved by FDA as 

safe and effective? Have they been subjected to safety testing for resistance in 

the past? 

The medically important antimicrobial drugs that are currently used for production 

purposes in animal feed (i.e., to promote growth, improve feed efficiency) were approved 

by FDA as safe and effective prior to the late 1970's. These drug products have not been 

subjected to the safety assessment process implemented through guidance in 2003 for 

evaluating antimicrobial resistance concerns. 

2. How do you determine when action should be taken for the protection of public 

health? What is the threshold? How do you respond to criticism that it is not a 

transparent process? 

FDA considers an antimicrobial new animal drug to be "safe" if the Agency concludes 

that there is "reasonable certainty of no harm to human health" from the proposed use of 

the drug in food-producing animals. This standard applies to safety evaluations 

completed prior to new animal drug approvals, as well as to those completed for drugs 

after approval. If this safety standard is not met before approval, the drug cannot be 

approved. If safety issues arise after approval, the Federal Food, Drug, and Cosmetic Act 

(FD&C Act or the Act) provides grounds for withdrawal of approval of new animal drug 

applications for safety reasons. Although the Agency is actively seeking to improve the 

transparency of all of its activities, certain limitations remain regarding disclosure of 

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certain information in cases where regulatory action is being contemplated for individual 

drug applications, especially when such action results in a formal evidentiary hearing. 

However, FDA decided to first pursue solutions for addressing the public health concernS 

regarding antimicrobial use in animal agriculture through the issuance of Draft Guidance 

#209. We believe this provides for a transparent process of seeking input from all the 

affected stakeholders and the general public on strategies for addressing the issue. 

The Agency has identified in the draft guidance its concerns that certain uses of 

medically important drugs are not judicious and are not in the interest of public health. 

Although we have not yet concluded that such uses are "unsafe" in the context of the Act, 

we believe there is sufficient scientific evidence to support the need for steps to address 

the public health concerns. The Agency requested public comment on the draft guidance. 

Though the docket formally closed on August 30, 2010, the public may submit comments 

on any FDA guidance document at any time. Regarding Draft Guidance #209, FDA 

received hundreds of substantive comments during the formal comment period and we 

are currently reading and considering each one. After this review is completed, the 

Agency will publish a final version of the guidance which mayor may not include 

changes, depending on what new information has been provided in the comments. Only 

after fmalization will Draft Guidance #209 become the Agency's formal policy on the 

judicious use of antimicrobial drugs in food-producing animals. 

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cc: The Honorable Frank Pallone, Jr. 

Chairman 

Subcommittee on Health 

Committee on Energy and Commerce 

The Honorable John Shimkus 

Ranking Member 

Subcommittee on Health 

Committee on Energy and Commerce 

The Honorable Joe Barton 

Ranking Member 

Committee on Energy and Commerce 

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QUESTIONS FOR THE RECORD 

Deputy Administrator Dr. John Clifford, D.V.M. 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture 

For the Committee- on Energy and Commerce 

Subcommittee on Health 

U.S. House of Representatives 

Hearing on Antibiotic Use in Animal Agriculture 

July 14, 2010 

Questions Submitted by the Honorable John Shimkus: 

1. The term "growth promotion" seems to cause concern among some members of Congress. Is it 

true that the mechanism by which subtherapeutic antibiotics work to promote growth is by 

preventing diseases which would otherwise inhibit growth? 

Antibiotics are used in animal agriculture for disease prevention, growth promotion, and treatment of 

diseased animals, but there is not a distinct boundary between which antibiotics have only growthpromotion effects without potential for therapeutic benefit. The mechanism of action for the growthpromotion effects of antibiotics is riot well understood. A number of hypotheses have been proposed, 

but there is no recognized single explanation for the growth-promoting mechanism of antibiotics. 

Suppression of disease-causing pathogens, which can lead to improved animal health and welfare, is one 

recognized benefit of antibiotic growth promoters. Producers could also see benefits from the 

subtherapeutic use of antibiotics through improvements in feed conversion rates, which would help 

animals get maximum benefit from feed. 

2. If legislation or regulation were enacted to ban the preventative uses of antibiotics, what does 

USDA calculate the cost to be for livestock producers? If USDA has not done this very basic cost 

analysiS, why is your agency already supporting FDA's efforts to pressure livestock producers and 

animal health companies to eliminate these uses? 

USDA has not calculated the economic impact on livestock producers because we are not requiring or 

mandating any specific actions on the part of producers. 

USDA did consult with the Food and Drug Administration on its guidance document and supports its 

general conclusion that medically important antibiotics in food-processing animals should be used 

judiciously. 

3.ln follow-up to your testimony before the Subcommittee on Health, an e-mail was sent from USDA 

stating that "USDA does not support the broad elimination of antimicrobials for specific uses in animal 

agriculture." Since this is exactly what Representative Slaughter's legislation, H.R. 1549, attempts to 

do, can we infer from this statement that USDA opposes this legislation? 

USDA does not support the broad elimination of antimicrobials for specific uses in animal agriculture. As 

we said in our testimony, determinations about the use of antimicrobials in animal agriculture must be 
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based on sound scientific evaluation and data-based decision making, to include the effect of changes 

upon animal health. 

We believe that the current risk assessment process for antimicrobials, which the Food and Drug 

Administration has in place, can provide a scientific basis for decisions about specific antimicrobial use. 

This is preferable to a broad approach that eliminates whole categories of antiinicrobials that mayor 

may not have an effect on resistance. 

With respect to your question on H.R. 1549, USDA does not have a formal position on the legislation. 

4. With respect to FDA's proposed guidance for antibiotic use, Guidance 209, FDA has proposed to 

require veterinary oversight for certain uses of antibiotics in animals. How does USDA suggest 

producers in veterinary shortage areas comply with this guidance? 

To clarify, the FDA guidance does not require veterinary oversight. The guidance is intended as a 

framework or suggestion to producers and veterinarians on the antimicrobial issue. There is no 

requirement that farmers or producers follow these guidelines, nor is there any sort of formal or 

informal enforcement mechanism related to it. The introduction to the guidance makes this clear when 

it says, "It does not create or confer any rights for or on any person and does not operate to bind FDA or 

the public." 

Although there is no requirement that producers follow the guidance, we remain committed to working 

with all our Federal partners to address the concerns you have raised regarding veterinary shortages. 

We are especially concerned with the lack of large animal veterinarians in rural areas and the challenges 

that longer distances and traveling times for veterinary consultation pose. USDA believes that we must 

work with our Federal partners, veterinarians, and other stakeholders to find feasible solutions on this 

issue. 

5. As you know, animals get sick just like people so should we not support the livestock industry's 

efforts to focus on the prevention of disease, not just trying to treat illnesses after they occur? 

USDA believes that antimicrobials should be available for the treatment, prevention, and control of 

disease. Ultimately, the decisions on judicious antimicrobial use should be addressed through sciencebased risk assessment and evaluation. We believe that this standard should apply to their use in both 

human and animal populations. Above all, we believe that the judicious use of antimicrobials should not 

result in undue risk to human or animal populations. 
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RADM Ali S. Khan, :-"1.D .. M.P.H. 

Assistant Surgeon General 

Director 

August 10, 2010 

for Emerging and Zoonotic lniectious Disease (Proposed) 

Centers for Disease Control and Prevention 

1600 CHft'1n Road 

Atlanta, FA 30333 

Deil! Dr. Kalll1: 

JOE. UARTON, TE;XAS 

Thank you for appearing before the Subcommittee On Health on July! 4, 201 0, at the 

hearing entitled "Antibiotic Resistance and the Use of AntibioticS in Animal Agriculture." 

Pursuant to the Committee's anaehed are written questions lor the record directed 

to you from certain Members of the In preparing your answers, please address your 

response the Member who submitted the questions. 

mail 

(202) 

by August 24, 2010, to Earley Green, Chief Clerk, viae-

~J:!.!'~~I?!l£!l'J!l2ill.L.l]Qill1!h!!.QY. Please contact Earley Grecn or Jennifer Berenholz at 

Sincerely, 

Attachment 
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The Honorable John Shimkns 

Q 1: In investigating cases ofMRSA, what has CDC conclnded abont animal contact as a 

risk factor for these infections? 

A. Methicillin-resistant Staphylococcus aureus (MRSA) ST398 is the predominant strain of 

MRSA identified in food-producing animals (primarily pigs) in Europe, Canada and the United 

States. Transmission of MRS A from either companion or food-producing animals to humans is 

thought to result from direct (Le., skin to skin) contact and appears to account for an extremely 

small proportion of human MRSA infections in the United States. 

Q 2: Is MRSA a foodborne infection, acquired by eating meat? If not, what is the pathway 

for resistance to be transmitted to humans? 

A. Unlike antimicmbial resistant Salmonella and Campylobacter in humans, neither transmission 

of MRS A from contaminated meat or other food, nor an association with antibiotic use in 

animals, has been described. In community settings, most MRSA infections are acquired by 

direct contact with the infected skin of other humans or direct contact with objects that have been 

contaminated with wound drainage. In health care settings, MRSA is most often transmitted from 

patient to patient on the hands of health care workers that have not performed adequate hand 

washing. 

In the United States, there have been no human infections to date identified with MRSA ST398 

(the predominant MRSA strain identified in food-producing animals in Europe, Canada, and the 

United States). CDC analyzed its collection of over 10,000 MRSA isolates from human 

infections and human nasal swabs and did not find any MRSA ST398. A recent non-CDC 

publication identified nasal colonization (Le., carriage without infection) with the MRSA ST398 

strain in workers at one Midwestern swine production system; however, these persons did not 

have MRSA infections. 1 

CDC will continue to assess the implications for human health of MRS A in food and foodproducing animals. 

Q 3: Do you recognize any limitations in the charts yon presented at the hearing, and 

should decisions be made based upon those charts with such significant limitations? 

A: CDC presented antimicrobial resistance data associated with fluoroquinolone use in the 

United States, quinolone use in the United Kingdom, and ceftiofur use in Canada. During the 

hearing, there was concern voiced with the data presented from the United Kingdom because the 

data were considered dated. The purpose of presenting these data was to demonstrate clear 

examples on how antimicrobial use in animals results in resistance, both in animals and humans, 

following a new intervention. Please be assured that CDC makes decisions and 

1 Smith Te, Male MJ, Harper AL, Kroeger JS, Tinkler GP, et aI. 2009 Methicillin-Resistant Staphylococcus aureus 

(MRSA) Strain ST398 Is Present in Midwestern U.s. Swine and Swine Workers. PLoS ONE 4(1): e4258. 

doi:10.137I1journal.pone.0004258 

http://www.plosone.orglarticlelinfo%3Adoi%2FI 0.1371 %2FjournaI.pone.0004258 
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recommendations based on all the data available, including the more recent data presented from 

the United States; it presented the United Kingdom data as an example of resistance development 

rather than as the sole case upon which current recommendations are being made. 
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Danish Veterinary and Food Administration 

23 August 2010 

Replies to the Honourable JOhn Shimkus on the Danish restrictions of non-therapeutical use of antibiotics for growth promotion and its consequences 

1. Would you agree that weaning pigs, the most susceptible population, suffered most from the ban on 

growth promoters? 

2. How do you account for the significant increase in therapeutic antimicrobials in swine between 1999 

and 2000? And the continued high level use oftherapeutics after that? 

3. If you took an average of the 5-10 years before the ban and the 5-10 years after the ban, do you think 

you would find the same results others have - that therapeutic use has nearly doubled? 

4. What kind of improvements have you seen in antibiotic resistance in humans since the ban? 

5. Has the number of swine farms in Denmark increased or decreased since the ban? Have production 

practices intensified to compensate for the declining number of farms? 

6. What has happened to total livestock consumption of all antimicrobials of human importance since 

2000? 

Replies: 

1. As no other species or age group of animals were influenced by the ban it would not be correct to 

state that weaner pigs suffered the most. There was a slight increase of therapeutic antimicrobials 

for weaner pigs just after the ban which might be correlated to the ban, but this increase could also be correlated to disease outbreaks related to Lawsonia intercellularis in Danish swine herds. 

Regardless of the reason for the temporary problems in weaner production, this was solved, as 

the farmers continuously improved their management when producing weaners. Neither weaner 

mortality nor average daily weight gain was affected by the ban in the long run, but only temporary shortly after the ban (Aarestrup et aI., AJVR, Vol 71, No.7, July 2010). 

2. The increase from 1999 to 2000 could be attributable to the temporary problems in weaner production after the ban or due to disease problems related to Lawsonia intercellularis. There has 

been a 50% reduction in the amount of antibiotics pro kg. pig from 1994 to 2008. In 1994 the 

amount used was 99 mg and in 2008 this was 49 mg. Denmark has a very low level use of therapeutical antimicrobials compared to other countries with comparable pig production. 
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3. Therapeutic use has not doubled regardless of which years you compare before and after the ban. 

If others have found that, they probably have forgotten to take the increase in pig production by 

more than 25 % into account since the ban. As stated above there has been a 50% reduction in 

antimicrobials given pr kg pig. 

4. Denmark has, compared to many other countries, traditionally had a low frequency of resistance 

among bacteria causing human infections. The ban on non therapeutic use of antimicrobial 

agents in Denmark was implemented to reduce an observed reservoir of bacteria in food animals 

and food products, which very resistant to classes of antimicrobial agents which at that time still 

had a limited use in human medicine. 

Page 2/4 

In connection to the different bans, monitoring of the effects was performed on food animals and 

food products and we have in detail documents a positive effect on all the bacterial species we 

have measured. Unfortunately no coordinated monitoring of the effects on human colonization in 

Denmark was implemented in connection with the different bans, mainly due to the need for ethical permission before samples from humans can be collected. Scientific studies from several 

other European countries, where the bans were implemented later than in Denmark, have however, documented a major positive effect in reducing the carriage rate of vancomycin resistant enterococci following the ban on avoparcin. 

In Denmark we can today with our monitoring in place document a low frequency of resistance 

to the antimicrobial agents which were banned. This picture is getting increasingly obscured by 

the fact that an increasing amount of food is imported from other countries, making it very difficult to point at specific sources in the future. 

Resistance in pathogens, common to both animals and humans, connected to human infections is 

so associated with antibiotic use in different reservoirs, that it is difficult to discern, which type 

or level of resistance derives from antibiotic use in humans and which in animals. Furthermore, it 

appears with increasing frequency, that at least in Denmark, most of the resistant bacteria humans acquire via food products derive from imported food (see DANMAP 2007 and 2008), 

which - since the data from antibiotic use in the veterinary sector is almost non-existent in most 

of the countries, that Denmark import food from again makes it difficult to point at a specific 

antibiotic use reservoir. 

We can however see important decreases in resistance associated to the ban of growth promoters 

in at least two different bacterial pathogens: Campylobacter sp. and Enterococci. For Enterococcus faecium, we can prove a marked reduction in resistance to all growth promoters (See 

DANMAP, all reports up to 2008), and there have been very few vancomycin-resistant E. faecium infections in humans in the 2000' s. There are several reports in the literature on the decreasing carriage rate of Vancomycin resitant E. faecium in Europe after the growth promoter ban 

(e.g. Wolfgang Witte and coworkers). 

There has been a constant decrease in resistance associated to the ban of growth promoters in 

Campylobacter sp. Shown in the Figure 30 below from DANMAP 2008 one can follow the constant decrease in erythromycin resistance in Campylobacter coli, which started in 2000, the year 

where growth promoters were banned in Denmark. For C. jejuni the erythromycin resistance level has remained low in cattle, but resistance levels have been low in cattle in general due to the 
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relatively low antibiotic use in these animals (Fig. 29) (Dept. for Micorbiological Surveillance 

and Research, Statens Serum Institut) 

5. Yes, the number of farms has declined both in the swine industry as well as in the cattle industry. 

In the same time the average herd size has increased. This development has been seen for many 

years and is still going on as a consequence of a more and more modern and cost effective agricultural sector. 

6. Antimicrobials used for animals are typically divided into two groups: 

I) Critically important antimicrobials for human treatment (fluoroquinolones and 3. and 4 generation cephalosporins) and 

2) Other antimicrobials, which can be used for treatment of animals with less risk of development 

of humanly critically resistant bacteria. 

In 2002 fluoroquinolones were restricted in Denmark and can only be used if a current laboratory 

test shows that no other antibiotics can be used for that disease in that herd of production animals 

Figure I describes the use of fluoroquinolones before the restrictions. Today the use offluoroquinolones is still below I -2 kg annually for all production animals. 

Page 314 
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.!i 

j 

Figure 1. Total veterinary usage of tluoroqlJinolones in 

Denmatf<, 2001 and 2002 

Using the consumption in 2001 as index 100, the development in usage ofthe critically important antimicrobials is described in figure 2. 

100~~~------~-------------------------------------

'001 "" 2003 ,,.. '''''' "" ,.,.. ~lospor1ner---¢-Fllioroklnolonerl 

Figure 2 • Development in usage of critically important antimicrobials for swine from 2001-2009. 

(Source: DANMAP2001-2008, DTU, DVFA). 

°The usage for december 2009 is estimated from figures from DIU for the january to november 2009 peri ode. 

Only the figures for swine are shown, as the usage in other livestock productions is negligible. 

Page 4/4 
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August 10,2010 

James R. Johnson, l>kD" FJ.D.SA, F.A.C.P. 

Professor of Medicine, of Milmesota 

Fellow, jnfectious Diseases of America 

Infectiolls Diseases (! 11 F) 

Room 3B-105 

V A Medical Center 

I Veterans Drive 

Minneapolis, MN 554!7 

Dear Dr. Johnson: 

JOf BARTON, TEXAS 

RANKING 

Thank YOll for appearing before the Subcommittee on Health On July! 4, 2010, at the 

hearing entitled "Antibiotic Resistance and the Use of Antibiotics in Animal Agriculture." 

Pursuant to the Committee's Rules, attached are written questions for the record directed 

to you from certain Members oIthe Committee. In preparing y()tlr answers, please address your 

response to the Member who submitted the questions, 

mail 

(202) 

by August 24, 2010, to Earley Green, Chief Clerk, via eY~ll~m@lru!l1hQlt~;:m:, Please contact Earley Green or Jennifer Berenholz at 

Sincerely, 

Attachment 
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August 23, 2010 

The Honomble Henry Waxman 

Chair, Energy and Commerce Committee 

United States House of Representatives 

Washington, DC 20515 

Re: Questions Submitted for the Record 

Dear Mr. Chairman: 

In regard to the July 14,20 I 0, hearing on "Antibiotic Resistance and the Use of 

Antibiotics in Animal Agriculture," held before the Subcommittee on Health, 

one question for the record was submitted by Representative John Shimkus to 

James R. Johnson, MD, who testified on behalf of the Infectious Diseases 

Society of America: 

Question: IDSA publishes a website called "Facts about Antibiotic 

Resistance, " which identifies the specific bacterial infections that present 

the biggest challenges to doctors and healthcare facilities from 

resistance to antibiotics. Salmonella and campylobacter do not appear 

on that list. Of the seven bacteria listed on the website. do any have a 

connection to antibiotic use in food animals? 

Answer: IDSA is concerned about antibiotic resistance when it occurs in !!!y 

type of disease-causing microorganism, especially if the resistance makes 

treatment of the associated infection more difficult, expensive, or toxic. 

The specific resistant organisms mentioned on the "Facts about Antibiotic 

Resistance" page on the IDSA web site are of concern to IDSA because of the 

number and severity of associated infections, their recent and rapid emergence, 

the scarcity of treatment options, and other factors. These citations are neither 

comprehensive nor all-inclusive. 

The list of all problem organisms and resistance phenotypes is much too 

extensive to be given full treatment on the web site. However, of various 

resistant organisms listed on the many pages of the IDSA web site, at least four 

have a connection to antibiotic use in food animals. 

For example, Salmonella and Campy/abacter are mentioned in 2004 and 2006, 

respectively, as organisms of concern with respect to acquired antibiotic 
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PAGE TWO-lDSA Letter to Chairman Waxman 

resistance (see pages I and 12 of the 2004 report, "Bad Bugs. No Drugs" 

(I1ttl;::!/wwwJdsociety.o1lt'Bf!NDWhitePmerQ4.btm) and page 2 oflDSA's 2006 "Statement on 

Use of 4th Generation Cepllalosporins in Livestock" presented before the Food and Drug 

Administration's Center for Veterinary Medicine Advisory Committee 

(httl;:,llwww-idsociety.omI\VorkArealDownlolidAsseta!>px?id", 16P3». For both of these 

bacteria, antibiotic use in food animals is a wel1~recognized contributor to their antimicrobial 

resistance. and food animals are established as the single most important source of these strains 

that cause human infections. 

Multidrug-resistant Escherichia coli (E. coil) and methicillin-resistant Staphylococcus auretls 

(MRSA) (both of which are mentioned on the "Facts about Antibiotic Resistance" page, 

h!1J!.:llwwwjdsooi!i)i,y.oa;tCODtent!!lt2!?iiE5650) also have connections to antibiotic use in 

animal agriculture. Multidrug-resistant E. coli strains are increasingly encountered in the 

community as well as the hospital. Several genetic-based studies suggest that most such strains 

are not human-source strains that acquired resistance while in humans. but instead likely were 

transmitted to humans from poultry which was already resistant. These studies also suggest that 

the poultry-source resistant E. coli likely became antibiotic-resistant while residing in poultry 

by conversion of poultry-source susceptible strains to resistant strains. This most plausibly 

would occur in relation to antimicrobial use in poultry. 

MRSA strain ST398, which exhibits tetracycline resistance (unlike most other MRSA strains). 

is strongly associated with swine and swine production facilities, where tetracyclines typically 

are used extensively. Although as yet ST398 is a minor contributor to the global MRSA 

epidemic. this strain has caused serious and sometimes fatal infections in humans. mostly in 

persons with direct or indirect contact with swine or other food animals. This strain has 

recently been found in swine in Iowa and Illinois. 

As you already know. antibiotic resistance is an important concern to IDSA, and we would be 

happy to provide any additional infonnation as needed. 

Sincerely, 

J 

Robert J. Guidos. 10 

Vice President, Public Policy and Government Relations 
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HENRY 

August 10, 2010 

Christine Hoang, D.V.M., M,P.H., C.P.ll. 

Assistant Director 

Scientific Activities Division 

American Veterinary Medica! Association 

1931 North Meacham Road, Suite 100 

Schaumburg, IL 60173 

Dear Dr. Hoallg: 

Thank you 

hearing entitled"', nf,hl,,,;,, 

betore the Subcommiltee on Health on 

and the Use of AntlbiOllcs in 

14, 2010, attne 

Agriculture," 

Pursuant to the Committee's Rules, attached are vwitten questions tor Ihe record directed 

to you tram certain Members of the Committee. In preparing your answers, please address your 

response to the Member wllo submitted the questions. 

Altachment 

by Allgus! 24, 2010, to Earley Green, Chief Clerk, via ePlease contact Earley Green or lennifer Berenholz at 

Sincerely, 
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Honorable John Shimkus 

Committee on Energy and Commerce 

2125 Rayburn House Office Building 

Washington, DC 20515-6115 

Dear Congressman Shimkus, 

Thank you for the opportunity to address this issue on behalfofthe veterinarians 

represented by the American Veterinary Medical Association (AVMA), Pursuant to 

the Committee's Rules, attached please find responses to your questions for the record 

referencing the Jury 14,2010 Subcommittee on Health hearing entitled "i\ntibiotic 

Resistance and the Use of Antibiotics in Anima! Agriculture. 

1. Does pain and suff~ring and premature animal death inc~ease if you take 

away antibiotics that lire preventing animals from getting sick? 

The A VMA believes that without the usc of antibiotics to prevent disease, there 

will be increased animal disease and therefore increased animal pain and suffering 

that would occur associated with the disease condition, Premature animal deaths 

can also occur if the disease becomes too advanced or severe for efficient 

treatment. 

2. Is it better to prevent livestock disease before tllere arc serious outbreaks, or 

treat animalS after tbey get sick? Would a veterinarian use larger doses of 

antibiotics to treat the disease than would be used in prevention? 

The A VMA believes that it is more appropriate and judicious to prevent diseases 

before they occur rather than use greater doses and potentially stronger drugs to 

treat diseases after animals show clinical signs. 

3. Is tbere any specific evidence to sbow tbat tbere bas actually been a decrease 

in antibiotk resistance infections in humans subsequent to tbe European ban 

on growth promoters? 

No, there is no clear evidence of a significant decrease in antibiotic resistant 

in[t'ctions in human as a resllll of the European ban on growth promoters. \\'bilc 

resistance in some pathogens to some antimicrobials has declined, resistance in 

other pathogens has increased. More importantly, the same trends can be seen in 

other counmes, such as the US, whcrc no ban has taken place, therefore no causal 

relationship can be inferred. 
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4. Would you describe for me what producers do today to implement judicious use 

guidelines and what these guidelines are? 

Producer groups have their own judicious use guidelines that are a part of quality assurance 

programs such as PQA plus (the pork quality assurance program) orBQA (the beef quality 

assurance program). Thcy arc very similar to AVMA's Judicious Therapeutic Use of 

Antimicrobials species specific policies that can be found at 

http://www.avma.orgiissues/antimicrobial use resistance. asp 

These principles outline objectives and strategies to optimize therapeutic efficacy and 

minimize resistance to antimicrobials to protect public and animal health. Specifically, the 

A VMA Judicious Therapeutic Use of Antimicrobials policy is attached in its entirety as 

Attachment A. 

5. I understand tbat the federal government is doing a great deal to collect data on 

possible antimicrobial resistance. One way we are doing that is through the National 

Antimicrobial Resistance Monitoring System (NARMS). The goal of the NARMS 

program is to collect data on, and facilitate the identification of, antimicrobial 

resistance in humans, animals and retail meats. What information bas been gathered 

through the NARMS program? 

NARMS gathers information on antimicrobial resistance patterns of specific bacteria from 

human enteric isolates, retail meats, and animal isolates. For example, in reviewing the 

information available through NARMS, the A vMA bas found that human isolates of 

Salmonella spp. (non-Typhi) were more than twice as likely to be resistant in 1996 as 

compared to 2007 and Salmonella set. Typhi (a human reservoir foodborne pathogen) are 

more than 4 times as likely to be resistant in 2007 as compared to 1999. 

6. It has been shown that a ban on grol\1h promoting antibiotics in Denmark led to an 

increase in the use of therapeutic antibiotics, which are those that are considered 

medically-important in hllmans. Is it likely that restrictions on the lise of growth 

promoting antibiotics in the United States will lead to the same trend? 

The A VMA believes that bans on low level uses in the US, such as those that have taken 

place in Denmark, the Netherlands, and the EU, will result in similar effects increased 

therapeutic uses (at higher doses and potentially more often in the same classes as important 

human drugs), and increased animal pain and suffering and potentia! death with associated 

diseases. 

7. I am concerned about the welfare of farm animals liS every farmer In America is. In 

your professional opinion, is it wise to restrict tile use of these products in feed to 

prevent diseases in animals? Is PAMTA in the best interests of animal wellbeing'! 

Would banning many feed and water uses for prevention result in having to use more 

potent therapeutics as was tile case in Denmark? 
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No, restricting veterinary drug availability to prevent disease is not in the best interest of 

animal health and welfare. There is no question that ifitrfectious diseases are not prevented 

before clinical signs are apparent, higher doses and potentially more important medications 

will need to be administered to treat the disease once it is widespread. 

Respectfully, 

~\"\...-~ 

Christine Hoang, DVM, MPH, CPH 

Assistant Director, Division of Scientific Activities 

c. Eiltley Green, Chief Clerk 

Attachment 
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Attachment A 

Judicious Therapeutic Use of Antimicrohials 

(Oversight FSAC; Approved by the A VMA Executive Board, November 1998; Revised Aptil2004, November 2008) 

Position Statement 

When the decision is reached to use antimicrobials for therapy, veterinarians should strive to 

optimIze therapeutic efficacy and minimize resistance to antimicrobials to protect public and 

animal health. 

Objectives 

S:upport development of a scientific knowledge base that provides the basis for judicio:us 

therapeutic antimicrobial use. 

Support educational efforts that promote judicious therapeutic antimicrobial use. 

Preserve therapeutic efficacy of antimicrobials. 

Ensure current and future availability of veterinary antimicrobials. 

Strategies 

Facilitate development and distribution of appropriate antimicrobial use guidelines by 

practitioner species-interest groups. 

Improve scientifically based therapeutic practices through education. 

Recognized Needs 

Improved monitoring and feedback systems for antimicrobial use and resistance patterns. 

Research to improve scientifically based therapeutic practices. 

Judicious Use Principles 

Preventive strategies, such as appropriate husbandry and hygiene, routine health monitoring, and 

immunization, should be emphasized. 

Other therapeutic options should be considered prior to antimicrobial therapy. 

judicious use of antimicrobials, when under the direction of a veterinarian, should meet all 

requirements of a veterinarian-client-patient relationship, 

Prescription, Veterinary Feed Directive, and extralabel use of antimicrobials must meet aU the 

requirements of a veterinarian-cHent-patient relationship. 

Extralabel antimicrobial therapy must be prescribed only in accordance with the Animal 

Medicinal Drug Use Clarification Act amendments to th~ Food, Drug, and Cosmetic Act and its 

regulations. 
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Attachment A 

Veterinarians should work with those responsible for the care of animals to use antimicrobials 

judiciously regardless of the distribution system through which the antimicrobial was obtained. 

Regimens for therapeutic antimicrobial use should be optimized using current pharmacological 

information and principles. 

Antimicrobials considered important in treating refractory infections in human or veterinary 

medicine should be used in animals only after careful review and reasonable justification. 

Consider using other antimicrobials for initial therapy.l 

Use narrow spectrum antimicrobials whenever appropriate. 

Utilize culture and susceptibility rcsults to aid in the selection of antimicrobials when clinically 

relevant. 

Therapeutic antimicrobial use should be confined to appropriate clinical indications. 

Inappropriate uses such as for uncomplicated viral infections should be avoided. 

Therapeutic exposure to antimicrobials should be minimized by treating only for as long as 

needed for the desired clinical response. 

Limit therapeutic antimicrobial treatment to ill or at risk animals, treating the fewest animals 

indicated. 

Minimize environmental contamination with antimicrobials whenever possible. 

Accurate records of treatment and outcome should be used to evaluate therapeutic regimens. 

lhl this context, this principle takes into account development of resistance or cross-resistance to 

important antimicrobials. 

Glossary: 

"'These terms are to be defined and utilized in the context of Judicious Therapeutic Use, with the 

intent of focusing on antimicrobials that may be of significance to human health. They are to be 

applied to the principles of Judicious Use outlined within the context of this document. 

Antibiotic--a chemical substance produced by a microorganism which has the capacity, in dilute 

solutions, to inhibit the growth of or to kill other microorganisms. 

AntimkrobiaJ--an agent that kills microorganisms or suppresses their multiplication or growth. 

Broad Spectrum Antimicrobial--a type of antimicrobial effective against a large number of 

bacterial genera; generally describes antimicrobials effective against both Gram-positive and 

Gram-negative bacteria. 
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Attachment A 

Narrow Spectrum Antimicrobial--a type of antimicrobial effective against a limited number of 

bacterial genera; often applied to an antimicrobial active against specific families of bacteria, 

Antimicrobial Resistance--a property of microorganisms that confers the ability to inactivate or 

elude antimicrobials or a mechanism that blocks the inhibitory or killing effects of 

antimicrobials, 

Extralabel Use--extralabel use means actual use or intended use ofa drug lroder veterinary 

direction, in an animal in a manner that is not in accordance with the approved labeling. This 

includes, but is not limited to, use in species not listed in the labeling, use for indications (disease 

or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of 

administration other than those stated in the labeling, and deviation from the labeled withdrawal 

time based on these different uses, 

Immunization--the process of rendering a subj ect immune or of becoming immune, either by 

conventional vaccination or exposure. 

Monitoring--monitoring includes periodic health surveillance of the population or individual 

animal examination, 

Therapeutic--treatmcnt, control, and prevention of disease, 

Veterinarian/Client/Patient Relationship (VCPR) -- A VCPR exists when all of the following 

conditions have been met: 

1. The veterinarian has assumed the responsibility for making clinical judgments 

regarding the health of the animal(s) and the need for medical treatment, and the 

client has agreed to follow the veterinarian's instructions. 

2, The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general 

or preliminary diagnosis ofthe medical condition of the animal(s). This means that 

the veterinarian has recently seen and is personally acquainted with the keeping and 

care of the animal(s) by virtue of an examination of the animal(s) or by medically 

appropriate and timely visits to the premises where the animal(s) are kept. 

3. The veterinarian is readily available for follow-up evaluation, or has arranged for 

emergency coverage, in the event of adverse reactions or failure of the treatment 

regimen. 

Veterinary Feed Directive (VFD) Drug--The VFD category of medicated feeds was created by 

the Animal Drug Availability Act of 1996 to provide an alternative to prescription status for 

certain therapeutic animal pharmaceuticals for use in feed. Any animal feed bearing or 

containing a VFD drug shall be fed to animals only by or upon a lawful VFD issued by a 

licensed veterinarian in the course of the veterinarian's professional practice. 
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HENRY A, 

Richard Carnevale, D.V.M. 

Vice President 

A,ugust 2010 

Regulatory, Scientific and IntemationaJ Afthlrs 

Animal Health Institute 

1325 G Street NW, Suite 700 

Washington. DC 20005 

Dear Dr. Carnevale: 

'Thank you for 

hearing entitled "l\UTlOlc.nc 

before the Subcommittee on Health on 14,2010, at the 

Agriculture." 

Pursuant to the Committee's Rules, attached are written questions for the recurd directed 

to you from certain Members of the Committee. In preparing your answers, please address your 

response to the Member who submitted the questions, 

mail 

(202) 

responses by Augus!24, 2010, to Earley Green, Chief Clerk, via ePlease contact Earley Green or Jennifer Berenh(llz at 

Sincerely, 
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1. How is antibiotic use by livestock producers tracked? 

Since 1995 AHI has been surveying their members on antibiotic sales. The data is tabulated by 

pounds of various classes of antibiotics and antimicrobials such as tetracyclines and penicillins. 

AHI members manufacture about 85% of the antibiotics produced for the United States. The 

latest information on that survey is available at 

http://www.ahi.orgifileslMedia%20Center/ Antibiotic%20Use%202007.pdf 

Other surveys of antibiotic use that are periodically conducted are in the USDA National 

Animals Health Monitoring System where they query producers on the types and amounts of 

antibiotics used in particular species. These surveys are conducted every 3-5 years on an animal 

species basis. 

Recently, the amended Animal Drug User Fee Act (ADUFA) of2008 directed FDA to collect 

data on antibiotic use from animal drug sponsors beginning in calendar year 2010. The data was 

due to the agency in March 2010 and a report is expected from FDA later this year. 

2. Is it true that the specific types of antibiotic resistance found in human medicine are not 

related to the use of antibiotics in animals, because the bacteria (causing these infections does 

not come from animals) or the drug of concern is not used in animals? 

Yes, the Centers for Disease Control and Prevention and the Infectious Disease Society of 

America, have identified the infectious bacterial diseases in humans that present the greatest 

concern for treatment with antibiotics because of resistance. 

(http://www.cdc.gov/drugresistancelDiseasesConnectedAR.html) 

(http://www.idsociety.orgiContent.aspx?id=5650.) 

• Staphylococcus infections (MRSA) - these are mainly hospital nosocomial infections 

but have been found in communities associated with schools and athletic facilities. These 

infections are a result of human to human transmission or contact with contaminated 

materials. IDSA says that 1 % of people carry MRSA in their nasal passages. CDC 

investigates cases of MRSA and has concluded that animal contact is not a risk factor for 

these infections. Furthermore, they have also concluded that MRSA is not a foodborne 

infection and cannot be acquired by eating meat. 

• Acinetobacter baumanni is an opportunistic pathogen associated with a high rate of 

infections in soldiers wounded in Iraq. It is most often associated with wound infections 

in hospitals and other medical facilities. It is inherently resistant to many antibiotics and 

has no connection to food animals or antibiotic use in food animals. 

• Vancomycin Resistant Enterococcus (VRE) is another hospital nosocomial infection 

that has developed resistance due to extensive use of vancomycin in U.S. hospitals. 
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Vancomycin or drugs in its class have never been approved for or used in food producing 

animals in the United States. 

• Pseudomonas aeruginosa is another opportunistic pathogen found in intensive care units 

that have become resistant to fluoroquinolone antibiotics. It occurs uncommonly in food 

producing animals where it can cause mastitis in dairy cows. Fluoroquinolones are not 

approved for use in dairy cows and furthermore Pseudomonas is not a foodborne 

pathogen. 

• Streptococcus pneumoniae is resistant to several classes of antibiotics and is strictly a 

human pathogen that causes respiratory infections. This organism has no known 

connection to food producing or companion animals. 

• Neisseria gonorrhea is strictly a human pathogen that causes venereal infections 

transmitted through human sexual contact. Resistance develops because of poor patient 

compliance with the prescribed course of antibiotic therapy. There is no connection with 

animals or antibiotic use in animals. 

• Drug resistant tuberculosis, Clostridium difficile, and Klebsiella species are other 

bacteria that are mentioned in the IDSA fact sheet. There is no known connection 

between these pathogens and food producing animals. 

Notably, bacterial diseases such as foodborne illness due to Salmonella or Campylobacter are not 

even mentioned but are the most likely infections that could be transmitted from food producing 

animals via uncooked meat or poultry. Apparently these infections are not considered a 

significant problem for treatment due to antibiotic resistance. 

3. What is your reaction to the data that Dr. Khan of CDC presented allegedly linking animal 

antibiotic use and human health problems? 

Dr. Khan presented three charts that appeared to document a "temporal" relationship between the 

use of certain veterinary antibiotics and the finding of resistance in human isolates to support his 

contention that the science is "unequivocal" regarding the link between animal use of antibiotics 

and negative impacts on human health. In my opinion, representing this data as unequivocal is a 

clear example of jumping to conclusions without having all of the information available: 

1. Slide entitled: "Fluoroquinolone approval in humans and poultryand percent 

resistance in human Campylobacter isolates, by year, 1989-90 and 1997-2008" 
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• This slide attempts to demonstrate that resistance to Ciprofloxacin increased the year 

after Baytril was approved yet the NARMS program only started the year following 

approval. No data had been collected on a national basis prior to that so it is not 

known what the percentage of resistance may have been prior to approval. 

• The data in NARMS is based on Campylobacter isolates that CDC receives from state 

public health laboratories. The isolates represent bacterial cultures from both 

domestically acquired as well as those associated with foreign travel. CD has stated 

in FoodNet, an active surveillance program, that there is a three-fold risk factor for 

acquiring fluoroquinolone (FQ) resistant Campylobacter from foreign as opposed to 

domestic sources. Another publication out of the Minnesota reports that 70% or more 

of resistant Campylobacter infections had a history of foreign travel. Therefore, it 

cannot be conclusively stated that the evidence is unequivocal that the approval of 

FQ's in poultry in the U.S. is the primary cause of the resistance seen in human 

infections. 

• Finally, even if some of the resistance was due to Baytril use in poultry, this still does 

not mean there will be greater human health harm. Campylobacter is usually a self 

limiting infection and not a candidate for antibiotic treatment. A review published in 

2007 of nearly 11,000 cases of human Campylobacteriosis found that there was no 

difference in duration of disease between FQ susceptible and FQ resistant infections 

indicating that FQ treatment does not affect the course of the disease. The mere 

presence of some level of resistance in a bacterium does not automatically mean that 

there will be human harm or that infections cannot be treated. 

2. Slide entitled: "Quinolone-resistant Salmonella Typhimurium DTl04 (UK)" 

• This slide marked with the World Health Organization logo represents data from 

isolates collected and analyzed by The UK Health Protection Agency's Laboratory of 

Enteric Pathogens. Dr. John Threlfall is the director of that laboratory and has 

published information on this Salmonella strain since the 1990's. 

• First, the resistance that was reported was for quinolones, which is a precursor to the 

fluoroquinolone antibiotics. The specific drug that was tested was a compound called 

nalidixic acid which is not used to treat human infections. Nalidixic acid is not a 

fluoroquinolone, like ciprofloxacin, which are used in human medicine, have greater 

effectiveness than quinolones, and are less susceptible to developing resistance. 

There was no clinical resistance reported to ciprofloxacin in this study. 

• Secondly, the chart stops at 1997. It is known that DT -104 is a multi-resistant 

Salmonella clone that was prevalent in the 1990's in the UK. Clones of several 

Salmonella serotypes have been known to increase and decrease in populations of 
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animals and people in the past irrespective of antibiotic use. A clone simply 

reproduces and passes its exact genetic makeup to the next bacterium and soon the 

population of bacteria is dominated by that particular serotype. If the data had been 

shown after 1997 it would have demonstrated an eventual decrease from 2000- 2004 

from 50% to 28% of DT -104 and an overall decrease in resistance to antibiotics 

despite veterinary use. 

• A paper published in 2006 (E.J. ThrelfaIl, et aI, Assessment of factors contributing 

to changes in the incidence of antimicrobial drug resistance in Salmonella 

enterica serotypes Enteriditis and Typhimurium from humans in England and 

Wales in 2000, 2002 and 2004, International Journal of Antimicrobial Agents 28 

(2006) 389-395) concluded that: 

" ... In relation to published data on veterinary sales of antimicrobials in the UK, 

the findings demonstrate that changes in the incidence of resistance do not 

correlate with changes in veterinary usage . .... "For S. Typhimurium, the most 

important factor has been an overall decline in the occurrence of multiple drugresistant S. Typhimurium definitive phage type 104." 

It is unfortunate that the CDC presented clearly incomplete data on the relationship between 

antibiotic use in animals and human resistance. What may have appeared to be a direct 

relationship between the two was later shown not to be the case. 

3. Untitled slide: Voluntary withdrawal ofcephalosporins in Quebec. 

• This is chart from the Canadian CIP ARS program which is similar to the U.S. 

NARMS program which tracks antimicrobial resistance in foodbome pathogens in 

Canadian provinces. In 2005 Quebec recommended that poultry producers stop 

injecting chicken eggs with ceftiofur, a veterinary cephalosporin, approved in the 

U.S. It must be noted that injecting eggs with this drug is not an approved use in 

either Canada or the United States. The drug is approved only for injecting day old 

chicks and turkey poults to prevent early mortality. While the data shows a decrease 

in retail chicken and in human isolates, missing is information from chicken carcasses 

which is important to support the case that the antibiotic resistant Salmonella actually 

came from the farm. 

• Furthermore, it is known that Salmonella Heidelberg as one of many strains of 

Salmonella was known to decrease in prevalence in chickens and humans over the 

same period oftime in other Canadian provinces that did not prohibit use of the drug. 

So the decline in resistance in Quebec may have been due to the overall decline in 

prevalence of this Salmonella strain. The chart also shows that between 2000 and 

2006 there was a greater than 50% reduction in cephalosporin use in humans which 

could also explain a decrease in resistance of human infections. 
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As a final note all three charts presented at the hearing were from studies with drugs approved 

only for therapeutic use. The subject of the subcommittee hearing focused on antibiotics used in 

feed for "non-therapeutic" purposes. No data was presented by any witness to link antibiotics 

used in feed to antibiotic resistance in human pathogens. 

4. You said in response to a question that the evidence was not unequivocal that animal 

antibiotics are impacting human health, particularly for antibiotics used infeed. What is the 

evidence for your response? 

• The mere finding of resistance in animals, people, or food products doesn't 

automatically equate to risk - Antibiotic resistance can be present with or without 

antibiotic use because a specific bacteria may be inherently resistant to particular 

antibiotics or the bacteria is a clone of another bacteria that has carried the resistance over 

through genetic transfer. 

• The vast majority of antibiotic resistant infections in humans are in bacteria that do not 

come from animals - MRSA hospital and community infections, VRE, gonorrhea, strep 

pneumonia, tuberculosis, acinetobacter baummani, etc. (See question 1) 

• Most of the antibiotics used in feed are not used to treat foodbome illness. The one 

exception, macrolides has very low resistance in Campylobacter of about 1-2% 

• Quantitative risk assessments in all major classes offeed antibiotics have shown 

extremely low levels of human risk. 

• Antibiotic resistance as seen in NARMS has been unchanged for 10 years for the feed 

additive antibiotics and historical data back to the 1970's shows the same general levels 

of resistance. Resistance developed early with the use of these drugs in humans and later 

animals and has essentially remained at those levels over decades of use. 

• The World Health Organization concluded that antibiotic resistance problems in humans 

due to growth promoters were rare in Denmark before or after the ban (Impact of 

antimicrobial growth promoter termination in Denmark, Foulum, Denmark, 6-9 

November 2002) 
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5. We commonly hear that "70 percent of all antibiotics are used for non-therapeutic 

purposes in animals." Do you know the source of that statement, and is it accurate? 

• This "estimate" comes from a 2001 publication by the Union of Concerned Scientists 

called "Hogging It," in which they multiplied the number of animals times the amount of 

antibiotics they guessed were being used. 

• The UCS estimates included 11,046,693 pounds of ionophores and other substances not 

used in human medicine, or 45 percent of their total estimated amount. Ionophores are 

compounds not used in human medicine and are excluded from the antibiotic resistance 

debate. In 2007, Margaret Mellon, one of the authors of "Hogging It," said, "In the more 

than 10 years I've been in this issue, they've never been considered antibiotics." Except 

when she counted them in "Hogging It." 

• The UCS estimate included 43,000 pounds of efrotomycin use in swine. Efrotomycin has 

never been sold in the United States. 

• The UCS estimate includes 1.4 million pounds of chlortetracycline and nearly 400,000 

pounds of erythromycin are used in chickens. Poultry veterinarians, however, indicate 

that few, if any, of these products are used in chickens today. 

• To get to "70 percent," UCS had to invent a definition for "non-therapeutic" that 

included disease prevention and control uses that FDA, OlE and Codex consider to be 

therapeutic uses. 

• There are no publicly available estimates of human use of antibiotics. So, to come up 

with "70 percent," UCS came up with their own estimate. 

6. Is there any specific evidence to show that there has actually been a decrease in antibiotic 

resistance infections in humans subsequent to the European ban on growth promoters? 

• We know of no evidence that has conclusively linked a decrease in antibiotic resistant 

infections in humans to the ban on growth promoters in Europe. As stated previously, 

the main problems in human medicine are with bacterial infections that do not 

originate in food animals. Furthermore, the antibiotics used as growth promoters in 

Europe were the types that are generally not active against the bacteria that 

commonly cause foodborne illness that could come from animals. The report by a 

WHO expert panel, cited in my answer to question # 4 above confirmed this in their 

conclusion that" " . direct effects of the termination of growth promoters on 

resistance in Gram-negative bacteria(e.g. E.coli. Salmonella) were neither expected 

nor observed. " 
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7. Is there an increased food safety risk if growth promoting or preventative antibiotics are 

removedfrom livestockfeed or water? 

• There could be. Scientists and veterinarians believe that antibiotics even used for 

growth promotion in reality suppress subclinical infections caused by bacteria that 

can inhabit the intestinal tract of food animals. Therefore, the use of antibiotics in the 

early stages of production allow for a "healthy" gut and facilitate the more efficient 

utilization of nutrients allowing the animal to gain weight faster with less feed. One 

2003 peer-reviewed article by Scott Russell at the University of Georgia 

demonstrated that there were higher Campylobacter counts on carcasses from flocks 

with airsacculitis infections as opposed to carcasses from flocks that were 

airsacculitis negative (S. M. Russell, The Effect of Airsacculitis on Bird Weights, 

Uniformity, Fecal Contamination, Processing Errors, and Populations of 

Campylobacter spp.and Escherichia coli, 2003 Poultry Science 82:1326-1331). 

Airsacculitis is an intestinal tract infection of broiler chickens that can cause the 

intestinal tract to more easily rupture upon processing spreading bacteria to chicken 

carcasses. 

• Another publication on a quantitative risk assessment on virginiamycin, a feed 

antibiotic in chickens, indicated that there could be increased human health risks from 

more pathogens reaching consumers if virginiamycin use is terminated (Cox L.A. 

Potential Human Health Impacts of Banning Antimicrobials Used in Food 

Animals: A Case Study of Virginiamycin. Environ Int. 2005; 31(4):549-63. 

8. Are you aware of evidence demonstrating that reductions in antimicrobial use in animal 

agriculture could be associated with a negative impact on the health of humans? 

• The two publications cited in my answer to question #7 indicates that reductions in 

antibiotic use that keep food animals healthy could lead to greater overall incidence 

of foodbome infections. 

9. When FDA approves a new antimicrobial animal drug, does it take into account the drug'S 

importance to human health? 

a. What happens if FDA concludes that the drug is important to human health? 

b. Does FDA not approve the drug for animals? 

c. Does FDA put restrictions on its use? 

d. Are there situations where Guidance 152 has resulted in more restrictive labeling 

of a product through the inherent risk mitigation steps that FDA can impose? 
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• FDA has always examined the impact of animal drugs including antibiotics for any 

on human health whether or not the drug is also important for treating diseases in 

humans. With antimicrobials, FDA requires the sponsor of a new antimicrobial 

product for food animals to demonstrate the drug is safe from any residues that may 

remain in the animal after use and that could also be present in meat, as well as 

evaluating the potential for an animal antimicrobial, that may also be medically 

important to humans, to select for resistance in certain foodbome pathogens that 

could be transferred to humans. 

o FDA will conduct a qualitative risk assessment on a new antimicrobial under 

Guidance for Industry # 152 and rank the drug as critically important, highly 

important, or important to human health based on criteria set forth in 

guidance. Depending on the ranking of the drug's importance it will affect the 

overall risk evaluation for the drug that is proposed for use in animal medicine 

and will affect whether or not the FDA approves the drug and if so, under 

what conditions of use. 

o The FDA could decide to not approve the drug for animals depending on the 

importance to human health ranking and the sponsor's proposed label claims 

and conditions of use. 

o FDA does require certain restrictions depending on the overall risk ranking of 

the antimicrobial. If the potential risk to human health is judged to be high 

then FDA can impose certain restrictions, such as, for use only in individual 

animals for short term therapy, and that it is only available on the order of a 

licensed veterinarian either as a prescription product or under a veterinary 

feed directive. 

o The experience with Guidance 152 has been that sponsors have tailored their 

applications for new antimicrobials to meet the inherent restrictions 

contemplated by the guidance. For example, it would be highly unlikely for 

any antibiotic ranked as critically important for human medicine to be 

approved by the FDA for extensive use in the feed oflivestock or poultry. 
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10. Would you describefor me what producers do today to implement judicious use guidelines 

and what these guidelines are? 

The A VMA, species-specific veterinary groups, and feed and producer groups have all worked 

with government agencies including FDA to produce Judicious Use guidelines for safe and 

judicious use of antimicrobials based on several principles for managing infectious diseases. The 

Judicious Use Principles are designed to minimize the need for antimicrobial use, but when 

needed, to use them properly, and to evaluate the outcome of the use. 

These guidelines are used as the basis for producer education programs and represent an 

important effort on the part of the animal agriculture community to ensure that antimicrobials are 

used properly. Many producers have used these guidelines to create standard operating 

procedures for antimicrobial use on the farm. The National Pork Board has instituted the "Take 

Care - Use Antimicrobials Responsibly Program." Take Care is based on five principles to 

guide antimicrobial use in pig production. It has been endorsed and adopted by numerous large 

and small producers. The National Cattlemen's Beef Association also operates under a Beef 

Quality Assurance program which stresses the use of FDA approved products only, that 

Judicious Use Guidelines be followed, and that any extralabel use be authorized by a veterinarian 

according to FDA regulations. 

11. I understand that the federal government is collecting data on possible antimicrobial 

resistance. One way we are doing that is through the National Antimicrobial Resistance 

Monitoring System (NARMS). The goal of the NARMS program is to collect data on, and 

facilitate the identification oj, antimicrobial resistance in humans, animals and retail meats. 

What information has been gathered through the NARMS program? 

NARMS is a joint program between the FDA, USDA, and CDC which has been collecting and 

analyzing foodbome bacterial isolates from carcasses and human infections since 1996 and retail 

meats since 2002. The isolates are tested for antibiotic susceptibility to 17 different 

antimicrobial compounds. The program attempts to relate what may be coming through the food 

supply from animal sources that could affect human health. Over 50,000 Salmonella and 

Campylobacter samples have been tested in all three arms of the NARMS program. The data 

indicate that resistance rates in human infections to critically important antibiotics have been 

very low and have remained relatively steady over the years. Resistance rates in animals are 

generally higher than those seen in humans for several antibiotics indicating that bacterial 

resistant bacteria are not being always being directly transferred from animal derived food to 

humans. Resistance rates to older antibiotics, such as tetracycline and penicillin are higher than 

those for the critically important drugs, but have remained at those same levels for years based 

on data collected prior to the NARMS program. 81 % of all human isolated Salmonella are 

susceptible to all antibiotics tested in the program. 
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12. It has been shown that a ban on growth promoting antibiotics in Denmark led to an 

increase in the use of therapeutic antibiotics, which are those that are considered medicallyimportant in humans. Is it likely that restrictions on the use of growth promoting antibiotics 

in the United States will lead to the same trend? 

Yes, there is every reason to believe that removing antibiotics from animal feed will cause an 

increase in disease and mortalities, particularly in young animals. Certainly, there has been a 

misunderstanding with the public and a negative perception of the value of low dose uses of 

antibiotics for growth promotion. These claims were established many years ago when 

antibiotics were first being used in animal production. There has not been a new growth 

promotion indication approved in more than 20 years for any antimicrobial considered medically 

important for human medicine. While the so called growth promotion indications imply that 

these uses simply "fatten" the animal, in fact, what many veterinarians and researchers believe is 

that their use functions in maintaining gut health by suppressing bacteria causing subclinical 

disease. Subclinical infections may not be readily apparent but can affect the animals' ability to 

efficiently utilize nutrients to reach its optimal production potential. This was most evident in 

Denmark when withdrawal of antibiotic growth promoters from pig production resulted in the 

outbre~ of intestinal disease in weanling pigs leading to increased incidence of scouring with 

attendant increase in mortalities. 

o