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54–484 2010

H.R. 1549, PRESERVATION OF ANTIBIOTICS FOR 

MEDICAL TREATMENT ACT (PAMTA) 

HEARING 

BEFORE THE

COMMITTEE ON RULES 

U.S. HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

MONDAY, JULY 13, 2009 

Printed for the use of the Committee on Rules 


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(II) 

COMMITTEE ON RULES 

LOUISE MCINTOSH SLAUGHTER, New York, Chair 

JAMES P. MCGOVERN, Massachusetts, Vice 

Chair 

ALCEE L. HASTINGS, Florida 

DORIS O. MATSUI, California 

DENNIS A. CARDOZA, California 

MICHAEL A. ARCURI, New York 

ED PERLMUTTER, Colorado 

CHELLIE PINGREE, Maine 

JARED POLIS, Colorado 

DAVID DREIER, California, Ranking Member 

LINCOLN DIAZ-BALART, Florida 

PETE SESSIONS, Texas 

VIRGINIA FOXX, North Carolina 

MUFTIAH MCCARTIN, Staff Director 

HUGH NATHANIAL HALPERN, Minority Staff Director 

SUBCOMMITTEE ON LEGISLATIVE AND BUDGET PROCESS

ALCEE L. HASTINGS, Florida, Chairman 

DENNIS A. CARDOZA, California 

CHELLIE PINGREE, Maine 

JARED POLIS, Colorado 

LOUISE MCINTOSH SLAUGHTER, New 

York 

LINCOLN DIAZ-BALART, Florida, Ranking 

Member 

DAVID DREIER, California 

LALE MAMAUX, Staff Director 

CESAR GONZALEZ, Minority Staff Director 

SUBCOMMITTEE ON RULES AND ORGANIZATION OF THE HOUSE

JAMES P. MCGOVERN, Massachusetts, Chairman 

DORIS O. MATSUI, California 

MICHAEL A. ARCURI, New York 

ED PERLMUTTER, Colorado 

LOUISE MCINTOSH SLAUGHTER, New 

York 

PETE SESSIONS, Texas, Ranking Member 

VIRGINIA FOXX, North Carolina 

KEITH L. STERN, Staff Director 

KEAGAN LENIHAN, Minority Staff Director 

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C O N T E N T S 

July 13, 2009 

Page 

Opening Statements: 

Hon. Louise McIntosh Slaughter, a Representative in Congress from the 

State of New York and Chair of the Committee on Rules ......................... 1 

Hon. Doris O. Matsui, a Representative in Congress from the State 

of California ................................................................................................... 4 

Hon. Chellie Pingree, a Representative in Congress from the State of 

Maine ............................................................................................................. 5 

Hon. Jared Polis, a Representative in Congress from the State of Colorado ................................................................................................................ 6 

Hon. Dennis Cardoza, a Representative in Congress from the State of 

California, prepared statment ...................................................................... 66 

Witness Testimony: 

Joshua Sharfstein, M.D., Principal Deputy Commissioner, Department 

of Health and Human Services, U.S. Food and Drug Administration ..... 7 

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

Margaret Mellon, PH.D., Scientist and Director, Food and Environment 

Program, Union of Concerned Scientists .................................................... 22 

Prepared statement .......................................................................................... 23 

Lance B. Price, PH.D., Director, Center for Metagenomics and Human 

Health, Associate Investigator, Pathogen Genomics Division, the 

Translational Genomics Research Institute ............................................... 28 

Prepared statement .......................................................................................... 30 

Robert Martin, Senior Officer, Pew Environment Group .............................. 31 

Prepared statement .......................................................................................... 33 

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

of Illinois ........................................................................................................ 52 

Prepared statement .......................................................................................... 53 

Hon. Leonard Boswell, a Representative in Congress from the State of 

Iowa ................................................................................................................ 54 

Prepared statement .......................................................................................... 57 

Fedele Bauccio, President and CEO, Bon Appe ́tit Management Company . 68 

Prepared statement .......................................................................................... 70 

Steve Ells, Chairman and CEO, Chipotle Mexican Grill .............................. 70 

Prepared statement .......................................................................................... 72 

Dr. Frank Moller Aarestrup and Dr. Henrik Wegener of the National 

Food Institute, Technical University of Denmark, prepared statement .. 121 

Additional Material Submitted for the Record: 

Curriculum Vitae and Truth in Testimony Forms for Witnesses Testifying 

Before the Committee (where applicable) ................................................... 78 

Letter from the Honorable Leonard Boswell to Chairwoman Slaughter 

dated July 8, 2009; ........................................................................................ 101 

Statement by Bill Niman and Nicolette Hahn Niman .................................. 103 

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IV 

Additional Material Submitted for the Record—Continued 

Article by Peter Collignon, et al., entitled ‘‘World Health Organization 

Ranking of Antimicrobials According to Their Importance in Human 

Medicine: A Critical Step for Developing Risk Management Strategies 

for the Use of Antimicrobials in Food Production Animals’’ ..................... 107 

Letter from Dr. Anne A. Gershon, M.D., with Infectious Diseases Society 

of America to Chairwoman Slaughter, dated July 10, 2009 ..................... 118 

Transcript from the Subcommittee on Livestock, Dairy, and Poultry, 

Committee on Agriculture hearing to review the advances of animal 

health within the livestock industry, Thursday, September 25, 2008 ...... * 

Keep Antibiotics Working Fact Sheet and letter to Dr. Joshua Sharfstein, 

MD, Deputy Commissioner of FDA from Mr. Richard R. Wood, Chair 

of Keep Antibiotics Working Steering Committee. ..................................... 126 

Article by Lance Price, et al., entitled ‘‘Flouroquinolone-Resistant 

Campylobacter Isolates from conventional and Antibiotic-Free Chicken 

Products’’ ........................................................................................................ 135 

Article by Lance Price, et al., entitled ‘‘The Persistence of 

Fluoroquinolone-Resistant Campylobacter in Poultry Production’’ .......... 140 

Article by Jayne Clampitt, entitled ‘‘Living by Large Animal Confinements Paradise Lost: One Country Family’s Story’’ .................................. 146 

*Previously printed by GPO, Serial No. 110–48 and can be accessed on 

the Committee of Agriculture’s website at http://agriculture.house.gov/testimony/110/110-48.pdf 

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ORIGINAL JURISDICTION HEARING ON H.R. 

1549, PRESERVATION OF ANTIBIOTICS FOR 

MEDICAL TREATMENT ACT OF 2009 

MONDAY, JULY 13, 2009 

HOUSE OF REPRESENTATIVES, 

COMMITTEE ON RULES, 

Washington, DC. 

The committee met, pursuant to call, at 2:28 p.m. in Room H– 

313, The Capitol, Hon. Louise M. Slaughter [chairwoman of the 

committee] presiding. 

Present: Representatives Slaughter, Matsui, Cardoza, Pingree 

and Polis. 

OPENING STATEMENTS 

The CHAIRWOMAN. I am required to wait for a third Member, so 

we will be starting in a few minutes. They are on their way. [2:34 

p.m.] 

The Rules Committee will please come to order. 

I thank all of you for coming today. I want to introduce my panel 

members: Congresswoman Doris Matsui from California, who has 

an enormous interest in health and agriculture subjects; and also 

Chellie Pingree, who is a freshman this year from Maine, who has 

a wonderful background in Common Cause. We are hoping for 

other Members who may or may not show up. In any case, we are 

delighted to have you here. My name is Louise Slaughter. I represent the 28th Congressional District of New York. 

OPENING STATEMENT OF HON. LOUISE MCINTOSH SLAUGHTER, A REPRESENTATIVE IN CONGRESS FROM THE STATE 

OF NEW YORK AND CHAIR OF THE COMMITTEE ON RULES 

The CHAIRWOMAN. I think this is a critically important issue. As 

a microbiologist, I can’t stress enough the urgency of absolutely 

making sure our current stock of antibiotics does not become obsolete. Every year 2 million Americans acquire bacterial infections 

during their hospital stays; 70 percent of the infections will be resistant to drugs commonly used to treat them. Seventy percent. As 

a result, every day 38 patients in our hospitals die of those infections. 

Sadly, children and infants are particularly susceptible to infections caused by antibiotic-resistant bacteria. For example, salmonella causes 1.4 million illnesses every year, and over one-third 

of all diagnoses occur in children under the age of 10. Additionally, 

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infants under the age of 1 are 10 times more likely than the general population to acquire a salmonella infection. 

In 1995, 19 percent of salmonella strains were found to be 

multidrug-resistant. That means our children are left to undergo 

multiple treatments for otherwise simple infections because we 

have allowed the traditional treatments to become ineffective. 

The cost of these infections and these ineffective treatments to 

our already strained health care system is astronomical. In fact, resistant bacterial infections increase health care costs by $4 billion 

to $5 billion each year. Currently, seven classes of antibiotics certified by the Food and Drug Administration as highly or critically 

important in human medicine are used in agriculture as animal 

feed additives. Among them are penicillin, tetracycline, macrolides, 

lincosamide, streptogramin, aminoglycoside, and sulfonamides. 

These classes of antibiotics are among the most critically important 

in our arsenal of defense against potentially fatal human disease. 

Penicillin, for example, used to treat infections from strep throat to 

meningitis; macrolides, sulfonamides used to prevent secondary infections in patients with AIDS and to treat pneumonia in HIV-infected patients. Tetracyclines are used to treat people potentially 

exposed to anthrax. 

But despite their importance to human medicine, the drugs are 

added to animal feed as growth proponents and for routine disease 

prevention. In other words, these are not animals that are ill. This 

is the most staggering number of all: 70 percent of the antibiotics 

and related drugs produced in the United States—70 percent—are 

given to cattle, pigs, and chicken to promote growth and compensate for crowded, unsanitary, and stressful conditions. The nontherapeutic use of antibiotics in poultry skyrocketed from 2 million 

pounds in 1985 to 10.5 million pounds in the late 1990s. 

This kind of habitual nontherapeutic use of antibiotics has been 

conclusively linked to a growing number of incidents of antimicrobial-resistant infections in humans and maybe contaminated 

groundwater with resistant bacteria in rural areas. 

In fact, the National Academy of Sciences report states that a decrease in antimicrobial use in human medicine alone will have little effect on the current situation. Substantial efforts must be made 

to decrease inappropriate overuse in animals and in agriculture as 

well. 

Resistant bacteria can be transferred from animals to humans in 

several ways. Perhaps, most glaringly, antibiotic-resistant bacteria 

can be found in the meat and poultry that we purchase every day 

at the grocery store. In fact, a New England Journal of Medicine 

study conducted in Washington, D.C., found that 20 percent of the 

meat sample was contaminated with salmonella, and 84 percent of 

those bacteria—that is salmonella—were resistant to antibiotics 

used in human medicine and animal agriculture. 

Bacteria can also be transferred from animals to humans via 

workers in the livestock industry who handle animals, feed, and 

manure. Farmers may then transfer the bacteria to their family. 

A third method is via the environment. Nearly 2 trillion pounds 

of manure generated in the U.S. annually contaminate our groundwater, our surface water, and our soil. Because this manure contains resistant bacteria, the resistant bacteria can be passed on to 

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humans that come in contact with that water or soil. And the problem has been well documented. 

A 2002 analysis of more than 500 scientific articles published in 

the Journal of Clinical Infectious Diseases found that many lines 

of evidence linked antimicrobial-resistant human infections to foodborne pathogens of animal origin. 

And the Institute of Medicine’s 2003 report on microbial threats 

to health concluded: ‘‘Clearly, a decrease in the inappropriate use 

of antimicrobials in the human alone is not enough. Substantial efforts must be made to decrease the inappropriate overuse in animals and agriculture as well.’’ 

If you don’t believe in evolution, just think what has happened 

to Staphylococcus aureus, which has now become MRSA. There is 

little doubt that antibiotic-resistant diseases are a growing public 

health menace demanding a high-priority response. Despite increased attention to the issue, the response has been inadequate. 

Part of the problem has been the FDA’s failure to properly address 

the effect of the misuse of animal antibiotics and the efficacy of 

human beings. 

Although the FDA could withdraw its approval for these antibiotics, its record of reviewing currently approved drugs under existing procedures indicate that it would take nearly a century to 

get these medically important antibiotics out of the feed given to 

food-producing animals. In October 2000, for example, the FDA 

began consideration of a proposal to withdraw its approval of 

therapeutic use of antibiotics in poultry. The review and the eventual withdrawal of approval took 5 years to complete. 

Under its current regulations, the FDA must review each class 

of antibiotics separately. The legislation we are here to discuss 

today would phase out the use just of the seven classes of medically 

significant antibiotics that are currently approved for nontherapeutic use in animal agriculture. Make no mistake, this bill would 

in no way infringe upon the use of these drugs to treat a sick animal. It simply proscribes their nontherapeutic use. 

When we go to the grocery store to pick up dinner, we should be 

able to buy food without worrying that eating it would expose our 

family to potentially deadly bacteria that will no longer respond to 

our medical treatments. 

Unless we act now, we will unwittingly be permitting animals to 

serve as incubators for resistant bacteria. And it is time for Congress to stand with the scientists, the World Health Organization, 

the American Medical Association, and the National Academy of 

Sciences and do something to address the spread of resistant bacteria. We cannot afford, as I said, for our medicines to become obsolete. 

I thank you for coming. I look forward to working with all of you 

and the other members of this committee to enact this bill and to 

protect the integrity of antibiotics and the health of all American 

families. 

The CHAIRWOMAN. Ms. Matsui. 

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OPENING STATEMENT OF HON. DORIS O. MATSUI, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Ms. MATSUI. Thank you very much, Madam Chair. And I commend you for calling today’s hearing and working so diligently on 

an important and salient issue. Your expertise on this subject matter is beyond question. The Congress is fortunate to have someone 

with your experience and knowledge working on the topic of antimicrobial resistance. 

Madam Chair, during today’s hearing I will try to represent two 

different perspectives, one as a Member of Congress, and one as 

the daughter of a farmer. 

On the one hand, I am serving on the Energy and Commerce 

Committee as we are tackling health care reform. In this capacity 

I have come face to face with the immense challenges of our country faced with out-of-control health care costs. Our health care system is broken, our economy is reeling, and our budgets are out of 

sync because health care costs go up and up and up and never 

come down. 

According to the National Academies of Science, health care in 

this country is about $4 billion more expensive every year because 

of drug-resistant bacteria. Here, in the House of Representatives, 

we have spent months trying to figure out how to reform our 

health care delivery system so that it reduces costs through efficiency and innovation, but one of the easiest and most effective 

ways to drive down costs is to ensure that people do not get sick 

in the first place. Fighting antimicrobial resistance is a key component of this kind of populationwide prevention strategy, and you 

have demonstrated, Madam Chair, impressive leadership on it. 

Your bill, the Preservation of Antibiotics for Medical Treatment 

Act, is a critical piece of public health legislation. 

The FDA needs clear statutory direction to take aggressive action 

against this resistance. Once it does so, fewer people will be hospitalized with illnesses like diarrhea, staph infections, and food poisoning. 

On average, every hospital stay caused by drug-resistant bacteria 

costs $6,000 to $10,000 extra. We are talking about billions of dollars that we could save in our health care system, and we are talking about untold numbers of lives, which should be the impetus for 

us to act on this legislation as soon as possible. I will urge my Energy and Commerce Committee colleagues to do so. 

I grew up also as a farmer’s daughter in the California Central 

Valley, and I know the kind of effort it takes to make a farm a productive business. My father worked harder than anyone I have 

ever seen, but he tried to do so in a way that was environmentally 

sustainable even at the time he was farming, which was over the 

last 30 years or so. He passed away about 10 years ago. He did this 

because it was the right thing to do and also because it was good 

business. 

Today, just like back when I was a little girl, people in America 

want affordable food that comes from natural sources. They do not 

want artificial or factory-farmed meat, especially if that meat poses 

serious public health threats. 

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The facts are clear. Animals fed these antimicrobial drugs on a 

daily basis are a serious public health risk. Farmers and ranchers 

are this country’s bedrock. They should be our strength and not our 

vulnerability. I am convinced that America’s farmers and ranchers 

can be successful raising high-quality natural livestock. They can 

do so in a way that does not breed the superbugs that are showing 

up in our hospitals and emergency rooms more frequently every 

day. 

The Preservation of Antibiotics for Medical Treatment Act will 

help us reach goals we all share. It will drive down health care 

costs, it will encourage more ranchers to use animal husbandry 

practices that we already know work, and it will give American 

consumers confidence that the foods they eat are safe and do not 

come with a price of endangering public health. 

I look forward to working with the people testifying today and 

hearing their testimony. Thank you, Madam Chair. 

The CHAIRWOMAN. Thank you, Ms. Matsui. 

We are joined by Congressman Jared Polis of Colorado. 

Ms. Pingree. 

OPENING STATEMENT OF HON. CHELLIE PINGREE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF 

MAINE 

Ms. PINGREE. Thank you very much, Madam Chair. I really appreciate the opportunity to participate in this open and very important hearing; and I want to commend the Chairwoman for introducing the bill and bringing the issue forward. As Ms. Matsui said, 

your professional training in microbiology and public health makes 

you the perfect advocate on this critical issue, and an invaluable 

asset to your colleagues in Congress. Thank you for your tireless 

dedication to protecting our Nation’s health and well-being. 

I am delighted that we have the opportunity to be here today in 

the Rules Committee to hear testimony on this very important 

issue. We spend so much time here on a regular basis listening to 

other committee bills. I sincerely look forward to hearing more 

about this bill today and hearing from our witnesses. 

This bill, the Preservation of Antibiotics for Medical Treatment 

Act, would mark a critical step forward in the fight to protect our 

Nation’s food supply. Americans have become so disconnected with 

their source of food, yet also fearful and frustrated about what is 

in it. They rarely participate in the process of growing produce or 

raising livestock, instead trusting that the food they buy at their 

local grocery store is safe for their families. Sadly, we know that 

all too often this is simply not the case. 

Experts agree, antibiotic resistance is a growing problem in this 

country, as we have already heard, and it is taking its toll on our 

health and on our pocketbooks. We spend more than $4 billion each 

year combating the spread of new and deadly strains of bacteria, 

and we have lost countless lives in the process. This can be attributed in large part, as we have already heard, to the overuse and 

misuse of antibiotics as nontherapeutic feed supplements for animals that are not sick. 

We cannot undo what has already been done, but by restricting 

the use of antibiotics to people and animals that are truly sick, we 

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can make sure that future generations have access to a safe food 

supply and effective antibiotic therapies. 

This issue affects all of us. As consumers, parents, grandparents, 

we have the right to know what is being put into our food, and we 

deserve a government that invests in its resources into protecting 

our health. 

I must say it is of particular interest to me not only as a Member 

of Congress, but as myself a former organic farmer. As Ms. Matsui 

said, she is the daughter of a farmer. I am the granddaughter of 

Scandinavian immigrants who were dairy farmers in Minnesota, 

but I took up my lot as an organic farmer in the State of Maine. 

I graduated from the College of the Atlantic with a degree in environmental sciences and spent many, many years selling milk, eggs, 

and vegetables to the people in my community. I can say without 

a doubt I hold the blue ribbon and the red ribbon in the politician’s 

cow-milking contest, and I can guarantee you I tested my cows for 

mastitis. If one of them was sick, I gave them an antibiotic. Case 

closed. That is it. That is all we needed to do. I stopped selling the 

milk while the cow was infected, made sure my cow was healthy 

again, and got them back on track. 

It is a completely unnecessary situation that they are in. And I 

continue to be involved in the organic food movement in my State. 

I know that the greatest growth of dairy farmers in my home State 

is those that are selling organic milk, some of them to Stonyfield 

Farms for the yogurt, others because consumers want to know 

what is in their food and buy healthy food. 

We are facing a time of unprecedented challenges, and perhaps 

none more important than reforming our health system. While we 

are considering hundreds of different ways to cut costs and deliver 

more effective care, we must not forget that the regulation of antibiotic use in farm animals has the potential to save billions of dollars every year and to protect Americans from unnecessary suffering from resistant and aggressive strains of bacteria. 

I again want to thank the Chairwoman for holding this hearing 

and the witnesses for taking the time to be here today. And I really 

look forward to hearing from each of you. 

Thank you. I yield back. 

The CHAIRWOMAN. Thank you. 

Mr. Polis. 

OPENING STATEMENT OF HON. JARED POLIS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Mr. POLIS. Thank you, Madam Chair. I am proud to be a cosponsor of H.R. 1549, and would like to thank Chairwoman Slaughter 

for bringing this important bill forward. 

Let me put a little bit of a human face on some of the issues of 

antibiotic-resistant bacteria. There is, in my congressional district 

in Boulder, Colorado, a Nobel Prize-winning physicist, Dr. Eric Cornell, teaches at the University of Colorado. A couple years ago, unrelated to his work, he had an infection of antibiotic-resistant bacteria in his arm, and they had to amputate his arm. He now has 

one arm because of this fast-growing, antibiotic-resistant bacteria 

that several people at the University of Colorado have contracted. 

These unfortunate—well beyond the greater public health threat, 

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the human toll of this has been felt by many of us right in our own 

Second Congressional District. 

I hear a lot about these issues. My partner is a vegan, and in 

doing so he is constantly critical of our animal husbandry practices 

of commercial agriculture in this country. And so beyond the public 

health arguments, I would like to add two additional important 

considerations for why this bill is important and these efforts are 

important. One has to do with the treatment of the animals themselves, and the second emerges from that. 

When you look at why people are seeking to use the nontherapeutic use of antibiotics, it is so they can crowd animals closer together and raise them in conditions that otherwise would not necessarily be healthy for those animals. This leads to stress among 

the animals and unhealthy conditions, which can directly lead, well 

beyond the direct public health negative outcomes, to simply a poor 

nutritional profile and deteriorating the health and nutrition of the 

meat for human consumption due to the stress of the animals 

caused by the overcrowding which has been enabled by the nontherapeutic use of antibiotics. 

My district is also home to the holding company of Horizon Dairy 

and also Aurora Organic Dairy, the two producers of the antibioticand hormone-free milk, which together control, I believe, over 70 

percent of the market share for those products. And, again, I think 

the consumers are wising up, and consumers are ahead of where 

we are from a regulatory perspective on these issues. People are realizing that to have residual antibiotic content in milk particularly 

for children is, in fact, not only a public health threat, but a very 

personal health threat that can lead to antibiotic-resistant bacteria 

for their children. 

So for these reasons I strongly support H.R. 1549, and I look forward to hearing the testimony today. 

I yield back. 

The CHAIRWOMAN. Thank you, Mr. Polis. 

Our first witness today will be Dr. Joshua Sharfstein. And I am 

happy to tell you that he is the Principal Deputy Commissioner, 

Health and Human Services, U.S. Food and Drug Administration. 

And I am happy to say that we have beefed up that budget considerably so you will be able to do your job better, Mr. Sharfstein, but 

we are delighted to have you here. 

WITNESS TESTIMONY 

STATEMENT OF JOSHUA SHARFSTEIN, M.D., PRINCIPAL DEPUTY COMMISSIONER, DEPARTMENT OF HEALTH AND 

HUMAN SERVICES, U.S. FOOD AND DRUG ADMINISTRATION 

Dr. SHARFSTEIN. Thank you very much. I am very pleased to be 

here. Madam Chairwoman and members of the committee, I am 

Dr. Joshua Sharfstein, the Principal Deputy Commissioner of FDA 

and the Department of Health and Human Services. I am also a 

pediatrician, and until recently a couple months ago, I was the 

health commissioner of Baltimore City. 

Thank you for the opportunity to discuss the important public 

health issue today of antibiotic use in animals. In my testimony I 

will provide background information on antimicrobial resistance, 

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discuss FDA’s involvement with the Interagency Task Force on 

Antimicrobial Resistance, set out a public health framework for assessing the use of antimicrobials in animals, and describe FDA’s 

work with respect to nontherapeutic use of antimicrobials in foodproducing animals. And I will also make several comments on the 

legislation that is under discussion today. 

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 that 

left individuals with severe disabilities are now treatable or preventable. However, bacteria are adept at becoming resistant to 

antimicrobial drugs. Misuse and overuse of these drugs contribute 

to a rapid development of resistance. After several decades of successful antimicrobial use, we have seen and continue to see the 

emergence of multidrug-resistant bacterial pathogens which are 

less responsive to therapy. Oftentimes infections with these pathogens are more severe, more likely to cause hospitalization, and 

more likely to cause death. 

Antimicrobial-resistant populations are emerging due to the combined impact of the various uses of antimicrobial drugs, including 

their use in humans and animals. And I can say as the health commissioner of Baltimore, it is a major public health issue that we 

face. And I will just mention that one of the last things that I did 

is we released a report from the RAND Corporation in the city 

about methicillin-resistant Staphylococcus aureus, MRSA, which 

found from 2000 to 2006 the number of cellulitis-associated hospitalizations, which are almost always from MRSA, increased by 74 

percent, which was about an extra 1,000 hospitalizations per year 

in the city of Baltimore. 

As of today, antimicrobial-resistant mechanisms have been reported for essentially 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. In the last decade there has been a significant increase in resistance to drugs of food-borne organisms, including salmonella and campylobacter, and there is no question 

from the perspective of public health that this is a serious issue of 

concern. 

The U.S. Interagency Task Force on Antimicrobial Resistance 

was created in 1999 to develop a national plan to combat the antimicrobial resistance. FDA cochairs the task force, along with the 

CDC and the National Institutes of Health. This interagency group 

put together an action plan with four components. 

Highlights of the plan includes surveillance to gather information 

and statistics about the emergence and spread of resistant microbes; prevention and control, including educational campaigns 

and the development of new therapeutics including vaccines, research including a research agenda on antimicrobial resistance in 

related fields to improve treatments and outcomes led by the National Institutes of Health, and product development. As antimicrobial drugs lose their effectiveness, new products must be developed to prevent, rapidly diagnose, and treat infections. 

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The priority goals and action items include developing new 

drugs, diagnostics, and vaccines, and stimulating the development 

of priority products, which market incentives are inadequate. 

I am here on behalf of the Food and Drug Administration. Dr. 

Margaret Hamburg, the Commissioner, is out of the country, or 

otherwise I am sure she would be here. This is an issue of personal 

interest to her. The Institute of Medicine, of course, that you cited, 

she was one of the editors of prior to coming to the FDA. Working 

with the staff of the Center for Veterinary Medicine, FDA, both Dr. 

Hamburg and I strongly support action to limit the unnecessary 

use of antibiotics in animals to protect the public health. 

There are four prominent labeled indications for use of these 

antimicrobials, including growth promotion, feed efficiency, prevention, control, and treatment. The vast majority of classes of 

antimicrobials used in animal agriculture have importance in 

human medicine. A few antimicrobial classes, such as ionophores, 

that are used in food-producing animals do not appear to impact 

human medicine at this time, although there are concerns that if 

you use a medicine, even if there is no human analogue, it could 

trigger the development of resistance that could cross over to 

human drugs. 

Protecting public health requires the judicious use in animal agriculture of those antimicrobials of importance to human medicine. 

To protect patients you must limit the spread of antibiotic-resistant 

bacteria from the food supply to humans. And I want to review how 

these principles apply to each of the uses. 

The first one I would like to talk about is growth promotion and 

feed efficiency. There is increasing evidence that use of antibiotics 

contributes to the high burden of resistance in bacteria. To avoid 

the unnecessary development of resistance under conditions of constant exposure, such as for growth promotion or feed-efficiency 

antibiotics, the use of antimicrobials should be limited to those situations where human and animal health are protected. 

Purposes other than for the advancement of animal or human 

health should not be considered judicious use. Eliminating these 

uses will not compromise the safety of food. As a result, FDA supports ending the use of antibiotics for growth promotion and feed 

efficiency in the United States. 

Second, I would like to talk about disease prevention and control. 

FDA believes that there are some prevention indications that are 

necessary and judicious to relieve or avoid animal suffering and 

death. Important factors in determining whether prevention use is 

appropriate should include, one, the evidence of effectiveness; two, 

evidence that such a preventive use is consistent with accepted veterinary practice; three, evidence is that the use is linked to a specific agent of bacteria; four, evidence that the use is appropriately 

targeted; and, five, evidence that no reasonable alternatives for 

intervention exist. 

To promote the judicious use and protect human patients, FDA 

believes that all use of medically important medications for prevention control should be under the supervision of a veterinarian. 

Finally, I would like to just mention briefly treatment. FDA supports the treatment of ill animals according to appropriate veterinary practice within a valid veterinary client-patient relationship. 

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The judicious use of antimicrobials in animal agriculture requires 

a strong commitment to surveillance and research, including monitoring resistance, studying the etiology and cause of resistance, 

tracking the use of antimicrobials in agriculture, assessing risk in 

different settings, and evaluating strategies to reduce resistance. 

Such data support science-based risk-management policies. 

Let me just briefly mention some of the things that are going on 

at FDA with respect to antimicrobial drugs in food-producing animals. 

First, FDA uses risk assessment methodologies, for example, 

something called Guidance 152, during the new animal drug evaluation process to quantify the human health impacts on antimicrobial use in animals. 

Second, FDA conducts research to advance our understanding of 

resistance and to support regulatory decisions. 

Third, we reach out to stakeholders on all sides of this issue. 

Fourth, we assess the relationship between antimicrobial use and 

subsequent human health consequences using the National Antimicrobial Resistance Monitoring System, otherwise known as 

NARMS. NARMS takes advantages of the expertise and resources 

of a large number of Federal agencies, and the data from NARMS 

provide regulatory officials and the veterinary medical community 

with critical information about resistance in bacteria. 

Finally, FDA participates in the international dialogue on the 

use of antimicrobials in animals, including with WHO and the 

Codex Alimentarius. 

Let me just mention several comments on H.R. 1549. FDA supports the idea of H.R. 1549 to phase out the growth-promotion/feedefficiency uses of antimicrobials in animals. 

There is no question that the current statutory process of withdrawing new animal drug approval is very burdensome on the 

agency. FDA recommends that any proposed legislation facilitate 

the timely removal of nonjudicious uses of antimicrobial drugs in 

food-producing animals, and we would be happy to provide technical assistance on the bill. 

At the same time, FDA believes that legislation should permit 

the limited judicious use of antimicrobials in animals for prevention and control as I previously discussed, and for treatment. 

To conclude, antimicrobial resistance is an important issue for 

children as it is for their pediatricians, for the public as it is for 

public health directors, and for industry and consumers as it is for 

the FDA. We look forward to working with Congress on this important issue. 

Thank you for the opportunity to testify. I look forward to your 

questions. 

[The prepared statement of Dr. Sharfstein follows:] 

PREPARED STATEMENT OF JOSHUA SHARFSTEIN, M.D., PRINCIPAL DEPUTY COMMISSIONER, DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S. FOOD AND DRUG

ADMINISTRATION

INTRODUCTION

Madam Chairwoman and Members of the Committee, I am Joshua Sharfstein, 

Principal Deputy Commissioner at the Food and Drug Administration (FDA or the 

Agency) in the Department of Health and Human Services (HHS). Thank you for 

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the opportunity to discuss the important public health issue of antibiotic use in animals. 

Preserving the effectiveness of current antimicrobials, and encouraging the continued development of new ones, are vital to protecting human and animal health 

against infectious microbial pathogens. Approximately 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 associated with bacterial pathogens displaying resistance to at least one antimicrobial drug. The trends toward increasing numbers 

of infection and increasing drug resistance show no sign of abating. Resistant pathogens lead to higher health care costs because they often require more expensive 

drugs and extended hospital stays. The problem is not limited to hospitals. Resistant infections impact clinicians practicing in every field of medicine, including veterinarians. 

In my testimony, I will provide background information on antimicrobial resistance, discuss FDA’s involvement with the Interagency Task Force on Antimicrobial 

Resistance, set out a public health framework for assessing the use of antimicrobials 

in animals, and describe FDA’s work with respect to the non-therapeutic use of 

antimicrobials in food-producing animals. 

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 described 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. Antimicrobial use in animals 

has been shown to contribute to the emergence of resistant microorganisms that can 

infect people. The inappropriate nontherapeutic use of antimicrobial drugs of human 

importance in food-producing animals is of particular concern. 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 that left individuals with severe disabilities are now 

treatable or preventable. However, because bacteria are so adept at becoming resistant to antimicrobial drugs, 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 due to the combined impact 

of the various uses of antimicrobial drugs, including their use in humans and animals. Many of these pathways are not yet clearly defined or understood. As of today, 

antimicrobial resistance mechanisms have been reported 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. 

U.S. INTERAGENCY TASK FORCE ON ANTIMICROBIAL RESISTANCE

The U.S. Interagency Task Force on Antimicrobial Resistance 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 (NIH). 

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

(AHRQ), the Centers for Medicare and Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), the Department of Agriculture 

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(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. 

PUBLIC HEALTH ACTION PLAN TO COMBAT ANTIMICROBIAL RESISTANCE

In 2001, the Task Force published the ‘‘Public Health Action Plan to Combat Antimicrobial Resistance’’ (Public Health Action Plan or the Action Plan). The Action 

Plan provides a blueprint for specific coordinated Federal actions to address the 

emerging threat of antimicrobial resistance. It reflects a broad-based consensus of 

Federal agencies, which was reached with input from consultants from state and 

local health agencies, universities, professional societies, pharmaceutical companies, 

health care delivery organizations, agricultural producers, consumer groups, and 

other members of the public. 

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

research, and product development. Highlights of the Action Plan include: 

Surveillance. Information and statistics about the emergence and spread of resistant microbes and the use of antimicrobial drugs can help experts interpret trends 

and identify strategies to prevent or control antimicrobial resistance. CDC is working with state health departments and other Task Force members to design and implement a strategy to coordinate national, regional, state, and local surveillance efforts. In addition, FDA, CDC, and USDA developed and expanded systems to monitor patterns of antimicrobial resistance among foodborne bacteria in human medicine, in agriculture, and in retail meat. 

Prevention and Control. Research shows that controlling the use of antibacterial 

drugs can help reduce the incidence of antimicrobial resistance. In 2003, FDA 

partnered with CDC on its launch of its Get Smart: Know When Antibiotics Work 

campaign. The goal of the campaign is to educate consumers and health care professionals on the appropriate use of antibiotics. In partnership with doctors and other 

medical professionals, CDC has developed clinical guidelines for health professionals 

on how best to use antimicrobials, and supports pilot projects to identify effective 

strategies to promote appropriate antimicrobial drug use. FDA has promulgated labeling regulations for the appropriate use of systemic antibacterial drugs in humans. FDA’s Center for Veterinary Medicine (CVM) has developed, in conjunction 

with stakeholders, in-depth antimicrobial prudent use principles for beef cattle, 

dairy cattle, swine, and poultry producers and veterinarians, and more recently, 

aquatic veterinarians. 

Measures that reduce the need for antimicrobial use also serve to reduce the 

emergence of antimicrobial-resistant microorganisms. Prevention of bacterial infections through the use of vaccines has effectively eliminated or markedly decreased 

the problem of resistance in organisms such as Haemophilus influenzae type b (virtually eliminated in the United States, while still a problem in other parts of the 

world) and Streptococcus pneumoniae, also known as pneumococcus. Published research has confirmed that the latter pneumococcal vaccine has lowered common infections that are often treated with antimicrobials. Prevention of viral infections 

through the use of vaccines can also indirectly help reduce antibiotic use and minimize the emergence of antibiotic-resistant microorganisms. For example, viral infections, such as respiratory infections due to influenza, often lead to unnecessary antimicrobial use and are sometimes complicated by serious secondary infections caused 

by bacteria such as staphylococcus or pneumococcus. In addition, development of increasingly sensitive diagnostic assays for detection of resistance allows for rational 

targeted antimicrobial use. 

Research. The Action Plan promotes expanding existing research in antimicrobial 

resistance and related fields in an effort to improve treatments and outcomes. NIH 

is leading a team of agencies to provide the research community with new information and technologies, including genetic blueprints for various microbes, to identify 

targets for desperately needed new diagnostics, treatments, and vaccines to combat 

the emergence and spread of resistant microbes. NIH supports clinical studies to 

test new antimicrobials and novel approaches to treating and preventing infections 

caused by resistant pathogens. NIH also continues to support and evaluate the development of new rapid diagnostic methods related to antimicrobial resistance, in 

conjunction with FDA’s Center for Devices and Radiological Health (CDRH). In addition, AHRQ funds various studies on the use of antimicrobial drugs and antimicrobial resistance, including ongoing research on reducing unnecessary prescribing of antimicrobials to children. FDA’s Center for Biologics Evaluation and Research (CBER) conducts research that facilitates vaccine development for diseases 

in which resistance is an issue, such as malaria, staphylococcus (MRSA), and enteric 

diseases. 

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Product development. As antimicrobial drugs lose their effectiveness, new products must be developed to prevent, rapidly diagnose, and treat infections. The priority goals and action items in the product development focus area of the Action 

Plan address ways to: • Ensure researchers and drug developers are informed of current and projected gaps in the arsenal of antimicrobial drugs, vaccines, and diagnostics, and 

of potential markets for these products; • Stimulate development of priority antimicrobial products for which market 

incentives are inadequate, while fostering their appropriate use; • Optimize the development and use of veterinary drugs and related agricultural products that reduce the transfer of resistance to pathogens that can infect humans; and • Facilitate development of effective prophylactic vaccines: in particular, focusing on vaccines against microbes that are known to develop antimicrobial resistance (e.g., MRSA), thereby reducing the need for antimicrobials and the occurrence of antimicrobial resistant strains. 

The Task Force met with consultants in December 2007 to discuss suggestions 

and recommendations for revising and updating the Action Plan. The consultants 

included both domestic and foreign experts in human veterinary medicine, pharmaceutical and diagnostics manufacturing, animal husbandry, clinical microbiology, epidemiology, infectious disease and infection control. and state and local public 

health. The Action Plan is being revised and is expected to be released later this 

year. 

A PUBLIC HEALTH APPROACH TO ANTIMICROBIAL USE IN ANIMALS

Antimicrobials used in animal agriculture are indicated for a variety of uses. 

There are four prominent label indications for use of these antimicrobials: growth 

promotion/feed efficiency; prevention; control; and treatment. The vast majority of 

classes of antimicrobials used in animal agriculture have importance in human medicine. A few antimicrobial classes (e.g., ionophores) used in food-producing animals 

do not appear to impact human medicine. 

Protecting public health requires the judicious use in animal agriculture of those 

antimicrobials of importance in human medicine. I will now review how this principle applies to each use. 

Growth promotion/feed efficiency 

There is clear evidence that the use of antimicrobials in general selects for resistant organisms. To avoid unnecessary development of resistance under conditions of 

constant exposure (growth promotion/feed efficiency) to antibiotics, the use of 

antimicrobials should be limited to those situations where human and animal health 

are protected. Purposes other than for the advancement of animal or human health 

should not be considered judicious use. Eliminating these uses will not compromise 

the safety of food. 

Disease prevention and control 

FDA believes that some prevention indications are necessary and judicious to relieve or avoid animal suffering and death. Important factors in determining whether 

a prevention use is appropriate include: (1) evidence of effectiveness, (2) evidence 

that such a preventive use is consistent with accepted veterinary practice, (3) evidence that the use is linked to a specific etiologic agent, (4) evidence that the use 

is appropriately targeted, and (5) evidence that no reasonable alternatives for intervention exist. FDA also believes that the use of medications for prevention and control should be under the supervision of a veterinarian. 

Treatment 

FDA supports the treatment of ill animals according to appropriate veterinary 

practice within a valid veterinary-client-patient relationship. 

Judicious use of antimicrobials in animal agriculture requires a strong commitment to surveillance and research, including monitoring antimicrobial resistance, 

studying the etiology of resistance, tracking the use of antimicrobials in agriculture, 

assessing risk in different settings, and evaluating strategies to reduce resistance. 

Such data will support science-based risk management policies. 

SPECIFIC ACTIVITIES BY THE CENTER FOR VETERINARY MEDICINE (CVM)

CVM is addressing potential human health risks associated with the use of antimicrobial drugs in food-producing animals by: (1) using risk assessment methodologies (e.g., Guidance 152) during the new animal drug evaluation process to quantify 

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bust monitoring, research, and risk management; (2) actively conducting research 

to advance our understanding of antimicrobial resistance mechanisms and to support our regulatory decisions; (3) reaching out to stakeholders, including consumer 

groups, through public meetings to provide educational outreach activities and to 

strengthen and promote science-based approaches for managing the potential 

human health risks associated with the use of antimicrobial drugs in food-producing 

animals; (4) assessing relationships between antimicrobial use in agriculture and 

subsequent human health consequences through the National Antimicrobial Resistance Monitoring System (NARMS). CVM is the lead coordinator of NARMS. NARMS 

is a multi-faceted monitoring system that takes advantage of the expertise and resources of a number of Federal agencies and state public health laboratories. 

NARMS data provide regulatory officials and the veterinary medical community 

with critical information to help assess the risk associated with antimicrobial use 

in food animal production; and (5) participating in international dialogue on the use 

of antimicrobials in animals, including the World Health Organization (WHO) and 

the Codex Alimentarius ad hoc Intergovernmental Task Force on Antimicrobial Resistance. 

CVM continues to collaborate with veterinary and animal producer associations 

to develop and distribute guidelines on the judicious use of antimicrobial drugs in 

food-producing animals. 

COMMENTS ON H.R. 1549

FDA supports the idea of H.R. 1549 to phase out growth promotion/feed efficiency 

uses of antimicrobials in animals. The current statutory process of withdrawing a 

new animal drug approval is very burdensome on the agency. FDA recommends that 

any proposed legislation facilitate the timely removal of nonjudicious uses of antimicrobial drugs in food-producing animals. At the same time, FDA believes that legislation should permit the judicious use of antimicrobials in animals for prevention 

and control as discussed above. 

CONCLUSION

Antimicrobial resistance is an important public health issue that can only be addressed by collaborative efforts of the relevant Federal agencies, state health departments, and the private sector. FDA looks forward to working with Congress on this 

important public health issue. 

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

I would be happy to answer any questions. 

The CHAIRWOMAN. Thank you so much for being here, and welcome to the FDA. We are delighted to have you. You worked on the 

Hill, I understand, for the great Henry Waxman. That is always a 

good sign. 

The timely removal that you were saying would be cumbersome 

for you, of removing those eight classes of antibiotics from animal 

feed, in my statement I mentioned that that could take a century. 

What would you all consider timely removal? 

Dr. SHARFSTEIN. I think that we would like to see, for the 

growth-promotion/feed-efficiency uses, a much shorter time period 

than a century, but also the ability of the agency to accomplish 

that without having to expend a tremendous amount of resources 

in the process, both time and money. And so there are mechanisms 

to accomplish that. We don’t want to be in a situation where we 

have bottled up many, many scientists writing papers for things 

that Congress could legislate and just make happen if we all think 

that is the right thing to do. 

The CHAIRWOMAN. Now, you are a pediatrician. I am sure you 

would not recommend giving a nursery class of 3-year-olds antibiotics every day to make sure they didn’t get an ear infection. So, 

obviously, you would not recommend this for animals. But does the 

FDA control that, or USDA? 

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Dr. SHARFSTEIN. The FDA controls the labels of drugs or how 

they would be used in animals. 

The CHAIRWOMAN. So you can forbid it if the legislation were 

passed. 

Dr. SHARFSTEIN. It would be under FDA. 

The CHAIRWOMAN. That is good to know. 

One of the things, obviously, that we are concerned about is the 

conditions under which these animals live. And I noted in the background, that Denmark, which banned the nontherapeutic use of 

antibiotics in animals in 1998, have found there was no significance significant impact on mortality or productivity. And I think 

it is terribly important that, after the ban, corresponding improvements in animal husbandry, such as better ventilation and cleaner 

barns, swine mortality and productivity were not affected at all. 

And I am sure that most of us who consume—I am sure that all 

of us want to think that they are raised in clean, healthy conditions, even though we know better. 

We are going to do a food safety bill here, I think, coming up 

pretty soon, and then we will need to talk to you again, I think, 

about other things that you might want in there. Thank you so 

much for being here. Your testimony is most important, and we 

really look forward to working with you on making this a reality. 

Thank you so much. 

Ms. Matsui. 

Ms. MATSUI. Thank you very much. And it is so good to see you 

here. 

Prevention of disease, whether it is in animal or humans, is a 

high priority of mine. Preventing sickness and disease before they 

occur just makes sense on many different levels, and I worked hard 

to make prevention a key element of the Congress’ push on health 

care reform. And I support the CHAIRWOMAN’s legislation because 

it doesn’t limit a rancher’s ability to use medicine in a rational way 

to prevent livestock disease. Prevention, though, is just a word, and 

it is not an effective strategy if we create more harmful diseases 

in the name of preventing minor ones. 

Dr. Sharfstein, I found your testimony very compelling because 

it really does tread the fine line between the need to prevent diseases in our animal populations without actually doing ourselves 

more harm in the process. 

In your testimony, you outlined how actions taken in the name 

of prevention can sometimes make things worse, as in the case of 

using antimicrobials to fight respiratory infections. Will you please 

elaborate on how dangerous it can be for animal producers to assume that simply blanketing their herds with antibiotics will not 

be counterproductive both to humans and to animals? 

Dr. SHARFSTEIN. I think that the prevention area is obviously an 

area that needs a lot of attention in trying to figure out how to 

craft a policy, whether by legislation or by regulation. And I think 

there clearly are situations where you can prevent illness by giving 

medicine. 

For example, in Baltimore, as the health commissioner, if we had 

a case of meningitis, we would give medicine to all the people who 

were in close contact. We had a very sad case of a teacher who died 

of meningitis, and we had to track down all the kids and make 

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sure they got medication. And they weren’t sick, but we were giving them medication. And in that case, there is in pediatrics, for 

example, very strong evidence for the use of medicine in that situation. There is evidence that people who get treated will be less likely to get sick. You understand what you are treating. It is the meningococcus bacteria. You understand that you are using a medicine that is targeted to that bacteria. 

And I think the concept for prevention is that, in animals as 

well, there are going to be some times when prevention is important, but that the decision on where that is permitted should be 

based on science, should be based on an understanding of what you 

are trying to prevent, the evidence that is there, the fact that there 

are no reasonable alternatives. And we want to use as few antibiotics in children, we want to use as few antibiotics as possible in 

animals, but when we are going to use medicines, it should be 

based on a solid foundation of evidence. 

So trying to set up a mechanism for that is challenging, but I 

think as we go through one use at a time, just like we do in pediatrics, this use of antibiotics is appropriate, and this one isn’t, that 

is what needs to happen. 

Ms. MATSUI. So you are looking at a situation where it is going 

to be difficult to have a working definition of this notion of ‘‘prevention’’; is that right? 

Dr. SHARFSTEIN. I think it is one of the things that has to be 

worked out. I think in the bill it says ‘‘routine prevention.’’ But how 

do you define routine prevention? That is somewhere in there. And 

I think that is the kind of thing like an agency like FDA has done 

before and can do. You know, we can talk about the kind of principles that would go into a determination like that or how you 

would assess what that is. 

But I think the point of your question, I agree with you completely. Just calling something prevention doesn’t make it based on 

evidence, doesn’t make it appropriate to use. It has got to truly be 

based on evidence. And that kind of assessment has to happen. 

Ms. MATSUI. But that is sort of your working definition on how 

we might move forward on this thing? 

Dr. SHARFSTEIN. I think these are some principles. We put in— 

I don’t think it is so much a working definition. I wouldn’t quite 

go that far. But I think there are some principles that we would 

want to look at and make sure that we are limiting what is appropriate prevention to what is based on the science and supported by 

veterinarians. 

Ms. MATSUI. But you believe the current agriculture practice in 

this country does not meet your sense of principles right now? 

Dr. SHARFSTEIN. There are two things. First of all, there is use 

for growth promotion and feed efficiency, which FDA has taken the 

position should not be used like for that period. And then I have 

been struck as I am learning about this issue at just how little we 

really understand about what is going on on farms in terms of the 

use of antibiotics, and I think it is a high priority for Dr. Hamburg 

and myself to get a better understanding of that. It is one thing 

for FDA to have the rules, but we need to know that it is actually 

being followed, and we need to see that the use of antibiotics is 

truly coming down. 

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The CHAIRWOMAN. That is a welcome change. 

Ms. MATSUI. Absolutely. On the FDA’s web site, there is a list 

of 15 ‘‘judicious’’ use principles that are endorsed by the American 

Veterinary Medical Association for the use of antimicrobial drugs. 

One of these principles is that other therapeutic options should be 

considered prior to antimicrobial therapy. 

It seems to me that the full range of other options has not yet 

been considered by many of our country’s ranchers. Do you agree 

that more can be done within the meat-producing industry to use 

alternative methods to achieve the same end of keeping animals 

safe from harmful infections? 

Dr. SHARFSTEIN. That is an excellent question. I don’t know if I 

could give you an answer insofar that I am not really an expert on 

the practices of the producing industry, but I do believe that that 

analysis should be undertaken, though, before those uses are permitted. In other words, if it is the case that there are alternatives, 

good alternatives, those should really pursued. It shouldn’t be a 

principle on the page; it should be something that really does 

apply. 

Ms. MATSUI. Okay. There is another judicious use principle from 

the web site, to minimize environmental contamination with 

antimicrobials whenever possible. Will you clarify for me what this 

means? Does it mean not to let antimicrobials get into the water 

supply or into the vegetable fields? Is that what we are talking 

about here? 

Dr. SHARFSTEIN. That is a good question, but I can’t answer that 

one either. I am sorry. That is a principle of American Veterinary 

Medicine Association, so I don’t know exactly what they intended 

with that principle. 

I could say that we are concerned at FDA about the environmental impact of drugs not just for animals, but for humans also, 

and that is an issue that we would as public health officials want 

to engage on. And if there is—I think we recently were written a 

letter by the attorney general of Maryland about a particular issue 

in antibiotics and poultry, and we are going to look at that issue. 

If there is an environmental issue that we need to be aware of, we 

will take a look and see if there is something that we could do. But 

I couldn’t quite exactly define it. I think I would say that we would 

look at the balance of the potential environmental impacts, and if 

there is a serious environmental harm, that is something that we 

should be aware of. 

Ms. MATSUI. Thank you very much. 

The CHAIRWOMAN. Ms. Pingree. 

Ms. PINGREE. Thank you. Thank you, Madam Chair. 

Thank you for your testimony, which was very interesting. And 

I appreciate your public health factor in Baltimore. That certainly 

adds to the dimensions of what we are talking about today. And 

I just want to follow up a little bit on what Representative Matsui 

was talking about. 

In your recommendation, or potential recommendation, where 

you talked about allowing for continued therapeutic use, I just 

want to clarify. I think we all generally know that this is in widespread use right now; that without significant changes in the way 

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the animals are raised, the idea of infections and outbreaks of infections could easily continue at the rate they do now. 

I am trying to understand when you mentioned that some of the 

criteria for not allowing it would be research that showed evidence 

of effectiveness. And has research already been done that shows 

that it is effective in preventing outbreaks when you distribute it 

widely through the feed, or is that something you want to determine? 

Dr. SHARFSTEIN. I think that is something you want to determine. I think that it may be that people may be using antibiotics 

not knowing what they are treating or if they are even having an 

effect. But in the realm of routine use, we are saying it shouldn’t 

even be permitted. If it is to prevent a disease, then what disease? 

Is it effective to prevent that disease? Have you looked at other 

ways to do it that are reasonable alternatives? Those are the sorts 

of things that should go into an assessment before that is permitted. 

So I couldn’t—in fact, I will tell you, in pediatrics it is very clear 

what you should be treating and what you shouldn’t be treating. 

The American Academy of Pediatrics has guidelines. There is a 

huge campaign amongst pediatricians. In fact, I called one of my 

old teachers last night and told him I was going to catch up on the 

pediatric side of this issue before testifying. And he pointed me to 

some research that antibiotic use among pediatricians has come 

down by 30 percent, and that is partly because of government efforts. And we are actually tracking what pediatricians prescribe, 

that it is truly coming down, also has to do with parent expectations. Kids are doing fine, just fine with that, probably better, but 

without being prescribed quite as much. 

And what we would like to see is something, I think, like that 

in animal use. There does not seem to be at this point a very 

clear—to me at least in kind of looking at it, a very clear list of 

what are the evidence-based uses of antibiotics for prevention in 

animals like there would be in pediatrics and other fields of medicine. And I think it has got to be that if the FDA is going to put 

a label on and permit a particular use like that, that it is very solidly backed up in science. 

Ms. PINGREE. It seems like an extremely important criteria. And 

I just would want to be sure that if you were to allow therapeutic 

use or a broad definition of that, that we didn’t stay with the status quo, because the example that you gave about the tragic loss 

of a teacher, which was a very good example, is about an outbreak 

of disease. And I think what we are talking about here is routine 

use that creates a constant use of the medications. And I wouldn’t 

want to see that be called therapeutic use or necessary, because 

that is very different than a disease outbreak. 

Dr. SHARFSTEIN. And that is one reason I talked about it separately. 

Ms. PINGREE. Thank you. 

The CHAIRWOMAN. Thank you, Ms. Pingree. 

And we have been joined by Congressman Cardoza from California. 

Mr. Polis. 

Mr. POLIS. Thank you for your testimony. 

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Would you say that there should be a different definition between therapeutic and nontherapeutic use as applied to humans 

and as applied to animals, or the same definition could cover both 

humans and animals? 

Dr. SHARFSTEIN. I mean, as I am thinking, I can’t think of the 

use of antibiotics in humans for growth promotion. So, there are 

other things that are used for growth promotion sometimes in pediatrics that are quite controversial, but I don’t know if the concept 

of nontherapeutic use really—I don’t know to what extent that 

even exists. 

The CHAIRWOMAN. Would the gentleman yield? That brings up a 

pet peeve of mine, and that is the overuse of antibiotics for viral 

diseases that pediatricians sometimes are guilty of doing. I think 

that also has helped contribute to it. 

Dr. SHARFSTEIN. I was trying to think where someone would 

come out and say using it in a nontherapeutic way. That doesn’t 

really exist in medicine. But certainly pediatrics has really taken 

aim at the use of antibiotics. 

The CHAIRWOMAN. That is good news that it has come down 30 

percent. 

Dr. SHARFSTEIN. That is the 30 percent decline for certain illnesses it has gone down, and it is a very high priority. Therapeutic 

use is to treat illness. I think that is a pretty similar definition. 

Mr. POLIS. So it would be the same working definition for both. 

Dr. SHARFSTEIN. I think for therapeutic. 

Mr. POLIS. In terms of the economic costs, would you agree that 

when we are—effectively, if you have an animal producer that is 

using antibiotics in a nontherapeutic way, thereby—well documented, of course—contributing to antibiotic-resistant bacteria, 

that there would then be a sizeable economic cost of that externality that then others would have to pay for, not the producer of 

that animal, but that somebody else would have to pay for treating 

people with secondary and tertiary antibiotics and other costs of 

treatment? 

Dr. SHARFSTEIN. Yeah. I do believe it could be quite costly to 

treat antibiotic-resistant infections directly and indirectly. 

Mr. POLIS. And maybe you could bring this down to your own experience as a doctor and M.D. For somebody who has an antibioticresistant infection, staph or strep or whatever it might be, what 

would then be the secondary and tertiary treatments for that individual? And approximately what might we be looking at from a 

cost perspective? 

Dr. SHARFSTEIN. It depends on the infection. 

Mr. POLIS. Take a typical example of, in your case, a kid who 

might, say, present with strep or something and doesn’t react to 

the first line of medications. 

Dr. SHARFSTEIN. Well, I think for something say a skin abscess 

that would be staph, you might want to treat that with a 

cephalosporin that would be relatively inexpensive. And you might 

wind up treating him with a more serious erythromycin. And I 

think that I couldn’t tell you off the top of my head the price differential now, but it could be relatively significant. Plus, you have 

the chance that if you don’t catch it soon enough, that you can’t get 

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20 

it with erythromycin because it has spread, and they are hospitalized. 

And one of the things I did as health commissioner is I rounded 

at St. Agnus Hospital, and they presented two kids who came in 

with serious staph infections. And I said, wow, I probably saw one 

of those every month when I was a resident, and you have two the 

same night. And they say, we get them every day now. So—and I 

was only a resident about 10 years ago. 

So there is the cost of the medicine. And then if you get hospitalized, which the evidence is that you are more likely to get hospitalized if it is resistant, then the costs escalate quite a bit. 

Mr. POLIS. And I am sure that Dr. Cornell would be hard pressed 

to put a price on the loss of his arm and extreme health outcomes 

that have a detrimental health impact for the rest of their life. But 

I think clearly we have demonstrated that even in the best-case 

scenarios where the health outcome is positive, the secondary or 

tertiary treatments can cost several times what the normal intervention would cost. 

I yield back. 

The CHAIRWOMAN. Thank you, Mr. Polis. 

Mr. Cardoza. 

Mr. CARDOZA. Thank you, Madam Chair. 

Sir, you work with USDA, correct? 

Dr. SHARFSTEIN. I work with FDA. 

Mr. CARDOZA. Now, it is my understanding that FDA—well, I 

personally know that every tanker load of milk that is delivered 

gets tested with an FDA-approved test; is that not correct? 

Dr. SHARFSTEIN. I am seeing a lot of nodding. 

Mr. CARDOZA. I think that is correct. And I am sorry that I have 

missed some of your testimony. I will go back and read it. But I 

am trying to understand this. So FDA has improved tests that they 

do of the milk that screens for antibiotic residues. 

Dr. SHARFSTEIN. Okay. 

Mr. CARDOZA. So is your contention that the test is inadequate? 

Or are you fearful that somehow, for example, in the milk, that 

antibiotics are causing children to ingest antibiotics that they 

shouldn’t? I mean, what is the problem here? The FDA has an approved test. Every tanker load of milk is tested; .038 of the tanker 

loads in America have a positive, and that entire tanker load is 

then jettisoned at a cost of about $12,000 a tanker load. There is 

a pretty big incentive for farmers not to let residue be in the milk 

production. So I am trying to figure out what the nexus is. 

Dr. SHARFSTEIN. I think when you think about the implications 

of the use of antibiotics in animals, there are three that people generally talk about. One is that there is bacteria that becomes resistant in the animal that the human then eats, the bacteria itself the 

human then eats. And that bacteria causes illness in the human 

by fluoroquinolones and campylobacters. And that would not apply 

to the milk because the milk should be pasteurized, and it 

shouldn’t be containing, I think, pathogenic bacteria. 

The second mechanism is that it is not dangerous bacteria, it is 

sort of the usual bacteria. But they are still resistant, and they can 

pass those genes on to human-illness bacteria in your body. That 

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21 

is a big concern that people have, and probably also would not 

apply to the milk. 

Third is the residue. Is there an amount of residue that causes 

selection within humans? And I have not been briefed on or testified about whether that is an issue with milk at all. I think what 

I am familiar with milk is more the first, through an indirect route, 

which is that if you are treating the dairy cows which may eventually wind up in the food supply, if they have been treated with 

antibiotics, can develop antibiotic-resistant bacteria, and then that 

antibiotic-resistant bacteria can cross into the human food chain 

when that dairy cow is slaughtered. 

And I am familiar with some evidence I believe, if I am not mistaken, the Salmonella Newport multidrug-resistant infection, I believe, may have implicated dairy cows. So I hope I am wrong about 

that, I will correct it. But I think there is some evidence that cows 

that have been treated with antibiotics and then go into the food 

supply may be linked to certain problems with antibiotics that way, 

but not through the milk, that I am aware of. 

Mr. CARDOZA. Well, as a legislative body—first of all, I think this 

is an appropriate discussion. My wife is a family doctor, and she 

is very concerned about overprescription of antibiotics and any 

medication that isn’t therapeutically necessary. So I understand 

that, and I appreciate the Chairwoman’s concern on this, because 

we certainly don’t want to do anything that is jeopardizing the 

health and safety of our citizens. But I want to make sure that we 

focus in on what is really going on, and we have to know what is 

happening. And I am sorry, again, that I haven’t had a chance to— 

I got delayed today and meant to be here for your opening statement. But you said you thought that there might be a connection. 

I really would like you to tell us for sure. 

Dr. SHARFSTEIN. Sure. I think that the connection—I am not 100 

percent sure of whether this particular example applies. But I am 

not uncertain about the issue of, if you are to treat a cow for dairy 

for many years, you would facilitate the production of resistant bacteria. And then the risk that we have been talking about is when 

that cow goes into the food supply directly, is there a risk of passing that on. 

What I can’t remember exactly is whether this particular example applies to that. 

The CHAIRWOMAN. Would the gentleman yield just for a moment? 

Maybe I can help a little bit here. 

We are talking about the use of antibiotics for cow and poultry 

that are not sick. In fact, 70 percent of all the antibiotics produced 

in the United States are given to animals that are not sick. That 

is the purpose of the hearing. We would like to save eight kinds 

of antibiotics which are most at use for human beings for the use 

of human beings. 

Mr. CARDOZA. I thank the chairwoman. 

And I thank the gentleman for his testimony. I will review it. I 

appreciate that. 

I will have some other questions later. 

The CHAIRWOMAN. Thank you very much. Welcome to Washington. We are delighted to have you here, and we look forward to 

working very closely with you on these issues. Thank you. 

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Dr. SHARFSTEIN. Thank you very much. 

The CHAIRWOMAN. Our next panel is Dr. Margaret Mellon, Ph.D., 

scientist and director, Food and Environment Program of the 

Union of Concerned Scientists; Dr. Lance B. Price, Ph.D., director, 

Center for Metagenomics and Human Health, and associate investigator, Pathogen Genomics Division, the Translational Genomics 

Research Institute; and Dr. Robert Martin, senior officer of Pew 

Environment Group. 

If you could come forward, please. 

We really welcome all of you here today. We are not used to such 

an intellectual powerhouse at the table in the Rules Committee. It 

is quite an honor to have you here. 

Why don’t we begin with you, Dr. Mellon. 

STATEMENT OF MARGARET MELLON, PH.D., SCIENTIST AND 

DIRECTOR, FOOD AND ENVIRONMENT PROGRAM, UNION OF 

CONCERNED SCIENTISTS 

Dr. MELLON. Thank you. My name is Margaret Mellon, and I am 

here representing the Union of Concerned Scientists, a nonprofit 

science organization working for a healthy environment and a safer 

world. 

I am also here on behalf of Keep Antibiotics Working, a coalition 

of environmental, agricultural, and humane organizations dedicated to addressing the overuse of antibiotics in production agriculture. 

I am really grateful to have the opportunity to appear here today 

to discuss an urgent public health and food safety crisis: the loss 

of the effectiveness of drugs due to antibiotic resistance. 

Before I begin, I want to thank Representative Slaughter for her 

steadfast leadership on this issue over almost a decade. 

Now, to go on, I have prepared written testimony, but my message can be summarized very briefly: The miracle drugs of the 20th 

and 21st centuries are at risk, and the enormous use of antibiotics 

in production agriculture is partly to blame. 

We all know that the more we use antibiotics, the more bacteria 

become resistant to them. What many do not know, however, is 

that we use huge quantities of antibiotics, something like 13 million pounds a year, every year, in the production of poultry, beef, 

and swine. Importantly, these antibiotics are the very same or in 

the same chemical class as those we use in human medicine. And 

that means when those drugs—the penicillins, tetracyclines, 

erythromycins—are used in hospitals or doctors’ offices, they do not 

work. 

Now, I want to be clear: Overuse of antibiotics occurs in both 

human medicine and in animal production, and both settings are 

responsible for the problem and need to take responsibility for solving it. But while the medical community, as Dr. Sharfstein made 

clear, has taken action on the issue, production agriculture has not. 

We simply cannot continue to profligate use of antibiotics to 

produce food animals. We need to reduce that use, and we can, because most of the drugs used by food producers, as has been said, 

are not used to treat sick animals, but to increase feed efficiency 

or for routine disease prevention and control. Those aims can be acmstockstill on DSKH9S0YB1PROD with HEARING

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1 Centers for Disease Control (CDC). 2004. Background on antibiotic resistance. Online at 

www.cdc.gov/getsmart. 

complished by other ways, including better management, and it is 

time that we get about that process. 

As has been said, the resistant bacteria generated in food animals have lots of ways of moving to humans, most prominently, but 

not solely, on food. But as a result, these bacteria are connected to 

many kinds of diseases, not just the foodborne illnesses like salmonella and campylobacter, but also to systemic blood infections, 

to urinary tract infections, and, most recently, to methicillin-resistant Staph aureus. 

We have delayed on this issue for too long. Keep Antibiotics 

Working has been on the case for almost a decade now, with little 

or nothing to show for our efforts. But the story, I think, is the 

same for most of the food safety issues. For decades, public health 

advocacy has been stymied by vested interests. But, finally, Congress is poised to act on food safety. And, as it does, it is imperative 

that the resistance dimension of the issue not be ignored. 

Mrs. Slaughter’s bill, the ‘‘Preservation of Antibiotics for Medical 

Treatment Act,’’ would require FDA to review the drugs in those 

classes that are used both in human and animal medicine, and if 

they cannot prove they are safe, get them off the market for purposes other than treating sick animals. The bill is supported by the 

American Medical Association, the American Nurses Association, 

the American Academy of Pediatrics, the Infectious Disease Society 

of America, and many other medical organizations. 

Getting the antibiotics off the market would preserve the efficacy 

of drugs for both humans and animals. In the words of an editorial 

in the prestigious New England Journal of Medicine, ‘‘It is time to 

stop.’’ In fact, it is way past that time. 

Thank you. 

[The prepared statement of Dr. Mellon follows:] 

PREPARED STATEMENT OF MARGARET MELLON, PH.D., SCIENTIST AND DIRECTOR, 

FOOD AND ENVIRONMENT PROGRAM, UNION OF CONCERNED SCIENTISTS

My name is Margaret Mellon. I am the Director of the Food and Environment 

Program at the Union of Concerned Scientists (UCS). UCS is a leading sciencebased nonprofit working for a healthy environment and a safer world. I am here 

today on behalf of UCS and Keep Antibiotics Working (KAW), a coalition of health, 

consumer, agricultural, environmental, humane and other advocacy groups, of which 

UCS is a member. Keep Antibiotics Working, whose organizations have more than 

ten million members, is dedicated to eliminating a major cause of antibiotic resistance: the inappropriate use of antibiotics in food animals. 

We appreciate the opportunity to submit testimony before the House Committee 

on Rules on what the Centers for Disease Control has long considered one of the 

‘‘most pressing public health problems:’’ 1 the urgent food safety and public health 

crisis of antibiotic resistance. KAW 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. We are grateful 

for Chairwoman Slaughter’s long standing efforts to address this critical issue. 

DISEASES RESISTANT TO ANTIBIOTICS: 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, including, I would guess, 

some in this room, have experienced this problem first hand. Sometimes when drugs 

don’t work, it means several days of unnecessary pain and suffering while doctors 

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2 Centers for Disease Control (CDC). 2005. National Antimicrobial Resistance Monitoring System (NARMS) for Enteric Bacteria: Human Isolates. Final Report. Atlanta, GA: U.S. Department of Health and Human Services, CDC. 3 CDC. 2005. NARMS. 

4Total number of illnesses from USDA (www.ers.usda.gov/Data/FoodBorneIllness) is multiplied by data from footnote 3 to obtain totals for resistant illness. 5 National Academy of Sciences Institute of Medicine. 1998. Antimicrobial Resistance: Issues 

and Options. Washington, DC: National Academies Press, p. 1. 6 Infectious Diseases Society of America. 2003. Bad bugs, no drugs: Defining the antimicrobial 

availability problem. Backgrounder. Online at www.idsociety.org/badbugsnodrugs. 7McEwen S, and Fedorka-Cray P. 2002. Antimicrobial use and resistance in animals. Clinical 

Infectious Diseases 34:S93–106. 

figure out that another drug is needed. But increasingly, resistance leads to more 

dire consequences. Treating a patient with an ineffective drug can give an infection 

a chance to progress to a 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. 

Antibiotic resistance is of particular concern in terms of food safety. The CDC has 

found that half of all human Campyobacter infections 2 are drug resistant as are one 

in five Salmonella infections.3 Nearly 100,000 of the Salmonella infections would resist treatment with at least five antibiotics. 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 year.4

Longer hospital stays to treat food borne illnesses and other diseases dramatically 

increase the nation’s health costs—by one estimate adding over $4 billion per year 

to the health care tab in the United States.5 And, of course, more time away from 

work is a drag on our economy. 

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. 

Unfortunately, the resistance crisis will not be alleviated by the arrival of new 

drugs. The discovery of new classes of antibiotics, once almost a predictable occurrence, has become frustratingly difficult in recent decades. The unhappy truth is 

that there are virtually no new classes of antibiotic drugs in the pipeline.6 Unless 

we act to preserve the antibiotics we have, the age of the miracle antibiotics may 

be coming to an end. 

ANTIBIOTIC RESISTANCE RESULTS FROM ANTIBIOTIC USE

Exposure to antibiotics selects for those bacteria that can withstand the drug. Resistant organisms are encouraged in settings where antibiotics are heavily used— 

primarily human medicine, veterinary medicine, and food animal production. Microorganisms exist in an interconnected ecosystem and travel back and forth among 

humans, animals, and other elements in the environment. Thus, antibiotic-resistant 

microorganisms generated in the guts of pigs in the Iowa countryside 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. Recently, lettuce, tomatoes, and spinach have all been found to be sources 

of food borne illness. 

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.7

The fundamental approach to prolonging the effectiveness of drugs is to curb unnecessary uses—whether in human medicine, veterinary medicine, or food animal 

production. 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. 

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8Mellon M, Benbrook C, and Benbrook K. 2001. Hogging it!: Estimates of Antimicrobial Abuse 

in Livestock. Cambridge, MA: Union of Concerned Scientists, p. 60. Online at www.ucsusa.org/ 

foodlandlagriculture/sciencelandlimpacts/impactslindustriallagriculture/hogging-it-estimates-of.html. 9Mellon M, Benbrook C, and Benbrook K. 2001. Hogging It!, pp. 51–53. 

10 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. 11 Hooton T, and Samadpour M. 2004. Is acute uncomplicated urinary tract infection a 

foodborne illness, and are animals the source? Clinical and Infectious Diseases 40:258–9. 12 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. 13 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 11:1965–6. 14Khanna T, et al. 2008. Methicillin resistant Staphylococcus aureus colonization in pigs and 

pig farmers. Veterinary Microbiolgy 128:298–303. 15Smith T, et al. 2008. Paper presented at the International Conference on Emerging Infectious Diseases, Centers for Disease Control and Prevention, Council of State and Territorial Epidemiologists, Atlanta, GA, March, and personal communication. 

PRODUCTION AGRICULTURE’S CONTRIBUTION TO THE PROBLEM

As it turns out, food animal production uses the lion’s share of the antibiotics in 

the United States—some 13 million pounds of antibiotics every year, 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—non-therapeutic purposes like growth promotion and routine disease prevention.8 All of these antibiotics, among them penicillins, tetracyclines, and erythromycin—are in classes of drugs used in human medicine.9 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 enormous 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 food borne illnesses mentioned above caused by Campylobacter and Salmonella. 

Contaminated retail meat used to be the primary source of such infections. But increasingly, produce like peppers and spinach is causing illness, likely the result of 

contamination by animal waste during the production and processing of crops. 

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 death.10 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 source.11

And the list continues to grow. Just last year, we learned that livestock can be 

an important source of life-threatening methicillin-resistant Staphylococcus aureus 

(MRSA). In Europe, strain of MRSA responsible for 20 percent of human MRSA infections in the Netherlands 12 has been shown to be transmitted from pigs to farmers and their families, veterinarians, and hospital staff.13 The pig-associated strain 

of MRSA has now been found in Canada 14 and in the United States.’’ 15 Small studies to determine whether the pig-associated strain will be found in hospitals and 

doctors’ clinics in the United States are underway, but larger more comprehensive 

studies are needed. 

Importantly, the list of resistant bacteria themselves traceable to animals does 

not convey the full scope of the problem. Bacteria are promiscuous. They can acquire 

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16Partridge SR, et al. 2009. Gene cassettes and cassette arrays in mobile resistance integrons. 

Federation of European Microbiological Societies (FENS) 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. 17 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. 

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 traits.16 In these 

circumstances, the use of one antibiotic, say penicillin, can simultaneously drive up 

the levels of resistance to other antibiotics, like tetracycline, cephalosporins, and 

fluoroquinolones. 

THE LITERATURE IN THIS ARENA IS VOLUMINOUS AND THE CONCLUSION IS CLEAR: ANTI- BIOTIC OVERUSE IN AGRICULTURE—JUST AS IN HUMAN MEDICINE—IS UNDERCUTTING

THE EFFICACY OF IMPORTANT HUMAN THERAPIES AND GENERATING MORE VIRULENT

PATHOGENS

Several major studies and reports make the point: • In 2002, Clinical Infectious Diseases published a special supplement on the 

‘‘Need to Improve Antimicrobial Use in Agriculture’’ that concluded the ‘‘[u]se 

of antimicrobials in food animals contributes to the growing problem of antimicrobial resistance in animal and human infections.’’ • In 2003, the World Health Organization concluded, ‘‘There is clear evidence 

of the human health consequences [from agricultural use of antibiotics, including] infections that would not have otherwise occurred, increased frequency of 

treatment failures (in some cases death) and increased severity of infections.’’ • In 2003, the National Academy of Sciences’ Institute of Medicine came to 

the same conclusion, stating, ‘‘Clearly, a decrease in antimicrobial use in human 

medicine alone will have little effect on the current situation. Substantial efforts 

must be made to decrease inappropriate overuse in animals and agriculture as 

well.’’ • In 2001, the prestigious New England Journal of Medicine published a special editorial whose title sums it up well—‘‘Antimicrobial Use in Animal Feed— 

Time to Stop.’’ 

THE SOLUTION IS REDUCING ANTIBIOTIC USE

As long as the massive use of antibiotics continues, animals, particularly animal 

guts, will remain a fountain 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 literature, these uses can be reduced or eliminated with 

modern management practices. The viability of such practices has been demonstrated in the industrial and alternative agricultural operations. On the industrial 

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 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 market place selling beef and pork produced without antibiotics. 

A recent 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 significant costs to produce.17 The USDA confirmed that large farms 

are more likely than small farms 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. A World Health 

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18Wegener H. 2008. Keynote Presentation. ASM Conferences Antimicrobial Resistance in 

Zoonotic Bacteria and Foodborne Pathogens, Copenhagen, Denmark, June 15–16. 19 European Commission. 2005. Ban on antibiotics as growth promoters in animal feed enters 

into effect, IP/05/1687. Online at http://europa.eu/rapid/pressReleasesAction.do?reference=IP/ 

05/1687&format=HTML&aged=0&language=EN&guiLanguage=en. 20Government 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. 21 Brooks E. 2008. Reconciling scarcity and demand through innovation. Food Business Asia, 

Issue 21, July/August. Online at www.efeedlink.com/ShowDetail/03c885e3-7852-439a-9ef0- 

a8a0b66a749c.html. 22GAO. 2004. Antibiotic Resistance. 

Organization (WHO) analysis of the Danish experience has shown that ban has had 

little or no impact on agricultural productivity and animal welfare.18 The comprehensive analysis, published in 2003, showed that there were no appreciable impacts from the antibiotic ban in broiler chickens or older, so-called ‘‘finisher,’’ pigs. 

In young nursery pigs, also called ‘‘weaners’’, there was a modest increase in the 

number of pigs requiring antibiotics for the treatment of diarrhea, but the increase 

was completely offset by the overall decrease in antibiotic use. According to the 

WHO report, the overall drop in antibiotic use was 54 percent. In the years following the ban, the Danish pig herd continued to grow and the production losses 

associated with the ban in weaner pigs have been overcome. 

POLICY RECOMMENDATION

Because as mentioned above, reduction in uses can often be accomplished by better management, 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 non-therapeutic purposes like growth promotion, feed efficiency, and 

routine disease prevention. The classes of medically important drugs are penicillins, 

tetracyclines, sulfonamides, lincosamides, streptogramins, 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 USE 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. 

The failure of the FDA to move gave impetus to the Preservation of Antibiotics 

for Medical Treatment Act (PAMTA). This 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. 

This 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.19 New Zealand,20 Thailand,21 and Korea 22 also have either enacted or 

will soon enact bans on certain non-therapeutic antibiotic use. 

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23GAO. 2004. Antibiotic Resistance. 24GAO. 2004. Antibiotic Resistance. 

As warned in a Government Accountability Office (GAO) report from 2004,23 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,24 if a major importer were to restrict trade from the United States because 

of the use of non therapeutic antibiotics, that action would override any economic 

benefits of this 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 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

We have waited far too long for action to reduce the unnecessary uses of antibiotics in food animal production. While we have dithered, new resistant diseases 

have emerged, old diseases have gotten worse, and people have died. 

There is simply no reason to continue the profligate use of valuable antibiotics for 

economic purposes or to compensate for the stressful, crowded animal 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. 

The CHAIRWOMAN. Thank you, Dr. Mellon. 

Dr. Price. 

STATEMENT OF LANCE B. PRICE, PH.D., DIRECTOR, CENTER 

FOR METAGENOMICS AND HUMAN HEALTH, ASSOCIATE INVESTIGATOR, PATHOGEN GENOMICS DIVISION, THE 

TRANSLATIONAL GENOMICS RESEARCH INSTITUTE 

Dr. PRICE. Thank you. Chairwoman Slaughter and distinguished 

members of the committee, my name is Lance Price. Like you, I am 

a microbiologist, with over 15 years of research experience. I also 

have training in public health. I appear today to present testimony 

in support of the ‘‘Preservation of Antibiotics for Medical Treatment Act.’’ 

Antibiotics have saved countless lives since they were introduced 

in medicine more than 50 years ago. Antibiotics save lives by killing or inhibiting bacteria when they are administered at proper 

doses. However, each time that you use an antibiotic, you risk the 

emergence of resistance, so it is a double-edged sword. 

When antibiotics are administered at low doses, a practice common in food animal production, you rapidly select for resistance. 

Concentrated animal feeding operations present an ideal setting for 

the growth of antibiotic-resistant bacteria. There are thousands of 

animals densely packed under unhygienic conditions and given routine antibiotics. When you treat an animal with antibiotics, you select for resistant bacteria to grow in their guts, and the bacteria 

are rapidly disseminated among the entire flock or herd via fecal 

contamination, which is rampant in concentrated animal feeding 

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29 

operations. Furthermore, fecal waste inevitably contaminates animal carcasses during the slaughter process. 

Just to underscore this point, I brought in a couple of products. 

I brought in raw pork and raw chicken. My research and from government research indicates that these are potential biohazards. 

These are just products that I bought at the grocery store. I don’t 

know if you have noticed, but when you buy these things, there is 

often this liquid leaking out. I think that this liquid is a potential 

biohazard, and there is good evidence for that. 

My own research and the research of NARMS indicates that 

there is a good chance that these two products are contaminated 

with antibiotic-resistant bacteria because of the antibiotic use in 

food animal production. 

Now, the most direct way to eliminate the antibiotic-resistant 

bacteria on products such as these is to eliminate antibiotic use in 

food animal production. So this includes any routine uses, whether 

for growth promotion, prevention, control, or even therapy. And 

this is whether or not they are accepted by the American Veterinary Association. This is not a public health association. If they are 

used on a regular basis, then that is a problem. 

And that brings me to my next point. If an animal production 

system requires routine antibiotic use to keep animals from becoming sick, then that system is broken. We do not try to prevent outbreaks of human disease using mass treatment of antibiotics, except in extremely rare situations like the anthrax mailings of 2001, 

like the meningitis case that we heard about. 

The prevention of infectious diseases within human populations 

is based on public health and hygiene interventions—things like 

underground sewers, things like vaccinations. We would never do 

away with these public health interventions and rely solely on antibiotics to maintain human health. So why do we do this with animals? 

The military learned long ago that if bunks were placed too close 

together, then the troops would fall ill to bacterial infections. The 

military’s response was not to provide prophylactic antibiotics to all 

recruits. The military’s response was to impose minimal distances 

between bunks, strategic placement of bunks, so that you don’t 

share bacteria between the troops. 

The food animal industry must be forced to modify their production methods in order to eliminate all routine antibiotic input. Successful models for large-scale, antibiotic-free animal production already exist and are used to produce millions of animals within the 

United States without the aid of antibiotics. 

Given the human health risks posed by overuse of antibiotics in 

animal production and the existence of viable alternatives, we 

should ban all non-therapeutic and routine antibiotic use in animal 

production in order to preserve the utility of these lifesaving drugs 

for treating sick people. 

An industry lobbyist might try to convince you not to regulate 

the antibiotic use in food and animal production by touting one of 

their favorite one-liners, ‘‘The science just isn’t there.’’ However, as 

a scientist and a public health researcher who does not have any 

financial stake in keeping antibiotics in food animal production, I 

am here to tell you that there is sufficient evidence to say that roumstockstill on DSKH9S0YB1PROD with HEARING

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tine antibiotics in food animal production poses a substantial 

human health risk. 

Infectious diseases do not respect political borders; they move 

freely—and now rapidly—around the world. The sooner we implement sound legislation to curb all unnecessary antibiotic use in the 

United States, the sooner we can begin leading the rest of the 

world to do the same and we can protect American citizens from 

antibiotic-resistant bacteria grown both in the United States and 

abroad. 

The ‘‘Preservation of Antibiotics for Medical Treatment Act of 

2009’’ is a solid first step towards becoming global leaders in the 

fight against untreatable antibiotic-resistant bacterial infections. I 

commend the distinguished Chairwoman for her commitment to 

this issue, and I thank the entire panel for the opportunity to 

speak today. 

[The prepared statement of Dr. Price follows:] 

PREPARED STATEMENT OF LANCE B. PRICE, PH.D., DIRECTOR, CENTER FOR

METAGENOMICS AND HUMAN HEALTH, ASSOCIATE INVESTIGATOR, PATHOGEN

GENOMICS DIVISION, THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE

Chairwoman Slaughter and distinguished members of the committee, my name is 

Lance Price. I am the director of the Center for Metagenomics and Human Health 

at the Translational Genomics Research Institute in Arizona. I am also a microbiologist with over 15 years of research experience. I appear today to present testimony 

in support of the ‘‘Preservation of Antibiotics for Medical Treatment Act of 2009’’. 

Antibiotic resistance is one of the greatest public health threats that we face 

today. For decades, the discovery of new antibiotics out-paced the emergence of antibiotic resistant bacteria. In recent years, however, the rate of new antibiotic discovery has plummeted; and, we are now witnessing the emergence of bacterial 

pathogens that are resistant to all of our approved antibiotics. Sadly, thousands of 

Americans die every year from infections that were once treatable with antibiotics. 

Antibiotics save human lives by killing or inhibiting bacteria when administered 

at proper doses and for sufficient time. When antibiotics are administered at low 

doses—a practice common in food animal production—then antibiotic resistance 

emerges quickly. 

Concentrated animal feeding operations present an ideal setting for the growth 

of antibiotic resistant bacteria—thousands of animals are densely packed under 

unhygienic conditions and fed antibiotics at sub-therapeutic doses. Most of the 9 billion food animals raised in the United States are raised in concentrated animal 

feeding operations and administered antibiotics on a regular basis. 

Antibiotics select for resistant bacteria in the gastrointestinal tract of treated animals. These resistant bacteria are rapidly disseminated to the entire flock or herd 

via fecal contamination. Fecal waste inevitably contaminates animal carcasses during the slaughter process; thus, antibiotic resistant bacteria are common contaminants of meat and poultry consumer products. Furthermore, the enormous quantities of fecal waste produced by food animals in the United States are applied to 

agricultural land with minimal treatment that is insufficient to kill many bacteria. 

Crops grown in these fields are prone to contamination by antibiotic resistant bacteria. 

Surveys of human gastrointestinal tracts indicate that people carry antibiotic resistant bacteria and that these bacteria likely come from the consumption of contaminated foods. The antibiotic resistant bacteria found on food and in human gastrointestinal tracts include some of the same organisms that are currently plaguing 

our hospitals. 

Regular antibiotic use in food animal production is an unnecessary public health 

risk and a crutch for improper animal husbandry practices. If an animal production 

system requires regular antibiotic inputs to keep the animals from becoming sick, 

then the system is broken. Except in extremely rare situations, we do not try to prevent outbreaks of human diseases using population scale antibiotic treatment. The 

prevention of infectious diseases within the human population is based largely on 

public health and hygiene interventions (e.g., underground sewage). We would never 

consider doing away with our hygiene-based interventions and relying solely on 

antibiotics to maintain human health, so why do we do this with animals? The milimstockstill on DSKH9S0YB1PROD with HEARING

31 

tary learned long ago that if bunks were placed too close together then troops would 

fall ill from bacterial infections. The military’s response was not to prescribe prophylactic antibiotics to all the recruits—the answer was to impose minimum distances 

between bunks. 

The U.S. food animal industry must find alternatives to antibiotics for preventing 

the spread of bacterial infections among the animals they produce. Successful models for large-scale antibiotic-free, animal production already exist and are used to 

produce millions of animals in the U.S. every year. However, until there is legislation to prevent unnecessary use of antibiotics then most producers will continue to 

use antibiotics to patch their outdated practices. Given the potential health risks 

posed by the overuse of antibiotics and the nonessential nature of their use in food 

animal production, society would be better served by preserving the utility of these 

antibiotics for treating sick people. 

Antibiotic resistance may be inevitable; however, we can slow the onset of resistance by eliminating all unnecessary uses of antibiotics. If we can slow the emergence of resistance, we give ourselves more time to develop alternative treatment 

strategies and discover new antibiotics. Eliminating the regular use of antibiotics 

by food animal producers should be one of our top priorities for slowing the emergence of antibiotic resistant bacteria. The ‘‘Preservation of Antibiotics for Medical 

Treatment Act of 2009’’ is a solid first step towards curbing unnecessary antibiotic 

use in food animal production. 

I commend the distinguished Chairwoman for her commitment to address this important issue and thank you for the opportunity to appear before this committee 

today. 

The CHAIRWOMAN. Thank you very much. 

Mr. Martin. 

STATEMENT OF ROBERT MARTIN, SENIOR OFFICER, PEW 

ENVIRONMENT GROUP 

Mr. MARTIN. Thank you, Madam Chairman. 

My name is Bob Martin. I am a senior officer at the Pew Environment Group. Previously, I was the executive director of the Pew 

Commission on Industrial Farm Animal Production. I very much 

appreciate the opportunity to appear here today on this important 

health issue, the silent part of our health care crisis, antibiotic-resistant infections. And I appreciate your introduction of the ‘‘Preservation of Antibiotics for Medical Treatment Act,’’ as well. 

The Pew Commission on Industrial Farm Animal Production was 

a 21⁄2-year study commissioned/funded by the Pew Charitable 

Trust. It was an independent commission involving a cross-section 

of individuals. The commissioners had expertise in animal agriculture, production of animal agriculture, public health, medicine, 

veterinary medicine, ethics, and State and Federal policy development. 

We were chaired by former Kansas Governor John Carlin, who 

had also been the Archivist of the United States. And one of our 

members was former Secretary of Agriculture Dan Glickman. We 

also have in the audience today, who will be speaking later, one of 

our commissioners, Mr. Fedele Bauccio, who was a leader among 

our commissioners as well. 

The general charge of the commission was to develop consensus 

recommendations to solve the public health, environment, animal 

welfare, and rural community problems caused by industrial farm 

animal production. As I said, we developed consensus recommendations using a fairly exhaustive process. We conducted 11 meetings 

around the country and spent 250 hours deliberating on the information we received. We received thousands of pages of information 

from the animal ag industry and all interested parties. We had two 

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32 

public hearings, one in North Carolina and one in Arkansas, where 

over 400 people attended the two meetings. We visited all types of 

industrial farm animal production in North Carolina, Iowa, Colorado, California, and Arkansas. We reviewed 170 peer-reviewed reports and commissioned eight reports of our own. 

We had a couple of general findings. One of our general findings 

was that the current system of food animal production in the 

United States is unsustainable. It represents an unacceptable level 

of risk to public health, an unacceptable level of damage to the environment, is harmful to the animals housed in these facilities, and 

is detrimental to the long-term economic activity of the communities where they are housed. 

Another general finding was that we found undue or significant 

influence at every turn by the industrial animal ag industry, 

whether it is policy development on the Federal or State level, policy enforcement on the Federal or State level, or academic research 

at our leading land grant schools. 

We developed 24 consensus primary recommendations. Twelve of 

those recommendations concern public health issues, five on antibiotic use alone. Our primary, number-one concern from a public 

health aspect was the end of the non-therapeutic use of antibiotics 

in food animal production. 

The second definition or the second recommendation that goes 

along with the first recommendation is how we defined therapeutic 

and non-therapeutic. We defined therapeutic use as being applied 

in the case of diagnosed microbial disease, period. All other use 

was non-therapeutic. 

We did have a provision for prevention or prophylactic use that 

would be covered in the case of a disease outbreak in a flock of 

birds or a herd or in anticipation of a disease that would be caused 

by shipping or other production practices. However, it was very important in our definition of prevention or prophylactic use that it 

be for a very, very limited amount of time. 

As the chairman indicated, the National Academies of Science 

has said that antibiotic resistance costs $5 billion a year. That is 

almost $18 a person for every person in the United States—man, 

woman, and child. And recently, in 2005, Tufts University upped 

that estimate to $50 billion a year of cost to the health care system. 

In 1999, the National Academy of Science followed the 1998 

study, saying that ending the non-therapeutic use of antibiotics in 

food animal production would increase prices, food prices, by $5 to 

$10 per consumer. So that is actually a savings of $12 to $7 a person if you go by the other study. 

The Pew Commission believes there is more than enough science 

to warrant the banning of non-therapeutic use of antibiotics. There 

have been scientific studies that have linked antibiotic use on the 

farm to resistant campylobacter, E. coli, and salmonella infections. 

And we also think that the Danish experience is very important, 

as the chairman said. They banned growth promotion, the use of 

antibiotics in 1998. The data has been analyzed for the last 10 

years, and a study is being released in the Journal of the American 

Veterinary Medical Association by the authors of the study. 

And what they found is, number one, in comparing the United 

States to the rest of the world, we use more antibiotics in food animstockstill on DSKH9S0YB1PROD with HEARING

33 

mal production than any country in the world. And that is on page 

10 of my submitted statement. 

In Denmark, looking specifically in Denmark, the total amount 

of antibiotics being used now post-ban is less than the total amount 

of antibiotics used pre-ban. That is the chart on page 11 of my 

written statement. It also shows that the pool of resistance in humans has declined post-ban. The resistance in the animal population has declined post-ban. 

And while they did show an increase in mortality for a short period of time among weaners and feeder pigs, once they started instituting better animal husbandry practices—cleaner barns, more 

ventilation for the barns, more space for the animals, better waste 

handling—then the mortality has decreased significantly in swine 

production. 

Productivity has actually gone up post-ban. There are more pigs, 

more piglets per sow. So the worry that there is going to be a world 

food shortage that some people would like to promote if we ban antibiotic use and non-therapeutic use of antibiotics in this country 

is not founded, based on the Danish experiment. 

Again, I thank you for this important piece of legislation and for 

this hearing today. And I was very impressed with all the knowledge that the members of the panel have about this very important 

issue. 

[The prepared statement of Mr. Martin follows:] 

PREPARED STATEMENT OF ROBERT MARTIN, SENIOR OFFICER, PEW ENVIRONMENT

GROUP

Good morning Madam Chair and members of the Rules Committee. My name is 

Robert P. Martin and I am a senior officer at The Pew Environment Group. Prior 

to my current position at The Pew Environment Group, I was the Executive Director of the Pew Commission on Industrial Farm Animal Production (PCIFAP). I appreciate the opportunity to appear today. 

The Pew Commission on Industrial Farm Animal Production was an independent 

commission funded by a grant from The Pew Charitable Trusts to the Johns Hopkins Bloomberg School of Public Health to investigate the problems associated with 

industrial farm animal production (IFAP) operations and to make recommendations 

to solve them. Fifteen Commissioners with diverse backgrounds began meeting in 

March of 2006 to start their evidence-based review of the problems caused by IFAP. 

I am attaching a list of the Commissioners with my statement. 

Over the next two years, the Commission conducted 11 meetings and received 

thousands of pages of material submitted by a wide range of stakeholders and interested parties, including the animal agriculture industry. Two public hearings were 

held to hear from the general public with an interest in IFAP issues. Approximately 

400 people attended those hearings. Eight technical reports were commissioned from 

leading academics to provide information in the Commission’s areas of interest. In 

addition, more than 170 peer-reviewed, independent academic studies were reviewed. The Commissioners themselves brought expertise in animal agriculture, 

public health, animal health, medicine, ethics, and rural sociology to the discussion. 

In addition, the Commission visited broiler, hog, dairy, egg, and swine IFAP operations, as well as a large cattle feedlot. 

The Commission’s findings make it clear that the present system of producing 

food animals in the United States is not sustainable and presents an unacceptable 

level of risk to public health, damage to the environment, as well as unnecessary 

harm to the animals we raise for food. In addition, the current system of industrial 

food animal production is detrimental to rural communities. 

The Commission released its full report on April 29, 2008, that included 24 primary recommendations. The Commission was so concerned about the indiscriminate 

use of antibiotics in food animal production, and the potential threat to public 

health, that five of those recommendations deal with antibiotic use. The top two 

public health recommendations call for the end on the non-therapeutic use of antimstockstill on DSKH9S0YB1PROD with HEARING

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1The PCIFAP defines non-therapeutic as any use of antimicrobials in food animals in the absence of clinical disease or known (documented) disease exposure; i.e., any use of the drug as 

a food or water additive for growth promotion, feed efficiency, weight gain, disease prevention 

in the absence of documented exposure or any other ‘‘routine’’ use as non-therapeutic. 2The PCIFAP defines non-therapeutic as any use of antimicrobials in food animals in the absence of clinical disease or known (documented) disease exposure; i.e., any use of the drug as 

a food or water additive for growth promotion, feed efficiency, weight gain, disease prevention 

in the absence of documented exposure or any other ‘‘routine’’ use as non-therapeutic. 3Fluoroquinolones are approved in animals only for therapeutic use (not for non-therapeutic 

use), and thus are not covered under PAMTA. 

biotics in food animal production and set strict definitions for their use. Those recommendations follow. 

Recommendation #1 Restrict the use of antimicrobials in food animal production 

to reduce the risk of antimicrobial resistance to medically important antibiotics. 

a. Phase out and ban use of antimicrobials for non-therapeutic (i.e. growth promoting) use in food animals 1

b. Immediately ban any new approvals of antimicrobials for non-therapeutic uses 

in food animals 2 and retroactively investigate antimicrobials previously approved. 

c. Strengthen recommendations in FDA Guidance #152 which requires the FDA 

determine that the drug is safe and effective for its intended use in the animal prior 

to approving an antimicrobial for a new animal drug application. 

d. To facilitate reduction in IFAP use of antibiotics and educate producers on how 

to raise food animals without using non-therapeutic antibiotics, the USDA’s extension service should be tasked to create and expand programs that teach producers 

the husbandry methods and best practices necessary to maintain the high level of 

efficiency and productivity they enjoy today. 

BACKGROUND

In 1986 Sweden banned the use of antibiotics in food animal production except 

for therapeutic purposes and Denmark followed suit in 1998. A WHO (2002) report 

on the ban in Denmark found that ‘‘the termination of antimicrobial growth promoters 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.’’ The report also determined that the overall health of the animals (mainly swine) was not affected and 

the cost to producers was not significant. Effective January 1, 2006, the European 

Union also banned the use of growth-promoting antibiotics (Meatnews.com, 2005). 

In 1998, the National Academy of Sciences (NAS) Institute of Medicine (IOM) 

noted that antibiotic-resistant bacteria increase U.S. health care costs by a minimum of $4 billion to $5 billion annually (IOM, 1998). A year later, the NAS estimated that eliminating the use of antimicrobials as feed additives would cost each 

American consumer less than $5 to $10 per year, significantly less than the additional health care costs attributable to antimicrobial resistance (NAS, 1999). In 

2005, Tufts University estimated that antibiotic resistant infections added $50 billion annually to the cost of health care in the United States. In a 2007 analysis of 

the literature, another study found that a hospital stay was $6,000 to $10,000 more 

expensive for a person infected with a resistant bacterium as opposed to an antibiotic-susceptible infection (Cosgrove et al., 2005). The American Medical Association, American Public Health Association, National Association of County and City 

Health Officials, and National Campaign for Sustainable Agriculture are among the 

more than 300 organizations representing health, consumer, agricultural, environmental, humane, and other interests supporting enactment of legislation to phase 

out non-therapeutic use in farm animals of medically important antibiotics and calling for an immediate ban on antibiotics vital to human health. 

The Preservation of Antibiotics for Medical Treatment Act of 2009 (PAMTA) 

amends the Federal Food, Drug, and Cosmetic Act to withdraw approvals for feedadditive use of seven specific classes of antibiotics 3 penicillins, tetracyclines, 

macrolides, lincosamides, streptogramins, aminoglycosides, and sulfonamides—each 

of which contains antibiotics also used in human medicine (2009a). PAMTA provides 

for the automatic and immediate restriction of any other antibiotic used only in animals if the drug becomes important in human medicine, unless FDA determines 

that such use will not contribute to the development of resistance in microbes that 

have the potential to affect humans. FDA Guidance #152 defines an antibiotic as 

potentially important in human medicine if FDA issues an Investigational New 

Drug determination or receives a New Drug Application for the compound (2009a). 

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4For the Commission’s recommendations, the members considered many definitions; a complete list of sources is in Appendix I. 5This definition is adapted from PAMTA 2007. 

Most antibiotics currently used in animal production systems for non-therapeutic 

purposes were approved before the Food and Drug Administration (FDA) began giving in-depth consideration to resistance during the drug approval process. The FDA 

has not established a schedule for reviewing existing approvals, although Guidance 

#152 notes the importance of doing so. Specifically, Guidance #152 sets forth the responsibility of the FDA Center for Veterinary Medicine (CVM), which is charged 

with regulating antimicrobials approved for use in animals: ‘‘prior to approving an 

antimicrobial new animal drug application, FDA must determine that the drug is 

safe and effective for its intended use in the animal. The Agency must also determine that the antimicrobial new animal drug intended for use in food-producing animals is safe with regard to human health (FDA–CVM, 2003).’’ The Guidance also 

says that ‘‘the FDA believes that human exposure through the ingestion of antimicrobial-resistant bacteria from animal-derived foods represents the most significant pathway for human exposure to bacteria that have emerged or been selected 

as a consequence of antimicrobial drug use in animals.’’ However, it goes on to warn 

that the ‘‘FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, the guidance describes the Agency’s current thinking on the topic and should be viewed only as guidance, unless specific 

regulatory or statutory requirements are cited. The use of the word ‘should’ in Agency guidance means that something is suggested or recommended, but not required’’ 

(FDA–CVM, 2003). 

The Commission believes that the ‘‘recommendations’’ in Guidance #152 should be 

made legally enforceable and applied retroactively to previously approved 

antimicrobials. Additional funding for FDA is required to achieve this recommendation. If any reviews of antibiotic use under Guidance #152 have been conducted by 

the Center for Veterinary Medicine, the results of the review should be released immediately. 

Recommendation #2. Clarify antimicrobial definitions to provide clear estimates 

of use and facilitate clear policies on antimicrobial use. 

a. The Commission defines as non-therapeutic 4 any use of antimicrobials in food 

animals in the absence of microbial disease or known (documented) microbial disease exposure; thus, any use of the drug as an additive for growth promotion, feed 

efficiency, weight gain, routine disease prevention in the absence of documented exposure, or other routine purpose is considered non-therapeutic.5

b. The Commission defines as therapeutic the use of antimicrobials in food animals with diagnosed microbial disease. 

c. The Commission defines as prophylactic the use of antimicrobials in healthy 

animals in advance of an expected exposure to an infectious agent or after such an 

exposure but before onset of laboratory-confirmed clinical disease as determined by 

a licensed professional. 

BACKGROUND

In 2000 the WHO, United National Food and Agriculture Organization (FAO), and 

World Organization for Animal Health (0IE, Fr. Office International des Epizooties) 

agreed on definitions of antimicrobial use in animal agriculture based on a consensus (WHO 2000). Government agencies in the United States, including the 

USDA and FDA, govern aspects of antimicrobial use in food animals but have varying definitions of such use. Consistent definitions should be adopted for the use of 

all U.S. oversight groups that estimate types of antimicrobial use and for the development of law and policy. The Preservation of Antibiotics for Medical Treatment Act 

of 2009 (PAMTA) defines non-therapeutic use as ‘‘any use of the drug as a feed or 

water additive for an animal in the absence of any clinical sign of disease in the 

animal for growth promotion, feed efficiency, weight gain, routine disease prevention, or other routine purpose (2009a).’’ If the bill becomes law, this will be the legal 

definition of non-therapeutic use for all executive agencies and therefore legally enforceable. 

THE DANISH EXPERIENCE

In 1998, Denmark banned the use of antibiotics as growth promoters. Now, after 

11 years of data are available, an updated assessment of the impacts of that ban 

will be published in the Journal of the American Veterinary Medical Association 

(JAVMA) later this year. It is important to understand the results of the ban on 

antibiotics used for growth promotion in Denmark, presently the European nation 

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36 

with the largest swine production, to have an idea of what would happen in the 

United States if a ban were implemented. 

The Danish study is titled, Use of Antimicrobials in the Danish Swine Production, 

1992–2007; The Meat of the Matter and Lesson Learned. The primary author of the 

study, Dr. Frank Aarestrup of the National Food Institute of the Technical University in Denmark, has met recently with United States producers at a conference at 

Kansas State University to discuss the findings of his team. 

• The United States leads the world in the use of antibotics in food animal production, whether you use estimates from the Animal Health Institute or the Union 

of Concerned Scientists, according to Dr. Aarestrup. (Figure 1) 


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37 

• Once the growth promotion ban was instituted in 1998, therapeutic use rose 

slightly from 1999 until 2003, but has leveled off since 2003. However, the total 

amount of antibotics used post-ban is less than half the amount used in 1992 and 

the lower than the total amount used each year from 1992 to 1999. (Figure 2) 


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38 

• Mortality in weaners increased for a brief time post ban and weight gain declined in the same period. However, according to a convention I had with the study’s 

author, mortality rates declined and weight gain recovered once production practices 

were improved, including better ventilation in the barns, more space provided for 

the animals, and more frequent cleaning of the barns. (Figures 3 and 4) 


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• The numbers of piglets per sow increased post-ban. (Figure 5) 


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41 

• Mortality in finisher pigs increased slightly post-ban but declined significant in 

2006 and 2007 following improvement in production practices such as improved ventilation in barns and improved waste handling and barn cleaning; growth of finishers remained steady post-ban, with the daily gain on finisher pigs increasing 

post-ban. (Figure 6) 

GENERAL CONCLUSIONS FROM THE DANISH STUDY

• Total antimicrobial consumption in swine has been reduced from 100 mg/kg to 

49 mg/kg from 1992 to 2008. 

• Limited (if any) long term effect on overall productivity. 

• Decrease in antimicrobial resistance has followed reduced use. 

The Pew Commission on Industrial Farm Animal Production made our recommendations in an effort to stem the advance of antibiotic resistance. It has been 

shown that antibiotics once rendered ineffective due to overuse can become effective 

again once that overuse is stopped. It is important to note that the Pew Commission 

never advocated ending all antibiotic use in food animal production. Such a recommendation would be irresponsible. We did seek to maintain the effectiveness of 

antibiotics to treat sick animals by limiting the routine use. 

Madam Chair, I commend you for introducing this important legislation and for 

conducting this hearing today. The increase in bacterial antibiotic resistance, and 

the inappropriate use in food animal production, is a serious—if silent—threat to 

our public health. 

Thank you. 


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The CHAIRWOMAN. Thank you. 

We certainly appreciate all three of you being here today. Your 

knowledge is important to us. 

First, I again want to thank you for the great work you have 

done. The Union of Concerned Scientists, for as long as I can remember, has really stood up for good science in a country where 

cheap science and bad science seems to be pretty prevalent. And 

I can’t tell you how much I have appreciated that over the years. 

I have to say that, in the last 8 or 9 years, my sense about the 

FDA, which I always thought was the gold standard for the world, 

has fallen to the point where I really hold the FDA in minimum 

low regard. I am so pleased that we see some light at the end of 

the tunnel now, with some new persons there. 

I was pleased you brought up the Denmark study again, because 

I think that is a terribly important thing for us to do. 

One of the questions that I wanted to ask for any of the three 

of you is about the FDA’s 2004 queries. The company that makes 

penicillin for use in food animals, did they present any evidence 

that it is safe for people that you know of? This was a 2004 inquiry. 

Dr. MELLON. Not that we know of. We know of a request sent 

to the companies by the FDA for evidence of food safety, but we 

don’t know that any of the companies responded. 

The CHAIRWOMAN. But the FDA simply just allowed it to go on. 

Dr. MELLON. The FDA simply hasn’t acted on—— 

The CHAIRWOMAN. Well, we don’t have any results from that 

study in 2004, is that correct? They released no report at all? 

Dr. MELLON. That is exactly right. It is amazing to me that, despite repeated past requests from Congress, that risk assessments 

that apparently have been done by the FDA have not been released, either to Congress or the public. 

The CHAIRWOMAN. Yeah. 

Cephalosporin, I think that has been an interesting example that 

had been prohibited; the FDA prohibited it July 3rd, 2008. And the 

Federal Register determined extra-label uses of cephalosporin presented a risk to human health, and the CDC agreed. But on November 28th, 2008, the FDA revoked the order prohibiting the 

extra-label use of cephalosporins in food-producing animals. They 

said that they had had too many comments on the order. 

Are you all aware of that? 

Dr. MELLON. I certainly am. 

The CHAIRWOMAN. Those are the agents who were supposed to 

be taking care of us. 

Dr. MELLON. They did. They revoked the order. And the Union 

of Concerned Scientists and Keep Antibiotics Working have requested that the agency reinstate the order. But, so far, we have 

not heard back from the FDA. 

The CHAIRWOMAN. That is something I think that those of us on 

the panel can take up with the FDA. 

Dr. Price, when you talked about the transfer, resistance transfer, that is a little hard to grasp. I think if you would explain to 

us how that is transferred among bacteria, we would appreciate it. 

Dr. PRICE. Sure, sure. 

So, antibiotic resistance in bacteria is coded for or elicited by either mutations in the DNA or fragments of DNA called resistance 

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45 

genes. A lot of those genes are on what we call mobile resistance 

elements, these little pieces of DNA that bacteria can hand back 

and forth, although without hands, right, but they can pass back 

and forth. It is sort of like a lateral pass in football, but in this case 

you make a copy of it before you hand it off. 

Or maybe you could think about spy secrets that allow you to escape arrest. You know, you make a copy of the secret and pass it 

on to one of your other spies, and you have now the information 

that it takes to escape that antibiotic. 

So every time you are using antibiotics, you are selecting for all 

of those bacteria that are containing that information. And so, 

maybe that passing of information is rare, but when you apply that 

antibiotic, then all of those that don’t have the information die off, 

or most of them die off, and the ones that do have the information 

grow. And so the system becomes dominated by the organisms that 

hold that information, hold those resistance genes. 

Does that help? 

The CHAIRWOMAN. It helps. Do you think genomics is going to 

play a role? 

Dr. PRICE. I think that is a backwards way to approach this. I 

think taking antibiotics out of food animal production is the way 

to do it. 

The CHAIRWOMAN. Well, that is what we would all prefer to do. 

That is the hope, of course, with this bill. 

Now, the industry that feeds antibiotics to their animals on a 

daily basis calls it ‘‘routine preventative use.’’ If we call it prevention but we use it every day, isn’t that an indication that we have 

a system that makes those animals prone to catching the disease? 

Dr. PRICE. I said it in my statement and I will repeat it right 

now: If you have to use repeated antibiotics, routine antibiotics to 

keep animals from being sick or to make animals healthy again, 

you have a broken system. 

The CHAIRWOMAN. Mr. Martin, you know that this bill is the result of all the work done at Pew, for which we greatly thank you. 

Concerning the terms for non-therapeutic, therapeutic, and prophylactic use of antibiotics, the commission considered it important 

that they be clearly defined. Tell us how you came to those conclusions. 

Mr. MARTIN. Well, we had leaders in medicine and veterinary 

medicine, and I think through the period of our inquiry, what we 

found is just what we have heard today at the hearing and what 

the chairwoman has expressed: Unless you very clearly define the 

terms, the industry will use antibiotics on a routine basis and call 

it disease control or prevention. 

And so we decided to make a very narrow definition of therapeutic use after, you know, several hours of discussion internally 

and consulting with other human health experts and veterinary 

medical experts. 

And I would just like to reiterate what Dr. Price said. I mean, 

the system is broken. It is the lack of animal husbandry, that antibiotics are a patch on a broken system. They are a crutch that allows us to overcrowd the animals and to not treat the waste properly. 

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46 

And they are also a linchpin, the commission found—I am getting a little bit off subject here—but they are a linchpin in keeping 

the animals together that escalates the development of novel flu viruses. We had a real concern that, because antibiotics allow the 

animals to be overcrowded and because of the intense exposure of 

individuals with the animals, that a novel flu virus would be generated, similar to the swine flu that we see. 

The CHAIRWOMAN. And we got one, didn’t we? 

I know that you have worked with lots of individuals. Did you 

work with the animal agriculture industry as well? 

Mr. MARTIN. We did. 

The CHAIRWOMAN. To what result? 

Mr. MARTIN. Well, in the report we said that the response to the 

commission by the animal ag industry was pretty broad. It ranged 

from wary cooperation to open hostility. 

We did work with the Animal Ag Alliance, and they helped us 

get some access to some facilities, because it is very hard to get in 

to see some of these industrial operations. We consulted a lot of 

academics that received funding from the industry. 

In the end, I think that they were pretty upset because we called 

for broad-scale changes. 

The CHAIRWOMAN. Thank you all very much. 

Ms. Matsui. 

Ms. MATSUI. Thank you, Madam Chair. 

And thank you all for being here today. And I truly respect your 

expertise and your experience in this matter. 

I am really interested in the economic imperative for why this 

legislation is needed. In the testimony that we received, it is clear 

that the failure to take action could have dire economic consequences. We have heard that failure to act on this bill means 

that we will continue spending over $4 billion a year on preventable hospital visits. We also heard that failure to act exposes our 

U.S. food industry to trade challenges in a global marketplace. 

Through April of this year, the country’s farmers exported almost 

$937 million worth of meat. That is about 277,000 metric tons of 

meat in the first 4 months of 2009 alone. This is a huge industry 

for our country at a critical time in history, and we can’t afford to 

leave our meat industry behind by market changes that we fail to 

see or react to. 

Dr. Mellon, you have devoted a great deal of your testimony to 

the potential market disadvantages that U.S. meat producers 

would face if we failed to enact Chairwoman Slaughter’s legislation. I am someone who does recognize the critical role that international trade plays in our country’s economy. So I am hoping you 

will be able to elaborate on your analysis of this. 

You used Korea, Thailand, and New Zealand as examples of 

countries that compete with U.S. beef and that could conceivably 

restrict beef imports that do not conform to their own quality 

standards. How would these countries taking such action hurt 

American beef producers? 

Dr. MELLON. Well, any country that has already restricted the 

non-therapeutic use of antibiotics in its own food animal production 

has what I would call a kind of card in its pocket that it can play 

anytime it chooses. 

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47 

And the card is as follows: Under the trade rules, a country is 

allowed to restrict the imports of products coming into the country 

where those products do not adhere to rules that the country is 

willing to impose on itself. So, where a country has itself decided 

to restrict antibiotic use, it has the card to play to restrict U.S. imports into that country because we do not adhere to those rules, 

and for so long as we don’t. 

We don’t know if they are going to play that card, but many of 

our competitors are looking for, you know, virtually any angle in 

what is a very competitive international marketplace. 

So that is the kind—they could establish rules, and those rules 

would not fall under a WTO challenge as long as, as I said, they 

are not allowing in products that don’t adhere to rules that they 

are willing to impose on themselves. 

Ms. MATSUI. So you are basically saying they could use that as 

an excuse to not—— 

Dr. MELLON. To restrict imports, yes. To not import our beef, or 

any other product. 

Ms. MATSUI. Okay. Then can you estimate what sort of economic 

impact such a development would have on American beef producers? Are we talking in millions or billions of dollars? 

Dr. MELLON. I really wouldn’t want to venture into that area. It 

is not my area of expertise. 

But I think it would—I mean, just because the size of the international marketplace is so large, that it could be important. I 

mean, I think the handwriting is on the wall. And I think the 

American meat industry is a lot like the auto industry; they just 

can’t see that it is in their own advantage to start doing what 

needs to be done. 

Ms. MATSUI. So do you feel like there are other countries that are 

moving towards limiting—— 

Dr. MELLON. Yes. 

Ms. MATSUI [continuing]. Antibiotic use so they can legally erect 

trade barriers against the United States? 

Dr. MELLON. No, I wouldn’t—I would say that certainly, you 

know, based on the Danish experience, the country is restricting 

antibiotic use in order to protect the health of its own citizens. But 

I think that smart producers—and Denmark, I believe, is the 

world’s largest exporter of pork; I mean, this is no small industry 

there—that they understand that there will be trade advantages as 

well. They would rather be ahead of the game than behind it. 

Ms. MATSUI. Thank you. 

Can you go on with the Denmark experience? Because my understanding is they have experienced little economic dislocation. I 

mean, they must have had some dislocation. 

Mr. MARTIN. Actually, not. I was fortunate enough to be on a 

conference call with the author of the study that is going to be published next month. There has been very little economic dislocation. 

But to answer the question about disruption in the marketplace, 

I think it would cost the American meat industry billions of dollars 

if a challenge like that were issued. And I think you only have to 

look at what happens when there is a BSE scare, what happens to 

exports. 

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48 

Russia periodically bans imports of U.S. pork because of concerns 

about antibiotic residue on the export. And the entire European 

Union has joined Denmark in the ban on non-therapeutic use of 

antibiotics in food animals, so in 2006 they did an EU-wide ban. 

So I think the potential for a trade challenge is pretty serious. 

But there has not been a lot of economic dislocation based on the 

Denmark study. They did find that I think more people had to be 

involved in agriculture to produce the animals, but it wasn’t this 

major disruption that the domestic U.S. industry would like you to 

believe. 

Ms. MATSUI. Okay. Thank you very much. 

The CHAIRWOMAN. Ms. Pingree. 

Ms. PINGREE. Thank you, Madam Chairman. 

And thank you for your interesting and very informative testimony. As you heard me say earlier, I am a strong supporter of 

what we are here to talk about today and have a little experience, 

so I was very pleased to hear all of you reinforce that. Thank you 

very much. 

I am just going to ask you a couple things, just to reinforce what 

you were already talking about. And thank you to Ms. Mellon for 

that, sort of, reinforcing the economic impact of what we are hearing about here and how it has already had unintended consequences, certainly in the health field, but how it could continue 

to be an economic disadvantage in our exports. And I thought it 

was important just to reinforce how significant this could be if we 

continue down this path. 

And I want to thank Dr. Price for reminding us again that, if a 

system requires constant use of antibiotics, it is already unhealthy. 

And, as I mentioned before, my educational background and my 

life experience is around organic farming. That is true with plants, 

animals. It seems like such a simple premise to me, and the fact 

we can’t get from there to here doesn’t make any sense to me. The 

fact that we would even have to have this hearing, knowing what 

we know about loss of life and economic issues doesn’t make any 

sense. 

So I just want to actually ask my only question of Mr. Martin. 

Thank you for the work that Pew did. That was obviously very 

helpful in bringing us to this point. 

You mentioned in passing the issue of undue influence and that 

you saw it at several levels. As far as I am concerned, we wouldn’t 

be here today if there wasn’t undue influence in reinforcing bad decisions being made. 

So could you kind of stretch that out a little bit? I am interested 

in hearing what you said with a little more length attached to it 

so we can really think about what the root problem is here and 

why we don’t fix it. 

Mr. MARTIN. Well, I think one of the main root problems is the 

lack of public funding for research at land grant schools. There 

have been widespread cutbacks, both at the State and Federal level 

that should be doing research, which, if it is public dollars, it will 

be for the common good. That cutback has been replaced by industry-funded research. And you can’t blame an industry for wanting 

to fund research that promotes its business model or the perpetuamstockstill on DSKH9S0YB1PROD with HEARING

49 

tion of its product, but that is not always in the vein of public 

health or in keeping broader public health in mind. 

There is also a lot of influence by some of the species promotional 

groups, like the National Pork Producers Council, influencing State 

and Federal policymakers and enforcement of existing regulations 

and laws. 

Ms. PINGREE. Uh-huh. Well, thank you. 

Thanks again to all you. 

The CHAIRWOMAN. Mr. Cardoza. 

Mr. CARDOZA. Thank you, Madam Chairman. 

I believe someone on the panel has said in the past that 70 percent of all antibiotics used in food animals are for non-therapeutic 

purposes, is that right? Isn’t it true that half of that 70 percent figure is ionophores, which aren’t really antibiotics? 

Dr. MELLON. No, I can take that question. 

Seventy percent of—well, I guess I should preface it by saying, 

there are two broad classes of chemicals that we are talking about 

here, antibiotics that are used in human medicine and antibiotics 

that are not. Often the entire class, including both antibiotics that 

are used in human medicine and those that are not, are called 

antimicrobials. And the figure that was cited in the report that the 

Union of Concerned Scientists actually published is that 70 percent 

of the antimicrobials used are used in animals, in only three species and for non-therapeutic use. 

Now, as we made clear and as I made clear in my testimony, 

only half of the 24 million pounds are drugs that that we use in 

human medicine and are, therefore, of concern, I think, to the folks 

here. But, in fact, the 70 percent number stands, whether it is a 

percentage of all of the antimicrobials used or whether it is all of 

the more narrowly defined antibiotics. 

Mr. CARDOZA. Is the entire 70 percent used by the animal consuming it, or are some of those antimicrobials dips or used to sterilize? 

Dr. MELLON. No. The 13 million pound number that we came up 

with represents antibiotics that were fed to animals for non-therapeutic purposes, mostly in feed, occasionally in water. It does not 

include the use of antibiotics for dips and for other purposes. 

And I would say, across the board, regardless of the purpose for 

which antibiotics are used, we do not have adequate data to answer 

the questions with the specificity and accuracy I would like to be 

able to answer them. 

Mr. CARDOZA. To get to the data question, the farm bill we 

passed last year, it was included that USDA and FDA are to collect 

that data, is that correct? 

Dr. MELLON. Well, in ADUFA last year, the Animal Drug—— 

Mr. CARDOZA. There were also some provisions with regard to 

control in the farm bill, if I am not mistaken. 

Dr. MELLON. There are no provisions that I am aware of in the 

farm bill that would require the collection—— 

Mr. CARDOZA. The collection. 

Dr. MELLON. Yes. There is some research that is authorized in 

the farm bill to, kind of, provide the background for the issue, to 

figure out why antibiotics are used to trace their movement off the 

farm. That is in the farm bill. It is a program that, although aumstockstill on DSKH9S0YB1PROD with HEARING

50 

thorized, there are no funds appropriated for it, which we would 

very much like to see happening. It is a kind of data that we would 

very much like to have. 

But on top of that, we also would like to have what they have 

in Denmark, for example. They are able to tell you precisely the 

quantities of antibiotics used in their animal agriculture and for 

what purposes. So they can really follow it over time. 

Mr. CARDOZA. I think that is very valid. I totally support having 

people have knowledge. For example, I am the chairman of the Organic Subcommittee on the Agriculture Committee. So I believe 

that people need to be able to make choices and to know what they 

are getting. 

As you talk about Denmark, and that has been mentioned several times today, when they banned the non-therapeutic use of 

antibiotics, it is my understanding that therapeutic use went up 

dramatically. In fact, it went up 135 percent between 1996 and 

2005. 

Dr. MELLON. It did go up some, primarily for the treatment of 

disease in young pigs. But it did not go up as much as overall use 

came down. 

Mr. CARDOZA. The reason why I raised this is because we have 

seen this a number of times in the Agriculture Committee when we 

studied this over the years. There is a reason why some diseases 

are treated, and we are concerned with what those diseases could 

cause in the human population as well. So there is some reason to 

be concerned not just with the treatment but with the disease that 

they are trying to get at. So that may go to other questions about 

how to prevent those diseases in other ways. But it is not just always a zero-sum game. 

Dr. MELLON. Absolutely. You are most correct. 

Mr. CARDOZA. Thank you. 

Dr. Price, are you a vegetarian? 

Dr. PRICE. No. 

Mr. CARDOZA. The way you handled that chicken, I thought that 

was maybe the first time you have ever done it. 

Dr. PRICE. I have handled a lot of chicken, actually, testing it for 

drug-resistant bacteria. 

Mr. CARDOZA. Well, the reason I wanted to talk to you about 

that, you mentioned that commercially produced chicken had toxic 

bacteria on it. Free-range chicken, would that have the same kind 

of toxins or potentially the same health effects? Would you cook it 

any different? 

Dr. PRICE. Well, I have done studies comparing poultry products 

from animals raised without antibiotics and conventionally raised 

products. And I was looking for fluoroquinolone-resistant 

campylobacter. This is the second leading cause of bacterial diarrhea in the United States, just behind salmonella. They, kind of, 

compete for first place. 

And there was a significant difference and a substantial difference—I probably need to go back to the numbers and I can give 

those exact numbers to you, but it was about a tenfold difference 

between those organic and raised-without-antibiotics products compared to conventionally raised. So there is much more 

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51 

fluoroquinolone-resistant campylobacter on the conventional products. 

Mr. CARDOZA. Was that a peer-reviewed study? 

Dr. PRICE. It was. 

Mr. CARDOZA. If you would get that to me, I would appreciate it. 

Dr. PRICE. I would be happy to. I have two different studies I 

conducted on that. I will share those both with you. 

Mr. CARDOZA. Was the chicken that you compared, was it prior 

to processing or after processing? I know there are some treatments that are used in processing that sometimes take care of 

some of those. 

Dr. PRICE. No, this was grocery store. Just like this. 

Mr. CARDOZA. Thank you. I would like to have that study. 

Dr. PRICE. I would be happy to share it with you. 

Mr. CARDOZA. Madam Chairman, I will withhold further questions. 

Mr. MARTIN. May I go back just to the—— 

The CHAIRWOMAN. Yes, Mr. Martin. 

Mr. MARTIN. I think the Danish experience is very important. 

And I just wanted to reiterate, on page 11 of my written testimony, 

this is the actual chart that will be issued in the Journal of American Veterinary Medical Association next month. It is by the doctor 

who conducted this study. 

It shows that this is the pre-ban antibiotic use, both therapeutic 

and growth promoter, and this is the antibiotic use post-ban. It 

does go up some, but it has leveled off, it looks like, starting in 

about 2004 to 2008. 

But you can see that it is a dramatic reduction in use when you 

combine non-therapeutic and therapeutic. And I think you have to 

look at that combined figure to get an accurate idea. 

Dr. PRICE. And I think there was a temporary spike due to— 

there were some outbreaks initially and it went down. 

The CHAIRWOMAN. Oh, I think you have mentioned that, with 

outbreaks. 

Mr. CARDOZA. I have one further question. Now, is that by 

weight, or is that by—because if you are mixing it in feed and you 

have diluted it somehow and it is a less dilute—I mean, if you provided a strong concentration but it is a very small pill, how are you 

measuring it? 

Mr. MARTIN. It is measured—well, and I think in your packet, 

Dr. Aarestrup and Dr. Wegener have actually submitted a written 

testimony that it will probably be better for them to address than 

me. But it shows milligrams used per kilograms of meat produced. 

Mr. CARDOZA. Thank you. 

The CHAIRWOMAN. Thank you all very much. We really appreciate your being here, and your testimony has been invaluable. 

Thank you so much. 

Our next panel will be two Members of Congress, Congresswoman Schakowsky from Illinois and Congressman Boswell from 

Iowa. If they will come forward, please. 

Dr. Price is going to take his chicken there, right? 

Ms. Schakowsky, can we begin with you? 

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STATEMENT OF THE HON. JANICE SCHAKOWSKY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. Thank you, Madam Chairman. I really appreciate the opportunity to come and talk to your committee. 

You know, some vulnerabilities are thrust upon us as a Nation, 

and others, like the one we are discussing, are really self-imposed. 

We all felt extremely vulnerable after 9/11, and we have looked 

for all of the ways that we could protect ourselves and all the potential attacks that might come upon us. We talked about biologic 

weapons that might threaten our country. And when the H1N1 

virus came out, I know it wasn’t a bacterial infection, but we said, 

oh, is this the big one, and are we ready for that, and is this going 

to be the plague of our generation? 

Well, on this battlefield, it seems as if we are disarming ourselves. And we are not doing it for good, solid health reasons. We 

are doing it in order to grow animals faster or, you know, to promote growth and not to promote health. 

And you have heard all the science, that the Food and Drug Administration has seven classes of antibiotics that are highly or critically important in human medicine, and they are used as feed additives. I am not going to go over the science, which I think has been 

very adequately presented. 

But my friend, for example, is one of these people who has had 

breast cancer and has had trouble with her arms since then, is 

very susceptible to bacterial infections and spends a lot more time 

in the hospital for every admission when she gets such an infection. 

And here we are at this moment looking for ways that we are 

going to be able to provide health care to all Americans and do it 

in an economical way. 

And, again, you have heard some of those numbers. Of the estimated 1.4 million people infected with salmonella each year, about 

one in five cases is resistant to antibiotics. What does that mean? 

It means longer stays in a hospital, more medical care. Of the 2.4 

million annual campylobacter infections, about half are drug-resistant, many resistant to two or more antibiotics. So we have to keep 

trying more and more things. 

We know that 2 million Americans acquire bacterial infections 

during their hospital stays every year. Seventy percent of their infections are resistant to the drugs commonly used to treat them. 

So we are bringing ourselves down at a moment when we want 

to protect ourselves as a Nation and we certainly want to protect 

the health care of Americans. 

The University of Illinois researchers found in 2001 and 2007 

that routine tetracycline used at hog farms was contaminating 

groundwater with tetracycline-resistant bacteria, which were then 

sharing resistance with other bacteria through gene transfer. So 

the researchers concluded that, quote, ‘‘Groundwater may be a potential source of antibiotic resistance in the food chain.’’ 

The Illinois Department of Health calculates that the incidence 

of one type of resistant bacteria, MRSA, has risen 57 percent, to 

over 10,000 cases, in just 4 years. 

So it seems to me, when the solution is at hand—and we have 

heard testimony about other countries that have done this without 

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53 

any dramatic effect at all to the industry—when we are talking 

about using these antibiotics not for therapeutic reasons in animals, and we are not really discussing that right now, that we 

ought to do the smart thing. 

As you may know, Madam Chairman, my hope was to introduce 

this legislation, your legislation, as part of the overall health reform that we are doing right now. We do have language in there 

now that would look at this issue and the importance of this issue. 

I did it as much, again, for the health of the country as an effort 

to save money on health care and do it in a smart way. 

So my hope is that this committee and that the full House then 

will look at this as a stand-alone issue, pass your legislation, H.R. 

1549, for all the reasons that I mentioned and with all the absolutely unassailable data behind us to back up its effectiveness and 

its importance. 

Thank you. 

[The prepared statement of Ms. Schakowsky follows:] 

PREPARED STATEMENT OF THE HON. JANICE SCHAKOWSKY, A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF ILLINOIS

• Madam Chairwoman, I am pleased to offer my testimony today in support of 

your bill, the Preservation of Antibiotics for Medical Treatment Act of 2009. 

• This bill would require the FDA to end the non-therapeutic use of antibiotics 

in livestock—a practice that is contributing to increasing prevalence of antibioticresistant diseases. 

• Food-borne illnesses are now becoming more difficult to treat due to the increase in antibiotic-resistant strains and the decreased effectiveness of antibiotics 

routinely used as a first-line defense. 

• Two million Americans acquire bacterial infections during their hospital stay 

every year, and 70 percent of their infections are resistant to the drugs commonly 

used to treat them. 

• In fact, resistant bacterial infections increase health care costs by $4 billion to 

$5 billion each year. 

• In addition, foodborne illnesses, which affect millions of Americans each year, 

are increasingly are resistant to one or more antibiotics, making them more difficult, and sometimes impossible, to treat. 

• Of the estimated 1.4 million people infected with Salmonella each year, about 

one in five cases are resistant to antibiotics. 

• Of the 2.4 million annual Campylobacter infections, about half are 27) drug resistant, many resistant to two or more antibiotics. 

• A contributing factor to this rise in antibiotic resistance is the routine feeding 

of important human antibiotics like penicillin, tetracycline, and ciproflaxin to food 

animals. 

• Seven classes of antibiotics certified by the Food and Drug Administration 

(FDA) as ‘‘highly’’ or ‘‘critically’’ important in human medicine are used in agriculture as animal feed additives. 

• Many factory farms give these antibiotics in the daily feed to cows, chickens, 

and pigs—not to treat disease, but to promote growth, improve feed efficiency, and 

compensate for overcrowding and bad sanitation. 

• These classes of antibiotics are among the most critically important in our arsenal of defense against potentially fatal human diseases. 

• Approximately 70 percent of antibiotics and related drugs produced in the U.S. 

are given to cattle, pigs, and chicken to promote growth and to compensate for 

crowded, unsanitary, stressful conditions. 

• This kind of habitual, nontherapuetic use of antibiotics has been conclusively 

linked to a growing number of incidents of antimicrobial-resistant infections in humans, and may be contaminating ground water with resistant bacteria in rural 

areas. 

• University of Illinois researchers found in 2001 and 2007 that routine tetracycline use at hog farms was contaminating groundwater with tetracycline-resistant 

bacteria, which were then sharing resistance with other bacteria through gene 

transfer. 

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54 

• The researchers concluded, ‘‘groundwater may be a potential source of antibiotic 

resistance in the food chain.’’ 

• The Illinois Department of Health calculates that the incidence of one type of 

resistant bacteria—methicillin-resistant Staphylococcus aureus (MRSA)—has risen 

nearly 57% to over 10,000 cases in just 4 years. 

• We should be addressing food safety from farm to fork, including practices in 

food animal production—like routine antibiotic use—that can make our food less 

safe to eat and costs billions of dollars each year in health care costs. 

• I urge the Members of this committee to support passage of H.R. 1549. 

The CHAIRWOMAN. Thank you very much. 

Mr. Boswell. 

STATEMENT OF THE HON. LEONARD BOSWELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF 

IOWA 

Mr. BOSWELL. Well, thank you, Madam Chairman and the committee, for allowing me to appear before you today and to share my 

testimony. 

I might be a little different from my good friend from Chicago, 

and I do mean good friend. We came here together, and we do a 

lot of things together. But I believe that we are growing animals 

not just for rapid growth but for healthy animals and healthy food, 

to keep people healthy. And I believe that, and you will probably 

understand that as I share my testimony. 

I have spent most of my life involved in animal agriculture, and 

I have seen firsthand 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 today I still have a hand in managing a cow-calf operation on my farm in southern Iowa. 

Once I retired from 20 years in the Army, I moved back to Iowa 

to return to farming. I knew things had changed, so I wanted to 

learn about it. So I sat down with my local veterinarian, who actually manages our little cow-calf operation today, and his senior 

partner and people from Iowa State University, if you will, 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 is the rule. 

Part of that was my young son was going to have a calf in 4– 

H. He was just a junior high youngster, and I wanted him to learn. 

I thought maybe he would farm someday. Well, he is not, but nevertheless, so much for that. But I wanted him to understand what 

he was doing, and I thought, well, parents kind of like to take care 

of their kids, so when I went to the fair I would probably end up 

buying it and we would probably send it to the locker and take it 

from there. So I wanted to be sure what I fed my children was 

healthy. 

During the 110th Congress, it was my privilege to serve as the 

chairman of the Agricultural Subcommittee on Livestock, Dairy, 

and Poultry. On September the 25th of last year, we held a hearing 

to review the advances in animal health within the livestock industry. And I have a report here I would like to submit for the record, 

if I may. 

The CHAIRWOMAN. Without objection. 

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Mr. BOSWELL. Thank you. 

We specifically looked at how antibiotics are used on America’s 

livestock farms. 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. We believe that we heard 

from a good cross-section of the users of animal health products, 

the doctors responsible for the use of the antibiotics, and the experts studying the resistance trends for the 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 the responsibility to safeguard animal health and public health, 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. They developed the guidelines because it was 

the right thing to do for their animals and their consumers. 

I think that the perspectives the witnesses shared at our hearing 

last year are important to discuss here today about H.R. 1549. I 

would like to take a few moments to talk about what we learned 

from the hearing in terms of what H.R. 1549 would do to the livestock industry. 

As I understand, H.R. 1549 would remove seven classes of antibiotics from the market unless sponsors can demonstrate that they 

are safe and effective. Well, I can tell you our witnesses clearly outlined the rigorous approval process animal antibiotics must go 

through to gain approval already. All antibiotics used to keep animals healthy have passed the in-depth FDA process and have been 

shown to be safe and effective and have undergone review for their 

potential to cause increased antibiotic resistance. 

H.R. 1549 would require antibiotic sponsors to prove again what 

has already been proven during the initial FDA approval. This 

FDA process is a stringent, science-based, regulatory review, and 

it takes years and takes millions of dollars. Requiring another step 

undermines the FDA’s progress of reviewing the human health impacts of individual animal drugs based on science and risk assessment. 

H.R. 1549 overlooks the legitimate veterinarian need to preserve 

the antibiotics used in food animals to ensure that healthy animals 

enter the food chain. There are few new antibiotics anticipated for 

approval by the FDA, so if H.R. 1549 is enacted and these products 

are removed from the marketplace, America’s livestock producers 

will be left with few, if any, medicines to prevent and control animal disease. H.R. 1549 will result in more sick animals, and it is 

my fear and my concern that it will leave us with a potentially less 

safe food supply. 

In the mid-1990s, the European Union made a decision to phase 

out the use of antibiotics as growth promoters. Denmark, which 

has been talked about, has a pork industry roughly equivalent to 

the size of the pork herd in my State of Iowa, which is the largest 

pork-producing State in our country. And they instituted a full voluntary plan in 1998 which became mandatory in 2000. 

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56 

Many proponents of restricting the use of certain antibiotics as 

a model often point to this ban instituted in Denmark, citing the 

major drop in amount of antibiotics used in pork production in that 

country. Well, come on. When you ban the use of a product, it is 

self-evident that usage rates would drop. 

Interestingly, what the proponents never seem to discuss are the 

other effects of the ban. I would like to call your attention to the 

testimony received in my subcommittee where these effects were 

discussed in detail. Some of our witnesses had even visited Denmark and even seen firsthand the downturn in swine health in 

that country. After the ban became fully implemented, 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 

wellbeing might be acceptable if it resulted in improvements to the 

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 surpass what was used to prevent 

disease and promote growth prior to the ban and continues to rise 

each year. 

As for cost, a 2009 Iowa State University study estimated that 

the effect of a ban on States similar to Denmark’s would raise the 

cost of production by $6 per pig in the first year after such a prohibition. Ten years after the ban, the cumulative cost to U.S. pork 

production would exceed $1 billion. 

A recent study by Dr. Scott Herd, professor of 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 of food safety pathogens on their 

carcasses. This is a serious implication that must be considered 

when looking at the cost and benefits of antibiotic use in livestock. 

In our discussions on antibiotic use in food animal production, we 

need to be clear what the issue really is. H.R. 1549 is confusing the 

problem of antibiotic resistance in general with a faulty proposition 

that blames human resistance issues on antibiotic use in animals. 

Most informed scientists in public health professions acknowledge 

that the problem of antibiotic resistance in humans is overwhelmingly an issue related to human drug use. 

A 2006 report from the Institute of Food Technologists and International Scientific Studies said, quote, ‘‘Eliminating antibiotic 

drugs from food animal production may have little positive effect 

on the resistant bacteria that threaten human health.’’ In fact, 

eliminating healthy antibiotics may be detrimental to public 

health. 

As our witnesses outlined on my subcommittee, antibiotic-resistant bacteria develop from many factors, including human use of 

antibiotics and routine household use of disinfectants, such as antibacterial soap. 

According to a paper published in 2001 in the Journal of the 

American Veterinary Medical Association, people and their pets, on 

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57 

a per-pound basis, use 10 times the amount of antibiotics that are 

used in food animal production. More than 95 percent of the antibiotics used for animals are devoted to treating them for disease 

conditions, not as growth promoters, as many seem to claim. 

Protecting human health and providing safe food are paramount 

concerns of America’s livestock producers. That is why we test for 

antibiotic residue as part of our food safety programs. The FDA 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. 

Two-thirds of this bill has been enacted into law and should be 

allowed to work before removing products from the market. Provisions requiring more USDA research into the causes of and solutions to antibiotic resistance were passed as part of the farm bill 

in 2008. 

The animal drug user fee amendments of 2000 require the FDA 

to collect antibiotic sales data from companies and make a summary of that data public. The provisions were designed to provide 

better information to researchers conducting risk assessments and 

should be allowed to yield information before products are removed 

from the market. Congress has already taken action, and we should 

see results from our action before we start removing antibiotics 

from the market. 

As your witnesses today discuss a topic that is important to the 

livestock producers in not just my district in my home State but 

yours as well, I sincerely hope you consider what my subcommittee 

learned last Congress. 

H.R. 1549 will have detrimental effects not only on our farmers 

who feed the world safe and wholesome meat and products, but 

also on public health. 

Again, I want to thank you for allowing me the opportunity to 

testify today. I hope as a farmer and as a 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 the 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. 

And just as a closing note, Dr. Borlaug, the Nobel Peace Prize 

winner and also the World Food Prize winner, tells us that the 

global population is growing at a rate of 90 million a year. You 

have to feed them with safe, affordable, plentiful food. That is a 

part of what we are all about. 

Thank you for your considerations. 

[The prepared statement of Mr. Boswell follows:] 

PREPARED STATEMENT OF THE HON. LEONARD BOSWELL, A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF IOWA

Chairwoman Slaughter, Ranking Member Drier and members of the Rules Committee, I would like to thank you for allowing me the opportunity to testify here 

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 today I still have 

a hand in managing a cow-calf operation on my farm in Lamoni, Iowa. Once I retired from 20 years in the Army I moved back to Iowa to begin farming. I sat down 

with my local veterinarian to discuss the use of antibiotics to treat sick animals and 

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58 

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 110th Congress, it was my privilege to serve as Chairman of the Agriculture Subcommittee on Livestock, Dairy and Poultry. On September 25th of last 

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 farms. 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. We 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 health and public health. 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; they developed the guidelines because 

it was the right thing to do for their animals and their consumers. 

I think that the perspectives the witnesses shared at our hearing last year are 

important to the discussion here today about H.R. 1549, the Preservation of Antibiotics for Medical Treatment Act of 2009. I would like to take a few moments to 

take what we learned from that hearing in terms of what H.R. 1549 would do to 

the livestock industry. 

H.R. 1549 would remove seven classes of antibiotics from the market unless sponsors can demonstrate that they are safe and effective. Our witnesses clearly outlined 

the rigorous approval process that animal antibiotics must go through to gain approval already. All antibiotics used to keep animals healthy have passed the indepth FDA process, and have been shown to be safe and effective and have undergone review for their potential to cause increased antibiotic resistance. H.R. 1549 

would require antibiotic sponsors to prove again what has already been proven during their initial FDA approval. This FDA process is a stringent, science-based regulatory review takes years and millions of dollars. Requiring another step undermines the FDA’s process of reviewing the human health impacts of individual animal drugs based on science and risk assessment. 

Our witnesses also shared with us that not many antibiotics are currently available for use in livestock. H.R. 1549 overlooks the legitimate veterinary need to preserve these antibiotic classes for use in food animals to ensure that healthy animals 

enter the food chain. There are few new antibiotics anticipated for approval by FDA, 

so if H.R. 1549 is enacted and products are removed from the market place, America’s livestock producers will be left with few, if any, medicines to prevent and control animal disease. H.R. 1549 will result in more sick animals and it is my fear 

that it will leave us with a potentially less safe food supply. 

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. When you ban the use of a 

product, it is self-evident that usage rates would drop. Citing this obvious consequence as a rationale for restrictions in other countries borders on the illogical. 

Interestingly, what the proponents never seem to discuss are the other effects of 

that ban. I would like to call your attention to the testimony received in my Subcommittee where these effects were discussed in detail. Some of our witnesses had 

even visited Denmark and seen first-hand the downturn in swine health in that 

country. 

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 think the Danish pork industry can now attest to the 

validity of the age-old cliche ́ ‘‘an ounce of prevention is worth a pound of cure!’’ 

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59 

As for costs, 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 of food-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. 

In all discussions on antibiotic use in food animal production, we need to be clear 

what the issue really is. H.R. 1549 is confusing the problem of antibiotic resistance 

in general with the faulty proposition that blames human resistance issues on antibiotic use in animals. Most informed scientists and public health professions acknowledge that the problem of antibiotic resistance in humans is overwhelmingly 

an issue related to human drug use. 

A 2006 report from the Institute of Food Technologists, an international scientific 

society, said ‘‘eliminating antibiotic drugs from food animal production may have little positive effect on resistant bacteria that threaten human health.’’ In fact, eliminating animal antibiotics may be detrimental to public health. 

As our witnesses outlined for my subcommittee, antibiotic-resistant bacteria develop from many factors, including human use of antibiotics and routine household 

use of disinfectants such as antibacterial soap. According to a paper published in 

2001 in the Journal of the American Veterinary Medical Association, people and 

their pets on a per-pound basis use 10 times the amount of antibiotics that are used 

in food animal production. More than 95 percent of the antibiotics used for animals 

are devoted to treating them for disease conditions, not as growth promoters as 

many claim. 

Protecting human health and providing safe food are paramount concerns of 

America’s livestock producers. That is why we test for antibiotics residue as part 

of our food safety programs. The FDA 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. 

If I may speak specifically to H.R. 1549, two-thirds of the bill has been enacted 

into law and should be allowed to work before removing products from market. Provisions requiring more USDA research into the causes of and solutions to antibiotic 

resistance were passed as part of the Farm Bill in 2008. The Animal Drug User Fee 

Amendments of 2008 require FDA to collect antibiotic sales data from companies 

and make a summary of that data public. The provisions were designed to provide 

better information to researchers conducting risk assessments and should be allowed to yield information before products are removed from the market. Congress 

has already taken action, and we should see the results from our action before we 

start removing antibiotics from the market. 

Risk assessments are an important tool in approving antibiotics and ensuring that 

they are not harming public health. Voluntary risk assessments have been done by 

sponsors, and FDA is now requiring specific risk assessments for new and existing 

antibiotic products. Dr. Randy Singer, a veterinarian and epidemiologist working at 

the University of Minnesota, testified last September about a risk assessment in 

which he participated. His team assessed the risk of the agricultural use of the 

macrolide family of antibiotics poses to human health. The research hypothesis was 

that since macrolide-antibiotics are also used in human medicine, 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. The team developed a risk assessment model 

following the format of FDA’s guidance document #152. Dr. Singer and his team of 

researchers found that all macrolide antibiotic uses in animal agriculture in the 

U.S. posed a very low risk to human health. The highest risk was associated with 

macrolide-resistant Campylobacter infections acquired from poultry, but this risk 

was still estimated to be less than 1 in 10 million and would thus meet the standard 

of ‘‘reasonable certainty of no harm’’ employed by FDA–CVM. 

Dr. Singer also shared with us that animal illness likely plays a critical role in 

reducing the chances of contamination during processing. He participated with a 

team that developed a mathematical model relating animal illness to human illness. 

In this model, there was a large increase in human illness associated with small 

increases in animal illness. This suggested to the group that agricultural management strategies that fail to employ the judicious use of antibiotics may have significant negative impacts on human health. While I accept that there are those who 

will always believe that antibiotics administered in feed at low doses over several 

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60 

weeks raise hypothetical concerns about their potential to increase rates of resistance, in my opinion the evidence is undeniable that these applications improve animal health. Antibiotic uses in animals therefore have human health benefits. This 

goes back to our livestock producers’ moral obligation to care for their animals and 

protect public health. 

If policy decisions are going to be made regarding antibiotic use, we need to use 

the proper tool for making those decisions; risk assessments are the most appropriate tool, as Dr. Singer described to my subcommittee. Decisions made without 

considering the results of scientific risk assessments will result in unintended consequences, including increased animal death and disease and increased risks to public health as we saw in the Denmark example. 

As your witnesses today discuss a topic that is important to the livestock producers in not just my district and home state but yours as well, I sincerely hope 

that you consider what my subcommittee learned last Congress. H.R. 1549 will have 

detrimental effects, not only on our farmers who feed the world safe and wholesome 

meat and meat products, but also on public health. 

Again I would like to thank you for allowing me the opportunity to testify before 

you today. 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 

policy makers we must take a hard look at how our decisions affect human health 

and our ability to feed ourselves and the world. 

I’d be happy to answer any questions. Thank you. 

The CHAIRWOMAN. Thank you very much. 

Ms. SCHAKOWSKY. Madam Chairwoman, if I could correct my testimony. It was the food safety bill that I wanted to add, and there 

is language in there to look at this issue. And it could be in the 

overall health reform bill because that would be important. 

The CHAIRWOMAN. I sure hope so. 

Mr. Boswell, you and I have been good friends and I think the 

world of you, but I can’t agree with you on this at all. The Denmark study that you mentioned has been refuted by the scientists 

who really understand this. And Dr. Mellon herself talked about 

this great data collection that the FDA is supposed to do. There 

wasn’t a cent of money put in that bill for them to be able to do 

that. 

Our first witness was a new person at the FDA who says this 

is one of the most serious issues, he is a pediatrician, and that 

there would be absolutely no question about giving children, say 3- 

year-old children in a day care center antibiotics every day so they 

don’t get an earache. 

We are finding it in the water. As a microbiologist, it has been 

really offensive to me, as I mentioned earlier, to watch what has 

happened to Staphylococcus aureus. And we have salmonella infections so badly we can’t eat lettuce. The FDA—and I have made 

that clear earlier. Let me give you an example. I will just read this 

to you. 

Cephalosporin, is like many drugs used for purposes other than 

those indicated on the label. Extra label use is legal unless the 

FDA prohibits it. And they did that in an order published June 

3rd—I want you to pay attention to these dates. On July 3, 2008, 

in the Federal Registry, the FDA said that extra label of 

cephalosporin in food production animals presents a risk to human 

health and should be prohibited. Now, that was July. CDC said 

that they agreed and they supported the decision. Their letter came 

on November 7, 2008. On November 28, the FDA revoked the 

order, prohibiting the extra label use of cephalosporin in food animals, because they said they had received too many comments on 

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the order. That is how the FDA protects human beings in this 

country. 

Are you concerned that the EU has banned the use of antibiotics 

in meat, and that that would be a great loss on the trade, agriculture trade? 

Mr. BOSWELL. Well, I suppose it would. But the point I think we 

are trying to make and I think that is substantiated is that the use 

of therapeutic has gone up. 

The CHAIRWOMAN. Well, therapeutic is fine. We don’t want sick 

animals. It is the nontherapeutic and the preventative use of antibiotics mostly because animals are kept in some pretty awful conditions and the disease spreads so quickly among them and between 

them that it is—yes? Go ahead. 

Mr. BOSWELL. You are a very strong lady, and I want you to understand that. 

The CHAIRWOMAN. I am that. I know. I can’t help it. 

Mr. BOSWELL. I appreciate that and I have learned that over the 

last several years. And we have had some good discussions. 

The CHAIRWOMAN. Yes, we have. Yes, we have. 

Mr. BOSWELL. And I know you come from agriculture country, 

upstate New York, even though you sound like you come from Kentucky. I don’t understand all this. 

But the study by Ohio State University found that salmonella in 

conventional pig herds was 39 percent of those studied tested positive in comparison. But, you know, the Center for Disease Control 

in Atlanta, and we have the Animal Disease Control Center there. 

And we are taking this very seriously. I don’t want anybody to 

have unhealthy food and nobody here does. We know that. And we 

are spending a lot and we are doing a lot to improve the health 

of animals. 

One of the reasons I had the hearing last year was I knew, because I am out there among the producers. I make a point to do 

that from time to time. And that they are very serious about how 

they separate the animals, how they handle them, and how they 

go in and talk to the scientists and do the different things to make 

sure that they have the right atmosphere, certain air circulation, 

and all those things, and they make continuous adjustments and 

they want to do it right. Not one of us in production wants to 

produce a sick animal or something that would affect human 

beings. 

The CHAIRWOMAN. Our major concern here is these seven antibiotics which are really so efficacious in human beings. We are 

really finding that so many of them are no longer useful in humans, which, as Ms. Schakowsky pointed out in her testimony, creates dreadful hospital stays and death. You can die from MRSA in 

24 hours. Staph aureus didn’t kill anybody, to my knowledge, back 

in the days when I was in school. 

But in any case, that is our question. Are there any other questions of these witnesses? Ms. Matsui. 

Ms. MATSUI. Thank you both for being here today. And, you 

know, I appreciate both of you being strong advocates for your positions because I think both of you have very valid positions. I am 

here because I think about the children. That is really what I—I 

have grandkids 2 and 5 years old. And I may not have thought 

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about it so much until I began to see little kids again and understand what is so important to them. And I also tell you, Mr. Boswell, that I am a daughter of a farmer, and I know the hard work 

it takes to produce the food that many of us take for granted. 

Mr. BOSWELL. And I have grandchildren, too, and I am just as 

concerned for mine as you are. 

Ms. MATSUI. I know you are. And I know, and I understand how 

hard farmers work in order to bring us the healthy food that we 

need. 

And, Ms. Schakowsky, how do you see this legislation helping to 

improve children’s lives in this country? 

Ms. SCHAKOWSKY. I have four grandchildren myself, and I know 

that we all care about our grandchildren. But I think the nightmare scenario is that something that perhaps when we were young 

would have been a routine dose of penicillin or some other antibiotic suddenly is impotent, and now we are struggling to find exactly what it is that is going to prevent this from becoming even 

a life-threatening situation what started out as a bad knee scrape 

or something like that. 

And so I think that while obviously we want to treat sick animals, the use of these antibiotics in farm animals do, I think, endanger our health, and there is evidence to say that. This is not 

speculation. We know the increase of morbidity because of antibiotic resistance. 

Ms. MATSUI. In my home State in California, we have been buffeted in recent years by outbreaks of salmonella and E. coli, and 

our agriculture industry has suffered as a result, particularly the 

spinach and the tomato sectors. And I also know that FDA had to 

recall 96,000 pounds of Illinois beef in May because of concerns 

about E. coli. 

How do you see Chairwoman Slaughter’s legislation helping to 

eliminate these kind of harmful market disruptions? 

Ms. SCHAKOWSKY. You know as a member of the Energy and 

Commerce Committee, over and over again we have—that was 

really the stimulus behind the food safety bill. We have had to confront families that have lost loved ones, people who have been very 

sick because of a foodborne illness. And we are concerned that the 

nontherapeutic use of antibiotics has been linked to the number of 

incidents of foodborne illness and that it needs to be addressed. 

Ms. MATSUI. Mr. Boswell, I am not a vegetarian. I do like beef 

and pork. 

Mr. BOSWELL. I know that. I had dinner with you one time. 

Ms. MATSUI. I know. And so I really want to make sure, I do like 

this, my little kiddies like this, and so I want to ensure the economic stability of our Nation’s farmers, too. And one of the concerns that was brought to us, that Chairwoman Slaughter brought, 

that Dr. Mellon brought forth, the trade factor, the factor that we 

may be disadvantaged because we are not moving ahead as the EU 

and probably countries like Korea and Thailand as far as setting 

up situations where they are not going to be using antibiotics. So, 

that they can actually say to us: We are not going to have your 

meat products at all because you don’t have the standards that we 

necessarily must have in our country. 

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I feel certainly that that is something that we can’t have happen, 

and I think it is something that we ought to be thinking about as 

far as an agricultural industry about some of those global problems 

that might disadvantage us. 

Mr. BOSWELL. I think your point is very valid. And I can assure 

you that the different products, pork producers, beef producers, 

poultry, they are very conscious of that and they want to continue 

the science, they are going to be watching it very closely. They 

don’t want to give up that market for that reason, either. And I 

don’t think they will. 

And I would just like to add this. Jan referred to the time when 

we were young. I can remember when people worried about us 

dying as humans from smallpox and mumps and all those different 

things, and we figured out that doesn’t happen anymore. And we 

do the same thing with our animals. And we have regulations 

when you have got to go off of it and let’s get it out of the system 

and so on. I think we are trying very hard to do that and do it 

right. 

Now, that doesn’t mean there is not room for improvement, but 

we are willing to do that, and in appreciation of everything you 

have said, but I feel the same way. 

Ms. MATSUI. Thank you. 

The CHAIRWOMAN. Ms. Pingree. 

Ms. PINGREE. Thank you very much. Thank you for your testimony. I think we have already had some good follow-up questions. 

I will just reinforce one point that is important to me. Thank you 

very much, Mr. Boswell, for your testimony about the work that 

was done on your committee. And since everyone else is putting up 

their credentials, I just want you to know that my family, we are 

all Scandinavian immigrants to Iowa, and my uncle and cousins 

still own a family farm there. So we are still deeply involved in the 

agriculture industry, but I moved East and took up organic farming 

and kind of looked at it from a different perspective. 

And I want to reinforce what Ms. Schakowsky said, that I feel 

like all of the testimony that we have heard has reinforced this 

idea that this is something that we can change, that we are bringing this on ourselves, that our industry will survive, that with better health practices and limited use of antibiotics, therapeutic use 

of antibiotics, our animals will do just fine. It has been my experience in farming generally that that is how things work, and that 

we could make this transition without causing these undue consequences, whether they are economic loss to our farmers because 

countries like Denmark are changing their practices, or the incredible cost of hospitalization and loss of life through unintended consequences with antibiotics. 

And I will say my one grandmother was a Dane. And I don’t 

think they are stupid, I think they know what they are doing. And 

I think the reduction in the use of antibiotics there has been significant. Everything that we heard in our testimony today did not 

say that they use equal amounts of therapeutic antibiotics. It said 

they increased the amount of therapeutic antibiotics. But that is a 

targeted use. It is easier to remove from the animal before you ship 

it to market or ship their milk or ship their product. It is very different than talking about blanket use of antibiotics in the feed, and 

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64 

I think that is misuse of the data when people refer to it in that 

way. 

Thank you both. 

The CHAIRWOMAN. Mr. Polis. 

Mr. POLIS. Thank you, Madam Chair. 

There are no farmers in my family. I am not from Iowa. My family, since arriving from Eastern European shuttles around the year 

1900, has been city dwellers and occasionally suburban dwellers. 

But we do eat meat, most of us. And so we have a concern about 

these issues as well. 

Ms. SCHAKOWSKY. But we cook it do death. Right? 

Mr. POLIS. Exactly. 

Mr. BOSWELL. I hate to surprise you, but I do also cook it. 

Mr. POLIS. The question is that you mentioned that you are worried that livestock producers will be left with few, if any, medicines 

to prevent and control animal disease. And I think there is a difference between the prevention and then the control or treatment 

of animal diseases. Specifically, you earlier mentioned as well in 

answer to one of your questions smallpox and mumps. We have a 

number of vaccinations, inoculations. We have these for cattle, we 

have these for animals. These are prevention. These are not antibiotics, they are vaccinations. Sometimes they are weakened agents 

of the infection itself. Sometimes they are alternatives. But we do 

not for human health use antibiotics which are specifically designed to kill bacteria. And frequently more than just the bacteria 

they target, they kill other friendly bacteria. We don’t use the antibiotics in humans for prevention. 

And so my question is, obviously in different kinds of animals— 

humans are an animal, cows are an animal. We are all in this. 

Why would we have a different health code with regard to the use 

of antibiotics, and why would we want to use them as a preventative agent in some species but not in another species? 

Mr. BOSWELL. My answer to that is we have gone to science. We 

have gone to the research universities, and we have learned from 

them that this is the thing that would give us a healthier animal, 

healthier food, and healthier humans. 

Mr. POLIS. I just want to be clear. So you do dispute, we had earlier expert testimony that indicated that it is a belief among at 

least the scientists who presented to us—— 

Mr. BOSWELL. You have experts here and experts there. Which 

expert are you going to put in charge of the situation? I think we 

have to be very careful about jumping out here and doing something that could be detrimental to our food supply. 

Mr. POLIS. And your contention is that the use of antibiotics as 

a preventative treatment in animals has not contributed to antibiotic resistant bacteria in humans? 

Mr. BOSWELL. That is what science tells me. 

Mr. POLIS. Thank you. 

The CHAIRWOMAN. Mr. Cardoza. 

Mr. CARDOZA. Thank you, Madam Chair. I think the points that 

I was trying to make earlier have been made very well by Mr. Boswell, and these are very concerning issues. They are really legitimate, concerning issues, and we need to use the best science and 

complete science. There is reason—one of the things that people almstockstill on DSKH9S0YB1PROD with HEARING

65 

ways forget is farmers are in the business to try at the end of the 

day to make a profit. They don’t want to spend any more money 

on extra products that they don’t have to. I have got to tell you 

that one of the most frugal folks I have ever met are farmers, and 

they don’t like buying extra products. They do it for a reason. And 

one of the things that we don’t have on this panel is any—on any 

of the panels today are farmers who are actually engaged in the 

production of these products, because they have significant challenges sometimes to try to make sure the bacteria content in milk 

is such and so, and they have a number of different challenges that 

they have to meet very strenuous regulatory food safety regulations 

that we have imposed on them. 

And I will concur that there are differences between animal operations. Some of them are perfect and, frankly, some of them I 

would rather eat there than some of the other places I have eaten. 

Others are horrible, and those are the ones that we need to target 

and work on. And I think that is the kind of work that Mr. Boswell 

and I do on the Agriculture Committee. 

We had a hearing earlier in my committee last year on the question of the peanuts and the salmonella in the peanuts. And I happened to be one of the individuals who got sick from those peanuts. 

And I tell you, I spent 2 days feeling pretty rotten laying on my 

couch, continuing to vote, but I could barely raise my head for a 

couple days other than to drag myself to vote. And it is a very serious concern. We take this very seriously. 

The other thing I will tell you is that farmers are some of the 

folks that are the most concerned about this, because they don’t 

want anything to affect their product and put a taint on their marketing ability. And I will still submit this: That American foods are 

as safe or safer than anyplace else in the world. Consistently we 

get testimony to that effect. 

Now, Mr. Boswell put in his testimony that there is 10 times the 

consumption of antibiotics in humans and in pets as there are in 

farm animals. 

Mr. BOSWELL. On a per pound basis. 

Mr. CARDOZA. On a per pound basis. And I want to make sure 

that this is the same kind of pounds, because we were talking with 

the other gentleman about the quantity and the strength of those 

pesticides. 

And the other thing I would like to point out is that in Denmark 

we have not seen a decrease in the resistant bacterias, as I am 

told, in humans even despite the ban. 

So those two facts lead me to believe this: That we need to do 

more and significant research on this topic to find out what is really going on. Let’s let truth in the science dictate the policy. And 

that is one thing that we have done on the Farm Bill. It is another 

what we have done in the other act—I always forget the acronym. 

Somebody help me here. ADSA. It is the animal act—that is right. 

And I think that we really need to get to the bottom of this and 

we need to make sure that we do everything we need to to make 

sure that food is safe and that we are not promoting these microbial organisms that are getting out of control. 

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66 

So, Madam Chair, thank you again for doing the hearing and 

bringing this issue forward. And I would like to let Mr. Boswell answer. 

Mr. BOSWELL. Well, Mr. Cardoza, I agree with you. You know, 

again, I think it is a fact that we have the safest, most plentiful, 

least expensive food in the world, and there is a reason for it. One 

is everybody in this room contributes to it. Everybody does, whether you live downtown New York or Los Angeles or wherever. We 

subsidize our farms to some degree. But we get something for it. 

That is big. You think about someplace in the world where you 

can’t get enough to eat let alone it be healthy and safe. So it is a 

big thing. 

We have to be very careful about it, and we are willing to do this. 

And right now pork producers are losing money. Cattle producers 

are losing money. Dairy farmers have been losing money for over 

a year. They are in a very, very ticklish situation. And so if we 

don’t want to affect this plentiful, safe, affordable food supply, we 

have to think carefully. 

I would pledge, Madam Chairman, to work with Mr. Cardoza, 

who is on your committee and on our Ag Committee, to continue 

to put effort in to go back to our commodity groups and keep pushing if we need to, but at least monitoring to make sure that they 

are doing what they set out to do to start with to be sure and keep 

our food supply safe. 

The CHAIRWOMAN. My organic farmers are making money. I just 

throw that out there for public consumption. 

Mr. POLIS. If you would yield for a moment on that, Madam 

Chair. 

The CHAIRWOMAN. Yes, I will. 

Mr. POLIS. I mentioned earlier that in my congressional district 

is the corporate headquarters of Horizon Dairy as well as Aurora 

Organic Dairy, which is a private label organic dairy. And it is 

clear by the success and amazing growth rates of these companies, 

they have grown high double digits growth in the last decade, that 

consumers really get this and are willing to—I count myself as one 

of them, by the way. Consumers are willing to pay a premium for 

milk in this case that is free of antibiotics. 

So I think in this case, again, and as I think our next panel will 

also demonstrate, consumers are already a little bit ahead of where 

regulators are on this issue. 

The CHAIRWOMAN. Thank you both so much for coming. We really appreciate it. Thank you for giving us your time. 

Mr. CARDOZA. Madam Chair, may I insert my statement? 

The CHAIRWOMAN. Without objection, of course. And the Chair 

will yield to Mr. Polis for an introduction. 

[The prepared statement of Mr. Cardoza follows:] 

PREPARED STATEMENT OF THE HON. DENNIS CARDOZA, A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF CALIFORNIA

Thank you, Madam Chairwoman, for holding this important hearing today. 

As a Representative of a rural farming district, I know first-hand that antibiotics 

are critical to the health and safety of the livestock and dairy industries. They are 

also vitally important to human health because healthy animals, in turn, produce 

safe and healthy foods. Each livestock industry will be affected significantly by this 

legislation, and I think it is important to understand this impact on both the animals and their welfare, AS WELL AS ON human health and food safety. 

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67 

My district in California’s Central Valley is home to a significant portion of the 

milk production in this country. I personally know how producers treat their animals during the milk production process and how carefully that milk is screened 

before it is accepted into a processing plant. In fact, a sample from every single tanker of milk is tested before milk is unloaded to be processed at these facilities. These 

screen tests were evaluated and approved by the FDA. If a milk sample tests positive for animal medication residue, the entire tanker is rejected and the famer must 

pay for the entire load. This costs the farmer approximately $12,000 per tanker and 

acts as a strong financial incentive to ensure that no treated cows are milked. From 

1996–2005, positive milk tank samples declined by 70%. And in 2007, less than 

0.032% of all milk tanker samples tested positive for residues of animal medications. 

This proves that the program is effective at detecting and deterring animal medications in milk. In addition, it is extremely important that veterinarians have the 

tools to prevent and control infections such as mastitis and metritis. By controlling 

these painful infections, we keep dairy cows productive, and keep their milk wholesome, abundant and safe. If dairy producers are not able to use antibiotics to prevent these infections, the animal will suffer and even more antibiotics would be 

needed to treat the infections after they occur. In Europe, we’ve seen the push to 

ban antibiotics backfire. Animals in Europe now have an increase in animal disease, 

an increase in the use of therapeutic antibiotics to treat these diseases, and no improvement in human antibiotic resistance patterns. Recently published, peer-review 

articles document these impacts and warn us that political decisions can carry unintended consequences. 

I urge my colleagues on this committee to look at this issue carefully and to fully 

weigh the implications of this kind of legislation. Too often, we neglect to consider 

the unintended consequences of our actions. The health and safety of our domestic 

food supply is too important to not consider all of the implications. 

I once again thank the distinguished Chairwoman for holding this hearing today, 

and I yield back the balance of my time. 

Mr. POLIS. Well, it is my great privilege here today to introduce 

Mr. Steve Ells, who founded the first Chipotle in my congressional 

district in 1993. And as a result of my residual Jewish heritage, I 

have an aversion to pork so I avoid pork myself. But the closest 

that I came to eating pork was after I first met Mr. Ells, must have 

been 6 or 7 years ago, and he told me about how they were purchasing pork from these amazing organic farms. I had to wait several years to get my fulfillment. It was about a year and a half or 

2 years ago when they now announced that they are raising naturally raised chicken. I sent him a congratulatory e-mail when they 

made that announcement, and it has made a huge difference. And 

I continue to be a regular customer of Chipotle. He and Chipotle 

are changing the way the world thinks about and how it eats fast 

food. 

Steve Ells is a classically trained chef, has received considerable 

praise for his vision and leadership with Chipotle. And in 2006, 

Chipotle had a very successful public offering and has been featured in the Wall Street Journal and a number of other publications. Mr. Ells holds a bachelor’s degree in art history from the 

University of Colorado at Boulder in my district, and is a graduate 

of the Culinary Institute of America. 

It truly is testimony to his vision as a business leader that he 

considers the fact that Chipotle has the highest food cost as a percentage of revenue of any restaurant company as an asset, as 

something that they brag about to show that they have this vision 

that food cost can in fact be an inverse metric in their business and 

an asset to show that they have a valuable consumer value proposition, really is great testimony to a tremendous vision which has 

left as its legacy a company with over 900 restaurants around the 

country, annual revenues in excess of $1.3 billion. 

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68 

It truly is a great honor to introduce to our committee my good 

friend, Steve Ells. 

The CHAIRWOMAN. It is so nice to have him here. 

Please take your seat, Mr. Ells, and it is my great honor to introduce Mr. Bauccio. I am certainly happy to have you here. Mr. 

Bauccio began his career as a dishwasher in 1960, with Saga Corporation’s Education Division. And in 1987, Bon Appetit Management Company was born for the first time. His dream of the company as committed to culinary expertise became a reality, and his 

customers noticed and they fueled quick growth for the small San 

Francisco-based company. He also was the President of the Stuart 

Anderson restaurant chain, had over 25 years of experience, and 

knew that institutional feeding was ready for something more. 

In 1999, Fedele led his team once again to raise the bar for onsite food service making a commitment to socially responsible food 

sourcing. Today, Bon Appetit spends over $55 million annually on 

food from within a 150-mile radius of each cafe, using only sustainable seafood sources, turkey breasts, and chicken raised without 

antibiotics as a routine feed additive, features natural beef burgers, 

and leads the industry in using cage-free shell eggs. 

In 2007, the company debuted its low carbon diet, the first program to make the connection between food and climate change. 

Bon Appetit is now a $500 million company with over 400 cafes in 

28 States serving over 80 million meals a year. He is the recipient 

of the 1992 Restaurants and Institutions Ivy Award, and in 1998 

was presented with the Nation’s Restaurant News Golden Chain 

Award for Excellence. He was named the 2008 Innovator of the 

Year by Nation’s Restaurant News, and received the prestigious 

Going Green Award by the Natural Resources Defense Council. 

That is really impressive. 

He is a board member of the Compass Group of North America, 

serves on the board of Dynamic Payment Ventures in San Francisco, Chairman of the University of San Francisco Hospitality 

Management Board, and serves on the President’s Advisory Council of the University of Portland. 

We are so happy to have the two of you. And it is always a pleasure to eat in one of you restaurants. With that, I welcome you to 

the committee. And which one of you would like to begin? All right. 

STATEMENT OF FEDELE BAUCCIO, PRESIDENT AND CEO, 

BON APPE ́ TIT MANAGEMENT COMPANY 

Mr. BAUCCIO. Chairwoman Slaughter, honorable members of the 

Rules Committee, I am Fedele Bauccio, CEO of Bon Appe ́tit Management Company, a national on-site restaurant company that, as 

you heard, serves 80 million meals each year at over 500 locations, 

and I think we are now in 32 states. 

As a company, we are committed to two goals, culinary expertise 

and social responsibility. And in that vein, I appreciate the opportunity to be here today to voice my strong support for H.R. 1549, 

the Preservation of Antibiotics for Medical Treatment Act. 

It is imperative that we as a country discontinue the use of antibiotics for nontherapeutic purposes in animals. In addition to being 

harmful to the animals themselves, this common practice of using 

antibiotics as feed additives has led to dramatically increased antimstockstill on DSKH9S0YB1PROD with HEARING

69 

biotic resistance in humans and become a serious public health 

problem. I feel so strongly about this issue that I have banned most 

meat that has been raised in this manner to be served in my restaurants. And I would ban it entirely, but there isn’t enough supply 

for us to be able to make that commitment yet. 

Our concern about this issue goes back 7 years. In 2002, I 

learned that an estimated 70 percent of antibiotics used in this 

country are fed to farm animals that are not sick in order to promote growth or prophylactically treat diseases caused by questionable animal husbandry practices. 

As I learned more and realized how widespread these practices 

are in the meat production industry, Bon Appe ́tit formed a partnership with Environmental Defense Fund to look at how we could 

take the lead and discourage antibiotic use in meat and poultry 

production. Our partnership resulted in the creation of the farthest 

reaching corporate policy on antibiotics used to date. We only buy 

chicken raised without nontherapeutic routine use of human antibiotics as feed additives. In 2005, we extended this policy to turkey 

breast. We took this policy another step further, and since March 

2007 we only serve hamburgers from natural beef with no trim. 

While there is no strict legal definition of the word ‘‘natural,’’ our 

suppliers commit to using no antibiotics, no growth hormones, no 

animal byproducts in feed, and treating their animals humanely. 

Our biggest challenge in implementing our antibiotics policy has 

always been sourcing the products. We have recruited both major 

poultry producers as well as small local producers as suppliers. We 

only purchase food from those who provide written confirmation of 

their compliance. But there are not enough suppliers to meet our 

standards everywhere. We use a purchasing preference to acquire 

suppliers in many markets, but we don’t have the concentration of 

business in all our markets across the United States to buy enough 

chicken or turkey or beef to tip the scales as we have in some locations, and we can’t find a national pork supplier who will commit 

to taking care of us across the whole United States. Many producers are afraid to change even with an economic incentive. They 

need a push from this bill, and that could be the leverage of change 

we need. 

From 2006 to 2008, I served as a member of the Pew Commission 

on Industrial Farm Animal Production. I learned from physicians, 

poultry producers, farmers, and representatives on the committee 

as well as those who testified before us. I came away from that experience enriched and much better educated about animal husbandry. One of the many things I concluded is that there is absolutely no good reason and certainly no good moral reason for feeding medically important human antibiotics to animals that we eat. 

No reason at all. None. 

The bottom line is Americans want safe food. Food is nourishment. It shouldn’t be something that does us harm. Antibiotic resistance is harmful. These drugs are meant to treat humans and 

animals when we are really sick and need them, not as a feed additive so they won’t be effective when humans need them. 

Let’s get our priorities straight. The time to ban antibiotics as a 

feed additive is long overdue. I strongly support this measure. 

Thank you. 

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70 

[The prepared statement of Mr. Bauccio follows:] 

PREPARED STATEMENT OF FEDELE BAUCCIO, PRESIDENT AND CEO, BON APPE ́TIT

MANAGEMENT COMPANY

Chairwoman Slaughter, honorable members of the Rules Committee, I am Fedele 

Bauccio, CEO of Bon Appe ́tit Management Company, a national onsite restaurant 

company that serves 80 million meals each year at 400 cafe ́s in 29 states. As a company we are committed to two goals, culinary expertise and social responsibility, 

and in that vein I appreciate the opportunity to be here today to voice my strong 

support for H.R. 1549, The Preservation of Antibiotics for Medical Treatment Act. 

It is imperative that we, as a country, discontinue the use of antibiotics for nontherapeutic purposes in animals. In addition to being harmful to the animals themselves, this common practice of using antibiotics as feed additives has led to dramatically increased antibiotic resistance in humans and has become a serious public 

health problem. I feel so strongly about this issue that I have banned most meat 

that has been raised in this manner to be served in my restaurants, and I’d ban 

it entirely but there isn’t enough supply for us to be able to make that commitment 

yet. 

Our concern about this issue goes back seven years. In 2002, I learned that an 

estimated 70 percent of the antibiotics used in this country are fed to farm animals 

that are not sick in order to promote growth or prophylactically treat diseases 

caused by questionable animal husbandry practices. As I learned more and realized 

how widespread these practices are in the meat production industry, Bon Appe ́tit 

formed a partnership with Environmental Defense Fund to look at how we could 

take the lead and discourage antibiotic use in meat and poultry production. Our 

partnership resulted in the creation of the farthest-reaching corporate policy on 

antibiotics use to date: Bon Appe ́tit only buys chicken raised without the ‘‘nontherapeutic’’ routine use of human antibiotics as feed additives. In 2005, we extended this 

policy to turkey breast. We took this policy another step further and, since March 

2007, we only serve hamburgers made from natural beef with no trim. While there 

is no strict legal definition of ‘‘natural,’’ our suppliers commit to using no antibiotics, 

no added growth hormones, no animal by products in feed and treating the animals 

humanely. 

Our biggest challenge in implementing our antibiotics policy has always been 

sourcing the products. We have recruited both major poultry producers as well as 

small, local producers as suppliers. We only purchase food from those who provided 

written confirmation of their compliance. But there are not enough suppliers who 

meet our standards everywhere. We use a purchasing preference to induce suppliers 

in many markets, but we don’t have the concentration of business in all markets 

to buy enough chicken or turkey or beef in some states to tip the scales as we have 

in other locations, and we can’t find a national pork producer who will commit at 

all. Many producers are afraid to change, even with an economic incentive. They 

need a push. H.R. 1549 could be that lever of change we need. 

From 2006 to 2008, I served as a member of the Pew Commission on Industrial 

Farm Animal Production. I learned from physicians, poultry producers, farmers and 

industry representatives on the committee, as well as those who testified before us. 

I came away from that experience enriched and much better educated about animal 

husbandry. One of the many things I concluded is that there is absolutely no good 

reason, and certainly no good moral reason, for feeding medically important human 

antibiotics to animals that we eat. None. 

The bottom line is, Americans want safe food. Food is nourishment. It shouldn’t 

be something that does us harm. Antibiotic resistance is harmful. These drugs were 

meant to treat humans and animals when we’re really sick and need them, not as 

a feed additive for animals so they won’t be effective when humans need them. Let’s 

get our priorities straight. The time to ban antibiotics as a feed additive is long 

overdue. I strongly support this measure. Thank you. 

The CHAIRWOMAN. Thank you very much. 

Mr. Ells. 

STATEMENT OF STEVE ELLS, CHAIRMAN AND CEO, CHIPOTLE 

MEXICAN GRILL 

Mr. ELLS. Thank you. Thank you, Madam Chair, and thanks to 

the members of the Rules Committee for allowing me to speak to 

this very important act which we strongly, strongly support. I am 

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71 

Steve Ells, and I am the founder, Chairman, and co-CEO of 

Chipotle. 

A decade ago, we began a quest for more sustainably raised ingredients and to make those ingredients available so that everybody who wanted to could have access to these sustainably raised 

foods. Traditionally, these sustainably raised foods were available 

at high-end grocers and very expensive, fancy restaurants in bigger 

cities, but we wanted to make these kinds of foods available so everybody could eat better. 

Since I started the first Chipotle 16 years ago, actually 16 years 

ago this day, I wanted to show that just because Chipotle is fast 

and convenient doesn’t mean it has to be a traditional or typical 

fast food experience with all the trappings of the fast food restaurant. We wanted to cook fresh food, food that was prepared in 

front of the customer in an open kitchen so there was complete 

transparency, and we wanted to serve it in an interactive format 

so people could get exactly what they want not only for taste but 

for nutrition. 

Well, a decade ago I realized that fresh food is not enough anymore; that you really need to know where your food comes from 

and how it was raised and the effect on the environment and the 

effect on animal welfare and the effect on ultimately the health of 

the person eating the food. And so there are a lot of ramifications, 

and fresh didn’t cut it. 

I came to this conclusion because I had read an article about the 

way Niman Ranch was raising pigs up in Iowa, and so being curious, I went up and visited some of the farms. And I asked the folks, 

the farmers, these independent family farmers, what was so special 

about the way they were raising the pigs. It looked great to me, 

they were either raising them out on open pasture or in deeply bedded barns depending on the season, and they were feeding them a 

protocol that is similar, without antibiotics, an all vegetarian feed, 

and definitely in a humane way with room to roam around. And 

they informed me that the vast majority of pork raised in the 

United States, some 98 plus percent is raised in factories, is raised 

in confinement operations. And so being very curious about this, I 

went to see a lot of these factory farms. And at that moment, I 

knew that I didn’t want the kind of exploitation that I saw to be 

part of the reason Chipotle was successful. 

So pork was the first thing to come under what we call Food with 

Integrity or our Naturally Raised Program, and we started using 

only pork that met the very strict protocols, again, without antibiotics and the other things that I mentioned. 

Since that time, since we were very successful in introducing the 

naturally raised pork, we also introduced over the years naturally 

raised chicken, and today 100 percent of our chicken is raised without antibiotics. And we also have introduced naturally raised beef. 

And because of supply issues we are only able to supply about 60 

percent of our needs with naturally raised, but we are working 

very diligently with farmers and ranchers to increase that supply 

also. 

Chipotle is unique because of the economic model. We are successful because we have found a way to serve more expensive and 

sustainably raised ingredients, but in a way that really does remstockstill on DSKH9S0YB1PROD with HEARING

72 

main accessible and affordable for consumers. At the same time, 

though, we are able to produce attractive financial results to our 

shareholders. And it is a really difficult balance to strike. Most restaurant companies can only remain affordable and produce attractive returns by lowering their food costs, and this downward pressure on food costs has resulted in the industry driving down costs 

to the detriment of animal welfare and the environment and the 

overuse of antibiotics especially. 

So our journey to find better ingredients from more sustainable 

sources has been and remains difficult. There is no question about 

it, and progress has been slow at times and costly throughout. But 

that said, we are proud that we have been able to remain successful while serving food from these better sources rather than supporting a system that is often based on exploitation. 

We are still relatively a small piece of the puzzle, though, and 

a very small piece of the Nation’s overall food supply. And so while 

our quest might be made easier if other food companies chose to 

follow similar paths and suppliers changed their practices accordingly, we know very well the issues and complexities that have 

kept them from doing so. 

Passing this Preservation of Antibiotics for Medical Treatment 

Act is an important step in driving the kind of change that we have 

chosen to work toward over the last decade but that too many others have ignored. 

Madam Chair and members of this committee, ours is a company 

that has a long track record of remaining out of discussions involving politics and matters of public policy, but this is a cause we 

deeply believe in. So on behalf of Chipotle, our 900 restaurants, our 

25,000 employees, and our 2.5 million weekly customers, we thank 

you for introducing the Preservation of Antibiotics for Medical 

Treatment Act, and hope that it is given the consideration it deserves. Thank you all very much. 

[The prepared statement of Mr. Ells follows:] 

PREPARED STATEMENT OF STEVE ELLS, CHAIRMAN AND CEO, 

CHIPOTLE MEXICAN GRILL

Good afternoon Madame Chair and members of the Rules Committee. 

My name is Steve Ells and I am the founder, chairman and co-CEO of Chipotle 

Mexican Grill. I appreciate your giving me the opportunity to appear here today to 

speak to what I believe is a very important issue. 

When I founded Chipotle 16 years ago in 1993, I had what was a novel idea at 

the time. I wanted to show that food that was served fast didn’t have to be a typical 

fast food experience. All of the food we served was prepared in the restaurant using 

only fresh, high-quality ingredients. That restaurant had an open kitchen so our 

customers could watch as their food was cooked and their orders were prepared. It 

was all very transparent. There was nothing to hide. 

We take the same approach today, even though we now have some 900 restaurants around the country and annual revenue in excess of $1.3 billion. As we 

have grown, our vision has evolved. Now, we are changing the way the world thinks 

about and eats fast food. We are doing this by serving food made with ingredients 

from more sustainable sources. The cornerstone of this effort is a vision we call 

‘‘Food with Integrity’’ and it is shaping not only the kind of food we serve, but the 

way we run our company. 

This vision is not a response to recent consumer interest in ‘‘green’’ products, it 

is something we have been working toward for a decade now; well before ‘‘green’’ 

was the buzzword it is today. Nor was it rooted in any great epiphany that, ten 

years from now, consumers would want more natural, organic and local food. And 

it was not the result of scientific study about possible harm caused by using antibiotics in the food system, or the environmental impacts of large scale industrial agmstockstill on DSKH9S0YB1PROD with HEARING

73 

riculture. Our vision has always been based simply on doing what we thought was 

right. 

The decisions we are making to support more sustainable agriculture have presented us with many challenges—and wouldn’t be possible at all for most companies 

of similar size. And they come at a cost. The food we buy costs us more than it 

would to source food from large industrial processors. In fact, Chipotle now has the 

highest food cost (as a percentage of revenue) of any restaurant company, regardless 

of category. 

As a publicly traded company, this is very significant. But serving food from more 

sustainable sources is so important to us, that we have built our business model 

in a way that lets us invest more in better food. We’ve had to find efficiencies in 

all other areas of our business so we can afford to serve this better food at prices 

that remain reasonable for our customers. 

Through all of this, we have learned that many of our customers don’t really know 

where their food comes from and how it is raised. And they don’t want to be burdened with this information when they sit down in a restaurant to enjoy a meal 

with friends or family. For many people, paying the higher price of sustainably 

raised food simply isn’t possible. So it is our responsibility to understand and care 

about where our food comes from, and find ways to keep it affordable and accessible 

so everyone can eat better. 

Our quest for ingredients from more sustainable sources began when I was reworking the recipe for our pork carnitas. At the time, the pork we were using came 

from large, industrial suppliers. And I was not entirely aware of what this meant, 

or just how significant the environmental, economic, and social issues associated 

with this kind of animal production were—not to mention the horrific animal welfare standards that are involved. 

My explorations led me to the farms of Niman Ranch, a network of about 50 individual family owned farms that were raising pigs in a traditional way; on open pastures or in deeply bedded barns, without the use of antibiotics or added hormones 

or drugs that behave like hormones, and fed a pure vegetarian diet with no animal 

byproducts. I tested new recipes using Niman pork and found that pigs raised this 

way produced better tasting pork, marbled with more back fat to protect the animals from the elements. 

My research also took me to confinement hog operations, where some 60 million 

pigs are raised each year and spend their entire lives in large, barracks-like metal 

buildings. They never experience the sensation of the sun on their backs, or breathe 

fresh outdoor air. They spend their lives on hard, slatted flooring, forced to sleep 

where they urinate and defecate. Their waste is pushed down to lagoons where it 

festers just a few feet below them. They never have the opportunity to roam or root 

on open pastures or in deeply bedded barns as is their nature. Some five million 

breeding sows spend much of their lives confined to ‘‘gestation crates’’ or ‘‘sow stalls’’ 

that are so small they can’t even turn around. 

The crowding and contamination associated with this artificial living environment 

fosters disease, especially respiratory illnesses, so the pigs are fed some 10 million 

pounds of antibiotics, according to estimates from the Union of Concerned Scientists—an amount that is three times greater than all antibiotics used to treat 

human illness. 

Upon seeing this stark comparison for myself, I quickly decided that I did not 

want Chipotle’s success to be tied to this kind of exploitation. And that gave rise 

to my epiphany: Serving food that is merely fresh is not enough anymore. To serve 

the best-tasting food, you need to understand how animals are raised and how vegetables are grown, as those variables directly influence the taste of the food. They 

also have significant bearing on a number of other important issues—animal welfare, the environment, and the people who raise the animals and grow the produce. 

As a result, we began serving pork from Niman Ranch in all of our restaurants 

(about 50 at the time) in 2000. But pork from pigs raised this way costs more, so 

we had to raise the price of a carnitas burrito or order of tacos by a dollar (from 

$4.50 to $5.50). What was the cheapest item on our menu became the most expensive. So we produced communications pieces for our restaurants explaining this 

change, and the reasons for it, and began educating our customers about these 

issues; issues that were, and still are, new to many of them. 

Over the years, this decision has had a significant and positive impact on the 

farms of Niman Ranch, which had about 50 family farms participating in their hog 

program at the time. Today, they have more than 600, in part because of Chipotle’s 

commitment to serving pork from pigs that are raised this way. In all, our efforts 

in this area are helping to create and sustain opportunities for thousands of family 

owned farms that have shunned the use of antibiotics in favor of better animal husbandry to ensure the health of their animals. 

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This move also transformed the way we run our business, giving rise to the vision 

we call Food with Integrity. It set us on a journey to examine each of the ingredients we use to make our food, and how we could get them from more sustainable 

sources. We have made considerable progress over the last decade. 

Today, we serve more naturally raised meat—coming from animals that are 

raised in a humane way, never given antibiotics or added hormones, and fed a pure 

vegetarian diet with no animal byproducts—than any other restaurant company in 

the world: More than 60 million pounds this year alone. This includes 100 percent 

of the pork and chicken we serve, and more than 60 percent of all of our beef. 

Our commitment to sourcing better ingredients from more sustainable and healthful sources extends beyond meat. Today, a growing percentage of the beans we serve 

(currently 35 percent) is organically grown. We are the only national restaurant 

company with a significant commitment to locally grown produce, serving at least 

35 percent of at least one produce item from local farms in each of our restaurants 

when it is seasonally available. And we were the first national restaurant company 

to commit to serving dairy (cheese and sour cream in our case) made with milk from 

cows that are never treated with the synthetic hormone rBGH. 

Chipotle is a unique success story in that we have found a way to serve more expensive, sustainably raised ingredients, but in a way that remains affordable to the 

average customer. At the same time, we are able to produce attractive financial results for our shareholders. This is a difficult balance to strike. Most restaurant companies can only remain affordable and produce attractive returns by lowering food 

costs. This downward pressure on food costs has resulted in the industry driving 

down costs to the detriment of animal welfare, the environment, and the overuse 

of antibiotics. 

Our journey to find better ingredients, from more sustainable sources has been 

and remains difficult, and progress has been slow at times, and costly throughout. 

That said, we are proud that we have been able to remain successful while serving 

food from these better sources rather than supporting a system that is often exploitative. But we are still a relatively small piece of the puzzle that makes up the nation’s food supply. 

While our quest might be made easier if other food companies chose to follow 

similar paths and suppliers changed their practices accordingly, we know very well 

the issues and complexities that have kept them from doing so. Passing the ‘‘Preserving Antibiotics for Medical Treatment Act’’ is an important step in driving the 

kind of change we have chosen to work toward for the last decade, but that too 

many others have ignored. 

Madame Chair and members of the committee, ours is company that has a long 

track record of remaining out of discussions involving politics and matters of public 

policy, but this is a cause we deeply believe in. On behalf of Chipotle, our 900 restaurants, our 25,000 employees, and our 2.5 million weekly customers, we thank 

you for introducing the Preservation of Antibiotics for Medical Treatment Act and 

hope it is given the consideration it deserves. 

Thank you again for allowing me to speak with you today. 

The CHAIRWOMAN. I am so grateful to both of you. I am old 

enough to remember when a pork chop really tasted good. I feel 

sorry for people who only have been able to eat factory raised meat, 

and really appreciate so much that there is someplace that we can 

go and take our grandchildren and know that what they are having 

is fresh and good. There is simply no substitute for it. 

The tragedy of the overuse and now the resistance of antibiotics 

is one of the most ridiculous things that we have ever done in this 

country. People who can recall after the Second World War remember that it was really antibiotics at that point that saved our troops 

and the great experiment. I was getting my master’s degree in 

Kentucky at the time and remember that antibiotics were used— 

nobody really understood what they were about, and they were putting penicillin in toothpaste at the time and several people were 

dying of anaphylactic shock. So that was what I had done my master’s thesis on. 

I can’t believe that after that miraculous—that the discovery of 

antibiotics, which really made the biggest difference in the health 

of people in the world, could have been so misused that it was just 

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an everyday occurrence to just throw it to the chickens in the feed. 

It makes absolutely no sense. I don’t think anybody else in the 

country would have done it. 

And as a scientist, I can tell you the thing I love the most about 

science is it is true and it is accurate. The notion that science has 

several angles to it and you pick your scientist is abhorrent to me. 

We have really got to try, and I believe we can. I am so pleased 

to hear, and you were here as well, the young man from FDA. So 

I think that there is some hope there that we can have some 

change and that science once again will be important. 

I have to tell you that we had to pass legislation in this Congress 

to allow women to be used as health subjects for research projects 

because they were not used and that we had to write legislation 

to allow scientists to be able to present at NIH what work they 

have been doing on it. You can see how far we have come, at the 

same time though how far we have fallen particularly with the use 

of antibiotics. It makes absolutely no sense. 

And I think that the industry’s concern, I should hope about 

trade policy more than any other thing that we might be able to 

talk about, is so important. But the fact that both of you are so successful should say to everybody in the country that it is important 

that we have a supply of that kind of food for your restaurants, and 

that more and more gives us the assurance that when we go in 

that we are not eating that residue. 

We should never in this world have had salmonella infections 

from spinach. There is no reason in the world for that except that 

the FDA I think was asleep at the switch. And the more abhorrent 

thing to me is feeding the carcasses of dead animals to animals. 

The thought is so abhorrent to me. And, you know, that thought 

was really one of the reasons that we begged the FDA to really pay 

more attention because it had a lot to do, I think, with mad cow 

disease. At least that is what we think. 

Thank you so much. I can’t thank you enough. We want to tell 

the whole world where to go to have lunch. 

Ms. Pingree. 

Ms. PINGREE. Thank you. Thank you again to the Chair for holding these hearings and for using your years of expertise really to 

inform all of us about how long we could have been fixing this 

problem and we didn’t. And thank you to both of you for your fascinating testimony, for taking the risks in your own business to do 

the right thing and by doing so being a good example for everyone 

in business who uses the excuse, well, I couldn’t possibly make 

money if I did that. And both of you have shown not only are you 

keeping your customers healthier and happier, you have proven 

that you can also be successful in business as well. 

I just would recount what we have said many times, this seems 

like a problem that should be simple to solve. Economically, scientifically, we have kind of heard it said over and over again that 

we would be better off if we reduced the use of antibiotics. And it 

is heartening to hear both of you say that you would buy more if 

you could. And I think all of us have said in one way or another 

it is the organic farmers in our districts who are doing well. We 

heard our colleague from the Ag Committee talk about how many 

farmers aren’t doing well in this particular economy. So it just is 

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hard to understand what is standing in the way of good science, 

good economy, and helping our farmers to be more successful and 

our consumers to be happier and our constituents to stay healthier. 

So hopefully your businesses will continue to expand and grow, 

and we will find ways to create incentives for more businesses to 

provide the healthy products that you need. Thank you very much. 

The CHAIRWOMAN. Mr. Polis. 

Mr. POLIS. You know, I wish that Mr. Boswell was still here because I think that to a certain extent the concerns of some of the 

producing districts of my colleague, Mr. Cardoza as well, and perhaps to a lesser extent some of your districts might produce some 

of this but mine doesn’t in any major economic way, is that this 

would somehow hurt their ability to make money. But we find, 

quite to the contrary, that those of us who represent—and I represent a consuming district—my consumers would be thrilled to 

pay a few pennies more for their food knowing that it comes—and 

they voted with their dollars already, and that is what has led to 

the tremendous success of your businesses. 

We have lagged behind on the public health and government regulation front, well behind these pioneers in the private sector 

which have already championed these practices, and proven beyond 

a doubt that not only is it good for consumers and public health, 

it is good for producers as well. And I think that that is the message that we need to drive home with our colleagues, the gentleman from Iowa and the gentleman from California, and others, 

who might be worried about this impact with producers to instead 

seize the opportunity. 

My question for Mr. Ells is in regard to one of your statements. 

You mentioned the downward pressure on food costs has resulted 

in the detriment of animal welfare, the environment, and the overuse of antibiotics. I would like to add to that something that my 

colleague, our Chairwoman Ms. Slaughter, said, that it also detracts from the taste of the product itself, the taste and nutritional 

value of the product itself. 

If you could comment about the outcome of poor animal welfare, 

the crowding, poor muscular development, whatever it is. But you 

as a culinary chef, et cetera, can give personal testimony to the 

taste profile and the difference between animals that are raised in 

a healthy way and ones that are raised with antibiotics and hormones. 

Mr. ELLS. Sure. Absolutely. It is the reason that I went up to 

Iowa in the first place, to find better tasting pork. And sometimes 

when I talk about our mission I forget to mention that, of course 

we are a restaurant first, and we have to provide great tasting food 

in order to have a great business. And so that is something that 

we absolutely do. And so investing in better quality food results in 

better taste, which results in more visits by customers and so on. 

But additionally I would like to comment about this notion of 

this food costing more because—and I am not a scientist, but I 

have heard the argument that it doesn’t really cost more; that perhaps that confinement-raised pork chop might be a few cents less 

per pound, but you certainly make that up in health issues and environmental degradation and the loss of the independent family 

farmer and that effect on the loss of our some of our rural commumstockstill on DSKH9S0YB1PROD with HEARING

77 

nities. And so the real cost of that cheap pork chop is something 

very great indeed. 

Mr. POLIS. Thank you. And I think the economic concept you are 

referring to is externalities. And I raised this in my question in the 

original testimony with the first doctor who testified with regard 

to the cost of treating people who have contracted antibiotic resistant bacteria. I would also contradict again the good gentleman 

from Iowa that I believe the bulk of evidence, scientific consensus, 

does show that at least a large and significant part of antibiotic resistant bacteria that affects humans does stem from overuse of 

antibiotics in animals. 

Given that, all of those costs associated with treating people who 

encounter antibiotic resistant bacteria—and, by the way, animals 

that encounter antibiotic resistant bacteria is not accounted for in 

simply the simple cost equation that many of the producers are facing. If we had an accounting for those real costs as part of the production formula, I think that producers by and large would determine that it made economic sense to only use antibiotics for treatment rather than for prevention. And I think that this bill furthers 

that end, and that is why I am proud to be a cosponsor and also 

applaud Chairwoman Slaughter for holding this important hearing 

today. 

And I yield back. 

The CHAIRWOMAN. Thank you all so much. And I want to thank 

our panel of scientists who stayed with us all afternoon. Thank you 

for your help. 

I have got a little housekeeping we have to do before we can adjourn. 

I ask unanimous consent of my panel that the record be kept 

open 7 days for the submission of written testimony and extraneous materials. And I also ask unanimous consent that the record 

be kept open for 7 days for the submission of written questions. 

Without objection. 

I ask unanimous consent that the following be inserted into the 

record: The written testimony of all of our witnesses, along with 

their CVs and Truth in Testimony forms where applicable; the letter from the Honorable Leonard Boswell to Chairwoman Slaughter 

dated July 8, 2009; statement by Bill Niman and Nicolette Hahn 

Niman; article by Peter Collignon, et al., entitled ‘‘World Health 

Organization Ranking of Antimicrobials According to Their Importance in Human Medicine: A Critical Step for Developing Risk 

Management Strategies for the Use of Antimicrobials in Food Production Animals’’; letters from Dr. Anne A. Gershon, M.D., with Infectious Diseases Society of America to Chairwoman Slaughter, 

dated July 10, 2009; testimony of Dr. Frank Moller Aarestrup and 

Dr. Henrik Wegener of the National Food Institute, Technical University of Denmark; transcript from the Subcommittee on Livestock, Dairy, and Poultry, Committee on Agriculture hearing to review the advances of animal health within the livestock industry, 

Thursday, September 25, 2008; and the Keep Antibiotics Working 

Fact Sheet and letter to Dr. Joshua Sharfstein, MD, Deputy Commissioner of FDA from Mr. Richard R. Wood, Chair of Keep Antibiotics Working Steering Committee. 

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Thanks to you all. Thanks very much to you. The Rules Committee is now adjourned. 

[Whereupon, at 5:30 p.m., the committee was adjourned.] 

ADDITIONAL MATERIAL SUBMITTED FOR THE RECORD 

CURRICULUM VITAE AND TRUTH IN TESTIMONY FORMS FOR WITNESSES TESTIFYING

BEFORE THE COMMITTEE (WHERE APPLICABLE) 

JOSHUA M. SHARFSTEIN, M.D. 

Dr. Joshua M. Sharfstein was appointed by President Obama to be the FDA Principal Deputy Commissioner, Food and Drugs, in March, 2009. 

From December 2005 through March 2009, Dr. Sharfstein was the Commissioner 

of Health for the City of Baltimore, Maryland. In this position, he led efforts to expand literacy efforts in pediatric primary care, facilitate the transition to Medicare 

Part D for disabled adults, engage college students in public health activities, increase influenza vaccination of healthcare workers, and expand access to effective 

treatment for opioid addiction. Under his leadership, the Baltimore Health Department and its affiliated agencies have won multiple national awards for innovative 

programs, and in 2008, Dr. Sharfstein was named Public Official of the Year by 

Governing Magazine. 

From July 2001 to December 2005, Dr. Sharfstein served as minority professional 

staff of the Government Reform Committee of the U.S. House of Representatives for 

Congressman Henry A. Waxman. Dr. Sharfstein is a 1991 graduate of Harvard College, a 1996 graduate of Harvard Medical School, a 1999 graduate of the combined 

residency program in pediatrics at Boston Children’s Hospital and Boston Medical 

Center, and a 2001 graduate of the fellowship in general pediatrics at the Boston 

University School of Medicine. 

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THE LETTER FROM THE HONORABLE LEONARD BOSWELL TO CHAIRWOMAN SLAUGHTER

DATED JULY 8, 2009 

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STATEMENT BY BILL NIMAN AND NICOLETTE HAHN NIMAN

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ARTICLE BY PETER COLLIGNON, ET AL., ENTITLED ‘‘WORLD HEALTH ORGANIZATION

RANKING OF ANTIMICROBIALS ACCORDING TO THEIR IMPORTANCE IN HUMAN MEDICINE: A CRITICAL STEP FOR DEVELOPING RISK MANAGEMENT STRATEGIES FOR THE

USE OF ANTIMICROBIALS IN FOOD PRODUCTION ANIMALS’’ 

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LETTER FROM DR. ANNE A. GERSHON, M.D., WITH INFECTIOUS DISEASES SOCIETY OF

AMERICA TO CHAIRWOMAN SLAUGHTER, DATED JULY 10, 2009 

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PREPARED STATEMENT OF DR. FRANK MOLLER AARESTRUP AND DR. HENRIK

WEGENER OF THE NATIONAL FOOD INSTITUTE, TECHNICAL UNIVERSITY OF

DENMARK

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TRANSCRIPT FROM THE SUBCOMMITTEE ON LIVESTOCK, DAIRY, AND POULTRY, COMMITTEE ON AGRICULTURE HEARING TO REVIEW THE ADVANCES OF ANIMAL HEALTH

WITHIN THE LIVESTOCK INDUSTRY, THURSDAY, SEPTEMBER 25, 2008 * 

* Previously printed by GPO, Serial No. 110–48 and can be accessed on the Committee of Agriculture’s Website at http://agriculture.house.gov/testimony/110/110- 

48.pdf 

KEEP ANTIBIOTICS WORKING FACT SHEET AND LETTER TO DR. JOSHUA SHARFSTEIN, 

MD, DEPUTY COMMISSIONER OF FDA FROM MR. RICHARD R. WOOD, CHAIR OF

KEEP ANTIBIOTICS WORKING STEERING COMMITTEE

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ARTICLE BY LANCE B. PRICE, ET AL., ENTITLED ‘‘FLOUROQUINOLONE-RESISTANT

CAMPYLOBACTER ISOLATES FROM CONVENTIONAL AND ANTIBIOTIC-FREE CHICKEN

PRODUCTS

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ARTICLE BY LANCE B. PRICE, ET AL., ENTITLED ‘‘THE PERSISTENCE OF

FLUOROQUINOLONE-RESISTANT CAMPYLOBACTER IN POULTRY PRODUCTION’’ 

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ARTICLE BY JAYNE CLAMPITT, ENTITLED ‘‘LIVING BY LARGE ANIMAL CONFINEMENTS

PARADISE LOST: ONE COUNTRY FAMILY’S STORY’’ 

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mstockstill on DSKH9S0YB1PROD with HEARINGInsert graphic folio 207 54484A.073
153 


mstockstill on DSKH9S0YB1PROD with HEARINGInsert graphic folio 208 54484A.074
154 


mstockstill on DSKH9S0YB1PROD with HEARINGInsert graphic folio 209 54484A.075