[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
   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

[GRAPHIC] [TIFF OMITTED] TONGRESS.#13


             Printed for the use of the Committee on Rules



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                           COMMITTEE ON RULES

               LOUISE McINTOSH SLAUGHTER, New York, Chair
JAMES P. McGOVERN, Massachusetts,    DAVID DREIER, California, Ranking 
    Vice Chair                           Member
ALCEE L. HASTINGS, Florida           LINCOLN DIAZ-BALART, Florida
DORIS O. MATSUI, California          PETE SESSIONS, Texas
DENNIS A. CARDOZA, California        VIRGINIA FOXX, North Carolina
MICHAEL A. ARCURI, New York
ED PERLMUTTER, Colorado
CHELLIE PINGREE, Maine
JARED POLIS, Colorado
                    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        LINCOLN DIAZ-BALART, Florida, 
CHELLIE PINGREE, Maine                   Ranking Member
JARED POLIS, Colorado                DAVID DREIER, California
LOUISE McINTOSH SLAUGHTER, New York
                      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          PETE SESSIONS, Texas, Ranking 
MICHAEL A. ARCURI, New York              Member
ED PERLMUTTER, Colorado              VIRGINIA FOXX, North Carolina
LOUISE McINTOSH SLAUGHTER, New York
                     Keith L. Stern, Staff Director
                Keagan Lenihan, Minority Staff Director


                            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 Appetit 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
    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


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, 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 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 food-borne 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.

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.
    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 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, 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 
antibiotic- and 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, 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 food-producing 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.
    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.
    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/feed-efficiency 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 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 (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.
    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 the human health impact from 
antimicrobial use in animals, in conjunction with robust 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?
    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 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.
    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 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.
    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 
antibiotic-resistant 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 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 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.
    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 accomplished 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 science-based 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.
---------------------------------------------------------------------------
    \1\ Centers for Disease Control (CDC). 2004. Background on 
antibiotic resistance. Online at www.cdc.gov/getsmart.
---------------------------------------------------------------------------
  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 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\
---------------------------------------------------------------------------
    \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.
    \4\ Total number of illnesses from USDA (www.ers.usda.gov/Data/
FoodBorneIllness) is multiplied by data from footnote 3 to obtain 
totals for resistant illness.
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    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.
---------------------------------------------------------------------------
    \5\ National Academy of Sciences Institute of Medicine. 1998. 
Antimicrobial Resistance: Issues and Options. Washington, DC: National 
Academies Press, p. 1.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \6\ Infectious Diseases Society of America. 2003. Bad bugs, no 
drugs: Defining the antimicrobial availability problem. Backgrounder. 
Online at www.idsociety.org/badbugsnodrugs.
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           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\
---------------------------------------------------------------------------
    \7\ McEwen S, and Fedorka-Cray P. 2002. Antimicrobial use and 
resistance in animals. Clinical Infectious Diseases 34:S93-106.
---------------------------------------------------------------------------
    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.
          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.
---------------------------------------------------------------------------
    \8\ Mellon 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/
food_and_agriculture/science_and_impacts/
impacts_industrial_agriculture/hogging-it-estimates-of.html.
    \9\ Mellon M, Benbrook C, and Benbrook K. 2001. Hogging It!, pp. 
51-53.
---------------------------------------------------------------------------
    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\
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    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
    \14\ Khanna T, et al. 2008. Methicillin resistant Staphylococcus 
aureus colonization in pigs and pig farmers. Veterinary Microbiolgy 
128:298-303.
    \15\ Smith 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.
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \16\ Partridge 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.
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the literature in this arena is voluminous and the conclusion is clear: 
   antibiotic overuse in agriculture--just as in human medicine--is 
 undercutting the efficacy of important human therapies and generating 
                        more virulent pathogens
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \18\ Wegener H. 2008. Keynote Presentation. ASM Conferences 
Antimicrobial Resistance in Zoonotic Bacteria and Foodborne Pathogens, 
Copenhagen, Denmark, June 15-16.
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                         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.
---------------------------------------------------------------------------
    \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. 
    \20\ Government Accountability Office (GAO). 2004. Antibiotic 
Resistance: Federal Agencies Need to Better Focus Efforts to Address 
Risk to Humans from Antibiotic Use in Animals, GAO-04-490, April 22.
    \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.
    \22\ GAO. 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.
---------------------------------------------------------------------------
    \23\ GAO. 2004. Antibiotic Resistance.
    \24\ GAO. 2004. Antibiotic Resistance.
---------------------------------------------------------------------------
    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 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 routine 
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 military 
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 2\1/2\-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 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 animal 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 
antibiotics 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\
---------------------------------------------------------------------------
    \1\ The 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.
---------------------------------------------------------------------------
    b. Immediately ban any new approvals of antimicrobials for non-
therapeutic uses in food animals \2\ and retroactively investigate 
antimicrobials previously approved.
---------------------------------------------------------------------------
    \2\ The 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.
---------------------------------------------------------------------------
    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 feed-additive 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).
---------------------------------------------------------------------------
    \3\ Fluoroquinolones are approved in animals only for therapeutic 
use (not for non-therapeutic use), and thus are not covered under 
PAMTA.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \4\ For the Commission's recommendations, the members considered 
many definitions; a complete list of sources is in Appendix I.
    \5\ This definition is adapted from PAMTA 2007.
---------------------------------------------------------------------------
    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 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)
[GRAPHIC] [TIFF OMITTED] 54484A.001

     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)
[GRAPHIC] [TIFF OMITTED] 54484A.002

     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)
[GRAPHIC] [TIFF OMITTED] 54484A.003

[GRAPHIC] [TIFF OMITTED] 54484A.004

     The numbers of piglets per sow increased post-ban. (Figure 
5)
[GRAPHIC] [TIFF OMITTED] 54484A.005

     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)
[GRAPHIC] [TIFF OMITTED] 54484A.006

               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.
    [GRAPHIC] [TIFF OMITTED] 54484A.007
    
    [GRAPHIC] [TIFF OMITTED] 54484A.008
    
    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 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.
    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.
    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.
    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 perpetuation 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 authorized, 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 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?

 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 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 antibiotic-resistant 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.
     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.
    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.
    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 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 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 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 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!''
    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 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 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 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.
    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 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 always 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.
    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.
    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.
    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 on-site 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 APPETIT MANAGEMENT COMPANY

    Mr. Bauccio. Chairwoman Slaughter, honorable members of the 
Rules Committee, I am Fedele Bauccio, CEO of Bon Appetit 
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 antibiotic 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 Appetit 
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.
    [The prepared statement of Mr. Bauccio follows:]

 Prepared Statement of Fedele Bauccio, President and CEO, Bon Appetit 
                           Management Company

    Chairwoman Slaughter, honorable members of the Rules Committee, I 
am Fedele Bauccio, CEO of Bon Appetit Management Company, a national 
onsite restaurant company that serves 80 million meals each year at 400 
cafes 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 Appetit 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 Appetit 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 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 remain 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 agriculture. 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.
    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 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 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 communities. 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.
    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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