[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
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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
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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.
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\1\ Centers for Disease Control (CDC). 2004. Background on
antibiotic resistance. Online at www.cdc.gov/getsmart.
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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\
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\2\ Centers for Disease Control (CDC). 2005. National Antimicrobial
Resistance Monitoring System (NARMS) for Enteric Bacteria: Human
Isolates. Final Report. Atlanta, GA: U.S. Department of Health and
Human Services, CDC.
\3\ CDC. 2005. NARMS.
\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.
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\5\ National Academy of Sciences Institute of Medicine. 1998.
Antimicrobial Resistance: Issues and Options. Washington, DC: National
Academies Press, p. 1.
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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.
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\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\
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\7\ McEwen S, and Fedorka-Cray P. 2002. Antimicrobial use and
resistance in animals. Clinical Infectious Diseases 34:S93-106.
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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.
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\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.
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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.
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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.
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\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.
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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.
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\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.
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\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.
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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.
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\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.
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\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.
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[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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