[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
                   HEARING TO REVIEW THE ADVANCES OF 
                   ANIMAL HEALTH WITHIN THE LIVESTOCK 
                                INDUSTRY 

=======================================================================

                                HEARING

                               BEFORE THE

                            SUBCOMMITTEE ON
                     LIVESTOCK, DAIRY, AND POULTRY

                                 OF THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                      THURSDAY, SEPTEMBER 25, 2008

                               __________

                           Serial No. 110-48


          Printed for the use of the Committee on Agriculture
                         agriculture.house.gov

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                        COMMITTEE ON AGRICULTURE

                COLLIN C. PETERSON, Minnesota, Chairman

TIM HOLDEN, Pennsylvania,            BOB GOODLATTE, Virginia, Ranking 
    Vice Chairman                    Minority Member
MIKE McINTYRE, North Carolina        TERRY EVERETT, Alabama
BOB ETHERIDGE, North Carolina        FRANK D. LUCAS, Oklahoma
LEONARD L. BOSWELL, Iowa             JERRY MORAN, Kansas
JOE BACA, California                 ROBIN HAYES, North Carolina
DENNIS A. CARDOZA, California        TIMOTHY V. JOHNSON, Illinois
DAVID SCOTT, Georgia                 SAM GRAVES, Missouri
JIM MARSHALL, Georgia                MIKE ROGERS, Alabama
STEPHANIE HERSETH SANDLIN, South     STEVE KING, Iowa
Dakota                               MARILYN N. MUSGRAVE, Colorado
HENRY CUELLAR, Texas                 RANDY NEUGEBAUER, Texas
JIM COSTA, California                CHARLES W. BOUSTANY, Jr., 
JOHN T. SALAZAR, Colorado            Louisiana
BRAD ELLSWORTH, Indiana              JOHN R. ``RANDY'' KUHL, Jr., New 
NANCY E. BOYDA, Kansas               York
ZACHARY T. SPACE, Ohio               VIRGINIA FOXX, North Carolina
TIMOTHY J. WALZ, Minnesota           K. MICHAEL CONAWAY, Texas
KIRSTEN E. GILLIBRAND, New York      JEFF FORTENBERRY, Nebraska
STEVE KAGEN, Wisconsin               JEAN SCHMIDT, Ohio
EARL POMEROY, North Dakota           ADRIAN SMITH, Nebraska
LINCOLN DAVIS, Tennessee             TIM WALBERG, Michigan
JOHN BARROW, Georgia                 BOB LATTA, Ohio
NICK LAMPSON, Texas
JOE DONNELLY, Indiana
TIM MAHONEY, Florida
TRAVIS W. CHILDERS, Mississippi

                                 ______

                           Professional Staff

                    Robert L. Larew, Chief of Staff

                     Andrew W. Baker, Chief Counsel

                 April Slayton, Communications Director

           William E. O'Conner, Jr., Minority Staff Director

                                 ______

             Subcommittee on Livestock, Dairy, and Poultry

                   LEONARD L. BOSWELL, Iowa, Chairman

KIRSTEN E. GILLIBRAND, New York      ROBIN HAYES, North Carolina,
STEVE KAGEN, Wisconsin                    Ranking Minority Member
TIM HOLDEN, Pennsylvania             MIKE ROGERS, Alabama
JOE BACA, California                 STEVE KING, Iowa
DENNIS A. CARDOZA, California        VIRGINIA FOXX, North Carolina
NICK LAMPSON, Texas                  K. MICHAEL CONAWAY, Texas
JOE DONNELLY, Indiana                JEAN SCHMIDT, Ohio
JIM COSTA, California                ADRIAN SMITH, Nebraska
TIM MAHONEY, Florida                 TIM WALBERG, Michigan

              Chandler Goule, Subcommittee Staff Director

                                  (ii)



























                             C O N T E N T S

                              ----------                              
                                                                   Page
Boswell, Hon. Leonard L., a Representative in Congress from Iowa, 
  opening statement..............................................     1
    Prepared statement...........................................     2
Boyda, Hon. Nancy E., a Representative in Congress from Kansas, 
  prepared statement.............................................     6
Hayes, Hon. Robin, a Representative in Congress from North 
  Carolina, opening statement....................................     3
    Prepared statement...........................................     4
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, prepared statement..................................     5

                               Witnesses

Clifford, D.V.M., John, Deputy Administrator for Veterinary 
  Services and Chief Veterinarian, Animal and Plant Health 
  Inspection Service, U.S. Department of Agriculture, Washington, 
  D.C.; accompanied by Rob Hedberg, Acting Director, Legislative 
  and Governmental Affairs, Cooperative State Research, 
  Education, and Extension Service, U.S. Department of 
  Agriculture....................................................     6
    Prepared statement...........................................     8
Dunham, D.V.M., Ph.D., Bernadette, Director, Center for 
  Veterinary Medicine, Food and Drug Administration, U.S. 
  Department of Health and Human Services, Rockville, MD.........    15
    Prepared statement...........................................    17
Rowles, D.V.M., Craig, General Manager and Partner, Elite Pork 
  Partnership, Carroll, IA; on behalf of National Pork Producers 
  Council........................................................    32
    Prepared statement...........................................    34
    Supplemental material........................................   109
Rybolt, Ph.D., Michael L., Director, Scientific and Regulatory 
  Affairs, National Turkey Federation, Washington, D.C...........    37
    Prepared statement...........................................    40
Byrne, Ph.D., Robert D., Senior Vice President, Scientific and 
  Regulatory Affairs, National Milk Producers Federation, 
  Arlington, VA..................................................    41
    Prepared statement...........................................    44
Klopp, D.V.M., D.A.C.P.V., Spangler, Corporate Veterinarian, 
  Townsends, Inc., Georgetown, DE; on behalf of National Chicken 
  Council........................................................    47
    Prepared statement...........................................    49
Van Zetten, Blair, President, Oskaloosa Food Products Corp., 
  Oskaloosa, IA; on behalf of United Egg Producers...............    50
    Prepared statement...........................................    52
Apley, D.V.M., Ph.D., D.A.C.V.P., Michael D., Associate Professor 
  of Beef Production Medicine, Clinical Pharmacologist, and 
  Director, PharmCATS Bioanalytical Laboratory, Kansas State 
  University; Member, Cattle Health and Well Being Committee, 
  National Cattlemen's Beef Association, Manhattan, KS...........    54
    Prepared statement...........................................    55
Carnevale, V.M.D., Richard A., Vice President, Scientific, 
  Regulatory and International Affairs, Animal Health Institute, 
  Washington, D.C................................................    64
    Prepared statement...........................................    67
    Supplemental material........................................   110
Hoang, D.V.M., M.P.H., Christine N., Assistant Director, 
  Scientific Activities Division, American Veterinary Medical 
  Association, Schaumburg, IL....................................    73
    Prepared statement...........................................    75
Singer, D.V.M., M.P.V.M., Ph.D., Randall S., Associate Professor 
  of Epidemiology, Department of Veterinary and Biomedical 
  Sciences, College of Veterinary Medicine, and Division of 
  Environmental Health, School of Public Health, University of 
  Minnesota, St. Paul, MN........................................    90
    Prepared statement...........................................   117

                           Submitted Material

Keep Antibiotics Working, submitted statement....................   102
Martin, Robert P., Executive Director, Pew Commission on 
  Industrial Farm Animal Production, submitted statement.........   108
Slaughter, Hon. Louise M., a Representative in Congress from New 
  York, submitted statement......................................    99
Steuer, Karen, Director of Government Operations, Pew Campaign on 
  Human Health and Industrial Farming, submitted statement.......   105
Submitted questions..............................................   117


                   HEARING TO REVIEW THE ADVANCES OF
                   ANIMAL HEALTH WITHIN THE LIVESTOCK
                                INDUSTRY

                              ----------                              


                      THURSDAY, SEPTEMBER 25, 2008

                  House of Representatives,
     Subcommittee on Livestock, Dairy, and Poultry,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to call, at 10:04 a.m., in 
Room 1300 of the Longworth House Office Building, Hon. Leonard 
L. Boswell [Chairman of the Subcommittee] presiding.
    Members present: Representatives Boswell, Kagen, Baca, 
Peterson (ex officio), Hayes, Foxx, Smith, and Goodlatte (ex 
officio).
    Staff present: Adam Durand, Alejandra Gonzalez-Arias, 
Chandler Goule, John Konya, John Riley, April Slayton, Rebekah 
Solem, John Goldberg, Pam Miller, and Jamie Weyer.

OPENING STATEMENT OF HON. LEONARD L. BOSWELL, A REPRESENTATIVE 
                     IN CONGRESS FROM IOWA

    The Chairman. The hearing of the Subcommittee on Livestock, 
Dairy, and Poultry to review the advances of animal health 
within the livestock industry will come to order.
    I appreciate you all being here and I first want to welcome 
you and thank you for joining us today to discuss a very 
important issue to rural America and food security across the 
country. A special thanks to our witnesses for appearing before 
the Subcommittee today, particularly from my territory, not 
that everybody is not equally as important of course. But, I 
want to call attention to Mr. Blair Van Zetten and Dr. Craig 
Rowles, here not only to represent their respective industries 
but my home state. Thank you very much for taking the time to 
come.
    Having spent most of my life involved in animal 
agriculture, and knowing the responsibility of using 
antibiotics, which I think all farmers do, I understand many of 
the issues that affect the industry firsthand. I spent most of 
my youth working in some aspect of livestock production, but 
when I left the Army and moved back to Iowa to be in farming 
again, I sat down with a local veterinarian that some of you 
may know, Dr. McElroy. We discussed the use of antibiotics to 
treat sick animals, prevent illness and to preserve the health 
of those animals. As I discussed my experience with producers 
and veterinarians, I learned this is not the exception but it 
is the rule that I find that all producers live by. We 
understand that it is something that is a very useful tool, but 
we have to use it carefully, and we have to use it according to 
the expectations of how to handle those antibiotics. For over 
40 years, the U.S. animal agriculture industry has used FDA-
approved drugs to ensure we have healthy animals because 
healthy animals produce healthy food.
    Also, I would like to take a moment to highlight very 
important programs for safe and efficient drug use, the Food 
Animal Residue Avoidance Databank, known as FARAD, and the 
Animal Drug User Fee Act, ADUFA. FARAD is a program that has a 
computer-based decision-support system which provides producers 
and veterinarians with practical information on how to avoid 
antibiotic residues in food. FARAD helps protect our food 
supply yet continually struggles for funding. In Fiscal Year 
2008, FARAD received no funding, and this year is in danger of 
shutting down completely. Ranking Member Hayes and I sent a 
letter to both USDA and the FDA, in July, regarding this 
critical issue, and I wanted to once again stress the 
importance of getting this program funded.
    I was pleased this year when Congress passed ADUFA, which 
also plays a vital role in maintaining a healthy animal 
agricultural industry. This critical program supports continued 
improvements of FDA's review program and assists FDA in a 
timely drug approval process.
    I must be cautious when people outside the industry talk 
about banning antibiotic use in livestock. I believe we must 
follow a science-based process to ensure that unintended 
consequences do not put human health at risk. I think a 
compelling example of this is the Denmark case where the 
removal of antibiotics for health maintenance or growth 
purposes resulted not only in the use of more antibiotics to 
treat animal disease, but also increased animal death and 
disease. Antibiotic use in livestock has been a hot topic of 
discussion for years, and this year is no exception.
    In recent months, both sides of the Hill have held various 
hearings over this subject. Today it is my hope that consumers 
can put their faith in science-based evidence that the use of 
antibiotics in animal agriculture not only gives us healthy 
animals but also a safe food supply.
    Once again, I would like to thank everyone for joining us 
here today.
    [The prepared statement of Mr. Boswell follows:]

  Prepared Statement of Hon. Leonard L. Boswell, a Representative in 
                           Congress from Iowa
    Good morning, I would like to thank everyone for joining us today 
to discuss a very important issue to rural America and food security 
across the country. A special thanks to our witness for appearing 
before the Subcommittee today, particularly Mr. Blair Van Zetten and 
Dr. Craig Rowles who are here not only to represent their respective 
industries but also the great State of Iowa.
    Having spent most my life involved in animal agriculture and 
responsibly using antibiotics, I understand many of the issues that 
affect the industry first hand. I spent most of my youth working in 
some aspect of livestock production but when I retired from the Army 
and moved back to Iowa to begin farming I sat down with the local 
veterinarian--Doc McElroy. We discussed the use of antibiotics to treat 
sick animals, prevent illness, and to preserve the health of those 
animals. As I have discussed my experience with producers and 
veterinarians I learned this is not the exception but the rule.
    For over 40 years the U.S. animal agriculture industry has used FDA 
approved drugs to ensure we have healthy animals. Because healthy 
animals produce healthy food.
    I also would like to take a moment to highlight two very important 
programs for safe and efficient drug use--the Food Animal Residue 
Avoidance Databank (FARAD) and the Animal Drug User Fee Act (ADUFA).
    FARAD is a program that has a computer-based decision-support 
system which provides producers and veterinarians with practical 
information on how to avoid antibiotic residues in food. FARAD helps 
protect our food supply yet continually struggles for funding. In 
Fiscal Year 2008, FARAD received no funding and this year is in danger 
of shutting down completely. Ranking Member Hayes and I sent a letter 
to both USDA and FDA, in July, regarding this critical issue and I 
wanted to once again stress the importance of getting this program 
funding. I was please this year when Congress passed ADUFA, which also 
plays a vital role in maintaining a health animal agriculture industry. 
This critical program supports continued improvements of FDA's review 
program and assists FDA in a timely drug approval process.
    I must be cautious when people outside the industry talk about 
banning antibiotic use in livestock. I believe we must follow a 
science-based process to ensure that unintended consequences do not put 
human health at risk. I think a compelling example of this is the 
Denmark case where the removal of antibiotics for health maintenance or 
growth purposes resulted not only in the use of more antibiotics to 
treat animal diseases but also increased animal death and disease.
    Antibiotic use in livestock has been a hot topic of discussion for 
years and this year is no exception. In recent months both sides of the 
Hill have held various hearings over this subject. Today, it is my hope 
that consumers can put their faith in science-backed evidence that the 
use of antibiotics in animal agriculture not only gives us healthy 
animals but also a safe food supply.
    Once again, I would like to thank everyone for joining us here 
today. At this time I would like to recognize my Ranking Member and 
good friend Robin Hayes from North Carolina for any opening remarks he 
would like to make.

    The Chairman. At this time I would like to recognize my 
Ranking Member and my good friend, Robin Hayes from North 
Carolina, for any opening remarks that he would like to make. 
Mr. Hayes.

  OPENING STATEMENT OF HON. ROBIN HAYES, A REPRESENTATIVE IN 
                  CONGRESS FROM NORTH CAROLINA

    Mr. Hayes. Thank you, Mr. Chairman, and you are a good 
friend and a trusted advisor. I had my sausage yesterday and 
not today, so I may not be at my peak.
    The Chairman. Oh, okay.
    Mr. Hayes. Thank you, Mr. Chairman, for holding this 
hearing relating to the use of antibiotics in animal 
agriculture. Agricultural use of antibiotics has received quite 
a bit of press lately. Unfortunately, the press coverage has 
not provided the full picture on the issue. It has not given 
adequate attention to the factual information surrounding the 
use of antibiotics for animal agriculture, and why it is so 
important that farmers have the ability to administer 
antibiotics to their livestock. The veterinary community, as 
well as farmers and ranchers, can attest to the fact that 
banning antibiotics will impose substantial cost on producers 
and provide no quantifiable public health benefit. Farmers have 
an economic incentive to keep their herd healthy. Obviously, 
livestock farmers would be discriminating in the frequency and 
quantity of the antibiotics they administer to prevent the 
adulteration of their product. At the same time, judicious use 
of antibiotics is necessary for both prevention and treatment 
of disease.
    One example of how a ban on antibiotics in animal 
agriculture can negatively impact the health of livestock is 
the instance that you referred to in Denmark. I won't go into 
detail. I will insert that in the record. You are looking at 
increased death and disease in herds, a 135 percent increase in 
the amount of antibiotics used to treat animal disease between 
1996 and 2005. Denmark is now using more antibiotics for 
treatment as a result of banning its use for prevention. There 
is no evidence that we are aware of to demonstrate that the 
decline in antibiotic resistance in humans is a result of the 
ban. The net result of the ban is an increase in disease and 
death in swine herds that discontinued use. Yet there is no 
evidence to suggest this ban resulted in a reduction of 
resistance.
    Mr. Chairman, many of our colleagues simply have no 
understanding of the challenges confronting animal agriculture. 
For them it would seem to be an easy decision to vote for 
legislation that imposes arbitrary restrictions on food 
producers under the mistaken assumption that they are helping 
address concerns in human medicine. Based on the Danish 
experiments and the balance of today's testimony, I think we 
can fairly conclude they would be mistaken.
    I appreciate you holding the hearing, and I might also add 
that our purpose is to confirm and reaffirm the quality and 
safety of the American livestock industry's product. This 
hearing will create additional oversight but also insight by 
exchanging ideas, experiences and results of stringent testing 
and evaluation. So I thank our witnesses and I thank our 
Chairman. Let us proceed.
    [The prepared statement of Mr. Hayes follows:]

 Prepared Statement of Hon. Robin Hayes, a Representative in Congress 
                          from North Carolina
    Thank you, Mr. Chairman, for holding this hearing relating to the 
use of antibiotics in animal agriculture. Agricultural usage of 
antibiotics has received quite a bit of press lately. Unfortunately, 
the press coverage has not provided the full picture on this issue. It 
has not given adequate attention to the factual information surrounding 
the use of antibiotics for animal agriculture, and why it is so 
important that farmers have the ability to administer antibiotics to 
their livestock.
    The veterinary community, as well as farmers and ranchers, can 
attest to the fact that banning antibiotics will impose substantial 
costs on producers and provide no quantifiable public health benefit.
    Farmers have an economic incentive to keep their herd healthy. 
Obviously, livestock farmers would be discriminating in the frequency 
and quantity of the antibiotics they administer to prevent the 
adulteration of their product. At the same time, the judicious use of 
antibiotics is necessary for both the prevention and treatment of 
disease.
    One example of how a ban on antibiotics in animal agriculture can 
negatively impact the health of livestock happened in Denmark.
          * * * * *
    In the late 1990s, Denmark instituted a voluntary ban on the use of 
antibiotics for growth promotion in feed; a compulsory ban was 
initiated in 2000. Since then the pork industry in Denmark, which has 
about the same number of swine as the State of Iowa, bas experienced 
the following as a result of this ban:

   Increased death and disease in the swine herds.

   135% increase in the amount of antibiotics used to treat 
        animal disease between 1996 and 2005. So, Denmark is now using 
        more antibiotics for treatment as result of banning its use for 
        prevention.

   Overall mixed results. Resistance to some antibiotics has 
        decreased, while resistance to others has increased.

   And, there is no evidence that we're aware of to demonstrate 
        a decline in antibiotic resistance in humans as a result of 
        this ban.

    The net result of the ban is an increase in disease and death in 
the swine herds that discontinued use. Yet, there is no evidence to 
suggest that this ban resulted in a reduction of antibiotic resistance 
patterns in humans.
          * * * * *
    Mr. Chairman, many of our colleagues simply have no understanding 
of the challenges confronting animal agriculture. For them, it would 
seem to be an easy decision to vote for legislation that imposes 
arbitrary restrictions on food producers under the mistaken assumption 
that they are helping address concerns in human medicine.
    Based on the Danish experiment and the balance of today's testimony 
I think we can fairly conclude that they would be mistaken. I 
appreciate your holding this hearing so that we can all make this point 
on the record. I yield back.

    The Chairman. Thank you, Mr. Hayes, and thank you for being 
here. We are going to follow the normal routine, move on to 
witnesses and welcome any statements that Members want to put 
into the record. Also, you will be recognized when we get to 
question time.
    [The prepared statements of Mr. Peterson and Mrs. Boyda 
follow:]

  Prepared Statement of Hon. Collin C. Peterson, a Representative in 
                        Congress from Minnesota
    First, I want to thank Chairman Boswell for holding this hearing. I 
also want to recognize two of the witnesses who have Minnesota ties. 
Dr. Randall Singer is a Professor of Epidemiology at the University of 
Minnesota's College of Veterinary Medicine and Dr. Christine Hoang, who 
is here on behalf of the American Veterinary Medical Association, 
graduated from the University. Thanks to both of you and to all of our 
witnesses here today.
    The livestock industry faces numerous challenges in today's market. 
Energy and other input prices are squeezing producers. Local, state and 
Federal regulations and requirements impose all kind of restrictions on 
their operations. Producers are being blamed by some for increasing 
antibiotic resistance in humans because they treat their animals with 
antibiotics.
    Like so many issues, the problem of antibiotic resistance is 
complicated, and there is not a single cause or simple solution. 
Without a doubt, antibiotic resistance is a serious public health 
problem, and we need to be sure that we take responsible steps to 
address it.
    The responsible use of antibiotics in animal agriculture decreases 
mortality rates and disease and increases food safety. The overuse of 
antibiotics, on the other hand, is clearly not acceptable. Professional 
associations and industry leaders in animal agriculture must lead in 
the development of best management practices and guidelines for 
responsible antibiotic use in livestock, and in educating producers 
about those practices. I am looking forward to hearing from those 
groups testifying here today about their education and outreach efforts 
on this issue and the results they are seeing among producers.
    There are some who would like to blame antibiotic resistance in 
humans on animal agriculture. I want to be clear that banning 
antibiotics from animal agriculture will have serious consequences and 
will not solve the problems we are seeing with antibiotic resistance. 
Without antibiotics, the supply of meat, poultry, dairy and eggs would 
decline at a time when demand for these products around the world is on 
the rise. In addition, banning antibiotics in animal agriculture will 
increase consumers' exposure to pathogens that cause foodborne 
illnesses and at the same time will increase food costs.
    I hope that in the testimony presented here today, we can get a 
better understanding of where we are in terms of antibiotic resistance 
in human as well as animal health. I appreciate Dr. Clifford from USDA 
and Dr. Dunham from FDA for joining us. This is an important issue, and 
we need to know what the facts are and what the implications would be 
if we severely restricted or banned the use of antibiotics in animal 
agriculture.
    Chairman Boswell, thank you again for holding this hearing, and I 
look forward to the testimony from our witnesses.
                                 ______
                                 
Prepared Statement of Hon. Nancy E. Boyda, a Representative in Congress 
                              from Kansas
    Chairman Boswell and Ranking Member Hayes, thank you for holding 
this hearing to review animal health. I appreciate the Committee 
addressing a subject so important to the Second District of Kansas.
    Although I am not a Member of the Subcommittee, I wanted to share 
my support for continued oversight and research into animal research. 
In particular, more research is needed into the link or lack thereof 
between antibiotics in animal feed and resistance to antibiotics in 
humans.
    I'd also like to take this opportunity to highlight the important 
research occurring in Kansas and Missouri and encourage support for H. 
Res. 829, which recognizes the region from Manhattan, Kansas, to 
Columbia, Missouri, as the Kansas City Animal Health Corridor. The 
Animal Health Corridor is home to 45 companies involved in the animal 
health industry; more than 120 companies involved in the animal health 
industry are located in Kansas and Missouri, including four of the ten 
largest global animal health companies and one of the five largest 
animal nutrition companies.
    Several leading veterinary colleges and animal research centers are 
located in Kansas and Missouri, including the College of Veterinary 
Medicine and the $54,000,000 Biosecurity Research Institute of Kansas 
State University and the College of Veterinary Medicine, the College of 
Agriculture, Food and Natural Resources' Division of Animal Sciences, 
the $60,000,000 Life Sciences Center, the National Swine Resource and 
Research Center, and the Research Animal Diagnostic Laboratory of the 
University of Missouri. Additionally, more than 45 percent of the fed 
cattle in the United States, 40 percent of the hogs produced, and 20 
percent of the beef cows and calves are located within 350 miles of 
Kansas City. H. Res. 829 would highlight the research taking place in 
Kansas and Missouri, and encourage more companies to relocate to the 
area.
    Thank you again for allowing me the opportunity to address the 
Subcommittee.

    The Chairman. We will start with our first panel, and I 
think we will recognize Dr. Clifford first and then Dr. Dunham. 
Dr. John Clifford, Doctor of Veterinary Medicine, is the Deputy 
Administrator, Animal and Plant Health Inspection, U.S. 
Department of Agriculture, Washington, D.C. So Dr. Clifford, 
please begin when you are ready, and thank you for your 
presence.

           STATEMENT OF JOHN CLIFFORD, D.V.M., DEPUTY
 ADMINISTRATOR FOR VETERINARY SERVICES AND CHIEF VETERINARIAN, 
ANIMAL AND PLANT HEALTH INSPECTION SERVICE, U.S. DEPARTMENT OF 
                          AGRICULTURE,
         WASHINGTON, D.C.; ACCOMPANIED BY ROB HEDBERG,
         ACTING DIRECTOR, LEGISLATIVE AND GOVERNMENTAL
 AFFAIRS, COOPERATIVE STATE RESEARCH, EDUCATION, AND EXTENSION 
                  SERVICE, U.S. DEPARTMENT OF
                          AGRICULTURE

    Dr. Clifford. Thank you, Mr. Chairman. My name is John 
Clifford. I am the Deputy Administrator for Veterinary Services 
with the Department of Agriculture's Animal and Plant Health 
Inspection Service, or APHIS. Thank you for this opportunity to 
testify before you.
    My agency's role in advancing livestock health is 
multifaceted. At any given time, APHIS is working to safeguard 
the health of U.S. livestock against foreign animal diseases, 
eradicate and control diseases that exist in the United States, 
and conduct surveillance related to issues affecting animal 
health. Important advances have been realized in all of these 
areas in recent years to the benefit of the U.S. livestock 
industry. This morning I would like to highlight for you 
APHIS's emergency planning and response efforts, the 
brucellosis program and our efforts related to the use of 
antibiotics in livestock.
    As USDA's Chief Veterinary Officer, I believe one of the 
most important ways of protecting and advancing livestock 
health is to ensure that we have a strong system in place to 
safeguard against animal diseases. Foreign animal disease 
incursions and other animal health emergencies can have a major 
impact on America. For example, studies have projected that an 
outbreak of foot-and-mouth disease contained in California 
could cost between $6 billion and $14 billion.
    The U.S. response to animal health emergencies involves a 
partnership between Federal, state and industry cooperators. In 
support of this effort, APHIS develops emergency response 
plans, operates the nation's repository of vaccines, personal 
protective equipment and other critical supplies and equipment, 
and provides laboratory and diagnostic services. Written 
response plans have been developed and tested for the most 
dangerous animal diseases that pose a risk to U.S. agriculture 
including highly pathogenic avian influenza and foot-and-mouth 
disease. Since its establishment in 2000, the National Animal 
Health Emergency Response Corps has deployed over 500 
volunteers to assist Federal and state responders during animal 
health emergencies and our National Animal Health Laboratory 
Network continues to grow with a current total of 58 
laboratories in 45 states. All the above preparations have us 
well positioned to safeguard livestock in the United States.
    In the event that a disease of concern is introduced or has 
existed in the United States, APHIS works with the livestock 
industry and states to eradicate and control the disease. One 
of APHIS's longstanding programs is our brucellosis program. 
This program has been highly effective, and in 1956 we had 
124,000 affected herds in the United States as a result of 
testing. By 1992, that number had dropped to 700. As of today, 
there are only two known affected domestic cattle herds 
remaining in the entire United States. Also, annual 
brucellosis-related losses due to aborted fetuses, reduced 
breeding efficiency and lowered milk production had decreased 
from more than $400 million in 1952 to almost zero today.
    In addition to safeguarding against diseases that affect 
livestock health, APHIS also collaborates with other Federal 
agencies and the livestock industry to conduct surveillance and 
collect data related to animal health issues such as the use of 
antibiotics in livestock. One of these cooperative efforts is 
the National Antimicrobial Resistance Monitoring System, or 
NARMS. The NARMS was established in 1996 by USDA, the 
Department of Health and Human Services, as well as other 
cooperators. That system provides data on the prevalence of 
antibiotic resistance in animals, humans and retail foods. 
APHIS contributes by providing isolates from clinically ill 
animals and isolates from healthy animals on farms. For 
example, APHIS in collaboration with the U.S. Department of 
Agriculture's Agricultural Research Service collects samples to 
be cultured for bacteria, which are subsequently evaluated for 
antimicrobial drug resistance as part of the NARMS.
    In 2003, APHIS, ARS and USDA's Food Safety Inspection 
Service undertook a pilot project that was designed to 
complement NARMS. This pilot project was the Collaboration in 
Animal Health and Food Safety Epidemiology and it was 
established to examine bacterial resistance to antimicrobial 
drugs on farms and to evaluate the potential for resistant 
organisms to persist in food products from the animals under 
study. The project was concluded in 2005.
    In closing, I believe we will continue to see advances 
within animal health and the livestock industry. Partnerships 
with the livestock industry, states and other stakeholders will 
continue to be critical in realizing advances in our livestock 
industry.
    Thank you for the opportunity to testify this morning, and 
I will be pleased to answer any of your questions.
    [The prepared statement of Dr. Clifford follows:]

 Prepared Statement of John Clifford, D.V.M., Deputy Administrator for 
  Veterinary Services and Chief Veterinarian, Animal and Plant Health
  Inspection Service, U.S. Department of Agriculture, Washington, D.C.
    Chairman Boswell, Ranking Member Hayes, thank you for the 
opportunity to testify before the Committee this morning. My name is 
Dr. John Clifford and I am the Deputy Administrator for Veterinary 
Services with the Department of Agriculture's (USDA) Animal and Plant 
Health Inspection Service (APHIS). In this position, I also serve as 
USDA's Chief Veterinary Officer.
    Today, the Committee is looking at an important issue--advances of 
animal health within the livestock industry. We at USDA are actively 
engaged in developing and utilizing innovative methods to provide 
leadership on food, agriculture, natural resources, and related issues 
based on sound public policy, the best available science, and efficient 
management.
    In furtherance of this mission, APHIS is the agency within USDA 
responsible for protecting and promoting U.S. agricultural health, 
administering the Animal Welfare Act, and carrying out wildlife damage 
management activities. Within APHIS, Veterinary Services protects and 
improves the health, productivity, quality, and marketability of 
animals, animal products, and veterinary biologics in the United 
States. Partnerships with the livestock industry, as well as other 
global and domestic stakeholders, are critical in accomplishing this 
mission.
    At any given time, my agency is working on multiple priorities in 
order to ensure the health of our nation's domestic animal resources. 
These priorities include safeguarding against foreign animal diseases, 
emergency planning and preparedness, animal disease eradication and 
control, and monitoring and surveillance for animal diseases. I am very 
pleased to provide the following outline of some of the advances that 
have been realized in these important areas.
Foreign Animal Diseases
    While I am going to look broadly at several components of USDA's 
programs that assist in advancing livestock health, including several 
of those that look at the use of antibiotics in production practices, I 
want to start with an area that is critical to me as the Chief 
Veterinary Officer. In my mind, one of the most important ways of 
protecting and advancing livestock health is to ensure we have a strong 
system for preventing and responding to animal diseases.
    Foreign animal diseases (FAD) represent an ongoing threat to human 
health and to the health of the U.S. agricultural industry. We expect 
that these diseases will continue to be of major concern because of 
increased trade and increased movement of people, animals, and 
pathogens. This fiscal year, we expect U.S. agriculture exports to 
reach approximately $114 billion, making it the highest export sales in 
a 12 month period ever in our history. U.S. agriculture imports are 
rising as well--increasing from nearly $58 billion in 2005 to an 
estimated $79 billion this fiscal year. APHIS works diligently with 
state animal health officials and veterinary professionals to protect 
U.S. agriculture from the introduction of animal diseases and to 
identify, control, and eradicate animal diseases and diminish their 
impact.
    Efforts to detect FAD events in the United States include 
surveillance in disease-specific programs, reporting by producers and 
private veterinarians, and field investigations conducted by specially 
trained Federal, state, and private accredited veterinarians. 
Additional detection efforts include state diagnostic laboratory 
surveillance, in which routine cases that are subsequently considered 
``suspicious'' for FADs are reported to Federal and state animal health 
authorities for further investigation. Early identification and quick 
response in the FAD investigations are critical steps to ensuring that 
any further spread is minimized.
    Several important events have occurred globally over the last few 
years involving foreign animal diseases, including foot-and-mouth 
disease (FMD) and exotic Newcastle disease. A few of these events have 
highlighted the importance of our emergency preparedness and response 
capabilities. Most recently, highly pathogenic avian influenza (HPAI) 
subtype H5N1 virus has captured global attention as a potential human 
and animal health threat.
    Preventing, preparing for, and responding to potential outbreaks of 
avian influenza (AI) require collaboration on the broadest scale. 
Successfully protecting avian health depends on our ability to work 
together effectively--across all levels of government, with private 
industry and the public, and around the world. This includes working 
with the World Organization for Animal Health (OIE), which sets 
international standards concerning diseases that affect human and 
animal health, the United Nations' Food and Agriculture Organization 
(FAO) and World Health Organization (WHO).
    Internationally, we are collaborating with a variety of partners to 
control, and eradicate HPAI in those countries where it currently 
exists, and to prevent its introduction into the United States and 
other areas. For example, APHIS works with its partners to identify 
reservoirs of the disease and develop biosecurity recommendations for 
farmers; conduct intensive diagnostic training sessions to expand 
international diagnostic resources; and offer funding, technical 
expertise, and equipment to countries affected by or at risk for HPAI.
    On the domestic front, APHIS has partnered with other Federal and 
state agencies and the commercial poultry industry in conducting 
surveillance efforts for AI for many years. APHIS implemented 
strategies to strengthen existing AI surveillance where necessary in 
2006, and continued the enhanced surveillance efforts in 2007. We also 
increased our AI preparedness by refining our response plans and 
strengthening existing core programs in 2007.
    Because of heightened animal- and public-health concerns, the 
poultry industry and state and Federal animal-health regulatory 
agencies are continuing efforts to increase biosecurity measures and 
conduct extensive surveillance for HPAI, as well as certain subtypes of 
low pathogenic avian influenza (LPAI), in commercial poultry, live-bird 
markets, and poultry raised in non-confinement operations. The H5 and 
H7 subtypes of LPAI are of concern because they have the potential to 
mutate into highly pathogenic forms. This is why we established 
regulations for a new monitoring and control program for the H5 and H7 
subtypes for LPAI in 2006.
    In addition, in partnership with the U.S. Department of the 
Interior's U.S. Geological Survey and U.S. Fish and Wildlife Service, 
APHIS' Wildlife Services program monitors wild birds for AI. Bird 
banding data are used in conjunction with U.S. Census of Agriculture 
data to rank counties with a high prevalence of domestic poultry 
production and relatively high numbers of migrant waterfowl to identify 
areas of critical concern and overlap between commercial poultry 
production and concentrations of migratory waterfowl.
    We at APHIS are proud of the success of our AI prevention efforts 
to date. And it is worth reminding ourselves that, in addition to 
routinely addressing outbreaks of LPAI, the United States has 
effectively eradicated outbreaks of HPAI in three past instances, in 
1924, 1983, and 2004.
Emergency Planning and Preparedness
    Foreign animal disease incursions, as well as other animal health 
emergencies, can have a major impact on America's infrastructure, 
animal and public health, food safety, economy, and export markets. For 
example, an outbreak of FMD in the United States could have significant 
economic impacts. There are many susceptible animals in the United 
States, including 96 million cattle, 61 million swine, and almost nine 
million sheep and goats. The 2001 outbreak in the United Kingdom cost 
an estimated 8 billion ($13 billion) and reduced the 
British gross domestic product by 0.2 percent. Studies have projected a 
cost of between $6 and $14 billion for a U.S. outbreak contained to 
California. The impact comes primarily from lost international trade, 
followed by costs directly associated with the eradication effort 
including the expenses of depopulation, indemnity, carcass disposal, 
and cleaning and disinfecting. In addition there are direct and 
indirect costs related to lost production, unemployment, and losses in 
related businesses.
    APHIS' Veterinary Services (VS) program is charged with preventing 
animal health emergencies in the United States, rapidly detecting such 
emergencies should they occur, and responding effectively to control or 
eradicate them.
    The U.S. emergency response to animal health emergencies involves a 
partnership between various Federal, state, tribal, local, industry, 
and other private-sector cooperators. Written response plans and 
guidelines address all areas of an emergency response, such as the 
initial field investigation; local disease control and eradication 
activities; emergency management, including line of command, planning, 
logistics, and resources; and interagency coordination. Written 
response plans have been developed for the most dangerous animal 
diseases that pose a risk to U.S. agriculture, including HPAI and foot-
and-mouth disease.
    Disease outbreaks throughout the past several years have 
demonstrated the critical need for surge capacity personnel during an 
animal health emergency. In 2000, APHIS created the National Animal 
Health Emergency Response Corps (NAHERC) to provide a volunteer reserve 
of veterinary professionals to assist Federal and state responders 
during an animal health emergency. In 2001, 145 NAHERC members deployed 
to the FMD outbreak in the United Kingdom. In 2003, 340 NAHERC 
personnel assisted in the exotic Newcastle disease outbreak in 
California and 71 NAHERC personnel responded to a LPAI outbreak in 
Virginia. Their efforts were critical in protecting the nation's 
livestock from these diseases.
    During an emergency, APHIS is responsible for rapidly deploying 
critical veterinary supplies and personal protective equipment for 
workers from the National Veterinary Stockpile (NVS). The NVS was 
established in February 2004 through Homeland Security Presidential 
Directive--9 (HSPD-9). HSPD-9 reflects concerns that terrorists could 
simultaneously, and in multiple locations, release catastrophic animal 
diseases. The mission of the NVS is to deliver critical veterinary 
supplies nationwide within 24 hours.
    In 2007, the NVS continued expanding its capabilities. It acquired 
personal protective equipment and antiviral medications against AI to 
protect 3,000 responders, portable vaccine storage containers for field 
use, emergency air and ground transportation contracts to ensure 
deployment within 24 hours, and satellite phones to provide reliable 
emergency voice and data communications, anywhere, anytime. It also 
established commercial partnerships with all-hazard response companies 
to provide large numbers of trained, experienced personnel with 
equipment to help states depopulate, dispose, and decontaminate if they 
do not have enough of their own personnel. Looking forward, the NVS is 
working with the Department of Homeland Security to acquire next-
generation FMD vaccines and to quickly deliver current vaccines should 
an FMD emergency occur.
    Laboratory and diagnostic services are an essential component of 
the U.S. emergency response to animal health emergencies. The National 
Animal Health Laboratory Network (NAHLN) is part of a national strategy 
to coordinate the activities of Federal, state, and university 
laboratories providing critical animal disease surveillance and 
testing. The NAHLN is a cooperative effort between two U.S. Department 
of Agriculture (USDA) agencies--APHIS and a portion of the Cooperative 
State Research, Education, and Extension Service's (CSREES) Integrated 
Activities program--and the American Association of Veterinary 
Laboratory Diagnosticians.
    The USDA Homeland Security Office established the NAHLN as part of 
a national strategy to coordinate and link the testing capacities of 
the Federal veterinary diagnostic laboratories with the extensive 
infrastructure (facilities, professional expertise, testing capacity, 
and support) of state and university veterinary diagnostic 
laboratories. This network enhances the nation's early detection of, 
response to, and recovery from animal health emergencies, including 
emerging diseases and FADs that threaten the nation's food supply and 
public health.
    In 2002, APHIS and CSREES initiated the network by entering into 
cooperative agreements with 12 state and university veterinary 
diagnostic laboratories. These were funded by the Department of 
Homeland Security. APHIS now contracts with 54 state and university 
diagnostic laboratories to assist with testing and surveillance; the 
number of NAHLN facilities totals 58 laboratories in 45 states, which 
includes those 54 laboratories plus the National Veterinary Services 
Laboratories (NVSL), the Department of the Interior (DOI) laboratory in 
Madison, WI; and the Food Safety and Inspection Service (FSIS) 
laboratory in Athens, GA. All of the above preparations have us well 
positioned to respond to animal health emergencies and to safeguard the 
animal health in the United States.
Animal Disease Eradication and Control Programs
    In the event diseases are introduced or have existed in the United 
States, a key component of APHIS' VS program is its role in 
eradicating, controlling, or preventing diseases that threaten the 
biological and commercial health of U.S. livestock and poultry 
industries. Diseases targeted in VS eradication programs include 
scrapie in sheep and goats, tuberculosis in cattle and cervids, 
pseudorabies and brucellosis in swine, and brucellosis in cattle and 
bison.
    APHIS' animal disease control and eradication programs generally 
include many of the same features. The programs center on regulatory 
measures that include, for example, quarantines to stop the movement of 
possibly infected or exposed animals; the establishment of state 
statuses, including regions or zones located therein that allow us to 
fight infection while enabling commerce to continue; testing and 
examination to detect infection; destruction of infected (sometimes 
exposed) animals to prevent further disease spread; treatment to 
eliminate parasites; vaccination in some cases; and cleaning and 
disinfection of contaminated premises. Advancements in these program 
areas have come through exhaustive work with states and industry over 
the years. There have been successes in several key eradication 
programs.
Pseudorabies
    One eradication program that has seen significant advances over the 
years is the pseudorabies program. Pseudorabies emerged as an 
economically important disease of swine in the late 1960s. After a 
virulent strain of pseudorabies virus (PRV) caused concentrated 
outbreaks in the Midwest in the 1970s, the Livestock Conservation 
Institute (now the National Institute for Animal Agriculture) set up a 
task force in the 1980s that defined two state stages and established 
the National Pseudorabies Control Board to oversee and determine the 
status of each state. In 1989, APHIS published the program standards 
for a plan to eradicate pseudorabies from commercial swine production 
by 2000. By 1999, the U.S. infection rate was down to less than one 
percent of all swine herds (about 1,000 herds), and the Accelerated 
Pseudorabies Eradication Program was established to remove the last 
infected domestic commercial herds through depopulation by the end of 
2004, but accomplished this by early 2003.
    Conducted in cooperation with state governments and swine 
producers, the National Pseudorabies Eradication Program eliminated 
pseudorabies from domestic commercial herds in all states, Puerto Rico, 
and the U.S. Virgin Islands by the end of 2004. As documented in the 
Pseudorabies Program Standards, program measures are based on 
prevention, vaccination (now largely discontinued), disease 
surveillance, and eradication. Primary program activities include 
surveillance, herd certification, and herd cleanup.
    Currently, there are no known domestic production swine herds 
infected with PRV in the United States. Nationally, 18 transitional 
herds, which are any herds with pigs that were exposed to feral or wild 
pigs, were disclosed through surveillance as infected with PRV during 
FY 2007. All herds were depopulated promptly. Complete epidemiologic 
investigations of all cases disclosed no evidence that infection had 
spread from the infected transitional herds to any contact herds. 
Extensive surveillance activities over the past 3 years also suggest 
that no commercial production farms have been infected.
    A comprehensive surveillance plan for PRV, specifically for rapidly 
detecting PRV introduction into commercial swine, was completed in 
2007. Although pseudorabies has been eradicated from commercial 
production swine, it is still endemic in feral swine and can be found 
occasionally in transitional swine herds. The distribution of feral 
swine continues to expand, with an estimated three million to four 
million feral swine now located in at least 35 states. Therefore, 
surveillance for PRV continues to be a priority for APHIS, particularly 
with respect to addressing the new challenge of wildlife disease 
reservoirs in feral swine populations. This prioritization of 
pseudorabies is consistent with the sense of Congress in the Food, 
Conservation, and Energy Act of 2008 (P.L. 110-246, 122 Stat. 1651) 
that pseudorabies eradication is a high priority the Secretary of 
Agriculture should carry out under the Animal Health Protection Act (7 
U.S.C. 8301 et seq.).
Brucellosis
    Another animal disease eradication program that I would like to 
highlight for you is the brucellosis program. USDA has been working 
with state and industry cooperators to eradicate brucellosis for many 
years. The disease affects numerous species of animals, including 
humans, and is caused by the bacteria Brucella abortus. Cattle, bison, 
and elk are especially susceptible to the disease.
    The Brucellosis Eradication Program was launched on a national 
scale in 1934, and a cooperative effort among the Federal Government, 
states, and livestock producers began in 1954. All states participate 
in APHIS' Cooperative State-Federal Brucellosis Eradication Program and 
are assigned a brucellosis classification by APHIS. These 
classifications--Class Free, Class A, Class B, and Class C--are based 
on herd prevalence rates for the disease and require various levels of 
movement restrictions and surveillance activities. Most importantly to 
cattle producers, restrictions on moving cattle interstate become less 
stringent as a state approaches or achieves Class Free classification.
    The program has been highly effective. In 1956, 124,000 affected 
herds were found in the United States as a result of testing. By 1992, 
this number had dropped to 700, and as of today, there are only four 
known affected domestic cattle or bison herds remaining in the entire 
United States. Currently, 49 states, Puerto Rico, and the U.S. Virgin 
Islands are considered free of brucellosis. Montana is the last 
remaining Class A status state. I am also pleased to report that annual 
brucellosis-related losses due to aborted fetuses, reduced breeding 
efficiency, and lowered milk production have decreased from more than 
$400 million in 1952 to almost zero today.
    The Greater Yellowstone Area (GYA), which encompasses approximately 
20 million acres in three states, is the last known reservoir of 
brucellosis in wild elk and bison in the United States. While 
management of the disease is our approach for the near term, our long 
term goal is to eliminate brucellosis from GYA wildlife, along with 
protecting the elk and bison populations from the disease. I should 
note that brucellosis in elk is widespread across the entire GYA, and 
indications are that all disease transmissions from wildlife to cattle 
in the GYA have come from elk. Transmission can occur through direct 
contact between infected elk or bison and non-infected cattle if they 
are allowed to co-mingle. Approximately 90 percent of GYA elk fall 
under state jurisdiction during the summer season.
    Surveillance testing of wild bison from the Yellowstone herd 
indicates that approximately 50 percent of the bison in the 2 million 
acre Park have been exposed to and are potentially infected with the 
disease. This disease reservoir poses a risk to cattle that graze on 
lands adjacent to the Park.
    APHIS works with the GYA States, the cattle industry, and the 
National Park Service to address the risk of brucellosis transmission 
from wildlife leaving the Park to cattle that graze in surrounding 
areas. Our sister agency within USDA, the U.S. Forest Service, also 
plays a key role in managing the public lands on the Gallatin National 
Forest, adjacent to Yellowstone National Park in Montana. The current 
Interagency Bison Management Plan carefully balances the need to 
preserve the Yellowstone bison herd with the need to prevent the spread 
of brucellosis from bison to cattle.
    USDA and the Department of the Interior (DOI) believe the next step 
is to develop a long-term plan for the elimination of brucellosis from 
the GYA. USDA and DOI have agreed to a draft a Greater Yellowstone 
Interagency Brucellosis Committee (GYIBC) Memorandum of Understanding 
and have forwarded it to the Governors of Idaho, Montana, and Idaho for 
their review and signature.
Monitoring and Surveillance for Diseases That Affect Production and 
        Marketing
    A key role of APHIS is the monitoring and surveillance for diseases 
of major impact on animal production and marketing. This includes 
monitoring animal health and production trends; facilitating the use of 
new technologies for early and rapid disease detection, response, and 
data analysis; and capturing, analyzing, interpreting, and 
disseminating data using standardized methods.
National Animal Identification System (NAIS)
    One of our more recently developed technologies for swift and 
effective disease response is the National Animal Identification 
System, or NAIS. NAIS is a modern, streamlined information system that 
helps producers and animal health officials respond quickly and 
effectively to animal disease events in the United States. from the 
beginning, NAIS has been a cooperative effort among states, APHIS, and 
industry.
    There are three components of NAIS--premises registration, animal 
identification, and animal tracing. Through NAIS, APHIS' ultimate, 
long-term goal is to have the capacity to identify all premises and 
animals that have had contact with a FAD or domestic animal disease of 
concern within 48 hours after its discovery.
    Our initial focus in developing NAIS has been to encourage farmers 
and ranchers to register their premises. Registering premises provides 
animal health officials with the key information needed to conduct 
disease investigations quickly and efficiently. To date, more than 
482,000 premises had been registered within the states, tribes and 
territories. This total represents more than 34 percent of the 
estimated number of premises nationwide. Thanks to the support and 
outreach efforts of our state and industry partners, NAIS continues to 
build momentum.
    APHIS is also working to accelerate participation in the animal-
identification component of the system. In terms of animal tracing, 
we've established 14 state and private databases to keep track of 
animal movements. We've also developed a system that will allow 
authorized state and Federal animal health officials to request 
information from these databases during an animal disease event.
    By working together with the public and with our partners, we will 
continue to increase our ability to respond to animal diseases and 
guarantee that we are successful in protecting the health and 
marketability of American agriculture.
Data Collection and Other Activities Related to the Use of Antibiotics 
        in Livestock
    Another area where APHIS, along with other agencies with the USDA, 
has contributed to advances in the livestock industry is in the 
collection of data related to animal health issues using standardized 
methods. Over the past several years, one such issue that has captured 
national attention is the use of antibiotics in livestock.
    As you may know, several Federal agencies have in place programs to 
learn more about, track, and reduce antimicrobial resistance in 
animals. Many of these activities are joint activities among several 
Federal agencies and are supported by the agricultural industries. In 
fact, in 1999, the U.S. Interagency Task Force on Antimicrobial 
Resistance was created to develop a national plan to combat 
antimicrobial resistance. The Task Force is co-chaired by the Centers 
for Disease Control and Prevention, the Food and Drug Administration 
(FDA), and the National Institutes of Health and also includes USDA, 
the Agency for Healthcare Research and Quality, the Health Care 
Financing Administration, the Health Resources and Services 
Administration, the Department of Defense, the Department of Veterans 
Affairs, and the Environmental Protection Agency. Within USDA, agencies 
that have contributed to the Task Force activities include APHIS, the 
Agricultural Research Service (ARS), the Food Safety and Inspection 
Service (FSIS), and CSREES.
    The first is surveillance. In 1996, HHS and USDA, in cooperation 
with several state and local health departments, established the 
National Antimicrobial Resistance Monitoring System--NARMS. The goal of 
the system is to provide data on the prevalence of antibiotic 
resistance in animals, humans, and retail foods. This monitoring system 
has been operating for about 10 years and has provided critical 
information on emerging resistance trends. USDA supports NARMS through 
three of its agencies. FSIS contributes isolates from its regulatory 
program for Salmonella and isolates of Campylobacter from its 
microbiological baseline data collection surveys. APHIS contributes 
isolates from clinically ill animals and isolates from healthy animals 
on farms. And, ARS conducts all testing and analysis of isolates 
collected by USDA. The impact of NARMS has been to assist the FDA in 
regulatory decision making on animal antimicrobial drugs, practitioners 
on prudent use practices, and commodity organizations on quality 
improvement.
    In addition, APHIS has been collecting an increasing amount of data 
on production practices and samples containing bacteria that have been 
used to evaluate levels and impacts of antimicrobial use on livestock 
operations throughout the United States. This data and the samples are 
collected through the National Animal Health Monitoring System (NAHMS), 
which conducts national studies on the health and health management of 
United States domestic livestock and poultry populations. Bacterial 
isolates gathered via NAHMS have been tested for antibiotic resistance 
and included in the NARMS. The data collected yielded information on, 
among other things, the types of antimicrobials used to treat various 
common diseases in animal populations, how producers decide to treat 
and what to treat with, how antimicrobial drugs are delivered to the 
animals (via feed, water, or parenterally), and primary influencers on 
the antimicrobial drug decision-making process. All of these factors 
are critical to understanding the ways to optimize antimicrobial drug 
use in animal populations.
    APHIS, in collaboration with ARS, has also been collecting samples 
to be cultured for bacteria as part of the NAHMS program, which are 
subsequently evaluated for antimicrobial drug resistance as part of the 
NARMS program. These studies provide information on the extent of 
antimicrobial drug resistance among potential foodborne pathogens and 
commensal organisms in livestock populations. Such information is 
critical to risk assessments that evaluate the potential for transfer 
of the resistant organism or resistance determinants through the food 
chain. To date, the NAHMS program has collected antimicrobial drug use 
and antimicrobial drug resistance data from 11 studies conducted 
between 1994 and 2008.
    Finally, in 2003, APHIS, ARS, and FSIS undertook a pilot project 
that was designed to complement the NARMS and the NAHMS. The mission of 
the Collaboration in Animal Health and Food Safety Epidemiology 
(CAHFSE) was to monitor bacterial resistance to antimicrobial drugs on 
farms over time and to evaluate the potential for resistant organisms 
to persist in food products from animals from the farms under study. 
Health and health management data were collected on the same operations 
where repeated samples were collected over time. The CAHFSE project was 
concluded in 2005.
    In addition to the data collection and surveillance activities that 
we are involved in, I would also like to mention two additional 
activities that other USDA agencies participate in with respect to the 
use of antibiotics in livestock: (1) Research and (2) prevention and 
control.
    In terms of research, ARS conducts hypothesis-driven research on 
various topics relevant to use of antibiotics in livestock. This 
includes research on the mechanisms of resistance development and 
transfer of resistance genes; the potential mitigation for resistance 
alternatives for antibiotic use in livestock; and alternatives to 
antibiotics for subtherapeutic use and potential interventions for 
foodborne pathogens that could affect resistance development. ARS also 
develops technologies for the detection and characterization of 
antibiotic resistance genes in foodborne pathogens, such as Salmonella, 
Campylobacter, and E. coli.
    In addition to ARS' research, a growing segment of CSREES' directed 
funding had been dedicated to research on antimicrobial resistance. 
from 1999-2008 there have been over thirty research, education and 
extension competitive grants funded by CSREES in the area of antibiotic 
resistance. The competitive grants, totaling over $17 million, were 
funded primarily through the National Integrated Food Safety 
Initiative, the National Research Initiative's (NRI) Epidemiological 
Approaches for Food Safety, and the NRI Microbiological Approaches for 
Food Safety; three flagship competitive grant programs administered by 
CSREES. These grants were funded at various land grant universities, 
professional societies, and other 4 year universities throughout the 
country. The research focuses on a variety of foodborne pathogens as 
they relate to antimicrobial/antibiotic resistance including Listeria 
monocytogenes, Salmonella, E. coli, E. coli O157:H7, and Campylobacter. 
Many of these studies are ongoing.
    Prevention and control is an area of emphasis within USDA, both 
domestically and internationally. On the domestic front, I would like 
to highlight that, while the FDA regulates the use of drugs given to 
food animals--including determining what drugs are permitted, what they 
can be used for, and setting the tolerance levels for those drugs in 
food animal tissues--FSIS is responsible for verifying the tolerance 
levels for antibiotics set forth by FDA. To accomplish this, FSIS 
collects samples of meat, poultry, and egg products at federally-
inspected establishments and analyzes these samples at FSIS 
laboratories for chemical residues of veterinary drugs, among other 
things.
    Since 1967, FSIS has administered the National Residue Program 
(NRP) to collect data on chemical residues in domestic and imported 
meat, poultry, and egg products. The NRP is designed to provide a 
structured process for identifying and evaluating compounds of concern 
by production class, statistical analyses of compounds of concern, 
appropriate regulatory follow-up of reports of violative tissue 
residues, and collection, analyses, and reporting of the results of 
these activities. When a violation of tolerance levels is found, FSIS 
notifies FDA of the violation and assist in obtaining the names of 
producers and other parties involved in offering animals for sale.
    Internationally, USDA has also taken an active role in the 
development of harmonized approaches and guidance on the use of 
antibiotics. For example, representatives from the USDA, including ARS 
and FSIS, are part of the ad hoc Intergovernmental Task Force on 
Antimicrobial Resistance that was established by the twenty-ninth 
Session of the Codex Alimentarius Commission. Its mandate is to develop 
science-based guidance, taking full account of its risk analysis 
principles and the work and standards of other relevant international 
organizations, such as FAO, WHO, and OIE. The intent of this guidance 
is to assess the risks to human health associated with the presence in 
food and feed including aquaculture and the transmission through food 
and feed of antimicrobial resistant microorganisms and antimicrobial 
resistance genes and to develop appropriate risk management advice 
based on that assessment to reduce such risk. The first session of the 
Task Force was held in October 2007. The session was very productive 
and resulted in the development of three project documents on risk 
assessment, risk management and risk profiling based upon project 
proposals submitted in response to the Circular Letter request for 
proposals for new work. The next session is scheduled for this fall.
Conclusion
    As the comments above indicate, we have made tremendous progress in 
collaborating with our partners in the U.S. Government and industry 
that have a stake in protecting public and animal health. Expanding 
current partnerships with the livestock industry, as well as other 
global and domestic stakeholders, will continue to be critical in 
realizing advances of animal health within the livestock industry and 
ensuring the health of our nation's domestic animal resources.

    The Chairman. Well, thank you, Dr. Clifford, and I think we 
will go ahead and ask Dr. Dunham to share, and then we will 
come to questions following that.
    But before Dr. Dunham delivers her testimony on behalf of 
the Food and Drug Administration, I feel it necessary to 
express a concern and frustration with the FDA that I have. 
This hearing was originally planned for June 24 but had to be 
postponed because we couldn't get a witness from the Center for 
Veterinary Medicine. It is my full belief that someone from the 
CVM, Center for Veterinary Medicine, would be the most 
qualified to discuss advances in animal health within the 
livestock industry, hence the title of this hearing. Today the 
FDA has provided us with such a witness. However, in comparing 
the testimony that was delivered by Dr. Linda Tolson on June 24 
to the Senate Health Committee and the testimony delivered 
today by Dr. Dunham, they seem to be the same. The testimony 
spends nearly 95 percent of its time talking about public 
health and completely ignores the topic of the hearing of 
advances in animal health within the livestock industry. Now, I 
understand the FDA has a message they want to get across but 
not taking the subject of this hearing seriously is a concern.
    Dr. Dunham, please begin when you are ready.

         STATEMENT OF BERNADETTE DUNHAM, D.V.M., Ph.D.,
    DIRECTOR, CENTER FOR VETERINARY MEDICINE, FOOD AND DRUG 
 ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, 
                         ROCKVILLE, MD

    Dr. Dunham. Thank you very much. Good morning, Mr. 
Chairman, Members of the Subcommittee. I am Dr. Bernadette 
Dunham, Director of the Center for Veterinary Medicine at the 
Food and Drug Administration. Thank you for the opportunity to 
discuss FDA's role with regard to antimicrobial resistance.
    Preserving the effectiveness of existing antimicrobial 
drugs, 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 resistant to at least one drug. The trends 
towards increasing numbers of infections and increasing drug 
resistance show no sign of abating. Resistant pathogens lead to 
higher healthcare costs because they often require more 
expensive drugs and extended hospital stays. Resistant 
infections impact clinicians practicing in every field of 
medicine, including veterinarians.
    The problem is not limited to hospitals or traditional 
healthcare settings. Community-acquired infections are also 
frequently resistant to multiple antimicrobial drugs such as 
community-acquired methicillin resistant Staphylococcus aureus, 
common respiratory pathogens including Streptococcus 
pneumoniae, and gram-negative bacilli, which can affect humans 
through contaminated food.
    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 may contribute to the emergence of 
resistant microorganisms that can infect people. Through 
international trade and travel, resistant microbes can spread 
quickly worldwide.
    Antimicrobial agents have been used in human and veterinary 
medicine for more than 50 years with tremendous benefits to 
both human and animal health. However, after several decades of 
successful antimicrobial use, we continue to see the emergence 
of multi-resistant bacterial pathogens which are less 
responsive to therapy. The emergence of antimicrobial resistant 
bacterial populations is a complicated phenomenon and is 
attributed in part to the combined impact of the various uses 
of antimicrobial drugs in both humans and animals.
    FDA co-chairs, along with the Centers for Disease Control 
and Prevention and the National Institutes of Health, the U.S. 
Interagency Task Force on Antimicrobial Resistance, which was 
created in 1999 to develop a national plan to combat 
antimicrobial resistance. In 2001, the Task Force published the 
Public Health Action Plan to Combat Antimicrobial Resistance. 
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 state and local 
health agencies, universities, professional societies, 
pharmaceutical companies, healthcare delivery organizations, 
agricultural producers, consumer groups and other stakeholders. 
The Action Plan has four major components: surveillance, 
prevention and control, research, and product development.
    Since 1996, FDA has actively addressed the issue of 
antimicrobial resistance. For example, FDA's Center for 
Veterinary Medicine is addressing potential human health risks 
associated with the use of antimicrobial drugs in food-
producing animals. As part of the new animal drug approval 
process, CVM developed and implemented an approach for 
assessing antimicrobial resistance concerns associated with the 
use of antimicrobial drugs intended for use in food-producing 
animals. This approach uses risk assessment methodologies to 
assess the potential human health impact from the proposed 
antimicrobial use in animals and outlines risk management 
strategies that may be applied. CVM is also applying the basic 
principles of this approach to an ongoing review of currently 
approved antimicrobial drugs. CVM believes that, while these 
potential public health concerns must be addressed, it is 
critical that veterinarians continue to have access to 
effective antimicrobial drugs for the treatment, control and 
prevention of disease in animals.
    Other key components of CVM's strategy for addressing 
antimicrobial resistance include robust research and monitoring 
programs, as well as educational outreach activities. CVM is 
actively conducting research to advance our understanding of 
antimicrobial resistance mechanisms and to support our 
regulatory decisions. CVM is the lead coordinator of the 
National Antimicrobial Resistance Monitoring System, referred 
to as NARMS. It is a multifaceted 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. 
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.
    FDA'S other Centers are also actively working on 
antimicrobial resistance. FDA's Center for Drug Evaluation and 
Research has launched several initiatives to address 
antimicrobial resistance, including regulating drug labels, 
emphasizing the prudent use of systemic antibacterial drugs in 
humans, and revising its guidance to industry on the 
development of drugs for the treatment of bacterial infections.
    FDA's Center for Biologics Evaluation and Research is 
focused on the development and continued availability of 
effective vaccines. Prevention of infections through the use of 
vaccines has markedly decreased antimicrobial resistance by 
reducing or nearly eliminating some types of infections. 
Vaccines also contribute to the control of resistance by 
reducing the need for antimicrobials.
    In addition, development of increasingly sensitive 
diagnostic assays for detection of resistance allows for 
rational, targeted antibiotic use. FDA's Center for Devices and 
Radiological Health leads several efforts to clarify regulatory 
requirements to both industry and the scientific community on 
clearance of diagnostic tests for use in antimicrobial 
resistance initiatives.
    In conclusion, I would like to mention that USDA and FDA 
are cosponsoring a meeting this afternoon to discuss agenda 
items and to present draft U.S. positions on them for the 
upcoming second session of the Codex ad hoc Intergovernmental 
Task Force on Antimicrobial Resistance to be held in Korea, 
October 20 through 24, 2008. The public meeting will be held at 
our Rockville facility in Maryland between 1 and 3 p.m. this 
afternoon. The antimicrobial resistance task force was 
established in 2006 to develop science-based guidance to be 
used to assess the risks to human health associated with the 
presence in food and feed, including aquaculture, and the 
transmission through food and feed of antimicrobial resistance 
microorganisms and genes. FDA will continue to work with 
Federal, state, local and foreign government officials, medical 
professionals including the veterinary community, the regulated 
industry and all of our FDA stakeholders in developing sound 
strategies to address and advance both human and animal health.
    Thank you for the opportunity to discuss FDA's role with 
regard to antimicrobial resistance, and I would be happy to 
answer any of your questions.
    [The prepared statement of Dr. Dunham follows:]

   Prepared Statement of Bernadette Dunham, D.V.M., Ph.D., Director, 
  Center for Veterinary Medicine, Food and Drug Administration, U.S. 
         Department of Health and Human Services, Rockville, MD
Introduction
    Good morning, Mr. Chairman and Members of the Subcommittee. I am 
Bernadette Dunham, D.V.M., Ph.D., Director of the Food and Drug 
Administration's (FDA or the agency) Center for Veterinary Medicine 
(CVM), which is a part of the Department of Health and Human Services 
(HHS). Thank you for the opportunity to discuss FDA's role with regard 
to antimicrobial resistance.
    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. Community-acquired infections are 
also frequently resistant to multiple antimicrobial drugs, such as 
community-acquired methicillin-resistant Staphylococcus aureus (CA-
MRSA), common respiratory pathogens including Streptococcus pneumoniae, 
and gram-negative bacilli, which can infect humans through contaminated 
food.
    In my testimony, I will provide background information on 
antimicrobial resistance, discuss FDA's involvement with the 
Interagency Task Force on Antimicrobial Resistance, and describe FDA's 
actions to combat resistance and promote product development.
Background
    Antimicrobial drugs are used to treat infections caused by 
microorganisms. The term ``antimicrobial'' refers broadly to drugs with 
activity against a variety of microorganisms including bacteria, 
viruses, fungi, and parasites (such as malaria). The term 
``antibacterial'' refers to drugs with activity against bacteria in 
particular. Another term commonly used to describe an antibacterial 
drug is ``antibiotic.'' This term refers to a natural compound produced 
by a fungus or another microorganism that kills bacteria that cause 
disease in humans or animals. Some antibacterial drugs are synthetic 
compounds; i.e., they are not produced by microorganisms. Though these 
do not meet the technical definition of antibiotics, they are referred 
to as antibiotics in common usage.
    Antimicrobial resistance is the ability of bacteria or other 
microbes to resist the effects of a drug. Antimicrobial resistance 
occurs when bacteria change in some way that reduces or eliminates the 
effectiveness of drugs, chemicals, or other agents designed to cure or 
prevent infections.
    Many factors contribute to the spread of antimicrobial resistance. 
In some cases, doctors prescribe antimicrobials too frequently or 
inappropriately. Sometimes patients do not complete the prescribed 
course of an antimicrobial, making it more likely that surviving 
microbes will develop resistance. Antimicrobial use in animals may 
contribute to the emergence of resistant microorganisms that can infect 
people. Through international trade and travel, resistant microbes can 
spread quickly worldwide.
    Antimicrobial agents have been used in human and veterinary 
medicine for more than 50 years, with tremendous benefits to both human 
and animal health. Many infections that were fatal, or left individuals 
with severe disabilities, are now treatable or preventable. However, 
because resistance to antimicrobial drugs is expected to occur with 
their use, it is essential that such drugs be regulated and used 
judiciously to delay the development of resistance. Misuse and overuse 
of these drugs contribute to an even more rapid development of 
resistance. After several decades of successful antimicrobial use, we 
have seen and continue to see the emergence of multi-resistant 
bacterial pathogens, which are less responsive to therapy. 
Antimicrobial-resistant bacterial populations are emerging because of 
the combined impact of the various uses of antimicrobial drugs, 
including their use in humans and animals. All of these pathways are 
not yet clearly defined or understood.
    New classes or modifications of older classes of antimicrobials 
over the past 6 decades have been matched slowly but surely by the 
systematic development of new bacterial resistance mechanisms. 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
    To address these challenges, 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), 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'' (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, healthcare 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 
        healthcare 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. CVM has developed, in conjunction with 
        stakeholders, in-depth antimicrobial prudent use principles for 
        beef, dairy, swine, poultry, 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 U.S. 
        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 is currently updating the Action Plan for the next 5 
years.
FDA Accomplishments on Antimicrobial Resistance
    Since 1996, FDA has actively addressed the issue of antimicrobial 
resistance. As an agency composed of several product centers, FDA has 
addressed antimicrobial resistance through a variety of initiatives, 
primarily through four key areas: surveillance, product development, 
education, and research.

   Surveillance: Monitoring and surveillance of antimicrobial 
        resistance and then promptly and effectively responding to 
        current threats from drug resistance.

   Product Development: Facilitating and encouraging 
        development and appropriate use of products, including new 
        drugs and vaccines, and improved, more timely tests for 
        infectious diseases.

   Education: Facilitating the safe and effective use of 
        antimicrobials and thus prolonging the life of these products 
        by helping improve the quantity and quality of information 
        available to consumers and health professionals regarding 
        antimicrobial resistance and principles of appropriate usage. 
        In addition, FDA has an important role in informing the public 
        and healthcare professionals both through educational outreach 
        and by assuring useful and accurate product labeling and 
        appropriate marketing.

   Research: Maximizing and coordinating FDA's scientific 
        research to address needs in antimicrobial resistance.

    Specific activities by the various Centers within FDA include the 
following:
Center for Veterinary Medicine (CVM)
    CVM is addressing potential human health risks associated with the 
use of antimicrobial drugs in food-producing animals. CVM's approach 
uses risk assessment methodologies to quantify the human health impact 
from antimicrobial use in animals, in conjunction with robust 
monitoring, research, and risk management. CVM is actively conducting 
research to advance our understanding of antimicrobial resistance 
mechanisms and to support our regulatory decisions. The agency also 
continues to participate in public meetings with stakeholders 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.
    One of the key components of CVM's strategy to assess relationships 
between antimicrobial use in agriculture and subsequent human health 
consequences is 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.
    As part of the new animal drug approval process, CVM developed and 
implemented an approach for assessing antimicrobial resistance concerns 
associated with the use of antimicrobial drugs intended for use in 
food-producing animals. This approach uses risk assessment 
methodologies to assess the potential human health impact from the 
proposed antimicrobial use in animals and outlines risk management 
strategies that may be applied. In 2003, FDA published Guidance for 
Industry #152 (``Evaluating the Safety of Antimicrobial New Animal 
Drugs with Regard to their Microbiological Effects on Bacteria of Human 
Health Concern''). Guidance #152 provides recommendations to drug 
sponsors on the use of a qualitative risk assessment approach for 
evaluating the likelihood that an antimicrobial drug used to treat a 
food-producing animal may cause an antimicrobial resistance problem in 
humans. The risk assessment approach recommended in the guidance 
considers a broad set of information, including the importance of the 
drug in question to human medicine. This information is collectively 
considered in determining whether the proposed antimicrobial product 
will pose a risk to public health.
    CVM is also applying the basic principles of this approach to an 
ongoing review of currently approved antimicrobial drugs. While 
potential public health concerns must be addressed, it is critical that 
veterinarians continue to have access to effective antimicrobial drugs 
for the treatment, control, and prevention of disease in animals.
    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.
Center for Drug Evaluation and Research (CDER)
    CDER has launched several initiatives to address antimicrobial 
resistance. Through CDER's initiatives, FDA has issued drug labeling 
regulations emphasizing the prudent use of systemic antibacterial drugs 
in humans. The regulations encourage healthcare professionals to 
prescribe these antibacterial drugs only when clinically necessary and 
to counsel patients about the proper use of such drugs and the 
importance of taking them as directed.
    Over the last several years, CDER has been evaluating the design of 
clinical trials that are used to study the safety and efficacy of drugs 
for the treatment of a variety of infections. CDER recognizes the 
importance of ensuring that antibacterial drugs are approved based on 
sound, informative clinical trials, because the clinical use of 
marginally effective antimicrobials can contribute to the development 
of antimicrobial resistance. For milder infections that are often self-
resolving over time, we are recommending different types of studies 
than what were used in the past. The agency is doing this in order to 
have studies that have the capacity to provide informative data to 
assess an antimicrobial drug's effects in these milder conditions. It 
is essential that clinical trials evaluating a new drug be performed in 
a manner that allows for assessment of the benefits and the risks of 
the drug in the condition under study. A better assessment of the 
benefits that a drug may provide and balancing these benefits with 
risks should provide better quality information on antimicrobial drugs 
to foster appropriate use and ideally reduce inappropriate use that is 
also contributing to the development of resistance.
    To that end, CDER has been revising its guidance to industry on the 
development of drugs for the treatment of bacterial infections. Since 
October 2007, CDER has issued four such guidance documents. In January 
of this year, FDA co-sponsored a workshop with the Infectious Diseases 
Society of America to discuss clinical trial designs for community 
acquired pneumonia (CAP). The agency also convened an advisory 
committee meeting in April 2008 to get additional advice and the agency 
is now writing a draft guidance document that will provide the agency's 
thinking on informative trial designs in CAP. By providing these draft 
guidance documents on developing drugs for these conditions we have 
provided some clarity on the types of study designs that will be 
informative in these conditions.
    Most of the discussion of drug development has focused on 
resistance in common bacterial infections, but resistance is also a 
problem in conditions such as tuberculosis (TB), fungal infections, and 
malaria. CDER has participated in a working group with other 
representatives from FDA and the European Medicines Agency to discuss 
strategies for developing drugs for TB. CDER also published a draft 
guidance document describing approaches to the development of drugs for 
malaria in June of 2007.
    Appropriate use of antimicrobial drugs is guided not only by 
understanding the safety and effectiveness of risks and benefits of 
these drugs, but also by having information on whether a particular 
drug is active against a patient's infection when culture results are 
available. Laboratory testing to assess whether a bacterial isolate is 
``susceptible'' to a particular antimicrobial drug can provide such 
information. There are a number of antibacterial drug labels that are 
in need of updating of the information on susceptibility testing. FDA 
recently published a draft guidance document on ``Updating Labeling for 
Susceptibility Test Information in Systemic Antibacterial Drug Products 
and Antimicrobial Susceptibility Testing Devices'' (published June 
2008). This draft guidance, in compliance with section 1111 of the Food 
and Drug Administration Amendments Act of 2007 (FDAAA), describes 
options for updating the antibacterial susceptibility testing 
information in antibacterial drug product labeling and we believe could 
facilitate the timely updating of this information.
    Section 1112 of FDAAA requires FDA to convene a public meeting to 
consider ``which serious and life threatening infectious diseases, such 
as diseases due to gram-negative bacteria and other diseases due to 
antibiotic-resistant bacteria, [would] potentially qualify for 
available grants and contracts under section 5(a) of the Orphan Drug 
Act . . . or other incentives for development.'' In compliance with 
Section 1112 of FDAAA, FDA held a public hearing on April 28, 2008, to 
discuss, in part, potential incentives to encourage pharmaceutical 
companies to develop new antimicrobial drugs.
Center for Biologics Evaluation and Research (CBER)
    Research and regulatory efforts have contributed to the development 
and continued availability of effective vaccines which have eliminated 
or markedly decreased antimicrobial resistance by reducing or even 
nearly eliminating some types of infections. Other vaccines contribute 
by reducing the need for use of antimicrobials. CBER has initiated a 
new research program to facilitate vaccine development to prevent MRSA 
and has ongoing research programs to foster the development of vaccines 
to prevent other frequent infectious diseases problems such as 
Salmonella or E. coli gastroenteritis, and TB, as multidrug-resistance 
has emerged as a national and international threat to health. In 
addition, CBER works with sponsors to develop safe and effective 
vaccines against emerging infectious diseases problems. Additional 
efforts at CBER address new diagnostic tests and evaluation of emerging 
technologies and test kits for detecting bacteria as it relates to 
transfusion medicine, mechanisms of resistance, alternative therapies 
for highly resistant organisms, and regulatory pathways to assess the 
potential value of probiotics to help reduce the development and spread 
of antimicrobial-resistant bacteria.
Center for Devices and Radiological Health (CDRH)
    CDRH leads several efforts to clarify regulatory requirements to 
both industry and the scientific community on clearance of diagnostic 
tests for use in antimicrobial resistance initiatives. For example, 
CDRH assisted device manufacturers to get an alternative method for 
detecting vancomycin resistant Staphylococcus aureus to market and 
assured timely introduction of this critically important new product 
through use of its expedited review process. CDRH has published 
guidance documents to ensure the safe and effective use of in vitro 
diagnostics for detecting novel influenza A or A/B viruses from human 
specimens. CDRH recently cleared a new assay developed by CDC for the 
detection of human infection with H5 Avian Influenza virus. CDRH also 
recently cleared a rapid test for confirming methicillin resistant 
Staphylococcus aureus, a rapid DNA test for detecting Group B 
Streptococcus in pregnant women, and a rapid test for detecting Shiga 
toxins one and two produced by E. coli in stool specimens to aid in the 
diagnosis of diseases caused by enterohermorrhagic E. coli infections.
Conclusion
    In conclusion, I would like to note that USDA and FDA are 
cosponsoring a meeting this afternoon to discuss agenda items and to 
present draft U.S. positions on them for the upcoming second session of 
the Codex ad hoc Intergovernmental Task Force on Antimicrobial 
Resistance (AMR) to be held in Korea, October 20-24, 2008. The public 
meeting will be held at CVM's Rockville, Maryland, offices between 1:00 
and 3:00 p.m. today. This AMR Task Force was established in 2006 to 
develop science-based guidance to be used to assess the risks to human 
health associated with the presence in food and feed, including 
aquaculture, and the transmission through food and feed of 
antimicrobial resistant microorganisms and genes. FDA will continue to 
work with Federal, state, local and foreign government officials, 
medical professionals including the veterinary community, the regulated 
industry and all of FDA's stakeholders, in developing sound strategies 
to address and advance both human and animal health.
    Thank you for the opportunity to discuss FDA's activities with 
regard to antimicrobial resistance. I would be happy to answer any 
questions.

    The Chairman. Well, thank you very much. I appreciate you 
being here and your statement.
    In taking note of the written testimony presented by the 
second panel, who will be talking to us shortly about their 
concern about the importance of FARAD, as I stated earlier, on 
July 10, Representative Hayes and I sent a letter to both USDA 
and FDA stressing the importance of the program, and also to 
provide emergency funding to keep the program operating. Over 2 
months later, here we are with no response from either agency, 
so what is the status of the funding for this program, either 
of you?
    Dr. Dunham. As you know, this program has actually been 
based within USDA CSREES for a very long time. With the 2008 
Consolidated Appropriations Act, USDA did not receive any 
appropriated funds to support the FARAD program, and we are 
currently working with a lot of the stakeholders to look at 
some potential, alternative mechanisms that may be available to 
assist with this program. I do agree that it is a very 
important program, and we are certainly hoping to be able to 
get back to you with some very positive results.
    The Chairman. Dr. Clifford?
    Dr. Clifford. Mr. Chairman, I have with me today Rob 
Hedberg, the Acting Director for Legislative and Governmental 
Affairs from CSREES, and I would ask that he respond to this 
question.
    The Chairman. Okay. State your name, please.
    Mr. Hedberg. My name is Rob Hedberg, and again, I am Acting 
Director of Legislative and Governmental Affairs for the USDA 
Cooperative State Research, Education, and Extension Service. 
Unfortunately, we do fully understand your concerns about the 
FARAD program. We have been active in management of this 
program for many years. We recognize the letter of the request 
for $2.5 million to provide bridge funding for this program, 
but the reality is that the program was last appropriated in 
2006, and since then there were no funds provided in 
appropriations in 2007 or 2008. It has been pointed out for 
2008, funds were provided by both FDA and USDA CSREES to 
provide just short of $1 million, which was bridge funding to 
keep the doors open until now, but unfortunately, our situation 
at USDA is, we do not have the funds available to continue 
support of this program. If funds are appropriated for this 
program, we would gladly continue our administration of it 
through CSREES.
    The Chairman. Well, I appreciate you saying that. Of 
course, we are all aware that you have within the agency 
transferred money around where you see priorities and so on. I 
appreciate that, and I hope that we will get something that we 
can share with the appropriate appropriators, if you will, a 
play on words, regarding what you have just shared with us. 
Thank you very much.
    Mr. Hedberg. You are welcome. Thank you.
    The Chairman. Another question, if I could. In the decade 
that the National Antimicrobial Resistance Monitoring System, 
NARMS, has been enacted, what have you learned about the scope 
of antimicrobial resistance? How rapid has resistant bacteria 
increased in agriculture?
    Dr. Dunham. The NARMS program has been very effective and 
helpful as we tried to follow this very complex issue--where do 
you see and how do you see antimicrobial resistance developing. 
This has allowed us to team with the CDC and USDA to take a 
look at samples that have been taken from the slaughter 
facilities; and to follow these through, as we do at FDA, to 
take a look at the final retail meat products that are in the 
market. From that, we have been able to, now--courtesy of the 
technology and the DNA fingerprinting--indicate if we are 
seeing any resistant serovars, specifically looking along the 
lines of Salmonella and Campylobacter. As we are able to track 
that, we can see if there are indications of some resistance 
developing, and that allows us then to take a look in the 
science to make new decisions as to how we may or may not take 
action. So it has been very helpful and we are hoping to see 
this expand. We had an external science board review recently 
complete an overview of the NARMS and they were very impressed 
and pleased with that, so we are hoping to see this grow. Thank 
you, sir.
    The Chairman. Thank you.
    Dr. Clifford?
    Dr. Clifford. Mr. Chairman, I definitely agree with Dr. 
Dunham. These types of things are very useful. We need to use 
appropriate science and collection of data to be able to make 
decisions about animal health as well as human health and 
public safety. So we find these types of things to be very 
effective in helping address and answer these types of 
questions that are before you.
    The Chairman. Well, thank you, and before I ask Mr. Hayes 
to participate, I think it is safe for me to say that you agree 
that healthy animals produce healthy food. In your opinion, 
does the Denmark case highlight the benefits of both 
therapeutic and growth antibiotics? What comment might you make 
about the Denmark example?
    Dr. Clifford. I am sorry, Mr. Chairman. Could you repeat 
that question, please?
    The Chairman. In your opinion, does the Denmark case 
highlight the benefits for both therapeutic and growth 
antibiotics?
    Dr. Clifford. Absolutely. It certainly does. We feel that 
the therapeutic use of antibiotics is extremely important in 
animal health as well as the prevention and the prophylactic 
use of antibiotics.
    Dr. Dunham. I think with the Denmark situation, we further 
did see just how antibiotics are being used and the importance 
of antibiotics to sustain the health of our animals. I think 
part of what we saw was when there was a removal of the 
antibiotics, the therapeutic need was clear. And the catch is, 
what we are looking at is how a veterinarian will take a look 
at the animals and be able to decide, from their own training 
and understanding of disease, when to intervene to treat, 
control and prevent disease, and that it is very important to 
keep our animals healthy. I think what we saw in the long run 
after the Denmark study was, at the time they did a complete 
ban, it clearly showed us that the antibiotics were working to 
address a pathogen and they ended up coming back with the 
therapeutic use of that drug. At that time we probably saw just 
where that was important. Weanling pigs, for example, will 
outbreak with diarrheal disease if you are not able to 
intervene and treat those animals.
    The Chairman. Thank you. I will have some more questions, 
but I would like to yield to Mr. Hayes.
    Mr. Hayes. Thank you, Mr. Chairman.
    Dr. Clifford, as you suggest, disease prevention is much 
more economical than treatment. In the context of the debate 
over the judicious use of animal health tools in livestock 
production, would the Department support or oppose legislation 
which arbitrarily prohibits the use of essential animal health 
tools by veterinarians?
    Dr. Clifford. The Department believes that, and APHIS--
actually I represent APHIS here today--would believe that it is 
important, very important for veterinarians and animal health 
professionals to have the opportunity to apply these drugs as 
necessary for therapeutic and prophylactic use in the field. It 
is extremely important, yes.
    Mr. Hayes. So you would oppose a ban.
    Dr. Dunham, in later testimony, Dr. Singer suggests that 
the risk assessment process currently used by FDA should be 
modified to take into consideration the impact of implementing 
specific interventions to reduce human and animal health risk. 
To what extent do you consider risk mitigation strategies when 
conducting your assessment?
    Dr. Dunham. When we go through our drug review approval 
process, we are looking to ensure that that drug will be safe 
and effective, and we look at the data that is given to us by 
the companies to assess that. At the time that you are looking 
at anything post our approval process, for example, if you were 
to look at risk mitigation within a slaughter plant--what is 
being used to handle the carcass, what is being used if you did 
irradiation before you packaged the meat--any of those 
interventions are something that would not be something we 
could take a look at as we are looking from the pharmaceutical 
company's review of data provided to us for the approval of 
that drug to be used in the animal for safety and 
effectiveness. We don't control those other interventions so it 
makes it very difficult for us to assess that. So we come back, 
first of all, with that product and the science that we look at 
to determine safety and effectiveness of that product being 
used in that animal. And for that reason, then we can approve 
that product for its safety and effectiveness. Then we do a 
post-surveillance monitoring of that afterwards to see if we 
are having any adverse reaction in the animal, and at the same 
time looking at any data to see, are we finding any problems 
with resistance.
    Mr. Hayes. I think that was a really good answer. I am not 
sure so much depth that I can get it. To boil it down, do you 
feel like the processes that we are using now are a reasonable 
and safe way to address the issue of prevention versus 
mitigation?
    Dr. Dunham. Yes, sir. As we at the FDA are looking at that 
product to determine if it is going to meet our approval 
standards, then we do base all of that with our scientific 
critique and review. I am very confident, by the time we do put 
our stamp on it to say this drug is approved for that use in 
that species and that indication, that yes, we are very happy 
with that process.
    Mr. Hayes. Thank you.
    Dr. Clifford, would you agree?
    Dr. Clifford. Yes, I do.
    The Chairman. Thank you, Mr. Hayes.
    The chair recognizes Mr. Kagen from Wisconsin for 5 
minutes.
    Mr. Kagen. Thank you, Mr. Chairman, and thank you both for 
appearing here before us this morning, and Dr. Clifford, I want 
to give you an opportunity here to identify, let me just assume 
that you don't want Congress to begin to practice veterinary 
medicine by dictating what drugs should or should not be used. 
Would that be a fair assumption?
    Dr. Clifford. Yes, Congressman, it would be. I would not 
want that dictated by Congress. I think it is appropriate as 
animal health officials that the veterinary professional who 
has the knowledge and the skill sets to be able to apply 
antimicrobials in an appropriate way and an appropriate use for 
animal health.
    Dr. Dunham. I think it is very true, the training that our 
veterinarians go through to practice medicine, they are the 
ones that you turn to. They are the ones that understand 
disease process and then, based upon the products that are 
approved, that they can reach for in their armamentarium, to be 
able to appropriately use those is the way it should be. So 
with the veterinarian's discretion, they are the ones that can 
decide when to intervene, to treat, prevent or control a 
disease.
    Mr. Kagen. And I will agree with you to the extent that you 
stay within veterinary medicine and don't go over to the human 
side because my natural inclination is to disagree with that.
    What would be the three most critical problems that you are 
facing in APHIS that you think need to be addressed? If I just 
was able to wave a wand or if my name was Secretary Hank 
Paulson, I could come up with $2 billion, forget the money, 
what are the three most critical problems that you are facing 
in APHIS that you think need to be addressed? It is a softball 
question. You didn't expect that.
    Dr. Clifford. No, I really didn't.
    Mr. Kagen. I have only got a couple minutes, so you have 
thought about this for your whole career, now you are here, 
your agency is counting on you right now, Dr. Clifford.
    Dr. Clifford. Well, it would be, I think in three areas. 
One, I think it is critically important that we use new 
technology and techniques to help us address animal health 
issues in this nation. I think it is important we be able to 
move toward a system where we can effectively eliminate disease 
or control disease through other methods other than massive 
depopulation in the future. Because, for one, the cost to 
taxpayers; two, really the waste of protein that that does. So 
that is through the research and development of new technology.
    Second, I think it is critically important as we look at 
animal health threats and issues that we have good continuity 
of operation planning within the United States so that we can 
keep producers viable and healthy, even in the face of an 
outbreak situation. So, that we can allow animals to move 
safely through mitigation measures and good biosecurity.
    Third, traceability, and that is part of our animal ID 
program that we are moving forward in. Traceability is 
critically important to animal health and to be able to 
effectively eliminate disease quickly. Thank you.
    Mr. Kagen. Dr. Dunham?
    Dr. Dunham. Thank you. I would also agree. I think one of 
the challenges we are facing now is being able to embrace the 
exciting field of where we are going with our biotechnology. 
Science is at the heart of everything we do for our decisions 
and we need to embrace the new science, and at the same time 
develop some new ways of intervening, as we just discussed, to 
keep the health of both people and animals moving forward. New 
technology will open those doors for us. Being able to adapt 
that means we need to have an opportunity to sustain the 
science and the research that is going to bring those to us. We 
do the review, so it is what is coming in the pipeline. So 
anything that continues to advance the research to allow our 
companies, universities to break through into new technologies 
and bring those forward to us is going to be very, very, very 
helpful.
    I think also we can try to harmonize. We talked earlier 
that, internationally, we are meeting with Codex this 
afternoon. We are one world, and we said before, people travel, 
animals travel and microbes travel. The more that we are aware 
of what is happening internationally, it is going to be 
quintessential as we try to get our hands around these issues 
because we don't know what is going to walk in the door. 
Veterinary students used to have a textbook and be told if you 
don't travel to country X, don't worry, you will never see this 
disease. That is not true anymore. So we as the agencies have 
to embrace the idea that what will be walking in our front door 
could impact the health of people and animals. That would be 
another venue of how we work internationally together. Also, 
with regards to methodologies, how we get to a standardization, 
where it is possible, that our labs can talk, not only within 
the state but across the states, so we know what is moving in 
the country, and we can really track appropriately. You are no 
longer having to compare apples to oranges; you can compare 
apples to apples. So all of that comes back down to a 
combination of technologies.
    Mr. Kagen. Thank you for your comments, and before I go too 
far over, I just have to make a comment about the disinterest 
of my constituents in northeast Wisconsin of being faced with 
the possibility of paying for the inspection of the quality and 
health of foreign food products that might be shipped into this 
country. We don't want to have to pay for somebody else's 
mistakes here, and along those lines, if I could just beg the 
Chairman for a minute to get your comments on what your 
agencies are doing to make sure that other countries who seek 
to ship their product here are doing to move up to our quality.
    Dr. Clifford. Congressman, at APHIS we have negotiations, 
bilateral negotiations with countries with the movement of live 
animals and animal products, and there are certain mitigations 
and certifications that are required for the movement of those 
products. Our agency as well as in cooperation with other 
organizations and Customs and Border Protection are there to 
assure that those products and animals that enter into the 
United States meet those conditions.
    Mr. Kagen. Does that mean that they are having anything to 
do with our standards about the use of antibiotics?
    Dr. Clifford. With regards to antibiotic use, I would have 
to defer that to those that are authorized or have the 
authority over that particular area. With our area though, they 
have certain standards relative to disease issues and threats.
    Dr. Dunham. Regarding again the harmonization that many of 
us are looking at with VICH that we have similar to the human 
side of ICH--where we understand what the review processes are 
within other countries and how they go through to decide the 
safety and effectiveness of the drugs that they approve and how 
they are being utilized--that open dialog helps a tremendous 
amount. Codex Alimentarius is one program that allows us to go 
through that, take a look at MRLs within various drugs and now 
most recently, as I mentioned, this afternoon there will be the 
second follow-up of the Codex group taking a look specifically 
at what countries are doing to address antimicrobial 
resistance. So what are the standards, what are the 
methodologies? The more we understand how each country is 
approving and utilizing those drugs in the practice, in this 
case, of agriculture, the more it will make it easy for us to 
work together and have that transparency.
    Mr. Kagen. Thank you very much. I look forward to working 
with you and making certain that consumers have an easy way of 
identifying what is in their food and where it comes from. 
Thank you for your work.
    I yield back my time.
    The Chairman. Thank you, Mr. Kagen.
    The chair recognizes the gentleman from Nebraska, Mr. 
Smith, for 5 minutes.
    Mr. Smith. Thank you, Mr. Chairman, and thank you to the 
witnesses.
    We know that the marketplace has high expectations and 
therefore producers want to meet those expectations. Otherwise 
they don't have a product that will sell and hopefully a 
commensurate profit. As we do look at this, we know that some 
groups are advocating a legislative ban on the use of 
antimicrobials for growth promotion and feed efficiency. What 
do you think would be the impact this legislative ban would 
have on development of antimicrobial resistance, and what 
impact would you believe the legislative ban would have on the 
actual animal health?
    Dr. Clifford. It would be a very devastating effect upon 
animal health if we did not have the ability and the use of 
antibiotics for therapeutic and prophylactic use to prevent a 
number of diseases. So from an animal health perspective, this 
is something that we would not support. This needs to be in the 
hands of professionals and veterinary professionals within the 
field to be able to handle it. We do agree that we need good 
data to be able to do proper analysis with regards to 
antibiotic resistance both in the protection of animal health 
as well as human health. I think we should rely upon the 
science to dictate the direction that we go versus legislation.
    Mr. Smith. Dr. Dunham?
    Dr. Dunham. We haven't taken any specific position on any 
legislation, as you well know, but separate from all of that, 
in general, it is absolutely true, with FDA having the 
opportunity to do the scientific review of any of the products 
coming through for us to look at to decide their safety and 
effectiveness in animals, our standards are very high and we 
hold to those. That being said, once a product has been 
approved and you have that claim on the label indicating its 
use--dosage, species, indication--the veterinarian is the one 
who then takes hold of that and, with their training, is 
therefore the capable person to indicate how to use that drug. 
At the same time, that is what we do when we embrace the use, 
the judicious use, of any antimicrobial. So there is an 
appropriate workup to decide when to treat, prevent or control 
a disease. This is done on a scientific basis and through the 
training that the veterinarians have to do that.
    Mr. Smith. Thank you very much. I will say that to be 
honest with you, I think for humans sometimes, the use of 
antibiotics and so forth might be a little overused and I say 
that for myself personally, but I don't really go to the doctor 
always looking for an antibiotic as often as it might be 
offered. It had never crossed my mind to seek a legislative ban 
on that because I might share some personal feelings about 
that. But it does, I think, speak to the larger issue of what 
the role of government is here, so I appreciate your input and 
I yield back.
    The Chairman. Thank you, Mr. Smith.
    Dr. Dunham, I would like to pursue a couple more questions. 
Would you please describe the process a food-animal drug must 
go through before it can be used on the market, and if you can, 
average how much time and money is invested?
    Dr. Dunham. Yes, sir. A company will give us a product to 
take a look at. We assess all the scientific information they 
provide to determine the safety of that drug, the target-animal 
safety, the effectiveness of that drug in that target animal. 
We take a look at environmental impact. We take a look at the 
chemistry and manufacturing surrounding that product to ensure 
it is stable and does exactly what it is supposed to do. We 
take a look at any toxicology that is involved, and when it is 
for use in a food-producing animal, then we have to also take a 
look at it with our human food safety group. They will then 
take a look to decide, for example, would there be any 
residues, and if so, what is an acceptable level, and that has 
to be reviewed as well. And when we have done all of that, we 
will then be able to decide if this product is safe and 
effective. So there are multiple teams that get pulled together 
in our Office of New Animal Drug Evaluation to take a look at 
all aspects of that package in order to have all of those 
various sections reviewed and completed before we can finally 
say yes, this drug is approved. And it depends upon the drug, 
depends upon the class, use, et cetera, as to how long that may 
or may not take and the data sets that are being provided for 
us to have that rigorous scientific review. So that is a very 
short overview of the procedure that is required for them to go 
through.
    And as you hear on the human side or veterinary side, there 
are a number of years that go into that when you are developing 
the first molecule and bringing it all the way through to what 
you can call molecules to miracles, when you have that drug in 
hand to be able to effectively use that to prevent or treat 
that disease that you are looking at. And companies then take 
all of that under consideration when they are developing that 
product and give us the data sets that we look at. If we have 
questions, if there is further data that we need, we dialogue 
that with the company and they usually work very well with us 
so that we absolutely make sure the i's are dotted and t's are 
crossed. So we have the confidence when we finally say it is 
approved that we can follow that through. Then we follow with 
post-surveillance to see whether or not, when it is finally out 
being utilized, we are seeing any adverse effects. At that 
time, based upon what we are seeing in the science again, we 
can take a look and make any potential changes to that label, a 
warning box or make any further changes that are appropriate. 
It is all based on the science and the data that we collect as 
we monitor this.
    The Chairman. That is pretty extensive. Do you have some 
kind of an idea what it costs to do this, maybe compare what it 
costs to get a drug on the market for human use?
    Dr. Dunham. I wouldn't be able to give you a direct cost of 
that. I think each one depends--the pharmaceutical companies 
usually have a pretty good idea and they can tell you how much 
it costs them to do the research, the developing, gathering the 
data that they then give to us for that review. I think those 
numbers are available but I can't give them to you off the top 
of my head. I would be happy to obtain that information and 
submit that to you.
    The Chairman. Okay. Is it true that if a food-animal drug 
has any risk to humans, the drug can't be used?
    Dr. Dunham. No. I think we go through the review process to 
assess how that drug will be used and we are able to decide 
limitations if that is appropriate, if we decide that. We do 
have, as you know, a guidance that has been developed. It is 
referred to as Guidance #152. And that allows us to take a look 
at a lot of the risk issues and it is one of our tools that can 
be utilized when we are going to be looking at the development 
and approval of an antimicrobial. At that point we do have a 
scenario, working with our counterparts in human medicine as 
well, to take a look at those drugs' very important use in 
humans. Sometimes that will be a limitation as to whether or 
not we have a green light to say whether that same drug can be 
used or not used in animal medicine. But for the most part, 
there are opportunities to take a look at this and decide when 
and where and how much we can use that drug for an approved use 
in animals, and that has been a very good guidance. It has 
worked very well and we have had a chance to have advisory 
committees work with us as well on that.
    The Chairman. In your testimony, you outline human public 
health numbers. How many livestock bacterial infections are 
there in the United States?
    Dr. Dunham. I don't think I have that on the tip of my 
tongue, but I could certainly take a look and work with John 
and get some information back to you.
    Dr. Clifford. I was just going to say, Mr. Chairman, we 
will work with FDA to provide that for the record.
    The Chairman. Okay. I appreciate that. All right. What are 
the four areas that FDA approves antimicrobial use in food 
animals? I understand there are four areas that FDA approves 
antimicrobial use in food animals.
    Dr. Dunham. They, again, are based upon the claim that is 
being requested by the company. We would be looking to see what 
the disease is that is being requested for us to take a look 
at, and approve that product to be utilized. I am not sure if I 
am looking exactly----
    Dr. Clifford. Mr. Chairman, just to clarify, are you 
referring to therapeutic, control, prevention and for feed 
efficiency?
    The Chairman. Yes.
    Dr. Dunham. In that case, based upon the claim that is 
coming through, if it is going to be used, we will then review 
that indication on the claim and approve that, just as you 
said, if it is going to be for therapeutic use, at what dose 
and what species. Then at the same time, if you are looking at 
this for control or intervention, we do have that. Those are in 
the claims.
    The Chairman. Mr. Hayes.
    Mr. Hayes. No questions.
    The Chairman. Mr. Smith.
    Mr. Smith. I do have one. I came across this advertisement 
in I think CongressDaily, Pew Charitable Trust, ``Bigger Beef, 
Tougher Bugs: Antibiotics in Livestock Feed Are Making Our 
Drugs Less Effective.'' Dr. Dunham, have you seen this ad? 
Would you say that that is an accurate portrayal of the 
scenario here?
    Dr. Dunham. No, I have not seen the ad, but I just think in 
general, all of us, as you have heard discussed today, it is 
very important that any of us, be it medicine for humans or 
medicines for animals, that we constantly embrace judicious use 
of these antimicrobials. The more that you put pressure on 
these pathogens, the pressure is just going to have the 
potential to enhance resistance. So that is why we do embrace, 
all of us, judicious use of these antimicrobials. We want to 
make sure that we have access to them. We need them to keep 
people and animals healthy. So if we have abuse, we would have 
a problem, but people aren't doing that. They are very 
conscientious because we do need those. At the same time, just 
how many do we have? So you want to treat them very carefully. 
So I do believe that, again, the responsible profession is 
approaching that in the best manner.
    Mr. Smith. Thank you.
    Dr. Clifford, would you care to comment on this ad? The Pew 
Charitable Trust ran the ad.
    Dr. Clifford. I haven't seen the ad. I have read some of 
their testimony before, but as far as my position that I have 
already stated stands. We need to not present the issues on 
fear and concern but on science.
    Mr. Smith. Thank you, Mr. Chairman.
    The Chairman. Well, thank you both. Do either of you have 
any further comment that you would like to make while you are 
at the table?
    Dr. Dunham. No, sir, I am fine, and I will get you the 
answers to the questions that you did ask. Thank you very much 
for the opportunity to attend.
    The Chairman. Thank you.
    Dr. Clifford.
    Dr. Clifford. Mr. Chairman, actually I would just like to 
make a comment. As Dr. Dunham talked about one world, this goes 
back to one world, one health. I think it is critically 
important in the scenario of one world, one health that the 
human health side and the animal health side work very closely 
using science, but remembering that while public health is 
important first and foremost to all of us, it is critically 
important that we maintain animal health and that animal health 
be heard. It is critically important for our livestock 
production in this country. Thank you.
    The Chairman. Well, thank you for that comment I will just 
add to that from my perspective, speaking for myself, I do 
believe in the science. I think healthy animals is healthy food 
and we have to look to the science of this to assure that, 
particularly in this growing, world population, the demand is 
going to continue to grow to provide adequate food. It is a big 
challenge for us, the science, but that is the way I think we 
go. So I appreciate your comments and thank you very much. You 
are both excused.
    We would like to--as quick as we can--call the second panel 
to the table.
    I would like to welcome you to the table. Thank you for 
being here. I will just recognize each one and then we will 
start with Dr. Rowles shortly.
    Dr. Craig Rowles, Doctor of Veterinary Medicine, pork 
producer, is here on behalf of the National Pork Producers 
Council from Carroll, Iowa. Dr. Michael Rybolt, Director, 
Scientific and Regulatory Affairs, National Turkey Federation, 
Washington, D.C. Dr. Robert Byrne, Ph.D., Senior Vice 
President, Scientific and Regulatory Affairs, National Milk 
Producers Federation, Arlington, Virginia. Dr. Spangler Klopp, 
Doctor of Veterinary Medicine, Diplomat, American College of 
Poultry Veterinarians, Corporate Veterinarian, Townsends, Inc., 
on behalf of National Chicken Council, Georgetown, Delaware. 
Mr. Blair Van Zetten, President, Oskaloosa Food Products, on 
behalf of United Egg Producers from Oskaloosa, Iowa. Dr. 
Michael Apley, Doctor of Veterinary Medicine, Ph.D., DACVCP, 
Director, PharmCATS Bioanalytical Laboratory, and Associate 
Professor, Department of Clinical Sciences, Kansas State 
University, on behalf of the National Cattlemen's Beef 
Association from Manhattan, Kansas.
    Thank you all for being here. We appreciate it. Dr. Rowles, 
please begin when you are ready.

STATEMENT OF CRAIG ROWLES, D.V.M., GENERAL MANAGER AND PARTNER, 
ELITE PORK PARTNERSHIP, CARROLL, IA; ON BEHALF OF NATIONAL PORK 
                       PRODUCERS COUNCIL

    Dr. Rowles. Good morning, Chairman Boswell, Ranking Member 
Hayes and Members of the Subcommittee. My name is Craig Rowles. 
I am a Doctor of Veterinary Medicine and I have spent 25 years 
in the pork industry as a pork producer and a veterinarian. I 
have spent the last 12 years as General Manager and Partner of 
Elite Pork, and prior to that I was in mixed animal practice in 
Carroll serving pork producers.
    I am testifying on behalf of the National Pork Producers 
Council, an association of 43 state producer organizations that 
represent the country's 67,000 pork producers. In providing 
pork to the world, producers operate under a set of ethical 
principles which broadly include humane and compassionate care 
for their pigs. Specific to animal health products, producers 
use antibiotics judiciously and responsibly to protect pig 
health and to produce safe pork and to manage antibiotic use 
and to protect public health. The health and well-being of our 
pigs is critical to the success of the U.S. pork industry and 
pork producers. Antibiotics are only one tool that help 
producers keep their animals healthy, their produce safe, 
wholesome and nutritious.
    Today, the FDA Center for Veterinary Medicine approves 
antibiotics for four uses: disease treatment, disease control, 
disease prevention and nutritional efficiency. Pork producers 
work in collaboration with their veterinarians to design herd 
health programs. These programs may include diagnostics for 
determining the best time to vaccinate for diseases or the best 
time to use antibiotics for preventing a disease outbreak. The 
health management plans may also include information on 
ventilation, balanced feed rations or parasite control. These 
plans are about total system health management, not just about 
what antibiotic to use to treat a specific illness.
    U.S. pork producers take the use of antibiotics very 
seriously. After 4 years of development and tests, the pork 
industry rolled out the first producer responsible antibiotic 
use program called Take Care--Use Antibiotics Responsibly. The 
program outlines principles and guidelines that protect public 
health, animal health and animal well-being through the 
responsible use of antibiotics. During the development of Take 
Care, the pork industry worked with Federal public health 
agencies including CDC and the FDA as well as numerous 
stakeholders such as the American Association of Swine 
Veterinarians, AVMA, AHI, the American Feed Industry 
Association and McDonald's. The pork industry's responsible use 
program has been praised by many Federal agencies, legislators, 
consumer organizations and food supply companies. The U.S. pork 
industry developed this program because it was the right thing 
to do. Producers care about animal health and we care about 
public health.
    Initially a voluntary program, Take Care is now 
incorporated into our Pork Quality Assurance Plus program, 
which includes on-farm assessments including reviews of whether 
antibiotic use principles are being practiced. Producer PQA 
Plus certification is required by U.S. packing plants as a 
condition of sale.
    Denmark's ban on antibiotic growth promoters, or AGPs, for 
pigs is often cited as an example of why there should be 
restrictions on the use of antibiotics in pork production. 
However, the reality of the impacts of that ban are seldom 
discussed. After the ban was put in place in 1999 for all 
swine, Danish pork producers saw an immediate increase in post-
weaning diarrhea and an increase in nursery pig mortality that 
has had long-lasting impacts on the Danish pig industry. In 
2002, two Iowa State economists estimated the effect of a ban 
on antibiotic use in the U.S. similar to Denmark's would 
increase the cost of pork production by $4.50 per pig in the 
first year. After 10 years, the ban's cumulative cost to the 
pork industry would be greater than $700 million, and that was 
back when corn was listed as $2.50. Denmark would not be a wise 
course of action for the U.S. pork industry.
    Upon graduation from veterinary school, I swore an oath to 
use my scientific knowledge and skill for the benefit of 
society through the protection of animal health, the relief of 
animal suffering, the conservation of animal resources, the 
promotion of public health and advancement of medical 
knowledge. As a swine veterinarian, I need all the tools 
available to live up to that oath. Legislative attempts to ban 
certain antibiotics will compromise the oath that every 
veterinarian took on his graduation day.
    In summary, pork producers and veterinarians have a moral 
obligation to use antibiotics responsibly to protect human 
health and provide safe food. Producers also have an ethical 
obligation to maintain the health of their pigs. Antibiotics 
are merely one piece of that healthcare system that pigs need. 
The U.S. pork industry has a long history of being proactive 
and doing the right thing for its pigs and consumers. Pork 
producers developed Take Care and PQA Plus not because they had 
to, but because it was the right thing to do.
    Thank you for the opportunity to share the views of the 
U.S. swine industry, and I would be happy to take your 
questions.
    [The prepared statement of Dr. Rowles follows:]

    Prepared Statement of Craig Rowles, D.V.M., General Manager and 
  Partner, Elite Pork Partnership, Carroll, IA; on Behalf of National 
                                  Pork
                           Producers Council
Introduction
    The National Pork Producers Council is an association of 43 state 
pork producer organizations and serves as their voice in Washington, 
D.C.
    The U.S. pork industry represents a significant value-added 
activity in the agriculture economy and the overall U.S. economy. 
Nationwide, more than 67,000 pork producers marketed more than 104 
million hogs in 2007, and those animals provided total gross receipts 
of $15 billion. Overall, an estimated $21 billion of personal income 
from sales of more than $97 billion and $34.5 billion of gross national 
product are supported by the U.S. hog industry. Iowa State University 
economists Dan Otto and John Lawrence estimate that the U.S. pork 
industry is directly responsible for the creation of nearly 35,000 
full-time equivalent jobs and helps generate 515,000 indirect jobs. All 
told, the U.S. pork industry is responsible for more than 550,000 
mostly rural jobs in the U.S.
    The U.S. pork industry today provides 21 billion pounds of safe, 
wholesome and nutritious meat protein to consumers worldwide. In fact, 
2007 was the sixth consecutive year of record pork production in the 
United States.
    Exports of U.S. pork also continue to grow. New technologies have 
been adopted and productivity has been increased to maintain the U.S. 
pork industry's international competitiveness. As a result, pork 
exports have hit new records for the past 16 years. In 2007, exports 
represented nearly 15 percent of production. This year, approximately 
2.8 billion pounds of pork and pork products are expected to be 
exported at a value of $4.1 billion.
    In providing pork to the world, producers operate under a set of 
ethical principles, which broadly include humane and compassionate care 
for their pigs. Specific to animal-health products, producers use 
antibiotics judiciously and responsibly to protect pig health, to 
produce safe pork and manage antibiotic use to protect public health.
    To meet the tremendous demands for pork in the domestic and export 
markets, pork producers have designed systems that maximize animal 
health and production. Pig barns are built to protect animal health by 
providing pigs a controlled climate and protection from the elements 
and predators. These barns help ensure that producers can observe 
animals daily and that each animal has access to ample water and feed, 
which is formulated to provide optimum nutrition for their life stage.
    To better manage disease challenges, modern U.S. pork production 
uses the practices of multisite production and all-in-all-out pig flow. 
Simply stated, that means that after baby pigs are weaned they are 
moved to barns that are geographically separated from the breeding 
animals. Pork producers strive to keep pigs together in groups that are 
the same age and come from the same breeding herd. Pork producers 
implement this to minimize disease. Before a new group of pigs is 
placed, the barns are completely emptied, cleaned and disinfected.
Antibiotics Used To Protect Pigs, Provide Safe Food
    The health and well-being of their pigs is critical to the success 
of the U.S. pork industry and pork producers. The prudent use of 
antibiotics in the pork industry is essential to providing consumers 
safe foods and to ensuring animal health. Antibiotics are only one tool 
to help producers do this. Today, the Food and Drug Administration's 
(FDA) Center for Veterinary Medicine (CVM) approves antibiotics for 
four uses:

    1. Disease Treatment: antibiotics used to treat animals after they 
        are clinically ill.

    2. Disease Control: antibiotics used to reduce a specific disease 
        after the animal has been exposed to the infectious agent.

    3. Disease Prevention: antibiotics administered to animals prior to 
        or directly following exposure to an infectious agent.

    4. Nutritional Efficiency: antibiotics used in feed at low 
        concentrations allow the animals to more efficiently utilize 
        the feed they eat.

    CVM allows antibiotics to be given to pigs through feed or water. 
Pigs can also be injected with antibiotics. Producers and veterinarians 
work together to make the decisions on how, when and which antibiotics 
should be administered.
    Pork producers and veterinarians take numerous steps to maximize 
animal health and reduce the need to use antibiotics. In addition to 
current U.S. pork industry production practices of multisite 
production, herd health management programs have been created and 
tailored to each production system and often to individual farms.
    Pork producers work in collaboration with their veterinarians to 
design herd health programs. These programs may include diagnostics for 
determining the best time to vaccinate for diseases or the best time to 
use antibiotics for preventing a disease outbreak. The health 
management plans also may include information on ventilation of the 
barns, balanced feed rations and parasite control. The plans are about 
total system health management, not just about what antibiotic to treat 
a specific illness.
    Diagnostics are used when pigs are sick. A producer calls his or 
her veterinarian who takes and submits samples to a veterinary 
diagnostic laboratory. The results of these tests isolate the bug or 
bugs causing the disease, as well as give an indication of the best way 
to treat the pigs and prevent the bug from making other groups of pigs 
sick.
Pork Industry Developed Guidelines on Antibiotic Use
    U.S. pork producers take the use of antibiotics very seriously. 
After 4 years of development and tests, the pork industry rolled out 
the first producer responsible antibiotic use program, ``Take Care--Use 
Antibiotics Responsibly,'' in 2005. The program outlines principles and 
guidelines that protect public health, animal health and animal well-
being through the responsible use of antibiotics. During the 
development of ``Take Care,'' the pork industry worked with Federal 
public health agencies, including the Centers for Disease Control (CDC) 
and the FDA, as well as numerous stakeholders such as the American 
Association of Swine Veterinarians (AASV), the American Veterinary 
Medical Association (AVMA), the Animal Health Institute (AHI), the 
American Feed Industry Association (AFIA) and McDonald's. The pork 
industry's responsible-use program has been praised by many Federal 
agencies, legislators, consumer organizations and food supply 
companies. The U.S. pork industry developed this program because it was 
the right thing to do. Like all Americans, pork producers care about 
animal health and public health.
    The guiding principles in ``Take Care'' are:

   Take appropriate steps to decrease the need for the 
        application of antibiotics.

   Assess the advantages and disadvantages of all uses of 
        antibiotics.

   Use antibiotics only when they provide measurable benefits.

   Complete the Pork Quality Assurance (PQA) Plus Program and 
        fully implement the management practices prescribed for 
        responsible use of animal health products into daily 
        operations.

     Use professional veterinary input as the basis for all 
            medication decision-making.

     Antibiotics should be used for treatment only when 
            there is an appropriate clinical diagnosis.

     Limit antibiotic treatment to ill or at-risk animals, 
            treating the fewest animals indicated.

     Antibiotics that are important in treating antibiotic-
            resistant infections in human or veterinary medicine should 
            be used in animals only after careful review and reasonable 
            justification.

     Mixing together injectable or water medications, 
            including antibiotics, by producers is illegal.

     Minimize environmental exposure through proper 
            handling and disposal of all animal health products, 
            including antibiotics.

    Initially, ``Take Care'' started as a voluntary program, and many 
producers participated. Today, however, the pork industry understands 
how important it is to use antibiotics responsibly, and ``Take Care'' 
is the way the U.S. pork industry does business. It's good for our 
pigs, it's good for our producers and families, and it's good for the 
bottom line. ``Take Care'' has been incorporated into the industry's 
Pork Quality Assurance (PQA) Plus program, which includes on-farm 
assessments, including reviews of whether the antibiotic-use principles 
are being practiced. Producer PQA Plus certification is required by 
U.S. packing plants as a condition of sale. Through 4-H and FFA, PQA 
Plus, including ``Take Care,'' is also taught to the next generation of 
pork producers, as the young producers have an obligation to use 
antibiotics responsibly.
    The veterinarians working in the U.S. pork industry also have been 
proactive in the responsible use of antibiotics. AASV was the first 
species-specific veterinary organization to collaborate with FDA and 
AVMA to create and endorse judicious-use guidelines for antibiotics.
Addressing Critics' Concerns
    There are some who believe that the use of antibiotics in pork 
production adversely affects public health. There is ample evidence to 
suggest that not only does the responsible use of antibiotics in pork 
production protect animal health and welfare, but it may actually 
protect public health.
    Denmark's ban on antibiotic growth promoters (AGPs) is often cited 
as an example of why there should be restrictions on the use of 
antibiotics in pork production. However, the reality of the impacts of 
the ban on antibiotic growth promoters in Denmark is seldom discussed. 
In 1998, Denmark banned the use of AGPs in finishing swine and in all 
swine in 1999. It should be noted that this ban was only on the use of 
AGPs, not all antibiotics in feed or water. Danish pork producers saw 
an immediate increase in post-weaning diarrhea and an increase in baby 
pig mortality that has had long lasting impacts on the Danish pig 
industry. [1]
    These increases in baby pig mortality and the overall impact on 
animal welfare might be acceptable if there were improvements to public 
health. But public health improvements have not materialized. In fact, 
even with intensive surveillance of the public health impacts, the only 
demonstrable change to public health could be considered potentially 
damaging. The Danes observed an increase in the number of human 
Salmonella infections that were resistant to the antibiotic 
tetracycline. They believe it was due to an increase in the use of 
tetracycline in pigs to combat the post-weaning diarrhea. [2]
    Proponents of imposing a similar ban on antibiotic use in the U.S. 
cite the drop in total tons of antibiotics used in pork production in 
Denmark. While overall use of antibiotics has declined, there has been 
a marked increase in the therapeutic use of antibiotics--antibiotics 
used for treatment, prevention and control of disease. Today, the use 
of therapeutic antibiotics in Danish pigs now surpasses what was used 
to promote growth prior to the ban in 1999 and continues to rise each 
year. [3] The therapeutic antibiotics used are more modern molecules 
considered to be more important in human medicine than the older drugs 
used to promote growth. In 2002, two Iowa State economists used an 
economic model to estimate the effect that the Denmark ban would have 
on U.S. pork production, finding that the cost of production would rise 
by $4.50 per pig in the first year after a ban. Over 10 years, a ban's 
cumulative cost to the pork industry would be greater than $700 
million. (In this model, the economists assumed the price of corn to be 
$2.50 per bushel.) Clearly, implementing a ban on antibiotic use 
similar to that in Denmark would not be a wise course of action for 
U.S. pork producers. [4]
    The Danish experience illustrates that if a ban were put in place 
in the United States on the use of antibiotics as feed additives, pig 
health and well-being would decline. More pigs would suffer, and more 
pigs would die.
    An Iowa State University study conducted by Dr. Scott Hurd, who now 
is USDA Deputy Under Secretary of Food Safety, demonstrated that when 
pigs have been sick during their life, those pigs will have a greater 
presence of food safety pathogens on carcasses. [5] This study 
reinforces the importance of using all of the tools available to 
protect the health of animals.
    Another study also answers the critics who suggest that raising 
animals in large groups inside barns using modern production methods, 
including the use of antibiotics, presents a human health threat. Dr. 
Wondwossen Gebreyes from the Ohio State University found that pork from 
pigs produced in modern, conventional systems had levels of three 
foodborne pathogens lower than pigs raised in outdoor systems without 
the use of antibiotics. [6]
    According to the AVMA, risk assessments on antibiotic use 
demonstrate a very low risk to human health from the use of 
antimicrobials in food animals, and some models predict an increased 
human health burden if antibiotic use in food animals were withheld.
    A final word on the issue of AGPs: Contrary to the untruths spread 
by some organizations, AGPs represent only 4.6 percent of all 
antibiotics given to animals and even the overwhelming majority of 
those antibiotics prevents and controls diseases. [7] Additionally, 
very few of them are important to human medicine.
Producers Work With Veterinarians
    Pork producers work very closely with their veterinarians. Those 
swine veterinarians, upon graduation from veterinary school, take an 
oath stating that they solemnly swear to uphold their ``scientific 
knowledge and skill for the benefit of society through the protection 
of animal health, the relief of animal suffering, the conservation of 
animal resources, the promotion of public health, and the advancement 
of medical knowledge.'' Swine veterinarians need all the tools 
available to live up to that oath. Legislative attempts to ban certain 
antibiotics will compromise the oath that every veterinarian took on 
his or her graduation day.
    In summary, pork producers and veterinarians have a moral 
obligation to use antibiotics responsibly to protect human health and 
provide safe food, both of which are paramount concerns to America's 
pork producers. Producers also have an ethical obligation to maintain 
the health of their pigs. Antibiotics are merely one piece to the 
health care system that pigs need. The U.S. pork industry has a long 
history of being proactive and doing the right thing for its pigs and 
consumers. Pork producer developed ``Take Care'' and PQA Plus not 
because they had to but because it was the right thing to do. The U.S. 
pork industry continues to adopt better techniques and new 
technologies, but it cannot lose the tools it already has developed, 
including antibiotics, to protect the well-being of producers' animals 
and the safety of pork.
Notes:
    \1\ Agence France-Presse. World-leading pork exporter Denmark sees 
sharp increase in pig mortality. Copenhagen Business Online. 2005. 
http://archive.wn.com/2005/09/06/1400/copenhagenbusiness/.
    \2\ World Health Organization. Impacts of antimicrobial growth 
promoter termination in Denmark. Online. 2002. http://
whqlibdoc.who.int/hq/2003/WHO_CDS_CPE_ZFK_2003.1.pdf.
    \3\ Danmap 2006. www.Danmap.org.
    \4\ Hayes, Jensen, Fabios. Technology choice and the economic 
effects of a ban on the use of antimicrobial feed additives in swine 
rations. Food Control, 2002.
    \5\ Hurd H.S., Brudvig J., Dickson J, et al. 2008. Swine health 
impact on carcass contamination and human foodborne risk. Public Health 
Reports: (123) pp. 343-351.
    \6\ Gebreyes W., Bahnson P., Funk J., et al. 2008. Seroprevalence 
of Trichinella, Toxoplasma and Salmonella in antimicrobial-free and 
conventional swine production systems. Foodborne Pathogens and Disease: 
(5) pp. 199-203.
    \7\ Animal Health Institute. 2007. www.AHI.org.

    The Chairman. Thank you, Dr. Rowles.
    I think we will go right down the table and then we will 
come back to questions, so Dr. Rybolt, please.

       STATEMENT OF MICHAEL L. RYBOLT, Ph.D., DIRECTOR, 
SCIENTIFIC AND REGULATORY AFFAIRS, NATIONAL TURKEY FEDERATION, 
                        WASHINGTON, D.C.

    Dr. Rybolt. Good morning, Chairman Boswell, Congressman 
Hayes and other Members of the Subcommittee. Thank you for the 
opportunity to be here to talk about the advancements in animal 
health in the poultry industry. My name is Dr. Michael Rybolt. 
I am with the National Turkey Federation. I am the Director of 
Scientific and Regulatory Affairs and I also oversee the Turkey 
Health and Welfare Committee. NTF, which represents more than 
98 percent of the U.S. turkey industry, greatly appreciates the 
opportunity to be here to talk about the advances in animal 
health within the U.S. turkey industry.
    In the United States, turkeys are raised on small family 
farms, around 227 acres in size. The advances the turkey 
industry has made has allowed these farms to produce large 
volumes of safe, wholesome product more efficiently. The 
advances have allowed the industry to raise more than 260 
million turkeys at an average weight of around 28 pounds. After 
processing, this has yielded 6 billion pounds of turkey 
products for human consumption. By contrast, in 1970, the 
industry only raised 105 million birds with an average live 
weight of 17 pounds, which equated to about 1.5 billion pounds 
of product for human consumption. The advances the industry has 
made in the past 30 plus years have been driven by science and 
the dedication of the turkey industry experts with the goal to 
produce the safest, highest-quality, nutritious products at an 
affordable price for the consuming public. In order to meet 
that goal, maintaining the health and welfare of the flock is 
paramount. The industry accomplishes this through a variety of 
means including raising the birds in environmentally controlled 
houses or barns, increased biosecurity on the farms, various 
animal health monitoring programs, the use of vaccination 
programs and using approved animal drugs or antimicrobials. All 
of these tools are important for the industry, and when used 
together help the industry meet its goal.
    Arguably, one of the most significant advances in the 
turkey industry that has played an essential role in improving 
the health of the turkey flock is the use of environmentally 
controlled houses or barns. Raising birds indoors helps protect 
them from predatory wildlife and inclement weather. In turn, 
this not only prevents the birds from becoming prey but also 
reduces the risk of a flock becoming exposed to disease agents. 
Raising turkeys indoors also creates a less stressful 
environment for the birds, which research from the University 
of Minnesota has shown leads to better production. A well-
treated turkey will grow to its full potential and provide the 
consumer with a low-fat, high-protein source.
    Likewise, increased biosecurity is also important to 
mitigate exposure of the flocks to potential disease-causing 
agents. By limiting access to only authorized personnel and/or 
ensuring proper sanitation of footwear and clothing, strict 
biosecurity is essential to maintain the health and well-being 
of our birds. Biosecurity programs have been implemented for 
many years and are continually updated and strengthened as 
needed, taking into account the latest scientific data.
    Additionally, the turkey industry has made significant 
advances in the animal disease-monitoring arena. Various 
programs exist that have benefited the industry and allowed for 
increased production gains. Such programs include the USDA's 
National Poultry Improvement Plan, or NPIP. The use of these 
programs has allowed the industry to monitor various diseases 
and to control and eradicate them before they spread, thereby 
allowing for increased livability and more food for humans to 
consume.
    Unfortunately, like humans, turkeys occasionally will 
become ill and will require medication. For some diseases, the 
industry has the ability to use prophylactic programs. However, 
there are also times when the flocks need to be treated with 
antimicrobials for controlling bacterial diseases. The use of 
antimicrobials for disease control, prevention and treatment is 
necessary for the health and welfare of the turkey flocks.
    To raise turkeys without antibiotics would increase the 
incidence of illness within the flocks. This would result in a 
decrease in density or an increase in the amount of land needed 
to raise the additional turkeys to meet the needs of the 
consuming public. This would also lead to a decrease in 
livability, an estimated ten percent reduction in gain per day, 
and a decrease of 0.05 percent in feed conversion.
    To compensate for the higher increased illness rates, a 
decrease in the feed conversion and to meet the growing need of 
the consuming public, we would require 175,550 tons more feed 
to feed the turkeys. This increased requirement would equate to 
about 3.7 million bushels of corn and 1.7 million bushels of 
soybeans just for the turkey industry alone. In order to fill 
this need, obviously there would need to be more acreage 
planted for crop production or an increase in crop yields. 
Obviously there is an economic impact with increased feed 
requirements. However, there is also an environmental impact. 
The decreased feed conversion leads to less efficiency in 
digestion and utilization of the nutrients in that feed and 
this will ultimately result in an increase in manure.
    With regard to the antibiotic use, each turkey veterinarian 
follows a set of prudent use guidelines that were adopted in 
1998 by AVMA in conjunction with FDA and CDC for prescribing 
and administering antimicrobials to turkey flocks. 
Additionally, the flocks that are treated are also required to 
undergo a withdrawal period prior to processing to ensure all 
antimicrobials have been eliminated from the bird and ensuring 
the consumer is not indirectly exposed to the antimicrobials. 
USDA's Food Safety and Inspection Service also maintains a 
monitoring program that tests for the antibiotic residue levels 
in turkey meats to ensure the industry is following the 
required withdrawal period. Current data indicates that 
virtually all turkeys are free of unsafe residues.
    The tools discussed previously have allowed the industry to 
make significant improvements in turkey health over the past 
decade which has allowed for increased production in a more 
efficient manner. Without these tools, the industry would not 
be in a position to supply the nearly 6 billion pounds of safe, 
wholesome, nutritious turkey products for the consumer. If the 
industry were not able to maintain its current status, there 
would without a doubt be a decrease in production and an 
increase in production costs which would inevitably be passed 
onto the consumer.
    The increased costs to raise turkeys without antibiotics is 
real. One can quickly see the impact on the consumer by walking 
into the grocery store and doing a price comparison between two 
similar products, one raised conventionally and one raised 
without antibiotics. Today at retail outlets here in the D.C. 
market, a conventionally raised turkey costs $1.29 per pound. A 
similar whole turkey that was produced without antibiotics 
costs $2.29 per pound. With the average consumer purchasing a 
15 pound whole turkey, that would mean there would be $15 
tacked on to their grocery bill. This increased cost to the 
consumer is a result of more advanced production practices. 
While some consumers are willing and able to afford the 
increase, not all Americans have that ability or luxury.
    Mr. Chairman and other Members of the Subcommittee, again 
let me thank you for the opportunity for the National Turkey 
Federation to provide testimony today. The number one goal of 
the U.S. turkey industry is to provide safe, wholesome, 
nutritious quality turkey products at an affordable cost to the 
consumer. All of the advances discussed previously have allowed 
the industry to meet its goals. Thank you very much, and I will 
be happy to answer any questions.
    [The prepared statement of Dr. Rybolt follows:]

 Prepared Statement of Michael L. Rybolt, Ph.D., Director, Scientific 
  and Regulatory Affairs, National Turkey Federation, Washington, D.C.
    Good morning Chairman Boswell, Congressman Hayes and Members of the 
Subcommittee. Thank you for the opportunity to participate in today's 
hearing on the advances of animal health with the livestock and poultry 
industry. My name is Dr. Michael Rybolt and I am the Director for 
Scientific and Regulatory Affairs for the National Turkey Federation 
and staff the Federation's Turkey Health and Welfare Committee. NTF, 
which represents more than 98% of the U.S. turkey industry, greatly 
appreciates the opportunity to provide comments on the advances in 
animal health within the U.S. turkey industry.
    In the United States, turkeys are raised on small farms of an 
average size around 227 acres. There have been many advances in turkey 
production that have allowed the industry to produce a larger volume of 
safe, wholesome product more efficiently. These advances allowed the 
industry to raise more than 260 million turkeys in 2007, with an 
average live weight per bird at 28 pounds. After processing, this 
yielded nearly 6 billion pounds of turkey products for human 
consumption. By contrast, in 1970, the industry only raised 105 million 
birds, with an average live weight of 17 pounds, which provided 1.5 
billion pounds of product for human consumption.
    The advances the industry has made in the last 30 plus years has 
been driven by science and the dedication of turkey industry experts 
with the goal to produce the safest, highest quality, nutritious 
products at an affordable price. In order to meet that goal, 
maintaining the health and well being of the turkey flocks is 
paramount. The industry accomplishes this through a variety of means, 
including raising the birds in environmentally controlled houses or 
barns, increased biosecurity on farms, various animal health monitoring 
programs, the use of vaccination programs, and using approved animal 
drugs or antimicrobials. All of these tools are important for the 
industry and when used together help the industry meet its goal.
    Arguably, one of the most significant advances in the turkey 
industry that has played an essential role in improving the health of 
turkeys flocks is the use of environmentally controlled houses or 
barns. Raising birds indoors helps protect them from predatory wildlife 
and inclement weather. This in turn not only prevents the birds from 
becoming prey but also reduces the risk of the flocks being exposed to 
disease agents. Raising turkeys indoors also creates a less stressful 
environment for the birds, which research from the University of 
Minnesota has demonstrated leads to better production. A well-treated 
turkey will grow to its full potential and provide consumers with a 
low-fat and high-protein source.
    Likewise, increased biosecurity is also important to mitigate 
exposure of the flocks to potential disease causing agents. By limiting 
access to only authorized personnel and/or ensuring proper sanitation 
of footwear and clothing, strict biosecurity is essential to maintain 
the health and well being of our birds. Biosecurity programs have been 
implemented for many years and are continually updated and strengthened 
as needed, taking into account the latest scientific data.
    Additionally, the turkey industry has made significant advances in 
the animal disease monitoring arena. Various programs exist that have 
benefited the industry and allowed for increase production gains. Such 
programs include the USDA National Poultry Improvement Plan. The use of 
these programs has allowed the industry to monitor for various diseases 
and to control and eradicate them before they spread, thereby allowing 
for increased livability and more food for human consumption.
    Unfortunately, like humans, turkeys occasionally will become ill 
and will require medication. For some diseases, the industry has the 
ability to use prophylactic programs; however, there are also times 
when a flocks needs to be treated with antimicrobials for controlling 
bacterial diseases. Use of antimicrobials for disease control, 
prevention and treatment is necessary for the health and welfare of the 
turkey flocks.
    To raise turkeys without antibiotics would increase the incidence 
of illness in turkey flocks. This would result in a decrease in density 
or an increase in the amount of land needed to raise the additional 
turkeys needed to meet the consumer demand. This would also lead to 
decreased livability, an anticipated 10% reduction in gain per day and 
a decrease of 0.05% in feed conversion.
    To compensate for the higher illness rate and resulting decrease in 
feed conversion and to meet the growing needs of the consuming public, 
an additional 175,500 tons of feed would be required for the turkey 
industry. This increase in feed requirement would equate to about 3.7 
million bushels of corn and 1.7 million bushels of soybeans, for the 
turkey industry alone. In order to fill this need, there would need to 
be either more acreage placed into crop production or an increase in 
crop yield.
    Obviously, there is an economic impact with the increased feed 
requirement. However, there is also an environmental impact. The 
decrease in feed conversion leads to less efficiency in digestion and 
utilization of nutrients, and this ultimately results in an increase in 
manure.
    With regard to antibiotic use, each turkey veterinarian follows a 
set of prudent use guidelines that were adopted in 1998 by the American 
Veterinary Medical Association in conjunction with FDA and CDC for 
prescribing and administering antimicrobials to the turkey flocks. 
Additionally, the turkey flocks that are treated are also required to 
undergo a withdrawal period prior to processing to ensure all the 
antimicrobial has been eliminated from the birds, ensuring the consumer 
is not indirectly exposed to the antimicrobials. The USDA Food Safety 
Inspection Service also maintains a monitoring program that test for 
antibiotic residues levels in turkey meat to ensure the industry is 
following the required withdrawal period. Current USDA data indicates 
that 99.9% of samples are free of unsafe residues.
    The tools discussed previously have allowed the turkey industry to 
make significant improvements in turkey health over the past decades, 
which have allowed for the increase in production in a more efficient 
manner. Without these tools, the industry would not be in a position to 
supply nearly 6 billion pounds of safe, wholesome, nutritious turkey 
products for human consumption. If the industry was not able to 
maintain its current status, there would without a doubt be decreases 
in production and an increase in production cost, which would 
inevitably be passed on to the consumer.
    The increased costs to raise turkeys without antibiotics are real. 
One can quickly see the impact on cost to the consumer by walking into 
a grocery store and looking at the price comparison between two similar 
products, one that is antibiotic free and the other that is not. Today, 
at retail outlets here in the D.C. market, a conventionally raised 
whole turkey costs $1.29 per pound. A similar whole turkey that was 
produced from antibiotic-free birds costs $2.29 per pound. With the 
average consumer purchasing a 15 pound whole bird, that is a $15 
increase in the grocery bill. This increase cost to the consumer is a 
result of the more advanced production practices. While some consumers 
are willing and able to afford the increased cost, not all Americans 
have that luxury.
    Mr. Chairman and other Members of the Subcommittee, again, let me 
thank you for allowing the National Turkey Federation the opportunity 
to provide this testimony today. The number one goal of the U.S. turkey 
industry is to provide safe, wholesome, nutritious quality products at 
an affordable cost to the consumer. All the advances discussed 
previously have allowed the industry to meet this goal. Thank you very 
much and I will be happy to answer any questions.

    The Chairman. Thank you.
    Dr. Byrne.

        STATEMENT OF ROBERT D. BYRNE, Ph.D., SENIOR VICE
         PRESIDENT, SCIENTIFIC AND REGULATORY AFFAIRS,
       NATIONAL MILK PRODUCERS FEDERATION, ARLINGTON, VA

    Dr. Byrne. Good morning. Thank you, Chairman Boswell, 
Ranking Member Hayes and Members of the Subcommittee. My name 
is Rob Byrne. I am Senior Vice President of Scientific and 
Regulatory Affairs for the National Milk Producers Federation. 
The National Milk Producers Federation, based in Arlington, 
Virginia, develops and carries out policies that advance the 
well-being of dairy producers and cooperatives they own. The 
members of NMPF's 31 cooperatives produce the majority of the 
U.S. milk supply, making NMPF the voice of more than 40,000 
dairy producers on Capitol Hill and with government agencies.
    I am very grateful that the Committee is holding this 
hearing to review the advances in animal health within the 
livestock industry and am pleased to discuss some of these as 
they relate to the dairy industry with you. There have been 
many advances in animal health in the dairy industry over the 
years and these have enabled the industry to become even more 
efficient in milk production. As an example of this efficiency, 
the dairy industry has changed dramatically in the last 50 
years. In 1960, there were 17.6 million dairy cows on 1.8 
million dairy farms. In 2008, there were 9.3 million dairy cows 
on 59,000 commercial dairy farms in all 50 states. During the 
same time, milk production has actually increased from 123 
billion pounds per year to almost 190 billion pounds per year. 
from these numbers, it is clear that the dairy industry is 
producing more milk with many fewer cows on many fewer farms. 
At the same time, milk safety and quality have continued to 
increase, resulting in the assurance that the dairy industry 
provides an abundant supply of high-quality, safe milk for 
consumers.
    Providing proper care to animals is the best means to 
ensure their health and this is of utmost importance to our 
members and dairy producers across the country. This is 
accomplished on dairy farms through a variety of measures 
starting with good herd management. Proper management and 
handling of animals keeps them healthy, producing an abundant 
supply of high-quality milk. Attention to animal nutrition and 
feeding for cows is also important, both to ensure they receive 
diets appropriate to their stage in life to keep them healthy 
and to ensure that the milk they produce is safe and wholesome. 
Last, the veterinary-client-patient relationship is one of the 
most important means to make sure that the health of dairy cows 
is constantly monitored. A veterinary-client-patient 
relationship demonstrates that the dairy farm uses a 
veterinarian for health and disease issues, allowing the 
producers to use medications appropriately for sick or injured 
animals. All of these items are very important in maintaining a 
healthy and productive dairy cow.
    To address animal care, NMPF is currently completing the 
purchase of the Dairy Quality Assurance Center in Stratford, 
Iowa, and assuming it within NMPF. The DQA program is widely 
recognized throughout the dairy industry as an excellent 
educational tool for dairy producers regarding animal care 
practices. Through a comprehensive set of best management 
practices, the program provides measurable and verifiable 
components to allow the industry to prove the good practices 
being conducted at the farm. While this program currently 
exists as a separate facility, housing it within NMPF will 
enable us to create a National Dairy Quality Assurance Program 
to assist dairy producers across the country in maintaining a 
viable, up-to-date, quality assurance program. This will 
provide us an appropriate vehicle to best implement future 
advances in animal health within our industry.
    Despite all these measures to address animal care and 
health, dairy cows occasionally do get sick and sometimes they 
must be treated with appropriate medications. When this 
happens, there are many safeguards in place to ensure that 
residues of these medications do not end up in the milk supply. 
I would like to address a few of these areas in a little more 
detail to describe how the dairy industry ensures that any 
animal health treatments that are given do not have a negative 
impact on the quality or safety of milk.
    On-farm therapeutic use of animal healthcare products 
occurs to cure animals from illness across all stages of their 
life. A recent survey of dairy farms in Pennsylvania showed the 
therapeutic use of medications on dairy farms for several 
illnesses of dairy animals. These illnesses include pneumonia, 
metritis, foot rot, enteritis and mastitis. It is important to 
note that the majority of animals are actually not treated with 
medications, rather, therapeutic usage is reserved for clinical 
cases of disease.
    The first step in deciding to treat a dairy cow is to use 
only medications that are approved by the Food and Drug 
Administration's Center for Veterinary Medicine for use in 
lactating animals. The process for animal drug approval that we 
heard about earlier involves safety assessments and providing 
withdrawal times to allow the animal drug to clear the animal's 
system. In the case of lactating animals, there are specific 
withdrawal times established to ensure that milk is not 
contaminated. The milk from any animals that are treated must 
be held out of the commercial supply until these withdrawal 
times are met. The approval process is very rigorous and 
assures that the product is safe both for animals and for the 
food supply and consumers.
    To reduce the level of potentially harmful bacteria which 
result in infections and sickness to animals, dairy cows may 
also be treated prophylactically. On-farm prophylactic use of 
animal medications occurs in two areas in the dairy industry: 
the use of medicated milk replacers fed to calves and the use 
of dry cow treatments to prevent mastitis infection during the 
dry cow period. Medicated milk replacers are used because 
studies have shown an improvement in animal performance and 
reduction of scours in dairy calves. Reported usage of 
medicated milk replacers on dairy farms ranges from 22 to 70 
percent, and the use of medicated milk replacers assists with 
the overall health of dairy calves in this important 
developmental stage of their life.
    Dry cow treatment often involves the use of a long-acting 
intramammary infusion given to cows between lactation cycles 
with the intention of treating existing infections and 
preventing new infections. The use of dry cow treatment is near 
universal. For example, in a survey in Washington State, 82 
percent of the dairy farms reporting using dry cow treatment on 
all of their cows. While dry cow treatment is near universal, 
two surveys of antimicrobial resistance of mastitis bacteria in 
dairy cattle found no consistent change in the prevalence of 
resistance.
    Recognizing that lactating dairy cows are occasionally 
treated for diseases and to ensure that no animal medications 
remain in milk, all milk is screened before it is accepted into 
a processing plant. This is a very important control step in 
the process, and it is part of a system that the dairy 
industry, in cooperation with the states and FDA, established 
in the early 1990s.
    As part of this regulatory program, a sample from every 
tanker of milk that arrives at a processing plant is tested 
before milk is unloaded using screening tests that have been 
evaluated and approved for use by FDA. Milk that tests positive 
is rejected for human consumption and is appropriately 
discarded. The dairy farmer causing the positive result must 
then pay for the entire load of milk. This costs approximately 
$12,000, so there is a large financial incentive to make sure 
that no treated dairy cows end up being milked. In addition, 
all milk from the dairy farm is then withheld until a negative 
farm test is obtained. In 2007, less than .032 percent of all 
milk tanker samples tested positive for residues of animal 
medications. Milk tanker samples testing positive declined 
nearly 70 percent from 1997 to the present, indicating that the 
program is effective at detecting and deterring animal 
medications in milk.
    Proper animal healthcare is the first step in the assurance 
that dairy products remain safe and wholesome. In fact, due 
largely to the part of the animal healthcare practices, and 
milk being the most highly regulated food product in the United 
States, dairy foods are lowest among major food groups as the 
cause of foodborne illness. Clean conditions, good 
manufacturing practices and the adoption of pasteurization have 
all enabled dairy products to maintain an excellent safety 
record. Of the 2,700 foodborne disease outbreaks summarized by 
CDC from 1993 to 1997, only ten were attributed to milk 
consumption and seven to cheese consumption. Most foodborne 
disease outbreaks associated with milk and cheese are due to 
the consumption of raw or unpasteurized milk and raw milk 
cheeses that have not been properly aged.
    As a result of the entire range of activities at the dairy 
farm which start with providing excellent care for animal 
health, to the measures taken at the processing plant, the 
dairy industry consistently provides a safe, wholesome and 
nutritious product for all consumers to enjoy.
    Thank you again for the opportunity to appear as part of 
this important hearing, and I would be happy to answer any 
questions you may have about advances in animal health within 
the dairy industry.
    [The prepared statement of Dr. Byrne follows:]

  Prepared Statement of Robert D. Byrne, Ph.D., Senior Vice President,
Scientific and Regulatory Affairs, National Milk Producers Federation, 
                             Arlington, VA
    Thank you Chairman Boswell, Ranking Member Hayes, and Members of 
the Committee. My name is Rob Byrne and I am Senior Vice President of 
Scientific & Regulatory Affairs for the National Milk Producers 
Federation. The National Milk Producers Federation (NMPF), based in 
Arlington, VA, develops and carries out policies that advance the well 
being of dairy producers and the cooperatives they own. The members of 
NMPF's 31 cooperatives produce the majority of the U.S. milk supply, 
making NMPF the voice of more than 40,000 dairy producers on Capitol 
Hill and with government agencies.
    I am grateful that the Committee is holding this hearing to review 
the advances of animal health within the livestock industry and am 
pleased to discuss some of these as they relate to the dairy industry. 
There have been many advances in animal health in the dairy industry 
over the years and these have enabled the industry to become even more 
efficient in milk production. As an example of this efficiency, the 
dairy industry has changed dramatically in the past 50 years. In 1960, 
there were 17.6 million dairy cows on 1.8 million dairy farms. In 2008, 
there are 9.3 million cows on 59,000 commercial dairy farms in all 
fifty states. During this same time, milk production has increased from 
123 billion pounds to almost 190 billion pounds. from these numbers, it 
is clear that the dairy industry is producing more milk with many fewer 
cows on many fewer farms. At the same time, milk safety and quality 
have continued to increase, resulting in the assurance that the dairy 
industry provides an abundant supply of high quality, safe milk for 
consumers.
    Providing proper care to animals is the best means to ensure their 
health and this is of the utmost importance to our members and dairy 
producers across the county. This is accomplished on dairy farms 
through a variety of measures, starting with good herd management. 
Proper management and handling of animals keeps them healthy and 
producing an abundant supply of high quality milk. Attention to animal 
nutrition and feeding for cows is also important, both to ensure they 
receive diets appropriate to their stage in life, to keep them healthy, 
and to ensure that the milk they produce is safe and wholesome. Lastly, 
the veterinary-client-patient relationship is one of the most important 
means to make sure that the health of dairy cows is constantly 
monitored. A veterinary-client-patient relationship demonstrates that 
the dairy farm uses a veterinarian for health and disease issues 
allowing the producer to use medications appropriately for sick or 
injured animals. All of these items are very important in maintaining a 
healthy and productive dairy cow.
    To address animal care, NMPF is currently completing the purchase 
of the Dairy Quality Assurance (DQA) Center in Stratford, Iowa and 
assuming it within NMPF. The DQA program is widely recognized 
throughout the dairy industry as an excellent educational tool for 
dairy producers regarding animal care practices. Through a 
comprehensive set of Best Management Practices, the program provides 
measurable and verifiable components to allow the industry to prove the 
good practices being conducted at the farm. While this program 
currently exists as a separate entity, housing it within NMPF will 
enable us to create a National Dairy Quality Assurance Program to 
assist dairy producers across the country in maintaining a viable, up-
to-date quality assurance program. This will provide us an appropriate 
vehicle to best implement future advances in animal health in our 
industry.
    Despite all of these measures to address animal care and health, 
dairy cows occasionally get sick and sometimes must then be treated 
with appropriate medications. When this happens, there are many 
safeguards in place to ensure that residues of these medications do not 
end up in the milk supply. I'd like to address a few areas in more 
detail to describe how the dairy industry ensures that any animal 
health treatments that are given do not have a negative impact on the 
safety or quality of milk.
    On-farm therapeutic use of animal health care products occurs to 
cure animals from illness across all ages of dairy animals. A recent 
survey of dairy farms in Pennsylvania \1\ showed the therapeutic use of 
medications on dairy farms for several illnesses of dairy animals. 
These illnesses include pneumonia, metritis, foot rot, enteritis, and 
mastitis. It is important to note that the majority of animals are 
actually not treated with medications; rather therapeutic usage is 
reserved for clinical cases of disease.
---------------------------------------------------------------------------
    \1\ Sawant, A.A., L.M. Sordillo, and B.M. Jayarao. 2005. A survey 
on antibiotic usage in dairy herds in Pennsylvania. J. Dairy Sci. 
88:2991-2999.
---------------------------------------------------------------------------
    The first step in deciding to treat a dairy cow is to use only 
medications that are approved by the Food and Drug Administration's 
(FDA) Center for Veterinary Medicine (CVM) for use in lactating 
animals. The process for animal drug approval involves safety 
assessments and providing withdrawal times to allow the animal drug to 
clear the animal's system. In the case of lactating animals, there are 
specific withdrawal times established to ensure that milk is not 
contaminated. The milk from any animals that are treated must held out 
of the commercial supply until these withdrawal times are met. The 
approval process is very rigorous and assures that the product is safe 
both for animals and the food supply.
    To reduce the level of potentially harmful bacteria, which can 
result in infections and sickness to animals, dairy cows may also be 
treated prophylactically. On-farm prophylactic use of animal 
medications occurs in two areas: (1) use of medicated milk replacers 
fed to calves and (2) use of dry cow treatments to prevent mastitis 
infection during the dry period.
    Medicated milk replacers are used because studies have shown an 
improvement in animal performance and reduction of scours in dairy 
calves.\2\ Reported usage of medicated milk replacers on dairy farms 
ranges from 22 to 70%.\3\ \4\ The use of medicated milk replacers 
assists with the overall health of dairy calves in this important 
developmental stage of their life.
---------------------------------------------------------------------------
    \2\ Quigley, J.D., J.J. Drewry, L.M. Murray, and S.J. Ivey. 1997. 
Body weight gain, feed efficiency, and fecal scores of dairy calves in 
response to galactosyl-lactose or antibiotics in milk replacers. J. 
Dairy Sci. 80:1751-1754.
    \3\ Raymond, M.J., R.D. Wohrle, and D.R. Call. 2006. Assessment and 
promotion of judicious antibiotic use on dairy farms in Washington 
State. J. Dairy Sci. 89:3228-3240.
    \4\ Sawant, A.A., L.M. Sordillo, and B.M. Jayarao. 2005. A survey 
on antibiotic usage in dairy herds in Pennsylvania. J. Dairy Sci. 
88:2991-2999.
---------------------------------------------------------------------------
    Dry cow treatment often involves the use of ``a long-acting 
intramammary infusion given to cows between lactation cycles with the 
intention of treating existing infections and preventing new 
infections.'' \5\ The use of dry cow treatment is near universal. For 
example in a survey from Washington State, 82% of dairy farms reported 
using dry cow treatment on all of their cows.\6\ While dry cow 
treatment is near universal, two surveys of antimicrobial resistance of 
mastitis bacteria in dairy cattle found no consistent change in the 
prevalence of resistance.\7\  \8\
---------------------------------------------------------------------------
    \5\ Ibid.
    \6\ Ibid.
    \7\ Erskine, R.J., R.D. Walker, C.A. Bolin, P.C. Bartlett, and D.G. 
White. 2002. Trends in antibacterial susceptibility of mastitis 
pathogens during a seven-year period. J. Dairy Sci. 85:1111-1118.
    \8\ Makovec, J.A., and P.L. Ruegg. 2003. Antimicrobial resistance 
of bacteria isolated from dairy cow milk samples submitted for 
bacterial culture: 8,905 samples (1994-2001). J. Am. Vet. Med. Assoc. 
222:1582-1589.
---------------------------------------------------------------------------
    Recognizing that lactating dairy cows are occasionally treated for 
diseases and to ensure that no animal medications remain in milk, all 
milk is screened before it is accepted into a processing plant. This is 
a very important control step in the process and is part of a system 
that the dairy industry, in cooperation with the states and FDA, 
established in the early 1990's. As part of this regulatory program, a 
sample from every tanker of milk that arrives at a processing plant is 
tested before milk is unloaded using screening tests that have been 
evaluated and approved for use by FDA. Milk that tests positive is 
rejected for human consumption and appropriately discarded. The dairy 
farmer causing the positive result must then pay for the entire load of 
milk. This costs approximately $12,000, so there is a large financial 
incentive to make sure that no treated dairy cows are milked. In 
addition, all milk from the dairy farm is then withheld until a 
negative farm test result is obtained. In 2007 less than 0.032% of all 
milk tanker samples tested positive for residues of animal 
medications.\9\ Milk tanker samples testing positive declined by nearly 
70% from 1996-2005 indicating that the program is effective at 
detecting and deterring animal medications in milk.\10\ \11\
---------------------------------------------------------------------------
    \9\ National Milk Drug Residue Database: Fiscal Year 2007 Annual 
Report. Available online at: http://www.cfsan.fda.gov/8acrobat/
milkrp07.pdf.
    \10\ Ibid.
    \11\ National Milk Drug Residue Database: Fiscal Year 1996 Annual 
Report. Available online at: http://www.cfsan.fda.gov/8ear/
milkrp96.html
---------------------------------------------------------------------------
    Proper animal health care is the first step in the assurance that 
dairy products remain safe and wholesome. In fact, due largely in part 
to these animal health care practices, and milk being the most highly 
regulated food product in the United States,\12\ dairy foods are lowest 
among major food groups in the cause of foodborne illness. Clean 
conditions, good manufacturing practices, and the adoption of 
pasteurization have all enabled dairy products to maintain an excellent 
safety record. Of 2,751 foodborne disease outbreaks summarized by the 
Center for Disease Control (CDC) from 1993-1997, ten were attributed to 
milk consumption (0.36%) and seven to cheese consumption (0.25%).\13\ 
Most foodborne disease outbreaks associated with milk or cheese 
consumption is due to the consumption of raw (unpasteurized) milk or 
raw milk cheeses that have not been properly aged.
---------------------------------------------------------------------------
    \12\ Milk production is regulated under the Grade ``A'' Pasteurized 
Milk Ordinance.
    \13\ S.J. Olsen, L.C. MacKinnon, J.S. Goulding, N.H. Bean, L. 
Slutsker. 2000. Surveillance for foodborne-disease outbreaks--United 
States, 1993-1997. MMWR CDC Surveill. Summ. Mar. 17;49(1):1-62 (Most 
recent summary).
---------------------------------------------------------------------------
    As a result of the entire range of activities at the dairy farm, 
which start with providing excellent care for animal health, to the 
measures taken at the processing plant, the dairy industry consistently 
provides a safe, wholesome, and nutritious range of products for all 
consumers to enjoy.
    Thank you again for the opportunity to appear as part of this 
important hearing. I will be happy to answer any questions you may have 
about advances in animal health within the dairy industry.

    The Chairman. Thank you.
    Dr. Klopp.

        STATEMENT OF SPANGLER KLOPP, D.V.M., D.A.C.P.V.;
            CORPORATE VETERINARIAN, TOWNSENDS, INC.,
     GEORGETOWN, DE; ON BEHALF OF NATIONAL CHICKEN COUNCIL

    Dr. Klopp. Good morning, Chairman Boswell, Congressman 
Hayes. I thank you for the opportunity to be here to speak on 
behalf of the National Chicken Council. My name is Buzz Klopp. 
I am a practicing poultry veterinarian and have been so for 36 
years.
    For the past 14 years, I have worked for Townsends 
Incorporated, which is an integrated broiler chicken growing 
and processing company. We grow and process chickens in the 
States of North Carolina and Arkansas. The chicken industry 
itself has made exceptional advances over the decades and this 
is due in large part to the lead of science and just a lot of 
hard work and a lot of smart thinking by a lot of different 
people. Today's industry grows approximately nine billion 
chickens a year. We grow these chickens on approximately 34,000 
independently owned and operated farms. Now, chickens are like 
anything else. They are a business, and the health of chickens 
is very important to the business, and maintaining the health 
of chickens is predicated on prevention of disease. We do this 
principally through vaccination, appropriate use of antibiotics 
and other antimicrobials, and good old sound poultry husbandry, 
or chicken house management, as we call it.
    We have some basic parameters that we use for measuring 
health and performance of chickens. One of these is average 
daily gain. This is nothing more than how fast does the chicken 
grow, how much does it grow every day. Another basic parameter 
that we use is livability: of the number of chicks we place on 
a farm, how many of them do we take to the processing plant to 
process for food. The third parameter we use is condemnation at 
processing. The USDA has a presence in every one of our plants 
and they reject and discard carcasses that are unfit for human 
consumption. These are referred to as condemned carcasses, 
percentage condemnation rates.
    We use vaccines to control diseases that cannot be 
controlled by antibiotics and husbandry. Antibiotics are used 
for control of specific types of bacterial and parasitic 
diseases. Now, I want to go back to the three parameters that 
we use in measuring chicken health and performance: average 
daily gain, or ADG, is the acronym. Back in the early 1970s 
when I came in the industry, we talked about a 4 pound chicken 
at 8 weeks of age. Today we talk about a 5\1/2\ pound chicken 
at 50 days of age. If we had to go back to the previous rates 
of average daily gain, we would need approximately 
2,484,000,000 more chickens to be grown and processed in this 
country.
    If we look at livability, livability percentages in the 
early 1980s were approximately 93\1/2\ percent. For today, the 
approximate livability is 95.6 percent. This is a real 
improvement of approximately 2.1 percent. Again, based on the 
nine billion chickens, if we do not have the appropriate 
interventions, we would have to have another 190,800,000 day 
old chicks placed to meet today's needs of the American public.
    If we look at condemnation at processing and the 
improvement here, I have actually put a percentage to this, it 
is 456 percent over 42 years, and I have broken it down in a 
chart that is on the page. I am not going to bore you with all 
of the details of what those are. If you want to know, I will 
be happy to answer your questions. But again, without the 
interventions that we have available to us today, we would have 
to place and produce another 155,700,000 chickens to meet the 
needs of the American public.
    Collectively, without the usage of the appropriate 
interventions that we have, this would total up to the need to 
raise approximately 2,830,500,000 more chickens to meet today's 
need. I think we all know that the population of the world is 
not holding on a steady line, it is not declining, it is 
increasing. So it is more food we need, not less food.
    It is important to remember when we talk about chickens and 
a lot of other animals that these are free-roaming animals, and 
chickens are like dogs, cows, pigs, a lot of animals. They pick 
at the ground. That is just their nature. So they are very 
prone for the development of diseases of the gastrointestinal 
tract, and the occurrence of antibiotic resistance is not due 
to us in the chicken industry. We have been concerned about it. 
Like I said, I have been a practicing veterinarian for 36 
years. We have been concerned with antibiotic resistance from 
that very time, and we manage this through the proper and sound 
usage of the products available to us through rotation 
programs, through dosage selections, through the proper 
selection of the given intervention available to us.
    Good chicken health is maintained through the responsible 
use of vaccines and antibiotics, and this is important not just 
to me, not just to my industry, but it is important to the 
American public. The adage that I use a lot of times is, hungry 
people are not happy people, and if you want to see a person 
that fits that mold, be around me if I don't each lunch. My 
whole personality changes.
    Now, in today's day, we end up producing a lot of different 
types of chickens, and we do produce some antibiotic-free 
chickens, and we have found, shock, shock, exactly what we 
would expect. We had 2.91 percent lower livability. We had 
basically 33 points lower average daily gain and over a quarter 
percent higher condemnation at processing. What this results in 
is not only less food but it results in food at a higher cost 
to the American consumer. The other thing that should be 
addressed here, and some of my colleagues have mentioned is, 
there are environmental impacts to growing more animals, and if 
we are going to do this, we are going to have a whole side 
range of aspects that are going to have to be evaluated.
    So in conclusion, I say to you, and I really do appreciate 
the opportunity to be here, that antibiotics are important to 
the industry as far as disease control is concerned and the 
phrase of today is ``animal welfare.'' In my years, we always 
talked about chicken house management or poultry husbandry or 
animal husbandry but today it is animal welfare, and the use of 
antibiotics is very important in that aspect as well as to the 
sustainability of American agriculture. I want to go back to 
the fact that we grow our chickens on approximately 34,000 
independently owned and operated farms, and the other part that 
is important, and I think that is why we are here, is that the 
appropriate use of antibiotics and interventions, it is 
important to the American public, yes, in terms of antibiotic 
resistance and sensitivity, but also in terms of producing a 
good, sound, nutritious, economically affordable food product.
    I thank you very much for the opportunity to be here, and I 
will be happy to entertain any questions.
    [The prepared statement of Dr. Klopp follows:]

  Prepared Statement of Spangler Klopp, D.V.M., D.A.C.P.V.; Corporate
 Veterinarian, Townsends, Inc., Georgetown, DE; on Behalf of National 
                            Chicken Council
    Good morning Chairman Boswell, Congressman Hayes, and Members of 
the Subcommittee. Thank you, Chairman Boswell for the opportunity to 
participate in this important hearing on the advances of animal health 
with the livestock industry. On behalf of the National Chicken Council, 
I appreciate your invitation to provide comments on the advances in 
chicken health in the U.S. chicken industry.
    My name is Spangler Klopp and I am the Corporate Veterinarian at 
Townsends, Inc. and former Chairman of the National Chicken Council 
Poultry Health Committee.
    The raising of chickens to produce food for human consumption has 
made exceptional advances over the decades due in large part to 
ingenuity and intelligence in following the lead of the sciences and a 
great deal of hard work. Today's broiler chicken industry processes 
approximately nine billion chickens/year, representing over $37 billion 
dollars in value. These chickens are raised to an average live weight 
of 5.53 lbs with a 75% yield at processing resulting in approximately 
37.5 billion pounds of chicken meat, valued at over $37 billion, for 
human consumption. The broiler industry contributes to sustainable 
agriculture by raising its chickens on approximately 34,000 
independently owned and operated farms.
    Maintaining the health of chicken flocks is predicated on disease 
prevention through vaccination, appropriate use of antibiotics and 
other antimicrobials and sound poultry husbandry. Critical measurement 
parameters for chicken performance are rate of gain, (Average Daily 
Gain or ADG), percentage livability, (number of chicks placed divided 
by number moved to processing), percentage condemnation at processing, 
(number of carcasses deemed unfit by USDA for human consumption divided 
by the number of chickens processed).
    Vaccines control diseases that cannot be controlled by antibiotics 
and husbandry. Antibiotics are used for control of specific bacterial 
and parasitic diseases especially those of the gastrointestinal tract. 
Such usages allow for improved health as indicated by improved 
livability, average daily gain and carcass condemnation at processing.
    ADG in the early 1970's was defined as 4 pound live weight at 56 
days of age or .0714 pound ADG. Today, the approximate figure for ADG 
is .1139 based on an average processing weight of 5.53 pounds. This 
represents a 160% increase in efficiency and that much more meat per 
chicken. Without today's technologies, approximately 2,484,000,000 more 
chickens would be required annually to meet the food demands of the 
American public.
    Percentage livability was approximately 93.52 in the early 1980s 
and the figure for today is approximately 95.64. This represents a real 
improvement of 2.12% and that much more meat per flock. Based on the 
national figure of nine billion chickens processed, without this 
improvement in livability, an additional 190,800,000 day old chicks 
would have to be placed annually to meet the needs of the American 
public.
    Condemnation percentage improvement, shown below, in the past 42 
years is 456% and represents improved meat quality, from taste, 
nutritional and microbiological aspects. If condemnations were at the 
level of earlier years, another 155,700,000 chickens would have to be 
grown annually to meet the needs of the American Public. Collectively, 
if the industry was not allowed use of appropriate interventions, an 
additional 2,830,500,000 chickens would have to be grown and processed 
annually to meet the needs of the American public.

 Percentage Field Related USDA Carcass Condemnation of Broiler Chickens
                         for Two Selected Years
------------------------------------------------------------------------
        Category                 1965 *                  2007 **
------------------------------------------------------------------------
                 Leukosis             .512                    .028
Septicemia/Toxemia                    .563                    .238
    Airsacculitis                     .922                    .109
Inflammatory process                  .128                    .113
              (IP)
        Synovitis                     .102                    .0003
                        ------------------------------------------------
  Total Field..........              2.227                   0.4883
------------------------------------------------------------------------
* Dr. L.V. Sanders, USDA, National meeting on Poultry Condemnations,
  Salisbury, MD, October 18-19, 1966.
** NASS/USDA/Slaughter Report, January-December, 2007, converted to
  percentages.

    It is important to remember that broiler chickens are free roaming 
and have certain natural tendencies, which include ``picking at the 
ground or litter.'' Thus disease control becomes a function of 
maintaining a balance between the chicken and its environment. Vaccines 
and antibiotics have played significant roles in the improvement of the 
health parameters cited above and are valued accordingly. Their usage 
is rigidly monitored by educated and trained professionals.
    The development of antibiotic resistant bacteria has been a concern 
of the industry long before the subject became popular with others and 
is viewed even more importantly today. Sound usage/rotational programs, 
proper pharmaceutical selection for use and use of proper dosage 
regimes have allowed for the continued effectiveness of antibiotics, 
some of which have been in use for over 25 years. Maintenance of 
antibiotic sensitivity at the chicken house level is an important 
issue.
    Good chicken health through the responsible use of vaccines and 
antibiotics is obviously important in feeding the American Public and 
is equally important in enhancing the quality of the environment and 
socioeconomic style of life in rural America. Healthy chickens require 
less feed while using less housing space, produce less manure and 
produce more meat as compared to the option of not having these 
important interventions for our use.
    In my current experience of producing chickens raised without 
antibiotics, those flocks have a 2.91% lower livability, 0.0033 lower 
ADG and a 0.275% higher condemnation. This may be fine for niche 
markets that cater to consumers who can afford to pay higher prices for 
chicken. But as I previously noted, without the use of appropriate 
interventions, an additional 2,830,500,000 chickens would have to be 
grown each year to meet the needs of the American public. Additionally, 
this loss would result not only in less food but also at a higher cost 
with more potential issues to the environment and to the way of life in 
rural America.
    In conclusion, it is apparent that antibiotics are important in 
disease control or as described in today's vernacular--animal welfare--
as well as to the sustainability of American Agriculture and to the 
American public in general.

    The Chairman. As long as it doesn't get into lunchtime. 
Thank you.
    Mr. Van Zetten.

   STATEMENT OF BLAIR VAN ZETTEN, PRESIDENT, OSKALOOSA FOOD 
    PRODUCTS CORP., OSKALOOSA, IA; ON BEHALF OF UNITED EGG 
                           PRODUCERS

    Mr. Van Zetten. Mr. Chairman, Mr. Vice Chairman, thank you 
for the opportunity to testify. My name is Blair Van Zetten. I 
am a proud member of the Iowa egg industry. We are the nation's 
number one egg-producing state. My company, Oskaloosa Food 
Products, produces liquid, frozen and dried egg products for 
the food industry.
    I am a member of the United Egg Producers. I am also a 
member of the Further Processors Division of United Egg 
Association. Animal healthcare is a critical concern for both 
of these organizations. UEP and UEA's Further Processor 
Divisions have taken a leadership role in animal health, and 
here are just a few examples.
    We supported the development of USDA'S Low Pathogenic Avian 
Influenza Program, a voluntary effort through the National 
Poultry Improvement Plan to prevent, control and identify LPAI 
throughout the poultry industry. We participated in the 
original design of the program and the private sector 
participants in NPIP, and worked with the Department of 
Agriculture and Congress to develop regulations for the program 
to secure adequate funding. Fortunately, the highly pathogenic 
H5N1 strain of avian influenza has never been found in North 
America. However, we all know that we have a responsibility to 
guard against this threat to both animal and human health. We 
have worked with respected academic and veterinarian experts to 
develop procedures for safe movement of eggs and egg products 
into and out of the quarantine zones in the event of an 
outbreak of highly pathogenic avian influenza.
    We presented our findings and recommendations to USDA 
veterinary experts and worked closely with them to ensure the 
maximum protection of both human and animal health. Just this 
week, UEP in conjunction with USDA and other animal health 
officials hosted a national conference to advance the egg 
industry's program that will ensure the containment of highly 
pathogenic avian influenza, should it be found, as well as the 
continuity of the nation's egg supply.
    We have worked to encourage all egg producers to register 
their premises under USDA's voluntary National Animal 
Identification System. If there is a disease outbreak, it is 
critical for USDA and the public health authorities to be able 
to locate and contact all producers in the affected area as 
soon as possible. The NAIS will make this easier.
    Nearly all egg producers have implemented quality assurance 
programs on their farms. These QA programs are primarily aimed 
at preventing Salmonella enteritidis, but they also provide 
important benefits for animal health, and because of the way 
they are designed, in particular, producers enforce strict 
biosecurity programs and take other steps that not only help 
bird health but have human health benefits as well.
    As part of our quality assurance and animal health 
programs, we routinely vaccinate for various infectious 
diseases of foodborne pathogens. Early in a bird's life, often 
on the first day of age, we administer vaccines for respiratory 
and immunosuppressive diseases. Some producers also vaccinate 
for Salmonella enteritidis. These vaccines may be live, 
inactivated or a combination, depending on the disease and the 
producer's own management practices.
    Nowadays we often get questions about antibiotics. 
Antibiotics aren't considered a food safety issue for eggs. Low 
levels of antibiotics are occasionally used to prevent or treat 
disease and ensure the health of the laying hens, just as for 
humans. Few antibiotics are permitted in commercial layers by 
regulations, and there is an economic incentive not to use them 
due to the additional cost. Because so few antibiotics are used 
and are used to such a small degree, they aren't likely to 
contribute to the problem of antibiotic resistance.
    In our own operations, we use antibiotics only for 
treatment. In my written statement, I have listed examples of 
several antibiotics that might be used in our industry and the 
disease which they treat. Through careful and appropriate 
regulations, the animal agriculture industry's ability to use 
antibiotics when necessary can and should be preserved. As a 
relatively small industry, we are a less lucrative market for 
veterinary drug makers than other larger segments of animal 
agriculture. Therefore, we are sensitive to whether the drug 
makers have incentives to develop new products.
    It is important to us that the regulation of antibiotics be 
based on sound science, not emotions, politics or popular 
press. We think science is the best basis on which to make 
highly technical public policy decisions. It is critical that 
regulators have the resources to do their jobs efficiently and 
thoroughly, and we hope Congress will continue to address FDA 
resource needs.
    Beyond the availability of veterinary products, it is also 
important that Congress find more resources for research in 
animal health issues. The work that our scientists do provides 
many benefits to the public and to our industry. Unfortunately, 
the funding for animal agricultural research has been stagnant 
for many years. There are many reasons to increase this 
research but one of them is surely to advance animal health. 
That will improve the welfare of animals under our care and 
also benefit consumers.
    Mr. Chairman, I thank the Subcommittee for its oversight in 
these matters, and I will be happy to try and answer any 
questions you may have.
    [The prepared statement of Mr. Van Zetten follows:]

   Prepared Statement of Blair Van Zetten, President, Oskaloosa Food 
    Products Corp., Oskaloosa, IA; on Behalf of United Egg Producers
    Mr. Chairman and Members of the Subcommittee, thank you very much 
for the opportunity to testify today. My name is Blair Van Zetten and I 
am a proud member of Iowa's egg industry. We are the nation's number-
one egg-producing state. My company, Oskaloosa Foods, produces liquid, 
frozen and dried egg products for the food industry.
    About \1/3\ of all the eggs produced in the United States are 
destined for further processing. In many cases, these eggs will become 
ingredients in a broad range of foods, bringing high-quality protein 
and other nutritional advantages as well as a number of functional 
properties that make the foods better and more convenient.
    I am a member of United Egg Producers (UEP), as are the producers 
of about 98% of the nation's eggs. I am also a member of the Further 
Processors Division of United Egg Association (UEA). Animal health is a 
critical concern for both of these organizations.
    Our industry pays a great deal of attention to animal health for 
several reasons.

   As producers, we care about the welfare of the birds under 
        our care.

   Healthier birds are more productive and animal health is 
        directly related to our ability to stay in business as 
        producers.

   Good animal health leads to a better, safer, more affordable 
        product for our ultimate customer, the consumer.

    I am proud to say that UEP and UEA's Further Processor Division 
have taken a leadership role in animal health. Here are just a few 
examples of what we and our industry have been doing in recent years:

   We supported the development of USDA's Low-Pathogenic Avian 
        Influenza Program--a voluntary effort through the National 
        Poultry Improvement Plan to prevent, control and indemnify LPAI 
        throughout the poultry industry. We participated in the 
        original design of this program as private-sector participants 
        in NPIP, and worked with the Department of Agriculture and 
        Congress to develop regulations for the program and secure 
        adequate funding. Virtually all of our membership participates 
        in this program.

   Fortunately, the highly pathogenic Asian H5N1 strain of 
        avian influenza has never been found in North America, not even 
        among wild birds, much less domesticated poultry. However, we 
        all know that we have a responsibility to guard against this 
        threat to both animal and human health. We have worked with 
        respected academic and veterinary experts to develop procedures 
        for the safe movement of eggs and egg products into and out of 
        quarantine zones in the event of an outbreak of highly 
        pathogenic avian influenza. We've presented our findings and 
        recommendations to USDA veterinary experts and worked closely 
        with them to ensure the maximum protection for both human and 
        animal health. Just this week UEP, in conjunction with USDA and 
        other animal health officials, hosted a national conference to 
        advance an egg industry program that will assure the 
        containment of highly pathogenic avian influenza should it be 
        found anywhere in the United States and the continuity of the 
        nation's egg supply in such an event.

   We have worked to encourage all egg producers to register 
        their premises under USDA's voluntary National Animal 
        Identification System. If there is a disease outbreak, it is 
        critical for USDA and public health authorities to be able to 
        locate and contact all producers in the affected area as soon 
        as possible. The NAIS will make this easier, and minimize the 
        time during which producers' ability to market their products 
        is restricted.

   Nearly all egg producers have implemented quality assurance 
        programs on their farms, either through state programs or as 
        part of programs designed by their own companies or their 
        customers. These quality assurance programs are primarily aimed 
        at preventing Salmonella enteritidis, but they also provide 
        important benefits for animal health because of the way they 
        are designed. In particular, producers enforce strict 
        biosecurity programs, control for disease vectors like rodents, 
        and take other steps that not only help bird health but have 
        human health benefits as well.

   As part of our quality assurance and animal health programs, 
        we routinely vaccinate for various infectious diseases or 
        foodborne pathogens. Early in a bird's life--often on the first 
        day of age--we administer vaccines for respiratory diseases 
        such as Newcastle disease and infectious bronchitis; and 
        immunosuppressive diseases such as Marek's disease and 
        infectious bursal disease. Some producers also vaccinate for 
        Salmonella enteritidis. These vaccines may be live, inactivated 
        or a combination, depending on the disease and the producer's 
        own management practices. We encourage support for USDA's 
        biologics division, which has been understaffed, to improve the 
        development and timeliness of vaccine availability.

    Nowadays, we often get questions about antibiotics. Antibiotics 
aren't considered a food safety issue for eggs. Low levels of 
antibiotics are occasionally used to prevent or treat disease and 
ensure the health of laying hens, just as for humans. Very few 
antibiotics are permitted in commercial layers by regulations, and 
there is an economic incentive not to use them due to the additional 
cost. Because so few antibiotics are used, and are used to such a small 
degree, they aren't likely to contribute to the problem of antibiotic 
resistance.
    In our own operations, we use antibiotics only to treat diseases. 
Examples of some antibiotics that might be used in our industry would 
be tylosin to treat mycoplasma infections, chlortetracycline to treat 
E. coli respiratory infections, and bacitracin to treat necrotic 
enteritis and other enteric diseases.
    Through careful and appropriate regulation, the animal agriculture 
industry's ability to use antibiotics when necessary can and should be 
preserved. As a relatively small industry, we are a less lucrative 
market for veterinary drug makers than other, larger segments of animal 
agriculture. Therefore, we are sensitive to whether the drug makers 
have incentives to develop new products.
    It is important to us that the regulation of antibiotics be based 
on sound science, not emotions, politics or the popular press. We think 
science is the best basis on which to make highly technical public 
policy decisions. It is critical that regulators, in this case the Food 
and Drug Administration, have adequate resources to do their jobs 
efficiently and thoroughly, and we hope Congress will continue to 
address FDA's resource needs.
    Beyond the availability of veterinary products, it is also 
important that Congress find more resources for research in animal 
health issues. The work that our scientists do provides many benefits 
to the public and to our industry. As just one example, USDA's 
Agricultural Research Service demonstrated conclusively that the low-
pathogenic avian influenza virus is inactivated through pasteurization, 
a process that all processed egg products undergo. Not only did this 
work give important reassurance to consumers, and inform industry 
practice, but it has also been enormously helpful to us in 
communicating to our overseas trading partners the safety of our 
products. Unfortunately, the funding for agricultural research has been 
stagnant for many years. There are many reasons to increase this 
research, but one of them is surely to advance animal health: That will 
improve the welfare of the animals under our care, and also benefit 
consumers.
    Mr. Chairman, I thank the Subcommittee for its oversight in these 
matters, and will be happy to try and answer any questions you may 
have.

    The Chairman. Thank you.
    Dr. Apley.

  STATEMENT OF MICHAEL D. APLEY, D.V.M., Ph.D., D.A.C.V.C.P., 
   ASSOCIATE PROFESSOR OF BEEF PRODUCTION MEDICINE, CLINICAL 
     PHARMACOLOGIST, AND DIRECTOR, PharmCATS BIOANALYTICAL 
LABORATORY, KANSAS STATE UNIVERSITY; MEMBER, CATTLE HEALTH AND 
 WELL BEING COMMITTEE, NATIONAL CATTLEMEN'S BEEF ASSOCIATION, 
                         MANHATTAN, KS

    Dr. Apley. Mr. Chairman, Ranking Member Hayes, other 
Members of the Subcommittee, my name is Mike Apley and I am an 
Associate Professor of Beef Production Medicine and a Clinical 
Pharmacologist at Kansas State University.
    I think one of the most important pieces of information 
that should come out of today's hearing is consumers need to 
know that by law, no meat sold in the United States is allowed 
to contain drug residues that violate FDA standards and 
additionally, all products approved by the FDA for use in food-
producing animals must first pass significant human food safety 
benchmarks.
    Animal drugs are important in treating disease, but more 
important is prevention, utilizing cattle management and 
vaccines. An example is the increasing availability of 
backgrounded cattle which have been immunized for bovine 
respiratory disease and held in local environments to overcome 
the stress of weaning prior to being shipped to a feeding 
facility. Another example of management practice is reducing 
the need for therapeutic intervention. It is a system which 
involves periodically moving cows which have not yet calved 
away to new calving areas and leaving behind the cows which 
recently calved. In this way, any shedding of disease organisms 
and related disease outbreaks are isolated within a subset of 
the animals and is prevented from spreading to the entire herd.
    However, when we can't prevent disease, we do need animal 
drugs to control it. An example is the use of an antimicrobial 
in controlling anaplasmosis in cattle. You may be familiar with 
this disease. It is a bloodborne parasite for which we do not 
have an adequate vaccine. In older cattle, this disease is 
often fatal. Chlortetracycline may be fed to cattle at risk for 
the disease during and immediately after the vector season to 
control clinical signs.
    This disease is a good example for examining the use of the 
term ``subtherapeutic,'' which is often interpreted to mean low 
dosage. In the case of anaplasmosis, a relatively low dose of 
the antimicrobial is effective in controlling a disease that 
can result in suffering and death of the cattle as well as 
economic devastation to the producer. The subtherapeutic 
categorization attempts to cast all antimicrobial regimens 
below an undefined threshold as inappropriate due to potential 
selection for resistant pathogens. In reality, resistant 
organism selection pressure is much, much more complicated than 
just a high concentration for a short term is good or a lower 
concentration for a longer exposure is bad. The use of the term 
``subtherapeutic'' to me indicates a cursory knowledge of the 
effects of antimicrobials in food animals relating to animal 
well-being, disease control and food safety. Each application 
of an antimicrobial is different and the attempts to supersede 
the regulatory process with blanket legislation prohibiting 
subtherapeutic uses will result in instances where a decreased 
ability to address disease pressures in cattle production will 
not be offset by a benefit in antimicrobial resistant 
selection. Circumventing the approval process and making leaps 
from effect back to cause will undermine the ability of the 
cattle industry to address disease challenges and in many cases 
may result in no benefit to human therapeutics.
    As Congress continues to have an interest in this issue, we 
recommend that the focus be put on the tools already in place 
rather than imposing new rules, regulations and prohibitions on 
animal agriculture. One way to do this would be to ensure that 
the National Antimicrobial Resistance Monitoring System, or 
NARMS, and the Food Animal Residue Avoidance Databank, or 
FARAD, be fully supported and funded. NARMS was developed to 
monitor changes in susceptibility of select bacteria to 
antimicrobial agents of human and veterinary importance. FARAD 
is another valuable tool that Congress and the Administration 
neglected. FARAD is a computer-based system that is invaluable 
in helping to avoid drug residue problems and keeping the food 
supply safe. Unfortunately, the funding for FARAD runs out next 
week, and unless Congress adds funding to the CR, the valuable 
information it holds will be gone.
    Finally, I would like to talk about the steps the industry 
has taken to police themselves. The Beef Quality Assurance, or 
BQA program, has set forth recommendations for how cattle 
producers should use antibiotics to protect and maintain the 
health of their animals. BQA was established in 1987 to provide 
cattle producers with the principles and tools to use every day 
to ensure animals are given proper care and attention.
    In conclusion, we find that in today's cattle industry, the 
need for animal health interventions that focus on prevention 
of disease, control of disease pressure and therapy of animals 
with disease is critical to the success of cattle producers 
across the country, as well as helping to keep our food supply 
safe. Antimicrobial drugs are a very important part of our 
carefully selected tools and should not be removed from use 
without definitive proof of a benefit to human health that 
overrides the increased suffering and economic losses that 
would be experienced in the cattle industry.
    Thank you for the opportunity to testify.
    [The prepared statement of Dr. Apley follows:]

  Prepared Statement of Michael D. Apley, D.V.M., Ph.D., D.A.C.V.C.P.,
       Associate Professor of Beef Production Medicine, Clinical
   Pharmacologist, and Director, PharmCATS Bioanalytical Laboratory,
     Kansas State University; Member, Cattle Health and Well Being
    Committee, National Cattlemen's Beef Association, Manhattan, KS
    Chairman Boswell, Ranking Member Hayes, and Members of the 
Committee, my name is Mike Apley. I am an Associate Professor of Beef 
Production Medicine, a Clinical Pharmacologist, and the Director of the 
PharmCATS Bioanalytical Laboratory located at Kansas State University. 
I am also a Member of the National Cattlemen's Beef Association's 
(NCBA) Cattle Health and Well Being Committee. I appreciate the 
opportunity to be here today to talk about the use of drugs to prevent 
and treat disease within the cattle industry.
    Animal health and well-being are top priorities for cattle 
producers across the country. Without healthy animals, we do not have a 
healthy industry, so we utilize important tools like vaccines, 
antimicrobials, and other drugs to control disease, treat disease, and 
provide a higher quality of life for our cattle while keeping the food 
supply safe. Ongoing activist and media reports, however, suggest that 
the use of drugs in animal agriculture is often inappropriate and that 
the use of drugs is poorly controlled. Misleading statements such as 
these have put an undue spotlight on animal drugs and threatens to 
undermine the science-based approval process we have for these 
products. One of the most important pieces of information that should 
come out of today's hearing is that consumers need to know that, by 
law, no meat sold in the United States is allowed to contain drug 
residues that violate Food and Drug Administration (FDA) standards. 
Additionally, all products approved by FDA for use in food producing 
animals must first pass significant human food safety benchmarks.
    It is also important to recognize that animal drugs go through a 
rigorous, science-based testing process before they are approved for 
use. FDA, the U.S. Department of Agriculture (USDA), veterinarians, 
animal health companies, producer organizations, and other stakeholders 
have implemented several layers of human health protections during the 
past decade to reduce any risks associated with antibiotic use in 
animals.
    FDA approves antibiotics and the specific dosage rates to treat 
specific diseases or conditions, and producers are legally required to 
follow these precise label directions. This rigorous approval process 
was made more stringent in 2003 when FDA finalized an additional safety 
measure requiring an antibiotic resistance risk assessment for all new 
and existing antibiotics known as Guidance #152 (Guidance for Industry 
Part 152).
    FDA's Center for Veterinary Medicine (CVM) is responsible for 
ensuring that animal drugs are safe, effective, and manufactured to the 
highest quality standards. The standards and processes for reviewing an 
antibiotic used to treat animals is essentially the same as that for an 
antibiotic used to treat humans, except for the fact that animal drugs 
have to go through additional food safety assessments that human drugs 
do not. Every drug is subject to a safety assessment, efficacy 
assessment, and quality or manufacturing assessment before it is 
approved.
    The safety assessment layer of the approval process requires 
sponsors to submit data showing use of the antibiotic is safe for the 
human or animal in which it is to be used. The safety assessment for 
food animals is more stringent than that for human antibiotics in three 
respects:

    1. While FDA conducts a risk-benefit assessment for human 
        antibiotics in which it weighs benefits against risks, there is 
        no consideration of benefits in the review of antibiotics used 
        in food animals. This means any animal or human health risks 
        for products under review must be extremely low since FDA does 
        not consider any benefits to offset the risks.

    2. The safety assessment for food animal antibiotics requires 
        sponsors to submit human food safety studies to ensure meat 
        from animals treated with the antibiotic will be safe for human 
        consumption. Data from these studies are used to establish 
        withdrawal periods, or the amount of time prior to processing 
        during which antibiotics cannot be used in order to ensure 
        there are no residues above tolerance levels in the final food 
        product.

    3. In 2003, FDA implemented an additional safety measure that 
        ``outlines a comprehensive, evidence-based approach to 
        preventing antimicrobial resistance that may result from the 
        use of antimicrobial drugs in animals.'' This risk assessment 
        process was a priority action item in the U.S. Public Health 
        Action Plan and is required for all newly proposed antibiotics. 
        Significantly, CVM is working with animal health companies to 
        also examine all existing, approved products using this new 
        methodology.

    Both the animal and human drug approval processes require efficacy 
assessments. This means the submitting company must provide data from 
geographically diverse, statistically-designed studies that show the 
product will work in the way it is intended to provide a clinical 
improvement or cure.
    Finally, approval of animal and human drug products require a 
quality or manufacturing assessment consisting of facility inspections, 
assurance of product stability, adherence to good manufacturing 
practices and other procedures to assure FDA the sponsor can 
manufacture the product in the approved form.
    In addition, USDA's Food Safety and Inspection Service (FSIS) 
conducts tests to ensure withdrawal periods are being followed and beef 
products entering the food supply do not contain antibiotic levels that 
violate FDA standards. The testing protocol for the FSIS National 
Residue Testing Program has been updated continuously since its 
inception in 1967.
    Once the products have been approved, many are used to prevent 
animal disease. There are some who will claim that the cattle industry 
is dependent on drugs to fix the problems associated with our 
production methods. While we prefer to prevent diseases, animal drugs 
are just one tool we utilize to control disease. The cattle industry 
strives to invent and improve production practices that help minimize 
the use of drugs and prevent diseases.
    An example of an advance in disease prevention management is the 
increasing availability of ``backgrounded'' cattle which have received 
appropriate immunizations for bovine respiratory disease and are then 
held in local environments to overcome the stress of weaning prior to 
being shipped to a feeding facility. These cattle are sold at a premium 
due to their reputation for decreased disease occurrence at the feeding 
facility.
    Another example of management practices reducing the need for 
therapeutic intervention is the ``Sandhills Calving System''. Named for 
the intense cow/calf production area in the sandhills of Nebraska, this 
system involves periodically moving cows which have not yet calved away 
to new calving areas and leaving behind the cows and calves which have 
recently calved. In this way any shedding of disease organisms and 
related disease outbreaks are isolated within a subset of the animals 
and prevented from spreading to the entire herd.
    The importance of assuring adequate colostrum intake in newborn 
calves has been demonstrated repeatedly, including data showing that 
inadequate intake can result in differences in health performance as 
far removed as in the feedlot phase of beef production. The economic 
incentive to pay attention to colostrum intake is now based on more 
than just neonatal health on the farm of origin in an industry where 
source identity of cattle throughout the production cycle becomes more 
common place through alliance programs, retained ownership, and branded 
beef programs.
    Despite continually advancing management practices, vaccines remain 
a staple of preventive programs in cattle. While there are vaccines 
with demonstrated field efficacy for some pathogens related to bovine 
respiratory disease, we still await vaccines with consistent, proven 
efficacy for diseases such as systemic or enteric salmonellosis, 
infectious pododermatitis (foot rot), Mycoplasma bovis involved in the 
bovine respiratory disease complex, infectious bovine 
keratoconjunctivitis (pinkeye), and anaplasmosis. It is crucial that 
funding be provided for basic and applied research leading to increased 
vaccine availability.
    Once a disease has taken hold, we must utilize animal drugs to 
control the disease and prevent its spread. Treatments for control of 
some cattle diseases have been approved by FDA/CVM. For example, there 
are five antimicrobials approved for control of bovine respiratory 
disease. When appropriate, these applications are very effective in 
decreasing morbidity and death.
    Another example of using antimicrobials to control disease is the 
occurrence of clinical anaplasmosis in cattle. Anaplasma marginale is a 
blood cell parasite that causes loss of red blood cells in cattle due 
to infected cells being cleared from the body. In cattle less than 1 
year old, the clinical signs are mild due to the animal's ability to 
regenerate red blood cells while mounting an immune response. As 
animals age, the severity of the disease worsens to include death as a 
likely outcome. Chlortetracycline may be fed to cattle at risk for the 
disease during and immediately after the vector season to control 
clinical signs while allowing infection that results in a carrier 
status and immunity to the disease.
    Anaplasmosis is a good example in examining the use of the term 
``subtherapeutic.'' Chlortetracycline is effective for controlling the 
effects of anaplasmosis. The approved in-feed dose for this application 
is 0.5 to 2.0 mg/lb of body weight per day in beef and non-lactating 
dairy cattle over 700 lbs, and 350 mg per animal per day in beef cattle 
less than 700 lbs. In comparison, A dose of 10 mg/lb per day may be 
used in the feed for treatment of bacterial pneumonia caused by 
Pasteurella multocida organisms susceptible to chlortetracycline.
    The point is that the term ``subtherapeutic'' is often interpreted 
to mean ``low concentrations'' or ``low dosage''. In the case of 
anaplasmosis, a relatively low dose of the antimicrobial is effective 
in controlling a disease that can result in suffering and death of the 
cattle as well as economic devastation to the producer. The term 
``subtherapeutic'' has been defined by some to include growth promotion 
and disease prevention claims. I would challenge these groups to define 
exactly where a drug becomes ``subtherapeutic'' and therefore incapable 
of having an effect on disease. The appropriate use of terms would be 
to address the drug use by the label claim of treatment, control, or 
increase in rate of weight gain and/or feed efficiency. Where 
appropriate, a relatively low dose of an antimicrobial may effectively 
control disease signs along with the resulting adverse animal welfare 
and economic effects. This relatively low antimicrobial exposure also 
minimizes the total exposure of normal and pathogenic bacterial flora 
to antimicrobials over time.
    The ``subtherapeutic'' categorization attempts to cast all 
antimicrobial regimens below an undefined threshold as inappropriate 
due to selection of resistant pathogens. In reality, resistant organism 
selection pressure is much more complicated than just ``a high 
concentration for a short term is good, a lower concentration or a 
longer exposure is bad''. The use of the term ``subtherapeutic'' 
indicates a cursory knowledge of the effects of antimicrobials in food 
animals as they relate to the combination of effects on animal well 
being, disease control, and food safety. Each application is different, 
and the attempts to supersede the regulatory process with blanket 
legislation prohibiting ``subtherapeutic'' uses, however well 
intentioned, will result in instances where a decreased ability to 
address disease pressures in cattle production will not be offset by a 
benefit in antimicrobial resistance selection.
    I would not propose that the bacterial pathogens in humans and 
cattle exist in total isolation from each other, nor would I claim that 
there are no possible links between antimicrobial use in cattle and 
therapy in humans. However, I would caution that circumventing the 
approval process in making leaps from effect back to cause will 
undermine the ability of the cattle industry to address disease 
challenges and in many cases may result in no benefit to human 
therapeutics.
    Separate scientific risk assessments have been conducted on the 
uses of virginiamycin and macrolides in food animals.\1\ \2\ The former 
supported by the FDA/CVM and the latter supported by a pharmaceutical 
company. Neither risk assessment defined a risk which any reasonable 
reviewer would classify as significant. It is absolutely essential to 
the wellbeing of animals and humans in the United States that 
discussions on antimicrobial resistance be focused on specific drugs, 
uses, and pathogens with appropriate data supporting the discussion. 
Efforts to cast all food animal antimicrobial uses in the same light 
are both misguided and dangerous.
    As Congress continues to have an interest in this issue, we 
recommend that the focus be put on the tools already in place rather 
than imposing new rules, regulations, and prohibitions on animal 
agriculture. One way to do this would be to ensure that the National 
Antimicrobial Resistance Monitoring System (NARMS) and the Food Animal 
Residue Avoidance Databank (FARAD) be fully supported and funded.
    NARMS was developed in 1996 to monitor changes in susceptibility of 
select bacteria to antimicrobial agents of human and veterinary 
importance and is a collaboration between three Federal agencies 
including FDA's CVM, the Centers for Disease Control and Prevention 
(CDC), and USDA. NARMS also collaborates with antimicrobial resistance 
monitoring systems in other countries, including Canada, Denmark, 
France, the Netherlands, Norway, Sweden, and Mexico so that information 
can be shared on the global dissemination of antimicrobial resistant 
foodborne pathogens.
    The NARMS program monitors changes in antimicrobial drug 
susceptibilities of selected enteric bacterial organisms in humans, 
animals, and retail meats to a panel of antimicrobial drugs important 
in human and animal medicine. Bacterial isolates are collected from 
human and animal clinical specimens, from healthy farm animals, and raw 
product from food animals. Retail meats collected from grocery stores 
were recently added to NARMS sampling. A pilot study of animal feed 
ingredients collected at rendering plants across the country was also 
started in 2002. The CDC and USDA provide the NARMS results annually in 
comprehensive summary reports.
    The stated goal of NARMS activities is to prolong the lifespan of 
approved drugs by promoting prudent and judicious use of antimicrobial 
drugs and to identify areas for more detailed investigation.
    NCBA feels the program could be improved if the FDA, USDA and CDC 
worked more collaboratively; this includes, among other things, 
division of funds as well as evaluation of the data. NCBA especially 
has concerns in how CDC analyzes and utilizes data. Data analysis 
should be purely science-based and without preconceived agendas. There 
are various examples of the damage that can be done to industry when 
Federal agencies do not cooperatively work together. The cattle 
industry cannot afford for Federal agencies to have an unscientific 
mis-step that can remove valuable animal health options from our 
producers.
    The issue of antimicrobial resistance is very concerning to cattle 
producers. We encourage and advocate for judicious use of all 
medications. In fact, NCBA policy supports the Producer Guidelines for 
Judicious Use of Antimicrobials which have been in place since 1987. In 
addition, NCBA participates in the Codex Alimentarius task for on 
antimicrobial resistance.
    Antimicrobial resistance is not a black and white issue. It is a 
multi-faceted and extremely complex issue that cannot be solely focused 
on the use of drugs in animal agriculture. Unfortunately, animal 
agriculture has been a primary target in this fight, with little or no 
consideration given by the public to the use, misuse, and mishandling 
of human drugs by the general population. To ensure that the issue of 
antimicrobial resistance is properly addressed, it is imperative that 
we gather accurate, appropriate, and complete data to identify any 
problems and all contributing factors. To date, only limited data 
exists. These data need to be gathered and scientifically evaluated 
without bias or a pre-determined agenda before any further action is 
taken by Congress. We need to have strong information on which to base 
any action that can impact the use of drugs in animal agriculture.
    Related to preventing selection for resistant pathogens is the need 
to know the optimal duration of antimicrobial therapy that balances 
initial treatment successes, subsequent relapses, and antimicrobial 
selection pressure in favor of resistant pathogens. In both human and 
veterinary medicine we are lacking critical studies that define optimal 
duration of therapy.
    FARAD is another valuable tool that Congress and the Administration 
have neglected.
    Operating since 1982, FARAD is a computer-based system designed to 
be utilized by veterinarians and livestock producers in finding 
information on drug use and residue problems. During the drug approval 
process, FDA establishes drug residue tolerances in order to help keep 
food safe. They also establish waiting periods and withdrawal times to 
determine how long you must wait for the animal to process and 
eliminate the drug from their systems before they can be harvested for 
food. The information in this database is invaluable in helping to 
avoid drug residue problems and keeping the food supply safe. FARAD 
also looks at pesticide and environmental contaminant residue issues. 
Unfortunately, the funding for FARAD runs out next week, and unless 
Congress adds funding to the continuing resolution, the valuable 
information it holds will be gone.
    Finally, I would like to talk about the steps the industry has 
taken to police ourselves. The Beef Quality Assurance (BQA) program has 
set forth recommendations for how cattle producers should use 
antibiotics to protect and maintain the health of their animals. BQA 
was established in 1987 to provide cattle producers with the principles 
and tools to use every day to ensure animals are given proper care and 
attention.
    BQA unites producers with experts (animal scientists, 
veterinarians, feed suppliers, animal health companies, meatpackers, 
retailers and state and Federal regulators) to develop management 
programs using the latest science and technology to assure proper 
animal care, beef quality, and safety. The BQA program provides 
guidelines for livestock care and handling, nutrition and veterinary 
treatment and incorporates current FDA, Environmental Protection Agency 
(EPA), and USDA regulations as well as Hazard Analysis Critical Control 
Point (HACCP) principles.
    Cattlemen can become BQA certified when they meet criteria for 
quality beef production set forth in the BQA guidelines. Producers also 
undergo continuous training to remain certified. The BQA Manual is the 
overarching guideline that provides consistency across the nation, but 
states can go beyond national standards to meet state needs and 
opportunities. Most states have individual BQA programs that are 
tailored to the needs of their particular state beef industry, and can 
offer their own certification standards. State certification 
requirements vary, but may include third party verification and testing 
procedures to ensure good management practices.
    Today, BQA influences more than ninety percent of U.S. cattle. 
Approximately 185,000 copies of the brochure of NCBA's Care and 
Handling Guidelines have been sent to producers, veterinarians, 
Departments of Agriculture, and Universities. BQA is not a static 
program. An advisory board made up of cattle producers, beef and dairy 
veterinarians, University and Extension scientists, meat scientists, 
auction markets, and the transportation industry continually work to 
update and strengthen the program. NCBA continues to improve this 
scientifically based program in order to meet current and future needs 
of our industry in order to maintain a healthy cattle population and a 
safe beef supply for our consumers.
    In conclusion, we find that in today's cattle industry, the need 
for animal health interventions that focus on prevention of disease, 
control of disease pressure, and therapy of animals with disease is 
critical to the success of cattle producers across this country, as 
well as helping to keep our food supply safe. However, our industry 
believes that the use of these drugs comes with much responsibility, 
and that is why we have worked together with our partners in industry 
to educate and train cattle producers. The success of programs such as 
BQA shows our industry's commitment. This commitment cannot be 
overlooked by those who want to end or restrict the use of animal drugs 
without having any credible information to base their accusations. That 
is why we urge Congress to turn their efforts towards proven tools such 
as NARMS and FARAD in helping to keep our animal and human populations 
healthy, and to continue to support the established scientific methods 
for drug approval and review as the forum in which to evaluate 
antimicrobial use in food animals. Thank you for the opportunity to 
testify today and we look forward to working with you in the future.
Endnotes
    \1\ Virginiamycin risk assessment. FDA Center for Veterinary 
Medicine website, http://www.fda.gov/cvm/CVM_Updates/
virginiamycinup1.htm. Accessed 9-23-08.
    \2\ Hurd H.S., Doores S., Hayes D., et al. Public health 
consequences of macrolide use in food animals: a deterministic risk 
assessment. J. Food Prot. 2004:67(5):980-992.

    The Chairman. Thank you. I wish the whole country could 
have heard the testimony that you have given this morning, all 
of you. I think there will be a lot of comfort and satisfaction 
that you are doing your very best to not only have healthy 
animals but healthy, safe food.
    Somebody may comment, what safeguards do you have to combat 
antibiotic residue; anybody? What safeguards do you have?
    Dr. Klopp. I will be happy to respond to that one first. 
There has been a lot of focus placed on a national animal ID 
system. In the chicken industry, we have had an animal ID 
system for over 30 years through vertical integration. So the 
way we monitor residues is by reports that are in black and 
white as far as the use of any antibiotic or intervention that 
we use. We document the dates, the dosages, when we started 
treatment, when we ended treatment, and this is all documented 
in relation to processing and also to make sure that the 
appropriate dosages are used. We also, as I am sure every 
industry does, we participate through the FSIS residue testing 
program, and I also want to compliment Dr. Apley on the fact 
that he mentioned the need for funding especially for FARAD. 
That needs to happen.
    The Chairman. I agree.
    Please, go ahead, Dr. Byrne.
    Dr. Byrne. Certainly in the dairy industry, we do a very 
active job to prevent antibiotic residue starting with 
treatment records, much like the rest of the livestock 
industry, following appropriate withdrawal times and then 
testing every tanker of milk that arrives at a processing plant 
to ensure that it doesn't contain animal drug residues. So all 
those systems are there to ensure that we do not end up with 
any residues in the milk supply.
    The Chairman. Thank you.
    Anybody else? Dr. Rowles?
    Dr. Rowles. I can't speak for every producer, but I can say 
that in our operation, we are very, very cognizant of residues. 
We have to think about not only U.S. residues but we also have 
to think about Japanese residues because we ship about 40 
percent of our product overseas. And so we are very, very 
cognizant of those issues and make sure that we are physically 
removing those products from the site so that there is no 
chance of a mistake.
    Dr. Rybolt. Mr. Chairman, I would just add that as 
mentioned in my testimony, we follow our residue avoidance 
program that was developed by the National Turkey Federation 
and we also ensure that we follow the prescribed withdrawal 
timeframes for the particular antimicrobial to ensure that 
there is no residue.
    The Chairman. Thank you.
    Dr. Apley?
    Dr. Apley. Yes. Mr. Chairman, in the feedlot industry, we 
routinely work with written treatment protocols that have 
withdrawal times incorporated then into them and at the 
majority of the feedlots, we have computerized individual 
animal records that record the drug given to that animal, the 
withdrawal time, and before penned-up cattle can be shipped, 
those records are checked, and if we cannot--if we have an 
animal that still has a withdrawal in effect and we cannot 
identify it, that pen is not shipped until that animal is 
identified or clears its withdrawal time.
    The Chairman. Anybody else? Well, thank you very much.
    I'll just welcome our Committee Chairman to join us here, 
Mr. Peterson from Minnesota.
    Mr. Peterson. I just want to say, I want to thank you and 
the Ranking Member for the outstanding job you are doing 
keeping on top of this.
    The Chairman. Well, we are trying. Thank you.
    Robin?
    Mr. Hayes. Gentlemen, I don't know how you could have been 
any more thorough. The questions that I was contemplating have 
been answered in tremendous detail. Thank you for your 
attention to this important subject.
    The Chairman. I recognize the gentlelady from North 
Carolina, Ms. Foxx.
    Ms. Foxx. Thank you. I agree with our Ranking Member, Mr. 
Hayes, and I too thank the Chairman and the Ranking Member for 
staying on top of this issue.
    The Chairman. Well, I appreciate it. Your testimony has 
been good. Blair, I have seen your operation and I know that 
you go to a great extent, great means, besides the cleanliness, 
the way you do things. I think that the public ought to know 
that as well, and I am sure that throughout the industry that 
you represent that you do that. I have been to several other 
locations over the years.
    I would like to just throw this question out for any of you 
again. If antibiotic medication were prohibited, could current 
food demands be met? Dr. Klopp, you kind of made me suspicious 
of that in your testimony, but anyway, does anybody want to 
make a comment? Do you think we can do it without the 
antibiotics?
    Dr. Klopp. Well, this industry didn't get where it is, the 
only way we get things done is because we get it done. So, yes, 
but there would be a huge price to pay both in the availability 
of the amount of meat, the cost of the chicken meat, and the 
other part that gets a lot of attention is on the microbial 
quality of the meat because bacteria are a fact of life. And 
the given food safety aspects that would suffer from the lack 
of antibiotic interventions would increase, and I do want to 
make a comment. There has been a lot of negative statements 
made about growth promotion and it has been mentioned here 
about subtherapeutics, and the way I look at antibiotics in 
feed is, that it is a dosage range for disease prevention. I 
don't look at growth promotion. I don't look at 
subtherapeutics. I look at a dosage range, and this is how you 
control disease. But yes, you don't want to overstate anything, 
but there would be tremendous negative implications for the 
American public.
    The Chairman. I appreciate that.
    I think both you and, I believe it was Dr. Rybolt, made a 
comment that if we didn't have antibiotics, the volume of 
manure and what to do with it environmentally would just 
skyrocket. Any comment about that?
    Dr. Rybolt. Yes, sir. In my written statement, I stated 
that if we did not have the use of antimicrobials in the turkey 
industry specifically, what would happen is, we would have a 
decrease in feed efficiency so we would have a decrease in 
utilization of the nutrients. You would have increased manure 
coming out of the birds, to put it bluntly, so therefore you 
would have that environmental impact as well and would have to 
deal with that.
    The Chairman. I appreciate that.
    Ms. Foxx. Mr. Chairman, your question has prompted me to 
think of one. Could I----
    The Chairman. I will get right back to you. I have a line 
of thought here and I want to stick with it and I will come 
right back to you, Ms. Foxx.
    Dr. Rowles, based on your practice of veterinary medicine, 
as well as a producer, maybe you could make a comment for us 
that we can have in the record about how a veterinarian sits 
with a producer and works out their health plan.
    Dr. Rowles. Certainly. In the swine industry, the 
veterinary profession is very, very actively involved in 
developing herd health plans for their operations. First of 
all, they look at issues of housing, they look at issues of 
biosecurity, they look at issues of management, nutrition, 
parasite control. All of those things are taken into account 
when decisions are made on how to handle, grow, raise and 
manage pigs. The antibiotics that we referred to today are only 
one of those tools, but it is a very, very important tool that 
we need to make sure that we maintain in that animal health 
program development.
    The Chairman. Thank you.
    Ms. Foxx.
    Ms. Foxx. Thank you, Mr. Chairman.
    Now, I grew up where we raised chickens running wild, and I 
am a huge consumer of eggs and chickens and so is my family. 
But, it occurred to me as somebody who tries to think about how 
things have changed over time and how we have to weigh the cost 
and benefits of change, in 1937, our average lifespan was 59 
years. That sticks in my mind because I often talk about Social 
Security being implemented. Our average lifespan now is almost 
80. So in a very short period of time, our lifespan has changed 
dramatically in this country. I don't think--I mean, I am a 
social scientist, so I know you can't attribute it to any one 
thing. It would seem to me that we have seen a tremendous 
change in the way we get our food and the way our food is 
processed, the way it is grown. Do any of you know of studies 
that have been done, any obscure dissertations out there, that 
have looked at causes of illness and death that used to be 
created by eating bad meat, eating bad food, and comparing that 
with what our situation is now? Was there something done in 
years past not even thought about to be compared with now? I am 
just not familiar with the literature in this area.
    Dr. Rowles. If I may, I may not be answering your question 
directly but I think this may speak toward what you are trying 
to address. Recently Ohio State did a study where they were 
comparing conventionally raised pigs versus antibiotic-raised 
pigs, and one of the findings that they found was that the 
incidence of things like trichonella, toxoplasmosis, which are 
true human potential problems, was higher in the antibiotic-
free pigs, and I should add, Salmonella as well. And so in the 
antibiotic-free-raised pigs, the incidence, the percentage of 
infected carcasses was higher in antibiotic-free versus 
conventionally. We would argue that the conventional production 
practices that we are using today are providing a much safer 
product than what we produced 10, 15, 20 or 40 years ago.
    Ms. Foxx. And Dr. Klopp indicated that also in the comments 
that he made about chickens, so I was just curious if there had 
been any real extensive work done. Thank you very much.
    The Chairman. I would like to offer the opportunity to all 
of you on the panel to make any additional comments you would 
like to make if you care to at this time.
    Dr. Rowles. I would like to add just one further comment. 
We talked about the issue of manure, but one other factor in 
the efficiency discussions is also the input side on the corn. 
Right now we have corn prices that are extremely high, and 
industries are struggling in terms of a profitability 
standpoint. Not only is there an increase in manure but there 
also would be an increased need and demand for corn and/or 
soybean meal to produce that extra product at a time when those 
prices are at a premium.
    The Chairman. Your point is well taken. We are going 
through a transition period, but every producer out there that 
I know in the corn, soybean production side, I was hoping some 
day they might be able to get a better price and now we have to 
figure out how to work with it, and we will. I think we are. 
But I appreciate your comment. Your point is well taken. 
Anybody else? Please.
    Mr. Van Zetten. Mr. Chairman, obviously from the testimony 
you have heard, to the entire livestock industry, animal health 
is very important, and thank you for holding this hearing in 
order to allow us to talk about the advances in animal health 
and the importance of being able to maintain animal health for 
high-quality, safe products for all consumers. Thank you.
    The Chairman. You are welcome.
    Anybody else?
    Dr. Apley. Mr. Chairman, one of the things I would like to 
make sure the public realizes is the sophistication with which 
we monitor our antibiotic use and treatment results in food 
animals. For example, I mentioned the feedlots, and ones that I 
work with, with the individually identified animals, we 
routinely monitor treatment success, treatment failure rate, 
relapses. We look at the case fatality rate, the numbers of 
those treated that die. We work on the case definitions for 
those and we go back and concentrate very aggressively on how 
early we are able to identify cattle with disease to minimize 
the need for further treatment. It is really very sophisticated 
and I think in the swine industry, I am very familiar with this 
and I am sure it is that way in the other industries that are 
here today. The level of monitoring that we are at and our 
ability to tell you on a daily basis what is going on in our 
herds or flocks has come to a point that I am not sure the 
public appreciates. I think we would all say we are really 
proud of the way we are able to monitor what we are doing with 
the tools we have.
    The Chairman. I appreciate that comment very much and I 
think that what you have done today is a good step in that 
direction or an additional step, I might say, and I would 
encourage you to keep it up.
    We will dismiss the panel at this time and thank you very 
much for your testimonies. We appreciate it, and we will take 
the liberty to come back to you for further information if we 
need it. You are excused at this time and we would invite the 
third panel to come to the table.
    Mr. Peterson [presiding.] Mr. Boswell had to step out for a 
minute, so there is no reason we can't get the panel going, and 
welcome to the Subcommittee. I want to welcome Dr. Singer, who 
is from my home State of Minnesota. They do an outstanding job 
there at the university in monitoring animal health and a lot 
of other things, so welcome to the panel. Dr. Carnevale, I 
guess you are first. You have 5 minutes, and your full 
statement will be made part of the record, so feel free to 
summarize.

        STATEMENT OF RICHARD A. CARNEVALE, V.M.D., VICE
             PRESIDENT, SCIENTIFIC, REGULATORY AND
  INTERNATIONAL AFFAIRS, ANIMAL HEALTH INSTITUTE, WASHINGTON, 
                              D.C.

    Dr. Carnevale. Thank you, Mr. Chairman and Members of the 
Subcommittee. Thank you very much for the opportunity to appear 
before you today. My name is Dr. Richard Carnevale and I am a 
Veterinarian by training. I am also a Vice President of the 
Animal Health Institute, Scientific, Regulatory and 
International Affairs. The Animal Health Institute is a trade 
association here in Washington that represents the companies 
that make medicines and vaccines for animals. Before I worked 
for AHI, I spent nearly 20 years with both the Food and Drug 
Administration and the U.S. Department of Agriculture working 
on animal drugs and food safety.
    While I have submitted extensive comments for the record, I 
would like to talk to you today about one simple truth, and you 
have heard this a number of times on the panel before me: 
animals need medicine, including antimicrobials. Without safe 
and effective medications to treat, control and prevent 
diseases, suffering and death would increase. Additionally, 
since healthy farm animals are one of the pillars of safe food, 
human health would be threatened by increased animal disease 
and increased bacterial loads in foods.
    Research-based animal health companies work hard to provide 
livestock and poultry producers, and the veterinarians who work 
with them, the products needed to keep food animals healthy. 
These products must go through stringent science-based review 
processes. All products including antimicrobials are required 
to meet the same standards as medicines approved for humans, 
meaning they must be shown to be safe and effective.
    Now, there are several benefits to animals, producers and 
consumers from the use of antimicrobials in animal agriculture, 
and you have heard this theme before this morning. Animal 
welfare is improved as a result of veterinarians and producers 
having the tools to protect animal health and keep them 
healthy. Producers are more efficient because they can produce 
more food with fewer animals. This is especially important in 
this market environment that has seen escalating feed costs, 
and fewer animals mean less land mass is needed to raise the 
number of livestock and poultry to meet current demands. I 
think you have heard some very interesting statistics from some 
of the producer groups this morning to support that.
    There are also benefits to global food markets. 
Antimicrobials and other animal drugs that improve animal 
health and productivity are critical to American agriculture's 
ability to feed the world's growing population. The Food and 
Agriculture Organization, FAO, estimates that 75 million more 
people worldwide were below the hunger threshold in 2007 as a 
result of rising food prices. They propose that one solution is 
to help producers raise their output. Finally, consumers 
benefit because healthy animals produce safe food. Published 
peer-review studies have shown that carcasses from chickens 
without subclinical disease that are prevented by antibiotics 
are more likely to be free of human foodborne pathogens such as 
Salmonella and Campylobacter.
    Now, for more than 40 years, there has been an active 
debate over the potential for antimicrobial use in animals to 
contribute to the human burden of antimicrobial resistance. 
Antimicrobial resistance is a serious public health threat, but 
I would emphasize that resistance is not a single problem. It 
is a problem comprised of several different bacteria-drug 
combinations. For instance, some of the most widely recognized 
antimicrobial resistance problems in humans are respiratory 
tract infections and venereal diseases like gonorrhea. In 
neither of these cases is there any evidence that antimicrobial 
use in animals is associated with these problems. In a survey 
published in 2000, a group of medical experts estimated that 
the animal contribution to the overall resistance problem is 
likely to be less than four percent. This small contribution 
was attributed to the potential for antimicrobials used in food 
animals to transfer certain resistant foodborne bacteria like 
Salmonella and Campylobacter to humans.
    Because of the potential for both antimicrobial-resistant 
and antimicrobial-susceptible bacteria to contaminate foods, 
our food safety systems are comprised of multiple layers of 
protection to guard against this transfer taking place. The 
first layer of protection is a stringent regulatory review 
process at FDA that you heard Dr. Dunham speak of this morning. 
Antimicrobials for use in animals must meet all the same 
requirements as antimicrobials used in humans with two 
additional important requirements. First, sponsors must show 
the drug residues left in meat, milk and eggs are safe for 
human consumption. Second, FDA instituted what is called 
Guidance #152 several years ago, which outlines a qualitative 
risk assessment process that is applied to all antimicrobials 
approved for use in animals. The process is designed to 
estimate and manage the risk of antimicrobial-resistant 
bacteria being transferred from animals to humans.
    In addition to the FDA process, there have been several 
quantitative risk assessments that have been conducted on 
antimicrobial compounds, and they have resulted in findings 
that show an extremely low level of risk. A quantitative 
assessment is a more detailed review of each step along the 
food production continuum from farm to table that could 
increase or decrease risks from a hazard such as resistant 
bacteria. We believe that risk assessment is the proper tool 
for making policy decisions about the use of antimicrobials in 
animals. Without this scientific basis for decision-making, we 
do run the real risk of making decisions that have unintended 
consequences that are damaging to both human and animal health.
    A second layer of protection, and one of the most 
important, is reducing bacteria contamination in slaughter in 
processing plants. Antimicrobial-resistant bacteria represent 
only a small subset of bacteria that could contaminate meat and 
poultry products. USDA through implementation of the Hazard 
Analysis and Critical Control Point system, or HACCP, and 
pathogen reduction regulations assures that slaughter plants 
are following hygienic procedures to minimize bacterial 
contamination. Results have shown that HACCP has worked to 
reduce bacterial contamination of meat and poultry products, 
and therefore, has reduced antimicrobial-resistant bacteria as 
well.
    A third layer of protection is comprised of several 
monitoring programs established by FDA and USDA to assure 
antimicrobials are being used properly and according to labels. 
We heard mention of the National Antimicrobial Resistance 
Monitoring System, which is a multi-agency program between 
USDA, CDC and FDA to monitor antimicrobial-resistant bacteria 
in humans, animals and meat products.
    A fourth layer of protection is the responsible or 
judicious use guidelines. Generally, these guidelines have been 
prepared collaboratively between the Federal agencies and 
veterinary groups to help assure there is no unnecessary use of 
antimicrobials in agriculture. Members of the panel discussed 
this previously.
    Before I close, I want to note that Congress twice this 
year passed legislation dealing with the use of antimicrobials 
in animals. The farm bill, passed by this Committee, included a 
mandate for additional research on the development of resistant 
bacteria in animals and its potential transfer to humans. Then 
in the recently enacted Animal Drug User Fee Act, Congress 
required FDA to collect data from sponsors on the amounts of 
antimicrobials sold for food-producing animals. Our member 
companies will of course cooperate with FDA in this endeavor.
    Mr. Chairman, there are clear benefits to using 
antimicrobials to keep animals healthy including attending to 
animal welfare and assuring food safety. FDA has a stringent 
review process to assure that antimicrobials used to keep food 
animals healthy do not significantly contribute to the burden 
of antimicrobial resistance in humans. Monitoring data from 
NARMS and several private and public risk assessments 
demonstrate that this process is working and that utilizing 
important medicines like antimicrobials to protect animal 
health provide far more benefits than risk to public health 
overall.
    Thank you for the opportunity to appear here today and I 
welcome any questions from the Subcommittee.
    [The prepared statement of Dr. Carnevale follows:]

  Prepared Statement of Richard A. Carnevale, V.M.D., Vice President,
    Scientific, Regulatory and International Affairs, Animal Health
                      Institute, Washington, D.C.
    Mr. Chairman and Members of the Subcommittee:

    Thank you for holding this hearing on recent developments in animal 
health. I am Dr. Richard Carnevale. I am a veterinarian by training 
with a degree from the University of Pennsylvania and I am here today 
on behalf of the Animal Health Institute, a trade association that 
represents companies that make medicines for animals. Prior to joining 
AHI about 12 years ago, I served as Deputy Director for the Office of 
New Animal Drug Evaluation at FDA's Center for Veterinary Medicine and 
later as Assistant Deputy Administrator for the Office of Science at 
USDA's Food Safety & Inspection Service. AHI companies work to provide 
products to livestock and poultry producers that help keep their 
animals healthy. By doing this, companies contribute to public health 
and food safety. Research shows that the first link in the chain of 
producing safe meat, milk and eggs is keeping animals free from 
disease.
    Food safety starts on the farm, and our companies spend millions of 
research and development dollars to find new and innovative products to 
keep farm animals healthy. Some animal health products are used to 
treat and prevent or control disease in animals. Others help increase 
animal productivity, allowing producers to meet the growing world food 
demand while minimizing the use of natural resources. More recently, 
products are being developed that will contribute to food safety by 
reducing bacteria that do not make animals sick but have the potential 
to make people sick.
    Animal health products are subject to stringent, science-based 
review processes at two Federal agencies: pharmaceutical products are 
reviewed by the Food and Drug Administration under the Federal Food, 
Drug and Cosmetic Act, and biologic products, or vaccines, are 
regulated by USDA under the virus, Serum, Toxins and Analogous Products 
Act. All products are reviewed for safety and efficacy: Efficacy, which 
protects producers by ensuring the products deliver the benefits they 
promise; and safety, to ensure the products are safe for the animal 
being administered the drug or vaccine and to ensure the meat from the 
animal is safe for human consumption and safe for the environment.
    One class of products important to the health of food animals is 
antibiotics. Antibiotics are used by livestock producers, poultry 
producers and the veterinarians who work with them to prevent, control 
and treat often fatal bacterial infections. There are many benefits to 
animals, producers and consumers that come from the use of antibiotics 
in animal agriculture:

    1. Animal welfare is improved as a result of veterinarians and 
        producers having the tools to be able to maintain the animal's 
        health.

    2. Producers are more efficient because they can produce more food 
        from fewer animals. Without antibiotics to prevent and control 
        diseases, more animals get sick and die with producers losing 
        not only the animal but all the input costs, including feed, 
        that have gone into the animal.

    3. There are ecologic benefits. Without antibiotics that improve 
        weight gains and feed conversion, more land and feed are 
        necessary to maintain the same herd and flock sizes. Moreover, 
        some studies have shown that certain antimicrobials used in 
        cattle feeds reduce levels of methane emissions important as 
        greenhouse gases.

    4. Benefits to global food markets. With the concern over food 
        costs and availability in today's economic climate, 
        antimicrobials and other animal drugs that improve animal 
        health and productivity are critical to American agriculture's 
        ability to feed the world's growing population. The Food and 
        Agriculture Organization (FAO) of the United Nations estimates 
        that 75 million more people worldwide were below the hunger 
        threshold in 2007 due to increasing food prices. They propose 
        that one solution is to help producers to raise their output.

    5. Consumers benefit because healthy animals are needed to produce 
        safe food. Over the past 5 years, published, peer-reviewed 
        studies have indicated that carcasses from chickens without 
        subclinical diseases are more likely to be free of human 
        foodborne pathogens.\1\-\4\ Research shows this is 
        due in part to more standardized carcass size, reducing the 
        potential for intestinal breakage during mechanical 
        evisceration.

    Antibiotics are approved and labeled for four specific purposes.

    1. Disease treatment.

    2. Disease prevention.

    3. Disease control.

    4. Growth promotion, as measured by the amount of feed needed to 
        produce a pound of animal weight or increased rate of weight 
        gain.

    The first three uses--disease treatment, prevention and control--
are considered to be therapeutic uses by FDA, the American Veterinary 
Medical Association (AVMA) and such international bodies as Codex 
Alimentarius and the OIE. While critics of antibiotic use like to use 
the term ``nontherapeutic'' to refer to disease prevention, disease 
control and growth promotion, this term is not used nor recognized in 
national or international regulation.
    Many assume in-feed uses equate to growth promotion, but this 
confuses the use with the route of administration. In fact, any of the 
four uses, including therapeutic, can be administered via feed or 
water, as that is under certain circumstances the only practical way to 
administer medication to large flocks or herds. In most cases, a 
veterinarian is involved in this process, recommending feed that is 
specifically formulated for the health management system used for the 
flock or herd.

    How are antibiotics regulated?

    Animal health companies rely on a rigorous, efficient, predictable 
and science-based review process at the Food and Drug Administration's 
Center for Veterinary Medicine (CVM) to provide these products. The 
standard for the approval of antibiotics used in animals is the same as 
that for antibiotics used in human medicine: They must be shown to be 
safe and effective.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    The GFI #152 process applies not only to new submissions, but to 
all existing products as well. FDA has established a priority list for 
the re-evaluation of all antibiotics currently approved and marketed. 
Most of the drugs on the list are antibiotics administered in animal 
feed for the prevention and control of animal diseases or to increased 
the weight gains and improve feed efficiency. The re-review under 
Guidance #152 was stimulated by new funding that FDA received and 
continues to receive via annual appropriated money specifically 
earmarked for these reviews. Bear in mind, though, the evaluation of 
these products did not begin with Guidance #152. In response to 
concerns raised some 30 years ago, the Bureau of Veterinary Medicine in 
FDA, in the 1970's, required sponsors of these products to conduct 
tests to determine the potential for resistance to be selected in the 
animals and to be transferred to bacteria that could cause human 
disease. While the standards and science may have changed over the 
years, the safety of these products has been an ongoing exercise at 
FDA. Moreover, published quantitative risk assessments performed by 
both the agency and individual product sponsors have generally affirmed 
that the risks to human health from these antibiotics in animal feed 
under approved conditions of use are quite low.
    We fully support efforts by the agency to continue to evaluate the 
safety of these products using all available scientific data under a 
sound risk assessment approach in order to determine the true risk to 
public health and guide appropriate risk management interventions to 
protect public health.
    FDA/CVM has a great deal of authority to act when data or risk 
assessments indicate a threat to public health. CVM can--and has--
successfully asked companies to withdraw products voluntarily or to 
modify their conditions of use, including restricting extra label use. 
The agency can also undertake a notice of proposed rulemaking against a 
product, setting in motion a process to rigorously review the science 
and determine if a product should continue to be marketed. This 
authority has been used to remove antibiotics from the market. Finally, 
if the agency determines there is an imminent hazard to public health, 
it can immediately remove a product from the market.
    In addition to the rigorous review process and the additional 
public and private risk assessments that have been conducted, there are 
other post-approval layers of protection to ensure the safe use of 
antibiotics.

    Monitoring programs

    USDA's Food Safety and Inspection Service monitor meat samples for 
the presence of antibiotic residues as a check on the observance of the 
withdrawal times set by FDA. It is very uncommon for FSIS to find an 
unsafe residue, an indication that products are being used according to 
label directions.
    The National Antibiotic Resistance Monitoring System (NARMS) is a 
multi-agency program coordinated by FDA to monitor antibiotic resistant 
bacteria and allow for implementation of management and control 
measures if needed. The three agencies involved are:

   The USDA Agricultural Research Service (ARS), which analyzes 
        Salmonella and Campylobacter isolates collected from carcasses 
        and meat samples in the USDA FSIS HACCP/Pathogen Reduction 
        Program for antibiotic resistance;

   The FDA, which monitors for resistant bacteria in retail 
        meats; and

   The Centers for Disease Control and Prevention (CDC), which 
        collects isolates from public health laboratories to monitor 
        for the emergence of antibiotic resistant enteric pathogens in 
        humans.

    To date, the program has produced 7 years of data representing over 
19,000 Salmonella isolates from livestock and poultry carcasses and 
meats and 12,000 human Salmonella isolates. Most bacterial species 
isolated from humans and tested for resistance against drug classes 
potentially related to animal usage have shown stable or declining 
resistance to most antimicrobials. Most of the multiple-drug resistance 
types, such as Salmonella typhimurium DT104 show stable or declining 
prevalence in both food animals and humans since 1996, according to an 
expert report issued in 2006 by the Institute of Food Technologists 
entitled ``Antibiotic Resistance: Implications for the Food System.''
    While AHI strongly supports continued funding of the NARMS program 
we would point out that there are inherent weaknesses in the sampling 
strategies that prevent the data from estimating a true national 
prevalence of resistance and yearly trends. The FDA Science Board has 
identified these weaknesses as well and has encouraged the agencies 
involved in NARMS to work to improve the data.\5\

    Judicious Use Guidelines

    Responsible, or judicious, use programs that are specific to 
different livestock species give veterinarians and producers specific 
guidelines to help them safely and properly use of antibiotics in their 
health management systems. Generally, these guidelines have been 
prepared collaboratively by FDA, CDC and veterinary groups. These 
guidelines help ensure there is no unnecessary use of antibiotics in 
animal agriculture. Others testifying today will provide additional 
detail on how these principles are used by veterinarians and producers.
    There are two additional layers of scrutiny that antibiotic use 
receives.
    First, at the international level, Codex Alimentarius is 
responsible for protecting the health of consumers and ensuring fair 
practices in food trade. Codex has established a committee on 
antibiotic resistance. Chaired by Korea, this committee is currently 
working to establish an internationally recognized process for risk 
analysis of antibiotics used in animals. International standards are 
important, because bacteria know no borders and actions taken here can 
be nullified if there is not concerted international action. It is also 
important that the international community establishes a sound 
scientific basis for countries to assess the risk of antibiotic use. 
Otherwise, government regulators are left open to outside pressure to 
take overly zealous precautionary measures that may be unjustified and 
in the long term harmful to animal health and food safety.
    Second, several risk assessments have been conducted on antibiotic 
compounds, and have uniformly found extremely low levels of risk. Some 
of these have been conducted and published by the sponsors, some by 
independent authorities, and some by FDA. In particular, the FDA risk 
assessment on virginiamycin found there were significant differences 
between the resistant enterococci bacteria found in animals and those 
found in humans. Even after they assumed an association for purposes of 
conducting the risk assessment, the levels of risk they estimated were 
quite small.
    We firmly believe that risk assessment is the proper tool for 
making policy decisions about the use of antibiotics in animals. 
Without this scientific basis for decision making, we run the very real 
risk of making decisions that have unintended consequences that are 
damaging for both human and animal health.

    Does the Use of Antibiotics in Animals Contribute to Human 
Antibiotic Resistance?

    There is no question that antibiotic resistance is a serious public 
health threat. But resistance is not a single problem: it is a problem 
comprised of several different bacteria-drug combinations. For 
instance, some of the most widely recognized antibiotic resistance 
problems in humans are in respiratory tract infections and venereal 
diseases like gonorrhea. In neither of these cases is there any 
evidence that antibiotics used in animals are associated with these 
problems. In fact, in a survey published in 2000 a group of medical 
experts estimated the animal contribution to the overall human 
resistance problem is less than four percent.\6\
    That small contribution was attributed to the potential for 
antibiotics used in food animals to contribute to resistance in certain 
bacteria which can be transferred from animal food products to humans. 
However, there is a chain of events from the ``farm to the fork'' that 
must be traversed by bacteria that develop resistance in animals as 
outlined in the accompanying chart:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    While we know this can happen, the question is, how often does this 
happen and how severe are the consequences? The answer to this much-
studied question is that it does not happen enough that we can find it 
and measure it. So, scientifically, we cannot say it does not happen, 
but we can say it is rare.
    Finally, there are some recurring questions in the debate about 
antibiotic use I would like to address.
    First, what is the quantity of antibiotics used in animal 
agriculture? Critics have charged that we don't know how big the 
problem is because we don't have reliable data about the use of 
antibiotics in animal agriculture. However, levels of antibiotic 
resistance are not correlated to the amount of use. Not all antibiotics 
are alike. Nevertheless, each year AHI surveys its members for the 
amount of antibiotics sold for use in animals. Attached to my testimony 
are the 2006 results. Note that there are large groupings of products. 
This grouping is done because of the small number of companies in the 
market and the need to protect confidential business information. The 
information is not species specific, because many of the compounds sold 
are used in more than one species. While critics have demanded species 
specific information, this would only be available if it comes from 
producers, adding to their costs and paperwork burden. About 7 years 
ago CVM began work on a rule to require data collection but dropped the 
effort as a result of these difficulties. Congress recognized this just 
this summer when antimicrobial sales and distribution data reporting 
requirements were included in the Animal Drug User Fee Amendments of 
2008. We are appreciative of the cooperation we received from Members 
and staff in working with the Animal Health Industry to craft 
appropriate legislative language for these reporting requirements.
    Notably, Congress also acted on this issue in the farm bill that 
was signed into law earlier this year. That legislation contained an 
authorization for USDA's Agriculture Research Service to conduct 
additional research to study the development of antibiotic resistant 
bacteria in livestock on how judicious use principles can help 
producers use these products to protect both human and animal health.
    Also, note that we ask sponsors to estimate the amount of 
antibiotics used for growth promotion. This estimate dropped to less 
than five percent of the total in 2006.
    What happens if producers lose access to these products? This 
question can be answered with data from the European experiment. In the 
late 1990s, the European Union phased out one particular use--the use 
of antibiotics for growth promotion. Data from the Danish Government, 
which you see on the accompanying chart, shows that use of antibiotics 
to treat disease has doubled since the ban. 

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    In summary, Mr. Chairman, antibiotics are vitally important to the 
health of our nation's livestock and poultry herds and flocks. 
Antibiotics are highly and vigorously regulated and are used carefully 
by veterinarians and livestock and poultry producers. The many 
regulatory layers of protection that have been put in place allow us to 
use antibiotics to protect both human and animal health and not add to 
the burden of antibiotic resistant infections in humans. The FDA 
regulatory process and risk assessment are the proper tools for making 
decisions about the use of these products, and to make decisions 
without these tools we place unwarranted risks on both human and animal 
health.
Notes
    \1\ Russell S.M. The effect of airsacculitis on bird weights, 
uniformity, fecal contamination, processing errors and populations of 
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003; 82:1326-31.
    \2\ Cox, Jr., L.A. Potential human health benefits of antibiotics 
used in food animals: a case study of virginiamycin. Environ. Int. 
2005;31:549-63.
    \3\ Hurd H.S., et al. Swine Health Impact on Carcass Contamination 
and Human Foodborne Risk. Public Health Reports, May-June 2008; 123: 
343-351.
    \4\ Berrang M.E., et al. Subtherapeutic Tylosin Phosphate in 
Broiler Feed Affects Campylobacter on Carcasses During Processing. 
Poult. Sci. 2007;86:1229-1233.
    \5\ http://www.fda.gov/cvm/Documents/NARMSExecSum03.pdf.
    \6\ Bywater, R.J. and Casewell M. An assessment of the impact of 
antibiotic resistance in different bacterial species and of the 
contribution of animal sources to resistance in human infections. J. 
Antimicrob. Chemother. 2000;46:643-635.
Additional References
    Phillips I., Casewell M., Cox T., et al. Does the use of 
antibiotics in food animals pose a risk to human health? A critical 
review of the published data. J. Antimicrob. Chemother. 2004;53:28-52.
    Antibiotic Resistance: Implications for the Food System. An Expert 
Report, Funded by the IFT Foundation. Comprehensive Reviews in Food 
Science and Food Safety 5 (3) , 71-137 doi:10.1111/j.1541-
4337.2006.00004.x.
    Hurd H.S. Assessing Risks to Human health from Antibiotic Use in 
Food Animals. Microbe 2006;1:115-119.
    Hurd H.S., S. Doores, D. Hayes, et al. The public health 
consequences of macrolide use in food animals: a deterministic risk 
assessment. J. Food Protect. 67:2369-2374.
    Wassenaar, T.M. Use of Antibiotic Agents in Veterinary Medicine and 
Implications for Human Health. Critical Reviews in Microbiology; 
31:1155-169, 2005.
                               Attachment
                              News Release
Contact: Ron Phillips
Trends in Sales of Lifesaving Animal Medicines Continue
    Washington, D.C., October 3, 2007--U.S. animal health companies 
responded to the increased demand for medicine to treat and control 
animal disease in 2006, increasing the volume of antibiotics sold for 
use in animals in the United States. Antibiotics are critical disease-
fighting medicines used to treat diseases in dogs, cats and other 
companion animals, and in farm animals to improve their well-being and 
ensure the production of safe and wholesome food.
    Continuing a trend observed the past 2 years, the volume of 
antibiotics sold to treat, prevent and control disease in animals rose 
in 2006, while the percentage sold to promote growth dropped. Total 
production for use in animals rose 8.2 percent, according to data 
provided by the research-based companies that produce animal medicines. 
One factor that may have contributed to the increase was a 2 billion 
pound increase in U.S. meat production
    The antibiotic data were collected from a survey of members of the 
Animal Health Institute (AHI), consisting of companies that make 
medicines for pets and farm animals.
    ``All animal owners rely on these important medicines to fight 
disease and keep their animals healthy, whether those animals are cats 
and dogs or farm animals,'' said AHI President and CEO Alexander S. 
Mathews. ``The careful use of these products contributes to human 
health by extending the life of our pets and by helping to provide a 
safe food supply.''
    Again this year, two classes of compounds, ionophores and 
tetracyclines, accounted for most of the increase. Ionophores are 
compounds not used in human medicine. All antibiotics undergo a 
rigorous approval process at the Food and Drug Administration that 
includes an assessment of safety of the product for the treated animal 
and safety of the milk and meat produced. In addition, all proposed 
antibiotic products as well as those previously approved undergo a risk 
assessment procedure, called Guidance #152, to scientifically measure 
the safety of the product with respect to health hazards resulting from 
the spread of antibiotic resistance.
    In 2006, 26.4 million pounds of antibiotics were sold for use in 
farm and companion animals, an increase from 24.4 million pounds sold 
in 2005. The small percentage of overall production used to enhance 
growth dropped slightly to 4.6 percent, down from 4.7 percent the 
previous year.
    The Food and Drug Administration (FDA) approves antibiotics used in 
animals for four purposes: Disease treatment, disease control and 
disease prevention, which are considered by FDA and the American 
Veterinary Medical Association to be therapeutic, and for growth 
promotion.

                             2006 AHI Survey
          Active Antibacterial Ingredients Sold by AHI Members
------------------------------------------------------------------------
                                         2004        2005        2006
          Antibiotic Class              Pounds      Pounds      Pounds
------------------------------------------------------------------------
Ionophores, Arsenicals, Bambermycin,   9,602,121  10,293,627  11,149,502
 Carbadox and Tiamulin *
Tetracyclines                          6,486,207   8,420,250   9,281,703
Cephalosporins, macrolides,            4,176,088   4,417,316   4,496,522
 lincosamides, polypeptides,
 streptogramins, fluoroquinolones
 and other minor classes of
 antibiotics **
Sulfonamides and Penicillins           1,117,815   1,043,645   1,198,478
Aminoglycosides                          357,077     267,600     327,901
                                     -----------------------------------
  Total                               21,761,128  24,442,438  26,454,107
------------------------------------------------------------------------
* Ionophores and arsenicals are unique drug products developed for
  animal production and not related to traditional antibiotics. Others
  in this grouping are therapeutic drugs with limited or no use in human
  medicine.
** Grouping necessary to abide by disclosure agreements.


    The Chairman [presiding.] Thank you.
    Dr. Hoang.

        STATEMENT OF CHRISTINE N. HOANG, D.V.M., M.P.H.,
 ASSISTANT DIRECTOR, SCIENTIFIC ACTIVITIES DIVISION, AMERICAN 
         VETERINARY MEDICAL ASSOCIATION, SCHAUMBURG, IL

    Dr. Hoang. Thank you, Mr. Chairman and Members of the 
Subcommittee for providing the American Veterinary Medical 
Association with the opportunity to speak about the advances in 
animal health within the livestock industry. My name is 
Christine Hoang and I work as an Assistant Director in the 
Scientific Activities Division of the AVMA. In addition to 
holding a doctorate in veterinary medicine, I also hold a 
master of public health with concentrations in veterinary 
public health policy as well as epidemiology.
    The AVMA as a whole, with nearly 77,000 member 
veterinarians, is highly focused on issues related to animal 
health, animal agriculture and public health and has committed 
extensive resources to their research and evaluation. 
Veterinarians are actively involved in research, continually 
looking for new and better ways to improve animal and human 
health. It is through this same process of careful study that 
veterinarians evaluate and determine the efficacy of products 
and interventions that safeguard our nation's food supply. With 
limited tools, our profession has made many advances in animal 
health and food safety in areas such as the development and 
implementation of animal disease control programs, 
interventions to minimize bacterial contamination, and 
biotechnology. Our successes include a decline in foodborne 
illness associated with meat and poultry products as well as a 
decline in the prevalence of associated foodborne pathogens 
including Salmonella and the decreased resistance of these 
organisms.
    The AVMA supports the use of multidisciplinary and 
integrated approaches to address issues affecting public health 
and food safety. For instance, in addition to supporting 
improved animal husbandry and management practices, we also 
support hazard controls in processing and the continued 
availability and judicious use of antimicrobials to safeguard 
the nation's food supply. Veterinarians also strongly encourage 
a veterinarian-client-patient relationship and veterinary 
consultation when implementing any treatment regimen.
    Dispensing or prescribing a prescription product including 
antimicrobials requires a veterinarian-client-patient 
relationship. Although there are critical shortages in the 
veterinary workforce, veterinarians provide oversight and 
advice on the use of medications including over-the-counter 
antimicrobials on a significant percentage of animal farms. We 
believe that further studies should appropriately address the 
availability of veterinary services and that the use of 
veterinary services can be improved through the resolution of 
the critical shortage of the veterinary workforce.
    With the large number of animals produced for food in this 
country, the topic of antimicrobial use in food production 
often becomes a topic of debate. By controlling and preventing 
disease through the judicious use of antibiotics and other 
therapeutic agents, veterinarians assist producers in 
maintaining and improving animal welfare, the health of the 
herd and ensuring a safe food supply.
    While the end goal is the same for all medical 
professionals--good health--veterinarians are severely limited 
in our tools for disease control and prevention. Regulations 
for drug approvals are more stringent. Therapeutic agents can 
be more difficult to develop, and there are fewer treatments 
available. Thus, veterinarians must rely on their knowledge of 
clinical medicine to determine the best course of treatment. 
Given the numbers of food animal species, in addition to the 
diversity of disease conditions that affect animals, a relative 
scarcity of labeled indications accompanying FDA-approved drugs 
exists. Though the FDA, the AVMA and others have, and continue, 
to make significant strides in enhancing drug availability 
including legislative initiatives such as the Minor Use and 
Minor Species Act, the numbers of FDA-approved drugs are 
inadequate to meet veterinary medical needs, placing animal 
health and welfare, and potentially human health, at 
significant risk.
    The Food Animal Residue Avoidance Database, or FARAD, has 
been a chronically under-funded program used by veterinarians, 
livestock producers, as well as state and Federal regulatory 
and extension specialists, to ensure that drug, environmental 
and pesticide contaminants are not in milk, eggs and meat that 
are consumed by Americans. FARAD serves as an informational 
resource for withdrawal times. Withdrawal times are periods of 
time when animals and animal products such as milk and eggs are 
not to be used for food, allowing time for the animals to 
metabolize and eliminate the drugs that had been used for 
treatment. The funding lapses of FARAD in 2007, and the 
continued lack of recurring support for FARAD, places the 
entire program in jeopardy. If funding is not appropriated 
before the end of this month, this vitally important asset to 
ensure food safety may be forced to close its doors 
indefinitely.
    The American Veterinarian Medical Association is committed 
to ensuring a safe, healthy and abundant food supply and 
supports the ongoing scientific efforts and funding for 
monitoring and surveillance of foodborne disease and resistant 
pathogens, education, development of new antimicrobials, 
biologics and other treatment options, and other research to 
advance animal health and to better define the challenges 
presented by animal agriculture.
    Thank you for the opportunity to appear before you today.
    [The prepared statement of Dr. Hoang follows:]

  Prepared Statement of Christine N. Hoang, D.V.M., M.P.H., Assistant
 Director, Scientific Activities Division, American Veterinary Medical
                      Association, Schaumburg, IL
    Thank you, Mister Chairman and Members of the Subcommittee on 
Livestock, Dairy, and Poultry, for providing the American Veterinary 
Medical Association (AVMA) with the opportunity to speak about the 
advances in animal health within the livestock industry.
    My name is Dr. Christine Hoang, and I work as an Assistant Director 
in the Scientific Activities Division of the American Veterinary 
Medical Association. In addition to holding a doctorate in veterinary 
medicine, I also hold a master of public health degree with 
concentrations in veterinary public health policy, both national and 
international, as well as epidemiology.a The majority of my 
work focuses upon food safety, zoonotic disease,b and 
antimicrobial resistance. As a result, issues related to animal health, 
animal agriculture, and human health have not only become topics of 
interest, but are topics that require a great deal of intensive 
research and evaluation.
    The AVMA represents nearly 77,000 U.S. veterinarians engaged in 
every aspect of veterinary medicine and public health. As 
veterinarians, our oath ethically charges us with promoting public 
health and protecting animal health and welfare. Thus, we share many of 
the same concerns as our human health counterparts. Among other things, 
our members protect the health and welfare of our nation's animals, 
help ensure food safety, and protect animal and human health through 
prevention and control of zoonotic diseases.
    The AVMA supports the use of multidisciplinary and multi-hurdle 
c approaches \1\ to address issues affecting public health 
and food safety. For instance, in addition to supporting improved 
animal husbandry and management practices, we also support the 
continued availability and judicious use of antimicrobials to safeguard 
the nation's food supply.
    The veterinary profession strives to achieve optimal animal health 
as well as animal welfare and human health. The fundamentals of food 
animal medicine and population medicine d are the same as 
the fundamentals of public heath--control and prevention of disease. 
While the end goal is the same for all medical professionals--good 
health--veterinarians are severely limited in our tools for disease 
control and prevention. Regulations for drug approvals are more 
stringent, therapeutic agents can be more difficult to develop, and 
there are fewer treatments available. Thus, veterinarians must rely on 
their knowledge of clinical medicine to determine the best course of 
treatment. Given the numbers of food animal species, in addition to the 
diversity of disease conditions that affect animals, a relative 
scarcity of labeled indications accompanying FDA approved drugs exists. 
Though the FDA, the AVMA and others have made and continue to make 
significant strides in enhancing drug availability, including 
legislative initiatives (such as the Minor Use and Minor Species Act), 
the numbers of FDA approved drugs are inadequate to meet veterinary 
medical needs, placing both animal health and welfare--and, 
potentially, human health--at significant risk.
    While it may seem intuitive to some that healthy animals are 
critically important for safe food, there are few who understand the 
intricacies of why. As an example, it is fairly intuitive that an 
effective antibiotic will help decrease the bacterial load in food. 
What many do not understand is that it is extremely difficult to 
ascertain whether or not a particular animal is carrying certain 
bacteria. Many bacteria, such as Salmonella, are shed intermittently, 
and cannot be easily detected by routine testing procedures. Animals 
can harbor types of bacteria in their intestinal tracts that have no 
effect on their health, but can cause illness in humans. Thus, we must 
rely on the combination of many different types of interventions to 
protect our food supply. These interventions would range from 
prevention and control of disease before it occurs in animals to post 
harvest interventions such as carcass rinsing to further minimize 
bacterial contamination in food. Another concept that is often 
misunderstood or overlooked is how seemingly unrelated illness, such as 
respiratory disease in a food animal, can affect the presence of 
enteric bacterial pathogens in the meat. For example, air sacculitis is 
a respiratory disease that affects poultry. It is a fairly common 
disease that can spread rapidly and often go undetected until 
slaughter. The disease causes tissues to become more friable 
e and difficult to remove during food processing. The 
increased handling and difficulty in processing increases the potential 
for damaging the intestines and contaminating the carcass with enteric 
pathogens that can be harmful to humans.\2\ By controlling this disease 
through the use of antibiotics and/or other therapeutic agents, 
veterinarians assist producers in maintaining a healthy flock and a 
safe food supply. This example further illustrates the necessity to 
continually maintain and improve animal health in the preservation of 
food safety.
Veterinarian's Role
    Veterinarians evaluate whether a therapy's benefits would outweigh 
its risks to both the patient and to public health. Veterinarians have 
been trained to ``do no harm'' as they make therapy recommendations, 
and they have the duty to utilize such agents to promote animal health 
and welfare in such a way that safeguards the public health. In 
addition, veterinarians protect America's food supply by ensuring food 
animal health from ``farm to fork,'' including their work in clinical 
practice, in state public health agencies, in the Federal Government, 
and in the corporate sector. Healthy animals make healthy food; for 
veterinarians to be effective in protecting our food supply, the 
appropriate tools for preventing, mitigating, and treating disease, 
which include antimicrobials, are paramount for veterinarians to be 
able to utilize.
    Veterinarians are actively involved in research, continually 
looking for new and better ways to improve animal and human health. 
Some veterinarians work in research through universities, private 
corporations, or through government projects, and many are actively 
involved in field research. It is through this process that we have 
learned so much about the nature of infectious diseases. It is through 
this same process of careful study that veterinarians evaluate and 
determine the efficacy of products and interventions that safeguard our 
nation's food supply. With limited tools, our profession has made many 
advances in animal health and food safety, including the development 
and implementation of animal disease control programs, pre- and post 
harvest interventions, and areas of biotechnology. Other successes 
through collaborative efforts include a decline in foodborne illness 
from meat and poultry products \3\ as well as a decline in the 
prevalence of foodborne pathogens (including Salmonella) associated 
with meat and poultry \4\ and resistance of those organisms.\5\ These 
are all a result of improvements in animal health and the joint efforts 
of stakeholders.
    Veterinarians are in the best position to prescribe and administer 
the most appropriate therapies for their patients. Veterinarians are 
licensed by state authorities to practice veterinary medicine and are 
authorized by both state and Federal Government entities to handle 
potent medical agents in the course of their professional practice. 
While there is governmental and regulatory oversight, veterinarians use 
professional judgment to determine the best therapy for their patients:

   Specifically, the Drug Enforcement Administration (DEA) 
        entrusts registered veterinarians to prescribe controlled 
        substances for animals, i.e., those drugs that are not 
        available to the general public due to the potential for abuse 
        and addiction.

   The Environmental Protection Agency (EPA) allows 
        veterinarians to use both restricted-use and conventional 
        pesticides in the course of their professional practice.

   The United States Department of Agriculture (USDA) 
        recognizes veterinarians as professionals who may vaccinate 
        animals to advance national animal disease control and 
        eradication programs.

    Of the tools that are available to veterinarians, one of the most 
important tools that veterinarians use to protect animal health and 
human health is the judicious use of antimicrobials. The continued 
availability of safe, effective antimicrobials for veterinary medicine, 
including the retention of currently approved drugs and future 
approvals of new drugs, are critical components of ensuring a safe food 
supply and essential to the improvement of animal health and welfare.
    The exact quantity of antimicrobials that are used in animal 
agriculture remains unknown and estimates vary greatly depending upon 
the source and the classification of antimicrobials. The Union of 
Concerned Scientists (UCS) estimates 24.6 million pounds of 
antimicrobials were used for non-therapeutic uses (defined by UCS to 
include uses for prevention and control of disease as well as for 
growth promotion) in cattle, swine, and poultry in 1999.\6\ However, 
The Animal Health Institute (AHI) has reported a general downward trend 
in total antibiotic use between 1999 and 2004, and estimates 95% 
therapeutic use (which includes disease control and prevention),\7\ and 
therefore about 1.2 million pounds for growth promotion or feed 
efficiency. Antibiotic use estimates are equally confusing and 
inconsistent when evaluating human use data. AHI reported in 2000 that 
32.2 million pounds of antibiotics are used annually in human 
medicine.\8\ However, the UCS estimate for human use (for inpatient and 
outpatient disease treatment and as topical creams, soaps, and 
disinfectants) was 4.5 million pounds. But the real issue is not the 
quantity of antimicrobials that are used but the outcomes of use.
    Despite all of these figures and other available data, no one knows 
for certain what role animal agriculture plays in the ecology of 
antimicrobial resistance. What we do know is that we need to be able to 
have as many tools as possible to uphold our oath.
    The number and supply of animals that is necessary to keep up with 
human demands for animal protein is rapidly increasing. The world's 
population is growing, and expected to increase by a third exceeding 
nine billion by 2050.\9\ With that population growth, comes an 
increased demand for a safe, healthy supply of food. Ban Ki-Moon, the 
United Nation's Secretary General, has noted in multiple venues that 
global food production must increase by 50% by 2030 to meet those 
demands.\10\
    In 2000, 9.7 billion animals were slaughtered for human consumption 
in the United States. In that same year, the U.S. Census Bureau 
reported a population of approximately 281 million. The U.S. population 
today is well over 300 million, and the world's population is rapidly 
approaching seven billion.\11\ Red meat production alone in the U.S. 
totaled 48.8 billion pounds last year.\12\ Today, the European Union's 
population is nearly 500 million, but in 2007 slaughtered only 42 
million animals for food \13\ compared to the U.S.'s nearly ten billion 
animals slaughtered annually. While the United States is often compared 
to the European Union in the discussion of differing husbandry and 
management practices, few recognize the vast difference in per capita 
production and that the United States has the most affordable, 
abundant, safe, and healthy food supply in the world.
    With the large number of animals produced for food in this country, 
the topic of antimicrobial use in food production often becomes a topic 
of debate. Much of the discussion revolves around a category of 
antimicrobial use commonly known as growth promotion or a group of 
antimicrobial uses that are poorly categorized as ``non-therapeutic.'' 
The term ``non-therapeutic'' has no meaning in Federal regulation or 
common usage. The FDA approves antimicrobials for four purposes: 
disease treatment, disease prevention, disease control, and growth 
promotion/feed efficiency. The FDA does not approve antimicrobials for 
``non-therapeutic'' uses. Also, the various organizations and people 
who use the term ``non-therapeutic,'' use it inconsistently. For 
example, the Pew Commission on Industrial Farm Animal Production 
(PCIFAP) provides an unclear definition of ``non-therapeutic'' that is 
different than H.R. 962, the Preservation of Antibiotics for Medical 
Treatment Act of 2007 (PAMTA). Additionally, the definitions use terms 
that are undefined, such as ``routine preventive uses and other routine 
uses.'' As a result, the term is not commonly understood. The use of 
exclusionary terms, such as ``non-therapeutic'', that are ill-defined 
serves to further confuse the issue. We caution against the use of this 
term.
    Instead, we believe the FDA labeled uses of antimicrobials should 
be used as the terminology, i.e., treatment, prevention, control, or 
growth promotion/feed efficiency. Alternatively, we advocate using the 
definitions of the Codex Alimentarius Commission (an organization of 
the World Health Organization and the Food and Agricultural 
Organization of the United Nations), the FDA, and AVMA. All three 
organizations classify treatment, prevention, and control of disease as 
therapeutic uses.
    Not all antimicrobials or all their uses are equal in their 
probability of developing resistance or creating a risk to human 
health. The EU's Scientific Committee on Animal Nutrition has agreed 
that possible theoretical human health concerns related to animal 
agricultural use of antimicrobials continue to be the focus while 
probable and scientifically based benefits to human and animal health 
are largely ignored.\14\
    There is little debate on the use of antimicrobials for treatment 
of disease in animals. However, few understand the importance of 
disease control and prevention, and even fewer have a clear 
understanding of growth promotants. Prevention and control of disease 
are key elements in the practice of veterinary medicine, particularly 
in animal agriculture, where the focus is on population health. This 
concept of disease prevention and control through herd health is 
analogous to public health efforts. Additionally, some of the growth 
promoting antimicrobials have no human health equivalent and thus no 
human health impact. In fact, studies show a potential health benefit 
from the use of growth promoting antimicrobials.\15\-\22\
Danish Experience
    The Danish experience has taught us that there can be serious 
negative consequences in animal health and welfare following the 
withdrawal of growth promoting antimicrobials and few, if any, 
improvements or positive human health impact.
    In the late 1990s, Denmark instituted a voluntary ban on the use of 
antimicrobials for growth promotion (AGPs). (A complete ban of AGPs was 
initiated in 2000.) The use of antimicrobials in feed and water for 
controlling and treating disease was not banned. The following has been 
observed as a result of the ban on the use of antibiotics for growth 
promotion in Denmark:

   There is little evidence to demonstrate a general decline in 
        antimicrobial resistance in humans and there is no evidence of 
        an improvement in clinical outcomes of antimicrobial treatment 
        of humans, the desired consequence of the antibiotic ban in 
        livestock. The results have been mixed. In fact, resistance in 
        humans to some of the banned drugs has increased dramatically.

   There has been increased death and disease in the swine 
        herds, especially at the weaning stage (information inferred 
        from DANMAP 2005 and other reports on pigs). According to 
        published news reports, there was a relative increase of 25% in 
        the number of pigs that died from illnesses from 1995 to 2005.

   While the total quantity of antimicrobials used in food 
        animals has decreased by 27%, the increase in disease has 
        resulted in a 143% increase in the quantity of antimicrobials 
        used for therapeutic purposes. And the antimicrobials now used 
        are classes such as tetracyclines that are also used in 
        humans.\23\

   Resistance to some antibiotics has decreased in some animals 
        while resistance to other antibiotics has increased

    The ban on antibiotic growth promoters in Denmark has not resulted 
in a significant reduction of antibiotic resistance patterns in humans. 
It has, however, resulted in an increase in disease and death in the 
swine herds and an increase in the use of antimicrobials for 
therapeutic uses in swine herds that discontinued the use of antibiotic 
growth promoters.
    Some important resistance trends reported by DANMAP:

   Salmonella typhimurium from human isolates f has 
        shown 34-49% increase in resistance to tetracycline, 
        sulfonamides, and ampicillin from 1997-2006; increases in 
        resistance to nalidixic acid and ciprofloxacin were 3.8% from 
        1997-2006

     In contrast, during the same period of time, poultry 
            isolates have shown only minimal increases (2-6%) in 
            resistance to the same antimicrobials.

     Isolates from pigs have also shown a lesser increase 
            (25-27%) in resistance to tetracycline and ampicillin than 
            human isolates during that time.

   Campylobacter jejuni from human isolates f has 
        shown 5-11% increase in resistance to tetracycline, nalidixic 
        acid, and ciprofloxacin from 1997-2006.

     In contrast, during the same period of time, poultry 
            isolates have shown lesser increases (4-6%) in resistance 
            to the same antimicrobials.

   Enterococcus faecium isolates from healthy human volunteers 
        has shown no increase in resistance to vancomycin (the 
        equivalent of avoparcin) from 1997-2006, and remains at 0%.

   However, resistance to virginiamycin (quinupristin/
        dalfopristin, e.g., Synercid) had been steadily increasing (up 
        to 25%) from 1997 to 2005 until the definition of resistance 
        was changed in 2006, bringing the level of resistance down to 
        0%.g

     When the definition of resistance is standardized to 
            the United States definition used by CDC and the level of 
            resistance in humans in Denmark to Synercid is compared to 
            the United States, we find that the level is ten times 
            higher in Denmark in spite of the Danish ban in 1998 of use 
            in animals and the continued use in the United States.

   During the same period of time, Enterococcus faecium 
        isolates from pigs and poultry has shown 8-20% decrease in 
        resistance to avoparcin,h virginiamycin, 
        erythromycin and tetracycline from 1997-2006 (using the same 
        definition of resistance as the human isolates from 1997-2005)

    Even though the results of the Danish experiment with antimicrobial 
growth promotant drug bans is very mixed, proposals within the United 
States go far beyond the Danish example by proposing to ban uses for 
the prevention and control of disease in addition to uses to promote 
growth and feed efficiency. Evidence shows that the Danish ban has 
caused animal health and welfare problems, without improving human 
health.
    Based on the results of a limited ban enacted in Denmark (i.e., the 
banning of growth promotants, not uses to prevent and control disease), 
we do not believe the public would benefit from such limitations on the 
use of antimicrobials. The loss of approved uses of antimicrobials will 
negatively impact animal health and welfare without significantly or 
predictably improving public health. Non-science based, broad bans of 
preventive uses of antimicrobials have the potential to harm public 
health, such as through increased foodborne disease.
    Significant decisions regarding animal health need to be science- 
and risk-based decisions. Decisions made without the benefit of 
veterinary input as well as a thorough evaluation of risks and benefits 
have the potential to further divert resources away from more 
appropriate disease control measures.
Actions Advancing Livestock Animal Health
AVMA's Efforts
    The AVMA has acted with three objectives in mind:

    1. Safeguarding public health,

    2. Safeguarding animal health, and the

    3. Continued availability of effective therapeutic agents, 
        including antimicrobials for veterinary medicine and the 
        retention of currently approved, safe drugs and biologics as 
        well as future approvals of new therapeutic agents.
Veterinary Oversight, Judicious Use, and VCPRs
    Since 1998, the AVMA has actively worked to mitigate the 
development of antimicrobial resistance related to the use of 
antimicrobials in food animals. The AVMA Guidelines for the Judicious 
Therapeutic Use of Antimicrobials were developed to safeguard public 
health by providing specific recommendations for responsible and 
prudent therapeutic use of antimicrobials. With support and input from 
the CDC, Infectious Diseases Society of America, the FDA, and the USDA, 
the guidelines were developed in collaboration with our species 
specific allied veterinary organizations. These guidelines were based 
upon carefully reviewed, scientifically sound research, and we believe 
that our members conscientiously adhere to the principles of judicious 
therapeutic use of antimicrobials to ensure the protection of human 
health, as well as animal health and welfare.
    We have actively encouraged and assisted our allied veterinary 
organizations to use the AVMA general principles as a template to 
develop more detailed guidelines appropriate to each species, disease 
and type of client. The AVMA also worked with these groups to develop 
and deliver a continuing education program to raise awareness within 
the profession and to encourage utilization of the principles. 
Fundamentally, the guidelines encourage scientifically based 
therapeutic practices, the use of antimicrobials only when needed, and 
compliance with all existing regulatory requirements when 
antimicrobials are used.
    Veterinarians also strongly encourage a veterinarian-client-patient 
relationship (VCPR) and veterinary consultation when implementing any 
treatment regimen. Dispensing or prescribing a prescription product 
(including antimicrobials) requires a VCPR. The VCPR is the basis for 
interaction among veterinarians, their clients, and their patients.
    The veterinarian must have sufficient knowledge of the animal(s) to 
initiate at least a general or preliminary diagnosis of the medical 
condition of the animal(s). This means that the veterinarian has 
recently seen and is personally acquainted with the keeping and care of 
the animal(s) by virtue of an examination of the animal(s), or by 
medically appropriate and timely visits to the premises where the 
animal(s) are kept.
    Veterinarians making treatment decisions must use sound clinical 
judgment and current medical information and must be in compliance with 
Federal, state, and local laws and regulations. The veterinarian must 
also include consideration of: judicious use principles; food safety 
and public health; and producer education as a part of the treatment 
plan. After considerations have been made for animal, human, and the 
environmental health impact, veterinary authorization is required prior 
to dispensing of the prescription product.
    There are older antimicrobials that are available in medicated 
feeds that can be purchased without a veterinary prescription. These 
are called over-the-counter or OTC drugs. OTC drugs have been approved 
for marketing without a veterinary prescription and include adequate 
directions for use under which a lay person can use the drugs safely 
and effectively. To our knowledge, no new classes of antimicrobials 
have been approved by the FDA as an OTC drug since the 1980s. A newer 
category of drugs, the Veterinary Feed Directive (VFD) Drug category, 
was created by the Animal Drug Availability Act of 1996 to provide 
veterinary control for certain animal pharmaceuticals for use in feed 
that are not suitable for OTC status. Any animal feed bearing or 
containing a VFD drug shall be fed to animals only by or upon a lawful 
VFD issued by a licensed veterinarian in the course of the 
veterinarian's professional practice.
    Veterinarians must balance the need for animal health and welfare 
with the need of human health. We are supportive of measures to 
mitigate risks to human health. Risk management measures can include 
any of the following: advisory committee review of an existing approval 
or application for a new animal drug approval; post-approval monitoring 
through systems such as the National Antimicrobial Resistance 
Monitoring System (NARMS); limitations on the extent of use (e.g., 
individual animals only for short duration of use); limited or broad 
extra-label use restrictions in some cases or all cases; antimicrobial 
use through prescription or VFD drugs only; and, finally, non-approval 
or withdrawal of a previously approved antimicrobial.
    Although there are critical shortages in the veterinary workforce, 
particularly in food supply veterinary medicine and veterinary public 
health, veterinarians provide oversight and advice on the use of 
medications, including OTC antimicrobials, on a significant percentage 
of animal operations. Feedlot '99 reports that all large operations and 
nearly all (96.5%) small operations used the services of a 
veterinarian. Large operations were more likely to use a veterinarian 
that made regular or routine visits or employ a full-time veterinarian 
on staff than small operations. Conversely, small operations were more 
likely to use a veterinarian when the need for one arose. Veterinarian 
recommendations had strong or moderate influence on selection of an 
antimicrobial for nearly 100% of feedlots. Laboratory test results 
influenced 58.8% of feedlots strongly or moderately. Veterinarian 
recommendations and laboratory test results were more likely to 
strongly influence selection of antimicrobials on large feedlots than 
small feedlots. Almost three out of four feedlots provided formal 
training in areas related to antimicrobial use.\24\
    The USDA Swine 2006 reports approximately seven of ten sites 
(69.1%) used a veterinarian during the previous year. A higher 
percentage of large and medium sites (88.1 and 85.0%, respectively) 
used a veterinarian during the previous year compared to small sites 
(60.8%). Nearly five of ten large sites (46.8%) used an on-staff 
veterinarian. A similar percentage of large sites (42.5%) used a local 
practitioner. Overall, approximately half of the sites (49.5%) used a 
local veterinarian during the previous 12 months. About one of four 
sites (24.7%) was visited by a veterinarian five or more times. 
Producers used the services of a veterinarian for many purposes during 
the previous 12 months. A higher percentage of large sites used a 
veterinarian for blood testing, production record analysis, employee 
education, and quality assurance compared to small sites. For sites 
that had at least one veterinary visit during the previous 12 months, 
the highest percentage of sites used a veterinarian to treat individual 
pigs (63.8%) and to provide drugs or vaccines (62.6%). These are 
followed by vaccination consultation (48.6%), quality assurance 
(47.9%), blood testing (47.6%), nutritional consultation (19.8%), 
environmental consultation (19.0%), and employee training/education 
(18.0%).\25\
    We believe that these numbers can be improved through the 
resolution of the critical shortage of the veterinary workforce by 
identifying resources and developing solutions in collaboration with 
key stakeholders to ensure that veterinary needs are met. Further 
studies should appropriately address the availability of veterinary 
services.
Data Collection and Review; Monitoring and Surveillance Systems
    The AVMA has also continually advocated for improved, more robust 
monitoring and feedback systems for foodborne disease and antimicrobial 
resistance such as FoodNet and NARMS. It is unfortunate that reporting 
by NARMS is not timelier. For example, the most recent Centers for 
Disease Control and Prevention NARMS report that is available to the 
public is for 2004--4 years ago.
    NARMS data, when combined with FoodNet data, demonstrates that the 
case rate of human infections with multi-drug resistant Salmonella spp. 
has decreased 49% between the NARMS baseline years of 1996-98 and 2004 
(the most current, publicly available human data from NARMS). In 
addition, there has been a 65% reduction in the case rate of penta-
resistant Salmonella typhimurium infections. The case rate for 
Campylobacter infections in humans that are resistant to ciprofloxacin 
have remained constant over that period.\26\
    Additional important resistance trends i reported by 
NARMS \27\ (Isolates from humans with clinical disease):

   Salmonella spp. (non-Typhi)--\1/2\ as likely to be resistant 
        in 2004 as in 1996

    c a highly significant j improvement in susceptibility 
            k (20% relative increase in susceptibility, from 
            66.2% in 1996 to 79.6% in 2004)

   Salmonella typhimurium--less than \1/2\ as likely to be 
        resistant in 2004 as in 1996

    c a highly significant j improvement in susceptibility 
            k (60% relative increase in susceptibility 
            k from 37.9% in 1996 to 60.7% in 2004)

   Campylobacter--only 0.03 times more likely to be resistant 
        in 2004 compared to 1997

    c a marginally significant j increase in resistance (2% 
            relative increase in resistance from 53% in 1997 to 54% in 
            2004)

    c However, Campylobacter was significantly less likely to be 
            resistant in 2003 when compared to 1997; there was a 
            significant j improvement in relative resistance 
            (8.2% decrease from 53% in 1997 to 49% in 2003)

   E. coli O157--\1/3\ as likely to be resistant in 2004 
        compared to 1996

    c a highly significant j improvement in susceptibility 
            k (10% relative increase in susceptibility)

    In addition to trends of improved susceptibility, trends 
i regarding multi-drug resistance l also showed 
improvement:

   Salmonella spp. (non-Typhi)--nearly \1/2\ as likely to be 
        multi-drug resistant l in 2004 when compared to 1996

    c a highly significant j improvement (44% relative 
            decrease) in multi-drug resistance l (decreased 
            from 27.0% in 1996 to 15.0% in 2004)

   Salmonella typhimurium--nearly \1/2\ as likely to be multi-
        drug resistant l in 2004 when compared to 1996

    c a highly significant j improvement (34% relative 
            decrease) in multi-drug resistance l (decreased 
            from 56.2% in 1996 to 37.2% in 2004)

   Campylobacter--slightly less likely to be multi-drug 
        resistant l in 2004 when compared to 1997

    c a marginally significant j improvement (10% relative 
            decrease) in multi-drug resistance l (decreased 
            from 15.7% in 1997 to 14.1% in 2004)

2    c However, when comparing 1997 to 2003, isolates were half as 
            likely to be multi-drug resistant l and there 
            was a highly significant j improvement (46% 
            relative decrease) in multi-drug resistance l 
            (decreased from 15.7% in 1997 to 8.5% in 2003)

    Most foodborne infections do not require treatment with 
antimicrobials. Information shows that there is a decreasing trend of 
foodborne diseases, thereby decreasing the potential numbers of 
treatments.\28\ The trends of increasing susceptibility/decreasing 
resistance mean more successful treatments when needed. This 
information indicates that there is not a public health crisis related 
to human pathogens that are thought to originate in animals.
    We have also advocated for more research to support scientifically 
based therapeutic practices, such as epidemiological studies, that 
assess the effects of antimicrobial use. In addition, we advocate for 
increased resources for the FDA's Center for Veterinary Medicine (CVM) 
so the agency can adequately implement its regulatory authority.
    We support the scientifically valid and meaningful collection and 
review of data for all uses of antimicrobials and other pharmaceuticals 
used in humans and animals. We urge that such data be collected in 
concert with other data necessary to explain or inform fluctuations in 
use, e.g., disease prevalence, regional data, populations of animals, 
etc. An example is the USDA program, Collaboration for Animal Health, 
Food Safety and Epidemiology, that is attempting to study the use of 
antimicrobials on farms correlated with disease occurrence, and the 
effects of antimicrobial use on antimicrobial resistance as measured 
both on the farm and during processing of the meat from the specific 
farm. Unfortunately, the program has not received adequate funding and 
is therefore not completed or ongoing.
    The AVMA provided start-up funding for projects to create a 
nationally coordinated laboratory system to test for and report on 
resistance in animal pathogens and to create a decision support system 
to assist veterinarians when making antimicrobial use decisions. 
Unfortunately, while this project received follow-on funding by the 
FDA, it has not been sustained or completed.
The FDA Role and Actions
    The FDA approves antimicrobials for four purposes:

    1. Treatment of disease,

    2. Prevention of disease,

    3. Control of disease, and

    4. Growth promotion or feed efficiency.

    The first three uses are classified as therapeutic uses by the FDA, 
the AVMA, and Codex Alimentarius Commission (an organization of the 
World Health Organization and the Food and Agricultural Organization of 
the United Nations), and the fourth has also been shown to have health-
promoting effects.
    The FDA process for the evaluation of food animal antimicrobials is 
at least as stringent as, and often more stringent than, the approval 
process for human antimicrobials. In addition to the testing for 
efficacy and safety to the individual (human or animal) receiving the 
drug that is common to the human and animal drug approval process, each 
food animal antimicrobial undergoes an assessment for human and 
environmental safety as part of the review by the FDA. The FDA's Center 
for Veterinary Medicine uses a very strict safety assessment approval 
process that requires sponsors to submit data proving the antibiotic is 
safe for both humans and animals. This is a zero-risk procedure for 
human safety--benefits to animals are not weighed to offset risks to 
humans, but rather, drugs that possess risks beyond ``a reasonable 
certainty of no harm'' to human health are rejected.
    Another safety measure was instituted in 2003 (Guidance for 
Industry #152, ``Evaluating the Safety of Antimicrobial New Animal 
Drugs with Regard to Their Microbiological Effects on Bacteria of Human 
Health Concern,'') that outlines a comprehensive, evidence-based 
approach to preventing the emergence and selection of antimicrobial-
resistant bacteria that may adversely affect human health. The Guidance 
requires antimicrobial manufacturers to provide information to the FDA 
showing that a proposed animal drug will not harm public health. The 
current FDA risk assessment on a drug-by-drug basis provides a 
scientifically sound process to protect human health. In the event that 
a determination is made that human health is jeopardized, FDA will not 
approve the antimicrobial or may limit the use of the antimicrobial in 
order to mitigate the adverse effect.
    We support GFI #152 while recognizing that it is very conservative 
in ensuring that preference is given to protection of human health 
without consideration of benefits to animal health and welfare. We also 
recognize that the ranking of antimicrobial drugs according to their 
importance in human medicine adds additional difficulty for approving 
animal drugs because the ranking design includes treatment of human 
diseases that are not in any manner associated with food animals. These 
diseases include gonorrhea, tuberculosis caused by Mycobacterium 
tuberculosis, neurosyphillis, meningitis, neutropenic fever, and 
Legionnaire's disease.
    In addition, we also recognize that the design of GFI #152 makes it 
extremely difficult or impossible for FDA to approve antibiotics for 
use in feed or water for treatment of groups of animals if those 
antibiotics are also used in humans. This is because the extent-of-use 
limitations table assigns a high ranking for intended administration to 
flocks or herds of animals regardless if the duration of use is short 
(less than 6 days) or long (more than 21 days).
    Since the mid-1990s, the FDA has coordinated the NARMS in 
cooperation with the CDC and the USDA. NARMS is a multi-agency program 
that includes monitoring for resistant bacteria in retail meats by the 
FDA, monitoring for resistant foodborne pathogens in humans by the CDC, 
and monitoring for resistant bacteria in animals on farms and animal 
products in slaughter and processing facilities by the USDA. NARMS has 
provided a great deal of useful information since 1996.
    Therefore, the AVMA does not believe that the FDA needs new 
authority to regulate the human safety of animal drugs. Instead, the 
FDA needs additional resources to fulfill its existing mission.
The USDA Role and Actions
    USDA Animal and Plant Health Inspection Services (APHIS) regulates 
veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, 
and other products of biological origin) to ensure that the veterinary 
biologics available for the diagnosis, prevention, and treatment of 
animal diseases are pure, safe, potent, and effective. According to the 
USDA, which regulates vaccines and other biologics for animals, over 80 
billion doses of approved vaccine were produced last year.\29\
    USDA also has oversight over many national programs for animal 
health monitoring and surveillance. Veterinarians in both public and 
private practice actively participate in these national programs and 
AVMA has consistently advocated for funding to maintain and continually 
improve all of these programs.
National Programs
    National Animal Health Surveillance System (NAHSS) (http://
www.aphis.usda.gov/vs/nahss/)--NAHSS integrates animal health 
monitoring and surveillance activities conducted by many Federal and 
state government agencies into a comprehensive and coordinated system.

   U.S. status for reportable diseases (http://
        www.aphis.usda.gov/vs/nahss/disease_status.htm) as reported to 
        the World Organization for Animal Health (OIE)

   NAHSS Outlook (http://www.aphis.usda.gov/vs/ceah/ncahs/nsu/
        outlook/index.htm)--Articles on U.S. animal health surveillance 
        issues and developments.

    National Animal Health Monitoring System (NAHMS) (http://
www.aphis.usda.gov/vs/ceah/ncahs/nahms/)--National studies on animal 
health and health management practices of U.S. livestock and poultry.
    National Animal Health Reporting System (NAHRS) (http://
www.aphis.usda.gov/vs/ceah/ncahs/nahrs/)--Information on the presence 
of reportable animal diseases in the United States.
    National Animal Identification System (NAIS) (http://
animalid.aphis.usda.gov/nais/index.shtml)--This program coordinates and 
expands animal identification programs and practices in livestock and 
poultry.
    National Animal Health Laboratory Network (NAHLN) (http://
www.aphis.usda.gov/vs/nahln/)--This network of state animal health 
laboratories provides, among other things, laboratory data to meet 
epidemiological and disease reporting needs.
    National Poultry Improvement Program (NPIP) (http://
www.aphis.usda.gov/animal_health/animal_dis_spec/poultry/index.shtml)--
National poultry health monitoring and surveillance.
    National Aquaculture Program (NAP) (http://www.aphis.usda.gov/
animal_health/animal_dis_spec/aquaculture/index.shtml)--National 
aquaculture health monitoring and surveillance.
    U.S. Animal Health and Productivity Surveillance Inventory (http://
www.aphis.usda.gov/vs/nahss/inventory.htm)--Search for surveillance 
programs, studies, and related information.
    Impact Assessments on Animal Health Events (http://
www.aphis.usda.gov/vs/ceah/cei/taf/current_iw.htm)--Reports on trade 
and production impact of animal disease occurrences in the U.S. and 
foreign countries.
    Emerging Animal Disease Notices (http://www.aphis.usda.gov/vs/ceah/
cei/taf/emergingdiseasenotice_files/notices.htm)--Information sheets on 
new and emerging animal diseases.
    National Surveillance Unit (http://www.aphis.usda.gov/vs/ceah/
ncahs/nsu/index.htm)--organization within APHIS tasked with 
coordinating activities related to animal health surveillance.\30\
FARAD Role and Actions
    The Food Animal Residue Avoidance Databank (FARAD) program was 
developed by pharmacologists and toxicologists at the university of 
California, Davis, University of Florida, North Carolina State 
University and the University of Illinois as a complement to the USDA 
Food Safety and Inspection Service (FSIS) Residue Avoidance Program 
(RAP) to reduce the rate of animal residue violations through 
education, and residue mitigation rather than enforcement.
    Whenever drugs are used to treat sick animals or prevent disease or 
when animals are exposed to chemicals in the environment, there is a 
potential that remnants of the drugs can be found in the meat or other 
animal products (often known as residues). The FDA establishes 
tolerances for drug residues to insure food safety. The FDA also 
establishes ``withdrawal times'' or ``withholding periods'' which are 
times after drug treatment when milk and eggs are not to be used for 
food, and during which animals are not to be slaughtered. This allows 
time for the animals to metabolize and eliminate the drugs that had 
been used for treatment.
    FARAD personnel collate residue avoidance information from many 
sources. These data are then reviewed by residue experts to insure 
accuracy and consistency, and further analysis is done by FARAD 
personnel at North Carolina State University to explore novel ways in 
which the data may be used to prevent residue problems. FARAD maintains 
an up-to-date computerized compilation of:

   Current label information including withdrawal times on all 
        drugs approved for use in food animals in the United States and 
        on hundreds of products used in Canada, Europe and Australia.

   Official tolerances for drugs and pesticides in meat, milk, 
        and eggs.

   Descriptions and sensitivities of rapid screening tests for 
        detecting chemical residues in meat, milk, and eggs.

   Data on the fate of chemicals in food animals.

    FARAD has been a chronically under-funded resource used by 
veterinarians, livestock producers, and state and Federal regulatory 
and extension specialists to ensure that drug, environmental, and 
pesticide contaminants do not end up in meat, milk, and eggs. AVMA has 
been a strong supporter of FARAD and has worked diligently with 
Congress on the 2008 Farm Bill to include authorization for a $2.5 
million annual appropriation for the Food Animal Residue Avoidance 
Databank from 2008 through 2012.\31\ However, if funding is not 
appropriated before September 30, 2008, this vitally important asset to 
ensure food safety may be forced to close its doors--permanently. Not 
only does FARAD ensure the safety of our meat, milk, and eggs, but the 
U.S. researchers from FARAD launched a global FARAD (gFARAD) initiative 
in response to an increasing need from foreign countries for residue 
data and requests made to FARAD to duplicate this successful program in 
other countries.
    FARAD's efforts in establishing gFARAD have, to date, been financed 
entirely by local funds in participating countries, and in the U.S. by 
private donations and use of facilities made available by the three 
U.S. Universities housing the FARAD program. These exciting 
developments, which have attracted collaborations (but no funding) from 
the Food and Agricultural Organization (FAO) and Commonwealth 
Agricultural Bureaux International (CABI), have far reaching 
implications for the safety of foods imported into the United States as 
well as upon global food safety and the harmonization of standards and 
procedures. Since 2003, the United Kingdom, France, and Spain have 
initiated gFARAD sites. The Canadian gFARAD became fully operational 
with significant, recurring support from the government of Canada in 
2003. In recent years, FARAD has provided training in gFARAD techniques 
and databases for China, as well as hosted the Taiwanese gFARAD 
consortium and South Korean delegate visits to FARAD.
    The funding lapses of U.S. FARAD in 2007 and the continued lack of 
recurring support for U.S. FARAD places the entire program in jeopardy. 
In addition, the lack of continued funding and support compromises U.S. 
leadership in the continued development of a program initiated by our 
own researchers. In 2007, gFARAD may have been able to assist in 
mitigating the Chinese melamine crisis, however, it was a necessity for 
funds to be utilized to maintain essential personnel and no funds were 
available for U.S. FARAD to leverage the gFARAD consortium. Global food 
safety and security will continue to be a concern for decades to come. 
Support for a strong U.S. FARAD is a critical investment in continuing 
relationships with our trading partners and global information sharing 
between governments to mitigate agroterrorism concerns and ensure a 
safe, abundant food supply.
Risk Assessments/Human Health Impact
Antibiotics as a Tool To Prevent and Control Disease in Animals and 
        Humans
    The use of drugs in animals is fundamental to animal health and 
well-being. Antibiotics are needed for the relief of pain and suffering 
in animals. For food animals, drugs additionally contribute to the 
public health by helping keep animals healthy and thereby keeping 
bacteria from entering the food supply. The hypothesis, supported by 
scientific information, is that a reduction in the incidence of food 
animal illness will reduce bacterial contamination on meat, thereby 
reducing the risk of human illness.\32\-\39\
    Several risk assessments have been performed that demonstrate a 
very low risk to human health from the use of antimicrobials in food 
animals, and some of the models predict an increased human health 
burden if the use is withdrawn. The unique farm-to-patient risk 
assessment performed by Hurd demonstrates that the use of tylosin and 
tilmicosin in food animals presents a very low risk of human treatment 
failure because of macrolide resistance, with an approximate annual 
probability of less than 1 in 10 million with Campylobacter infections 
and approximately 1 in 3 billion E. faecium infections.\40\ Cox 
performed a quantitative human health risks and benefits assessment for 
virginiamycin and concluded that there would be a significant human 
health risk if virginiamycin use is withdrawn. There would be 6,660 
excess cases per year of campylobacteriosis, which far outweighs the 
0.27 per year reduction of cases of streptogramin-resistant and 
vancomycin-resistant E. faecium (VREF) resulting from the 
withdrawal.\41\ Cox also performed a risk assessment regarding 
macrolide and fluoroquinolone use and concluded that withdrawal is 
estimated to cause significantly more illness days than it would 
prevent.\42\ Cox also examined the impact of the use of penicillin-
based drugs in food animals on penicillin/aminopenicillin resistant 
enterococcal infections and concluded that not more than 0.04 excess 
mortalities per year (under conservative assumptions) to 0.18 excess 
mortalities per year (under very conservative assumptions) might be 
prevented in the whole U.S. population by discontinuing current use of 
penicillin-based drugs in food animals. The true risk could be as low 
as zero.\43\ This equates to one potentially preventable mortality in 
the U.S. population roughly every 7-25 years. Alban's risk assessment 
concluded that the risk associated with veterinary use of macrolides in 
Danish pigs resulted in a low risk to human health.\44\
    Others have estimated that risk management strategies that focus on 
eliminating resistance are expected to create < 1% of the public health 
benefit of strategies that focus on reducing microbial loads in animals 
or on foods.\45\ In another paper, the authors concluded, ``We came to 
some surprising conclusions that were robust to many uncertainties. 
Among these were that antimicrobials that benefit animal health may 
benefit human health, while regulatory interventions that seek to 
reduce antimicrobial resistance in animals may unintentionally increase 
illness rates (and hence antimicrobial use and resistance rates) in 
humans. . . . In conclusion, our analysis suggests that the 
precautionary-principle approach to regulatory risk management may 
itself be too risky.'' \46\
    Information derived from studies of organic or antibiotic-free 
production practices compared to traditional production practices is 
inconclusive, but there are indications that organically grown meat may 
have less-resistant organisms but greater prevalence and quantities of 
pathogens on the meat. Therefore, the greater risk of foodborne illness 
is somewhat offset by an increased likelihood of treatment success if 
treatment is necessary.\47\-\50\
    The question of what the nature and magnitude of the risk to humans 
is can only be answered by performing systematic risk assessments. Such 
risk assessments must include identification of the endpoints of 
concern (e.g., increased illness or mortality caused by bacteria 
resistant to antibiotics used to treat the disease in humans), the 
nature of the treatment protocols in food animals, the potential routes 
of exposure, characterization of the population at risk, and the 
probability of occurrence.
    Just as in humans, resistant bacteria can and do develop in 
animals. However, many of the important details regarding the transfer 
of that resistant bacteria, or even resistance genes--to the 
environment or humans--still remains in question. Simply because 
resistance exists in animals, it does not necessarily equate to a human 
health risk. First, the bacteria or its resistance determinants may not 
effectively transfer to humans through the food chain. Second, the 
pathogen may not colonize in humans to create a foodborne disease. 
Third, if a disease does occur, antimicrobial therapy may not be 
needed, and the disease resulting from the resistant bacteria is in 
effect no different than any other bacteria. In the majority of cases, 
treatment is not needed. Supportive therapy, such as fluids, is the 
only treatment that is needed for most Salmonella, Campylobacter and E. 
coli infections. In fact, antimicrobial therapy of E. coli O157 
infections is contra-indicated because such treatment makes the effects 
of the disease worse. Last, if antimicrobial therapy is needed, the 
pathogen may be susceptible to the drug of first choice. The Therapy 
Guidelines for Enteric Infections for non-typhi Salmonella are, ``In 
uncomplicated infections antimicrobial therapy is not indicated because 
it has no effect on clinical illness and prolongs carriage and 
excretion of the organism. . . . Treatment recommended only for young 
infants (< or = 6 m) and immunocompromised individuals. Resistance is 
common. Agents that can be used include a fluoroquinolone or a third-
generation cephalosporin such as ceftriaxone for 5-7 days. Ampicillin 
and co-trimoxazole can be used if the infecting organism remains 
susceptible.'' \51\ NARMS \52\ reports the following resistance 
percentages of non-typhi Salmonella to fluoroquinolone 
(ciprofloxacin)--0.2%, third-generation cephalosporin (ceftriaxone)--
0.6%, ampicillin--12.0%, and co-trimoxazole (trimethoprim-
sulfamethoxazole)--1.8%. These resistance levels do not indicate a 
public health crisis associated with foodborne Salmonella.
Conclusion
    The American Veterinary Medical Association is committed to 
ensuring a safe and healthy abundant food supply. Among other things, 
our profession is dedicated to improving animal health, further 
safeguarding public health and food safety, and to maintaining the 
long-term effectiveness of antibiotics. The AVMA established a 
profession-wide initiative to create and implement judicious use 
guidelines for the therapeutic use of antimicrobials by veterinarians, 
and we launched an educational campaign to raise the awareness of the 
profession to the issue. Today, we continue to review and update those 
guidelines to reflect current practices and actively encourage 
compliance.
    Foodborne illness and the spread of antibiotic resistance is a 
public and animal health concern. There is no question that the public 
demands a safe food supply and that the human medical profession is 
facing extreme challenges because of hospital- and community-acquired 
resistant human pathogens. The human medical problem with resistant 
nosocomial and community-acquired infections has increased the concern 
of possible development of resistant pathogens in animals that could be 
transferred to humans through the food supply or environment.
    The AVMA shares the concerns of the human medical community, the 
public health community, governmental agencies, and the public 
regarding the potential problem of resistant foodborne pathogens 
developing in animals and then being transferred to humans. However, we 
emphasize the importance and primacy of using these medicines to 
prevent and treat diseases before they enter our food supply. Pre-
emptive bans of veterinary antimicrobials before science-based studies 
and risk-based evaluations are performed would be detrimental to animal 
and human health. Inappropriate reactions to a perceived problem could 
have unknown and unintended consequences that negatively affect animal 
health and welfare, and ultimately, could create other public health 
risks, such as increased foodborne illness.
    The AVMA does not believe that additional regulation of the uses of 
antimicrobials or other therapeutic agents in veterinary medicine and 
animal agriculture are necessary. Additional legislation and further 
regulation can put animal health and welfare and public health at risk. 
The FDA has adequate authority for oversight but lacks the resources to 
accomplish its many priorities.
    An analysis that compared the regulatory strategy of the European 
Union to ban or restrict animal antibiotic uses with the United States' 
approach of continued prudent use to prevent and control animal 
infections, together with measures to improve food safety, has some 
pertinent conclusions. Among these, prudent use of animal antibiotics 
may actually improve human health, while bans on animal antibiotics, 
intended to be precautionary, inadvertently may harm human health.\53\
    The AVMA supports the ongoing scientific efforts of monitoring and 
surveillance of foodborne disease and resistant foodborne pathogens; 
education; development of new antimicrobials, biologics, and other 
treatment options; and other research to better define the challenges 
presented by animal agriculture. Increased data collection and 
surveillance of disease, as well as continued veterinary input 
(including the appropriate use of pre- and post-harvest interventions, 
and compliance with judicious use guidelines for veterinarians and 
producers), may be sufficient to protect human health against the 
current small risks without compromising the health of food animals.
    We also support adequate funding for all efforts to improve animal 
health and food safety, including efforts to combat antimicrobial 
resistance. These efforts were high-priority tasks in the 2001 version 
of the Public Health Action Plan to Combat Antimicrobial Resistance 
that was created by a Federal Interagency Task Force on Antimicrobial 
Resistance. The Action Plan reflected a broad-based consensus of 
Federal agencies and stakeholders on actions needed to address 
antimicrobial resistance and provided a blueprint for specific, 
coordinated Federal actions that included the full spectrum of 
antimicrobial use: human medicine, veterinary medicine and animal 
agriculture. We are disappointed that the Action Plan was not 
adequately funded and prioritized by Congress. We are also concerned 
that the new Action Plan under development appears to not be as 
collaborative, broad-based or acceptable to the diverse community of 
stakeholders.
    The AVMA is committed to working in concert with the CDC, FDA, and 
USDA to provide consumers--not only in the United States, but all over 
the world--with the safest food possible. The judicious use of 
antimicrobials is but one of the essential components of the process 
that enables animal agriculture to meet that demand. Other components 
include veterinary care, good management practices, biosecurity, proper 
nutrition and good husbandry.
    Thank you for the opportunity to appear before you today and speak 
on behalf of our profession.
References
    a Epidemiology is a medical discipline that is the study 
of the causes, distribution, and control of disease in populations and 
serves as the foundation and logic of interventions made in the 
interest of public health and preventive medicine.
    b Zoonotic diseases are diseases that can be transmitted 
from animals to humans. CDC estimates at least 60 percent of all human 
diseases and 75 percent of all newly emerging diseases are zoonotic.
    c The multi-hurdle concept refers to the interaction of 
factors that affect microbial behavior in foods. Under some 
circumstances these effects are additive. Under others the implication 
is that synergistic interactions lead to a combined effect of greater 
magnitude than the sum of constraints applied individually.
    d Population medicine is a medical discipline focusing 
on the concepts of public health and epidemiology. In veterinary 
medicine, these concepts are incorporated to make strategic decisions 
to advance animal and herd health.
    e Friable is a term used in pathology to describe 
tissues that are brittle, fragile, and easily damaged.
    f Domestically acquired clinical cases.
    g The rationale for this change is unknown, but appears 
to introduce bias in reporting. DANMAP decided to use a preliminary 
European Committee on Antimicrobial Susceptibility Testing breakpoint 
instead of the previously used breakpoint established by the Clinical 
and Laboratory Standards Institute.
    h Avoparcin has never been approved for use in the 
United States.
    i Odds ratios were calculated based upon available data 
from NARMS assuming the reported isolates were representative of the 
bacterial population.
    j ``Marginally significant'' indicates a p-value between 
0.05 and 0.10; ``significant'' indicates a p-value between 0.01 and 
0.05; ``highly significant'' indicates a p-value of less than 0.01.
    k No resistance detected to any of five subclasses of 
antibiotics.
    l Resistant to two or more antibiotic subclasses.
Endnotes
    \1\ McMeekin, T.A., Presser, K., Ratkowski, D. Ross, T., Salter, 
M., Tienungoon, S. Quantifying the hurdle concept by modelling the 
bacterial growth/no growth interface. International Journal of Food 
Microbiology (http://www.sciencedirect.com/
science?_ob=PublicationURL&_tockey=%23TOC%235061% 
232000%23999449998%23178169%23FLA%23&_cdi=5061&_pubType=J&view=c 
&_auth=y&_acct=C000069188&_version=1&_urlVersion=0&_userid=6040261& 
md5=e025060af42d4f943d833909a70485dc). Volume 55, Issues 1-3, 10 April 
2000, Pages 93-98.
    \2\ Russell S.M. The effect of airsacculitis on bird weights, 
uniformity, fecal contamination, processing errors, and populations of 
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003 82: 1326-
1331.
    \3\ CDC. FoodNet. Facts and Figures related to ``Preliminary 
FoodNet Data on the Incidence of Infection with Pathogens Transmitted 
Commonly Through Food--10 States, United States, 2007'' published in 
the Morbidity and Mortality Weekly Report (MMWR) on April 11, 2008. 
(Available at http://www.cdc.gov/foodnet/factsandfigures.htm)
    \4\ United States Department of Agriculture, Food Safety Inspection 
Service. Progress Report on Salmonella Testing of Raw Meat and Poultry 
Products, 1998-2001.
    \5\ CDC. National Antimicrobial Resistance Monitoring System: 
Enteric Bacteria. 2004 Human Isolates Final Report. (Available at 
http://www.cdc.gov/narms/NARMSAnnualReport2004.pdf).
    \6\ Mellon M., Benbrook C., Benbrook K.L. 2001. Hogging it: 
estimates of antimicrobial abuse in livestock. Cambridge: UCS 
Publications.
    \7\ [AHI] Animal Health Institute. 2005. Antibiotic use in animals 
rises in 2004. News release. Washington, D.C.: AHI.
    \8\ [AHI] Animal Health Institute. 2000. Survey indicates most 
antibiotics used in animals are used for treating and preventing 
disease. Press release., Washington D.C.: AHI.
    \9\ United Nations. Department of Economic and Social Affairs. 
Population Division. (12 October 1999). The World at Six Billion. ESA/
P/WP.154. (Available at: http://www.un.org/esa/population/publications/
sixbillion/sixbilcover.pdf).
    \10\ United Nations. Department of Public Information. News and 
Media Division. (3 June 2008). Food production must rise by 50 percent, 
Secretary-General tells Rome high-level conference, stressing that 
crisis is chance to revisit past policies. (Available at http://
www.un.org/News/Press/docs/2008/sgsm11612.doc.htm).
    \11\ United States Census Bureau. Population Division. (2008) U.S. 
and World Population Clocks. (Available at http://www.census.gov/main/
www/popclock.html).
    \12\ United States Department of Agriculture. National Agricultural 
Statistics Service. (24 July 2008). Livestock and Animals--Slaughter 
Statistics. (Available at: http://www.nass.usda.gov/QuickStats/
indexbysubject.jsp?Text1=&site=NASS_MAIN& 
select=Select+a+State&Pass_name=&Pass_group=Livestock+%26+Animals&Pass 
_subgroup=Slaughter).
    \13\ EuroStat, European Commission. Luxembourg: Office for Official 
Publications of the European Communities, 2008. (Available at: http://
epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-ED-08-001/EN/KS-ED-08-
001-EN.PDF).
    \14\ Phillips I. et al. Does the use of antibiotics in food animals 
pose a risk to human health? A critical review of published data. J. of 
Antimicrobial Chemotherapy 2004: Vol. 53, pp. 28-52.
    \15\ Singer R.S. Modeling the Relationship between Food Animal 
Health and Human Foodborne Illness. Prev. Vet. Med. 2007; 79: 186-203.
    \16\ Russell S.M. The effect of airsacculitis on bird weights, 
uniformity, fecal contamination, processing errors, and populations of 
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003 82: 1326-
1331.
    \17\ Russell S.M. Ban Antibiotics In Poultry? [Why The Policymakers 
Have It Wrong], WATT Poultry/USA, March 2003.
    \18\ Dawe J. The Relationship between Poultry Health and Food 
Safety. Poultry Informed Professional 2004; 77:1-6.
    \19\ Cox L.A., Ricci P. Causal regulations vs. political will: Why 
human zoonotic infections increase despite precautionary bans on animal 
antibiotics. Environ. Int. 2008 (in press).
    \20\ Cox L.A., Popken D.A. Quantifying Potential Human Health 
Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in 
Chickens. Risk Analysis 2006; 26:135-146.
    \21\ Cox L.A. Potential human health benefits of antibiotics used 
in food animals: a case study of virginiamycin. Environ. Int. 2005; 
31:549-63.
    \22\ Hurd S. et al. Potential Human Health Implications of Swine 
Health, Abstract of Oral Presentation, 2007.
    \23\ DANMAP 2006. Use of antimicrobial agents and occurrence of 
antimicrobial resistance in bacteria from food animals, foods and 
humans in Denmark. ISSN 1600-2032. (Available at www.danmap.org).
    \24\ United States Department of Agriculture. Animal and Plant 
Health Inspection Service. (May 2000). Feedlot '99--Part I: Baseline 
Reference of Feedlot Management Practices, 1999. (#N327.0500). Fort 
Collins, CO: USDA/APHIS/VS/CEAH/NAHMS.
    \25\ United States Department of Agriculture. Animal and Plant 
Health Inspection Service. National Animal Health Monitoring System. 
(October 2007). Swine 2006--part 1: reference of swine health and 
management practices in the United States, 2006. (#N475.1007). Fort 
Collins, CO:USDA/APHIS/VS/CEAH/NAHMS.
    \26\ Antimicrobial Resistance--Implications for the Food System, 
Institute of Food Technologists Expert Report, Comprehensive Reviews in 
Food Science and Food Safety, Vol. 5, 2006 (Available at http://
members.ift.org/IFT/Research/IFTExpertReports/
antimicrobial_report.htm).
    \27\ CDC. National Antimicrobial Resistance Monitoring System: 
Enteric Bacteria. 2004 Human Isolates Final Report. (Available at 
http://www.cdc.gov/narms/NARMSAnnualReport2004.pdf).
    \28\ CDC. FoodNet. Facts and Figures related to ``Preliminary 
FoodNet Data on the Incidence of Infection with Pathogens Transmitted 
Commonly Through Food--10 States, United States, 2007'' published in 
the Morbidity and Mortality Weekly Report (MMWR) on April 11, 2008. 
(Available at http://www.cdc.gov/foodnet/factsandfigures.htm).
    \29\ United States Department of Agriculture, Animal and Plant 
Health Inspection Service. (June 2008). Veterinary biological products: 
Licenses and Permittees. Ames IA: Center for Veterinary Biologics.
    \30\ United States Department of Agriculture, Animal and Plant 
Health Inspection Service , Animal Health. (June 2008) (Available at: 
http://www.aphis.usda.gov/animal_health/).
    \31\ United States Department of Agriculture. Cooperative State 
Research, Education, and Extension Service. (no date). General 
information on FARAD: FARAD and food quality. (Available at: http://
www.farad.org/gen.html#food).
    \32\ Singer R.S. Modeling the Relationship between Food Animal 
Health and Human Foodborne Illness. Prev. Vet. Med. 2007; 79: 186-203.
    \33\ Russell S.M. The effect of airsacculitis on bird weights, 
uniformity, fecal contamination, processing errors, and populations of 
Campylobacter spp. and Escherichia coli. Poult. Sci. 2003 82: 1326-
1331.
    \34\ Russell S.M. Ban Antibiotics In Poultry? [Why The Policymakers 
Have It Wrong], WATT Poultry/USA, March 2003.
    \35\ Dawe J. The Relationship between Poultry Health and Food 
Safety. Poultry Informed Professional 2004; 77:1-6.
    \36\ Cox L.A., Ricci P. Causal regulations vs. political will: Why 
human zoonotic infections increase despite precautionary bans on animal 
antibiotics. Environ. Int. 2008 (in press).
    \37\ Cox L.A., Popken D.A. Quantifying Potential Human Health 
Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in 
Chickens. Risk Analysis 2006; 26:135-146.
    \38\ Cox L.A. Potential human health benefits of antibiotics used 
in food animals: a case study of virginiamycin. Environ. Int. 2005; 
31:549-63.
    \39\ Hurd S. et al. Potential Human Health Implications of Swine 
Health, Abstract of Oral Presentation, 2007.
    \40\ Hurd S. et al. Public Health Consequences of Macrolide Use in 
Food Animals: A Deterministic Risk Assessment. J. Food Protection 2004; 
67:980-992.
    \41\ Cox L.A. Potential human health benefits of antibiotics used 
in food animals: a case study of virginiamycin. Environ. Int. 2005; 
31:549-63.
    \42\ Cox L.A., Popken D.A. Quantifying Potential Human Health 
Impacts of Animal Antibiotic Use: Enrofloxacin and Macrolides in 
Chickens. Risk Analysis 2006; 26:135-146.
    \43\ Cox L.A. et al. Human Health Risk Assessment of Penicillin/
Aminopenicillin Resistance in Enterococci Due to Penicillin Use in Food 
Animals. 2008. In Press.
    \44\ Alban, L. et al. A human health risk assessment for macrolide-
resistant Campylobacter associated with the use of macrolides in Danish 
pig production. Prev. Vet. Med. 2008; 83:115-129.
    \45\ Phillips I. et al. Does the use of antibiotics in food animals 
pose a risk to human health? A critical review of published data. J. of 
Antimicrobial Chemotherapy 2004: Vol. 53, pp. 28-52.
    \46\ Cox LA. et al. Quantifying Human Health Risks from Animal 
Antimicrobials. Interfaces. 2007; 37:22-38.
    \47\ Antimicrobial Resistance--Implications for the Food System, 
Institute of Food Technologists Expert Report, Comprehensive Reviews in 
Food Science and Food Safety, Vol. 5, 2006 (Available at http://
members.ift.org/IFT/Research/IFTExpertReports/
antimicrobial_report.htm).
    \48\ Heuer O.E. et al. Prevalence and antimicrobial susceptibility 
of thermophilic Campylobacter in organic and conventional broiler 
flocks. Letters in Applied Microbiology 2001; 33: 269-274.
    \49\ Bailey J.S., Cosby D.E.. Salmonella Prevalence in Free-Range 
and Certified Organic Chickens. J. of Food Protection 2005; 68:2451-
2453.
    \50\ Wondwossen A. Gebreyes, Peter B. Bahnson, Julie A. Funk, James 
McKean, Prapas Patchanee. Seroprevalence of Trichinella, Toxoplasma, 
and Salmonella in Antimicrobial-Free and Conventional Swine Production 
Facilities. Foodborne Pathogens and Disease. April 1, 2008, 5(2): 199-
203.
    \51\ M. Bennish and W. Khan. Therapy Guidelines for Enteric 
Infections--A 12-Year Update. 2007. In APUA Newsletter, Vol. 25, No. 3, 
pp. 1-4.
    \52\ CDC. National Antimicrobial Resistance Monitoring System: 
Enteric Bacteria. 2004 Human Isolates Final Report. (Available at 
http://www.cdc.gov/narms/NARMSAnnualReport2004.pdf).
    \53\ Cox L.A., Ricci P. Causal regulations vs. political will: Why 
human zoonotic infections increase despite precautionary bans on animal 
antibiotics. Environ. Int. 2008 (in press)

    The Chairman. Thank you.
    Dr. Singer.

    STATEMENT OF RANDALL S. SINGER, D.V.M., M.P.V.M, Ph.D.,
 ASSOCIATE PROFESSOR OF EPIDEMIOLOGY, DEPARTMENT OF VETERINARY 
 AND BIOMEDICAL SCIENCES, COLLEGE OF VETERINARY MEDICINE, AND 
                          DIVISION OF
 ENVIRONMENTAL HEALTH, SCHOOL OF PUBLIC HEALTH, UNIVERSITY OF 
                    MINNESOTA, ST. PAUL, MN

    Dr. Singer. Mr. Chairman, Members of the Subcommittee, I 
would like to thank you for giving me the opportunity to 
discuss the role of antibiotics in animal agriculture. My name 
is Randall Singer. I am Associate Professor of infectious 
disease epidemiology at the University of Minnesota, both in 
the College of Veterinary Medicine and in the School of Public 
Health. I received both my veterinary degree and my Ph.D. in 
Epidemiology from the University of California at Davis.
    To begin, let me restate the issue as I see it. What we are 
really discussing is risk, and specifically, the potential that 
the use of antibiotics in animal agriculture might result in 
more antibiotic-resistant bacteria that can subsequently infect 
humans and that then lead to either treatment failures or 
prolonged illness due to that resistance. Given this 
definition, I want to focus on two points. First, how should we 
assess and manage these potential risks, and second, are there 
actually any benefits to human health associated with the use 
of antibiotics in animals?
    So how do we assess and manage these potential risks to 
human health? One approach is to employ the precautionary 
principle, which states that if there is a perceived potential 
for serious negative consequences, it is deemed better to avoid 
an action entirely rather than to suffer the potential 
consequences. The precautionary principle approach to managing 
antibiotic use in animal agriculture has only one real option: 
ban the antibiotic. But a more objective way to assess and 
manage the risks of animal antibiotic use is to develop 
scientifically based predictions using methods such as risk 
assessment. The FDA Center for Veterinary Medicine uses a 
science-based approach to decision-making, and in 1999 assessed 
the human health risk of an antibiotic in chickens. Based on 
the risk assessment model, FDA withdrew a very important 
antibiotic to poultry veterinarians. Now, even though this 
decision was science-based, I still had a major concern with 
the model. It did not evaluate any intervention strategies for 
reducing the risk to human health. Withdrawing the antibiotic 
was the only option. For risk assessments to be useful, they 
should evaluate strategies for reducing risk. Many potential 
interventions could have been explored in the FDA model such as 
processing chickens from treated and untreated flocks 
separately or cooking the chicken meat from treated flocks 
prior to distribution.
    This leads to my final point. Let me ask a rhetorical 
question. Let us say we start banning various antibiotics used 
in animal agriculture, either because of the precautionary 
principle or because our models do not evaluate risk reduction 
strategies. Will there be any unintended consequences from 
these actions? Stated another way, are there any potential 
benefits to human health associated with antibiotic use in 
animals? We have already heard about the animal health 
benefits. Research shows that animals that have experienced 
illness can lead to a meat product that has higher levels of 
harmful bacteria on it including Salmonella and Campylobacter. 
So healthier animals lead to a healthier food supply and 
therefore healthier people. Antibiotics improve animal health 
which under this argument leads to improved food safety and 
improved human health.
    Recently I was part of a team that developed a mathematical 
model that related animal health to human health and, 
simultaneously, evaluated the human health risks and benefits 
associated with the use of antibiotics in animal agriculture. 
The model showed that under certain circumstances, the 
potential benefits to human health of antibiotic use in animals 
far outweigh the potential risks.
    So in conclusion, Mr. Chairman, Members of the 
Subcommittee, I thank you again for the opportunity to speak 
today. Antibiotics are an integral component of animal health. 
All responsible uses of antibiotics improve animal health and 
these improvements can substantially improve human health. All 
uses of antibiotics also pose a risk mainly associated with 
increases in antibiotic resistance. Simply removing antibiotics 
from use in animal agriculture may help reduce some of the 
antibiotic resistance circulating today but it might also have 
severe unintended consequences. The key is to identify 
strategies that maximize the benefits and minimize the risks. 
The best way to manage antibiotic uses in animal agriculture is 
through sound, rational, science-based policy. Thank you.
    [The prepared statement of Dr. Singer follows:]

   Prepared Statement of Randall S. Singer, D.V.M., M.P.V.M, Ph.D., 
   Associate Professor of Epidemiology, Department of Veterinary and 
 Biomedical Sciences, College of Veterinary Medicine, and Division of 
Environmental Health, School of Public Health, University of Minnesota, 
                              St. Paul, MN
    Mr. Chairman and Members of the Subcommittee:

    Thank you for providing me with the opportunity to discuss the role 
of antibiotics in animal agriculture and the potential risks and 
benefits to animal and public health associated with these antibiotic 
uses. I am an Associate Professor of Infectious Disease Epidemiology 
and Ecology at the University of Minnesota. I have a dual appointment 
at the university, both in the College of Veterinary Medicine and the 
School of Public Health. I am a veterinarian by training with a degree 
from the University of California at Davis. Following my veterinary 
degree, I obtained a Ph.D. in epidemiology from the University of 
California at Davis. I have worked as a professor of epidemiology since 
1999, first at the University of Illinois, Urbana-Champaign and now at 
the University of Minnesota. I have spent the past 10 years engaged in 
research, teaching and service activities related to antibiotic use and 
antibiotic resistance in human and animal health. I will focus my 
discussion on four questions that I think are critically important:

    1. What are antibiotics and how are they used in animal 
        agriculture?

    2. What is antibiotic resistance and how is it selected?

    3. How do we assess and manage the risks of antibiotic use in 
        animal agriculture?

    4. Are there benefits to antibiotic use in animal agriculture?
What are antibiotics and how are they used in animal agriculture?
    Although many people assume that antibiotics are human-made 
compounds, antibiotics are actually small molecules that are naturally 
produced by microorganisms in the environment. Humans have created 
synthetic analogs to these naturally occurring compounds to improve 
their efficacy. The function of these molecules in nature is still not 
entirely understood. Because bacteria in the environment have been 
exposed to these antibiotics for eons, they have developed mechanisms 
for survival in the presence of these compounds. These mechanisms are 
what we refer to as antibiotic resistance, or a way for the bacterium 
to resist the action of the antibiotic. The presence of naturally 
produced antibiotics in the environment is rarely considered as a 
contributor to the amount of resistance that is found in bacteria 
around the world, and yet it is this environmental pool of resistance, 
lately termed the resistome [5], that is the basis for the resistance 
observed today. Antibiotic resistant microorganisms can be found in 
areas with little to no obvious human influence or impact, emphasizing 
that there is a large background reservoir of resistance that exists in 
the natural world.
    Antibiotics are used in animal agriculture in four major ways: 
disease treatment, disease control, disease prevention, and growth 
promotion. Briefly, disease treatment refers to the use of the 
antibiotic in an ill animal. Disease control refers to the use of the 
antibiotic in a population of animals during a time of illness. Not all 
of the animals receiving the antibiotic are necessarily ill at the time 
of antibiotic administration. Disease prevention refers to the use of 
the antibiotic in an animal or in a population of animals at a time 
when it is known that the animals are susceptible to disease. Finally, 
growth promotion refers to the use of the antibiotic in a low-dose 
fashion to improve the weight gain and feed efficiency of the animal. 
All four of these uses result in an improved health of the animal 
receiving the antibiotic, and as will be discussed later, can thereby 
improve the safety of the food supply.
    Even though all four of these uses can improve the health of the 
animal, there has still been confusion about them. One area of 
confusion is related to the amount of antibiotic that is administered. 
Because disease control, disease prevention and growth promotion can 
use smaller amounts of the antibiotic than is given to the sick animal 
during disease treatment, these uses have sometimes been labeled as 
``subtherapeutic'' or ``nontherapeutic''. Given that animals receiving 
an antibiotic in this manner are healthier than if they had not 
received the antibiotic, these terms are misnomers. Another area of 
confusion is related to the route of administration. Uses of 
antibiotics that are ``in-feed'' are often equated with growth 
promotion uses and are assumed to be long-term low-dose regimens of 
antibiotic administration for the sole purpose of improving weight 
gain. In fact, all of these uses can be applied via the feed or the 
water because the only realistic way to give antibiotic to populations 
of animals, such as a flock of chickens, is through the feed or the 
water. Antibiotics used for disease treatment and disease control are 
often given via the drinking water because sick animals may stop eating 
but often continue to consume water.
What is antibiotic resistance and how does it develop?
    Antibiotic resistance refers to the ability of a microorganism to 
survive the effects of an antibiotic. As stated previously, antibiotics 
are naturally produced by environmental microorganisms, and as a 
result, many microorganisms possess mechanisms that enable them to 
resist the action of the antibiotic. Some microorganisms are 
intrinsically resistant to the action of certain antibiotics, meaning 
that the antibiotic has no function on the organism. This type of 
resistance can not be spread and is not of concern when considering 
antibiotic uses. Instead, we are typically concerned about antibiotic 
resistance that is acquired by the microorganism. The two major 
mechanisms by which the microorganism can acquire resistance are 
through random changes in the genetic makeup, known as mutation, or 
through the sharing of genetic material with other microorganisms.
    When an antibiotic is applied to a population of bacteria, those 
bacteria that are not intrinsically resistant to its action must find a 
way to survive. The antibiotic will either kill or suppress the 
bacteria that are susceptible to the antibiotic. For this reason, the 
antibiotic is said to select for resistant bacteria because only the 
resistant ones can withstand the pressure imposed by the antibiotic. 
During the course of the antibiotic, the rates at which bacteria can 
acquire resistance might increase, and consequently, the use of the 
antibiotic may pose a risk to human and animal health through the 
selection of a more resistant bacterial population. The problem, stated 
simply, is how do we ensure that the human and animal health benefits 
of antibiotic use in animal agriculture outweigh the risks?
How do we assess and manage the risks of antibiotic use?
    There are two primary approaches for assessing and managing the 
potential risks associated with antibiotic use in animal agriculture. 
One approach is to employ the precautionary principle. In this 
argument, the precise public health risks associated with animal 
antibiotic use might not be known. Because there is a perceived 
potential for serious negative consequences, it is deemed better to 
avoid the action entirely rather than to suffer the potential 
consequences. Europe has used this principle to withdraw certain 
antibiotic uses from animal agriculture [1]. One reason why this 
approach is often relied upon, especially in the case of antibiotic use 
and resistance, is the belief that antibiotic use is negatively 
impacting human health. It is extremely difficult to design, implement 
and analyze the decisive study that will prove or disprove this theory. 
Caution would dictate that by the time such a study is complete, any 
negative effects associated with continued antibiotic use might be 
irreversible. Consequently, the precautionary principle approach to 
managing antibiotic use in animal agriculture has only one real option: 
withdraw the antibiotic use that might result in a negative human 
health consequence. Unfortunately, there can be negative unintended 
consequences associated with a precautionary measure [4] as will be 
discussed later.
    A more objective way to evaluate the potential consequences of 
antibiotic use in livestock and poultry is to develop scientifically-
based predictions, and through these models, evaluate interventions 
that reduce potential human and animal health risks associated with 
certain antibiotic uses in animal agriculture. This approach includes 
the methodology known as risk assessment. For example, in 2003 the FDA 
Center for Veterinary Medicine (FDA-CVM), which uses a scientific 
approach to regulatory decisions, issued a Guidance for Industry 
document #152 that described a qualitative risk assessment process that 
is utilized in the approval of all applications for new animal 
antibiotics and the reassessment of existing animal antibiotics. I was 
recently part of a team that conducted a risk assessment following the 
document #152 approach. Specifically, we assessed the risk that the 
agricultural use of a family of antibiotics known as macrolide 
antibiotics poses to human health [7]. The concern is that macrolide 
antibiotics are also used in human medicine, and therefore, the use of 
macrolide antibiotics in animal agriculture could compromise the 
efficacy of these antibiotics in human medicine and potentially 
increase the number of macrolide-resistant bacterial infections in 
people. We developed a semi-quantitative risk assessment model 
following the format of document #152. We 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.
    Currently, the international body Codex Alimentarius has formed a 
Task Force to delineate international standards for the conduct of risk 
assessment and risk management in the context of antibiotic use in 
animal agriculture. The main purposes of the Codex Alimentarius are 
``protecting health of the consumers and ensuring fair trade practices 
in the food trade, and promoting coordination of all food standards 
work undertaken by international governmental and non-governmental 
organizations.'' Once this Task Force has completed its objective, 
there will be a set of accepted, scientifically-based approaches for 
determining if antibiotic uses in animal agriculture pose a risk to 
human health, and if so, how these risks should be managed. Perhaps 
most important, the final document of this Task Force will outline 
procedures for assessing whether interventions that are used to 
mitigate risk have succeeded or whether they have been counter-
productive.
    Unfortunately, most risk assessments conducted to date in 
antibiotic resistance that have been used for regulatory purposes have 
not included specific interventions that can be implemented to reduce 
the human and animal health risks. Instead, the assessments seem to 
have been designed for the sole purpose of making the dichotomous 
decision of whether or not to withdraw an antibiotic from use. For risk 
assessments to be useful, they must include evaluations of potential 
interventions for reducing the risks to human and animal health. In the 
U.S. FDA-CVM risk assessment of fluoroquinolone use in chickens [2], 
the model only estimated the potential human health impact of this 
antibiotic use and did not evaluate ways for minimizing the risk 
associated with fluoroquinolone use in poultry. For example, the model 
could have examined the possibility of processing chickens from treated 
poultry flocks separately from chickens from untreated flocks as a 
potential risk reduction strategy. This separated processing could help 
reduce the chance of cross-contamination of chicken meat from non-
treated poultry flocks with the bacteria from treated flocks. The model 
could have examined a potential intervention in which farms that have 
received fluoroquinolones are cleaned in a more intensive manner than 
the normal cleaning, and all litter from these flocks is sterilized. 
Finally, the model could have assessed an intervention in which flocks 
that have been treated with antibiotics would have to wait for a longer 
period of time before processing. This type of approach would resemble 
the mandatory withdrawal times associated with antibiotic residues. 
Guidelines could then be developed to determine when specific 
antibiotic uses should be ceased in flocks before they go to processing 
in order to reduce the amount of antibiotic resistant bacteria in the 
birds. Consideration of such risk mitigation interventions rather than 
complete withdrawal of these drugs would have been very important to 
poultry veterinarians. Prescription drugs like the fluoroquinolones are 
a valuable option to control fatal respiratory disease in chickens 
since other effective therapeutic alternatives are not available.
    These types of interventions might sound labor-intensive and 
costly. They are, and that is the point. Under certain circumstances, 
it might be cost-effective and ethical for a veterinarian to use a 
powerful antibiotic to control a severe disease in the herd or flock, 
but this use would then have major repercussions on how the herd or 
flock as well as the farm are subsequently managed. Producers might not 
opt for this intensive measure, but at least they would have a choice 
that is accepted as scientifically-sound for reducing both the human 
and animal health risks associated with the antibiotic use on their 
farm. As we begin to gain a better understanding of the ecology of 
resistance and its relation to animal and human health, we will need 
these scientifically-based strategies for minimizing the impacts of 
antibiotic use on animal, human and environmental health.
Are there benefits to antibiotic use in animals?
    The models that we build to assess the potential risks of 
antibiotic use in livestock and poultry must begin to take a more 
holistic view of health into consideration. Specifically, these models 
need to include the potential risks and the potential benefits 
associated with antibiotic use. Phrased another way, are there 
potential unintended consequences of removing antibiotics from use in 
food animals? Recent models have predicted that there might be 
significant negative human health consequences associated with the 
removal of certain antibiotics from animal production. This is an 
instance in which the precautionary principle would lead to an action 
of banning antibiotics in animal agriculture, but that action could 
have even worse unintended consequences. It might not be intuitive, 
however, how an antibiotic that is used in animal agriculture can 
actually benefit human health.
    The health status of animals that are processed for meat can 
potentially affect food safety in two major ways. First, animals that 
are less healthy may shed higher levels of harmful bacteria, such as 
Salmonella and Campylobacter. Second, groups of animals that have 
experienced illness, either clinically or subclinically, can be smaller 
in size and more variable in size. During processing, these factors can 
contribute to an increased likelihood of the gastrointestinal tract 
being ruptured, and this processing error can lead to increased 
contamination and cross-contamination of the meat and thus increase the 
risk of human foodborne illness. Reducing animal illness likely plays a 
critical role in reducing the chances of contamination during 
processing.
    I recently was part of a team that developed a mathematical model 
that relates animal illness to human illness [8]. In our model, there 
was a large increase in human illness associated with small increases 
in animal illness, suggesting that agricultural management strategies 
may have significant impacts on human health. Antibiotics administered 
in feed at low doses over several weeks raise concern about their 
potential to increase rates of antibiotic resistance, posing a risk to 
human health. However, these applications also improve animal health 
and promote size uniformity among animals in the herd or flock. 
Antibiotic uses in animals can therefore have potential human health 
risks and benefits. Our model was able to evaluate simultaneously the 
human health risks and benefits associated with antibiotic use in 
animal agriculture. Specifically, the model addressed the relationship 
between the negative human health impact of increased antibiotic 
resistance and the positive human health impact of fewer foodborne 
infections, both of which are due to the use of the antibiotic in 
animal agriculture. The model showed that the potential benefits to 
human health associated with the use of antibiotics in animal 
agriculture can far outweigh the potential risks. This finding has now 
been validated by additional studies [3] [6].
    In summary, Mr. Chairman and Members of the Subcommittee, thank you 
again for the opportunity to discuss the role of antibiotics in animal 
agriculture. Antibiotics are an integral component of animal health. 
All uses of antibiotics improve animal health, and these improvements 
in animal health can substantially improve human health. All uses of 
antibiotics also pose a risk, mainly associated with increases in 
antibiotic resistance. The key is to assess the ability of 
interventions to maximize the benefits and minimize the risks 
associated with the agricultural use of antibiotics. Simply removing 
antibiotics from use in animal agriculture may help reduce some of the 
antibiotic resistance circulating today, but it might also have severe 
unintended consequences. The best way to manage antibiotic uses in 
animal agriculture is through sound, rational, science-based policy.
References
    [1] Aarestrup, F.M., A.M. Seyfarth, H.D. Emborg, K. Pedersen, R.S. 
Hendriksen, and F. Bager. 2001. Effect of abolishment of the use of 
antimicrobial agents for growth promotion on occurrence of 
antimicrobial resistance in fecal Enterococci from food animals in 
Denmark. Antimicrob. Agents Chemother. 45:2054-2059.
    [2] Bartholomew, M.J., D.J. Vose, L.R. Tollefson, and C.C. Travis. 
2005. A linear model for managing the risk of antimicrobial resistance 
originating in food animals. Risk Anal. 25:99-108.
    [3] Berrang, M.E., S.R. Ladely, R.J. Meinersmann, and P.J. Fedorka-
Cray. 2007. Subtherapeutic tylosin phosphate in broiler feed affects 
Campylobacter on carcasses during processing. Poult. Sci. 86:1229-1233.
    [4] Cox, L.A., Jr., P.F. Ricci. 2008. Causal regulations vs. 
political will: why human zoonotic infections increase despite 
precautionary bans on animal antibiotics. Environ. Int. 34:459-475.
    [5] D'Costa, V.M., K.M. McGrann, D.W. Hughes, and G.D. Wright. 
2006. Sampling the antibiotic resistome. Science 311:374-377.
    [6] Hurd, H.S., S. Malladi. 2008. A stochastic assessment of the 
public health risks of the use of macrolide antibiotics in food 
animals. Risk Anal. 28:695-710.
    [7] Hurd, H.S., S. Doores, D. Hayes, A. Mathew, J. Maurer, P. 
Silley, R.S. Singer, and R.N. Jones. 2004. Public health consequences 
of macrolide use in food animals: a deterministic risk assessment. J. 
Food Prot. 67:980-992.
    [8] Singer, R.S., L.A. Cox Jr., J.S. Dickson, H.S. Hurd, I. 
Phillips, and G.Y. Miller. 2007. Modeling the relationship between food 
animal health and human foodborne illness. Prev. Vet. Med. 79:186-203.

    The Chairman. Well, thank you very much. You may have heard 
us pose this question to an earlier group. Give us some idea of 
what goes into developing an antibiotic in time, cost to bring 
it to market. Can you give us some feeling for what is involved 
in all that?
    Dr. Carnevale. Yes, thank you, Mr. Chairman, for that 
question. It is a very rigorous process. I think Dr. Dunham 
explained that the drug has to be shown to be safe and 
effective to the animal as well as manufactured properly. There 
is an environmental impact component. Clearly, the human food 
safety from residues and antibiotics presents a significant 
amount of research. We have estimated at the Animal Health 
Institute that for a food-producing animal, it can take 7 to 10 
years to develop a product from essentially discovery to final 
approval, and it costs upwards of $100 million. However, there 
are some examples of products that have actually cost more than 
that and taken many more years than 7 to 10 years. But that 
would be an average. So it is a fairly rigorous time and costly 
process to get a new animal drug through the process and that 
would include antibiotics. Antibiotics have a particularly 
difficult time getting through the system today because of this 
resistance issue. FDA takes a lot of time and care and data 
requirements to prove that these antibiotics aren't dangerous 
to human health, so that adds another several years and 
probably several million more dollars to the development of 
those. It is very, very difficult to get a new compound on the 
market today because of that.
    The Chairman. Thank you very much. Anybody else?
    Mr. Hayes.
    Mr. Hayes. Again, very thorough. My only question would be 
from your perspective as scientists and doctors, is there 
anything that FDA or anyone in the community that is monitoring 
what you all are doing, any other testing from your perspective 
that could be done that would fill in any blank that I haven't 
seen today, but that in somebody's mind might exist?
    Dr. Hoang. Currently the only system that we have for 
monitoring outbreaks of foodborne illness is FoodNet, and that 
is the only system that has both a component that monitors the 
bacteria as well as the epidemiological study behind it. NARMS 
is a separate system that monitors antimicrobial resistance. 
However, there really is no link between those two systems to 
accurately indicate the incidence of foodborne illness of 
resistant pathogens in humans, and also have it be traced back 
to consumption of animal products. Thank you, sir.
    Mr. Hayes. I guess another thing, and as far as domestic is 
concerned, the evidence that all of you presented is, in my 
opinion, irrefutable. But, Mr. Chairman, as you know, we 
continue to run into artificial trade barriers based around 
some of these issues too. So, I guess my question was directed 
at that part of our agricultural economy as well. Any other 
comments from Dr. Carnevale, Dr. Singer?
    Dr. Singer. In relation to the global food system, I mean, 
this is part of what the Codex Alimentarius, the task force on 
antimicrobial resistance, is currently working on. How do we 
come up with international standards for looking at risks, for 
conducting risk assessments, and most importantly, for 
implementing risk management strategies. How do nations and 
regions interact in this case, and so that pilot process is 
underway. It is a 4 year process, the specific task force.
    Mr. Hayes. I have no further questions, Mr. Chairman. Thank 
you.
    The Chairman. Thank you, Mr. Hayes. Because of your 
expertise and background, I wonder if any or all of you would 
care to make a comment about your analysis of the situation 
that happened in Denmark and the impact. What would be your 
analysis of that whole thing that happened there?
    Dr. Hoang. Based upon our analysis of the experience in 
Denmark, we found that there has been no significant human 
health benefit as a result of that ban. However, we have seen 
that there has been a decrease in animal welfare and animal 
health and the increase of therapeutic use of antimicrobials. 
Unfortunately, some of the therapeutic antimicrobials are in 
the same classes as human medications, which poses more of a 
risk to human health. Thank you, sir.
    Dr. Carnevale. Yes, I would certainly support what 
Christine said. I think the situation in Denmark was a clear 
example of the government wanting to take an action based on 
the idea that there was a perceived risk to human health. What 
they found is that there was a greater risk to animal health by 
their action. It was very interesting to me that a couple of 
years after that Denmark ban on growth promoters, a Danish 
official at a meeting here in the United States actually 
admitted that they did not realize that these growth-promoting 
antibiotics added to feed were suppressing disease. They 
thought they were strictly promoting growth, but in fact they 
found out when they took them out of feed that they had a lot 
of nursery pig diarrhea and a significant number of nursery pig 
deaths in the first several years of that program. So I think 
that that program has been, although they would not admit it, a 
real failure because it simply increased cost to their pork 
industry. And as Christine said, there has been no indication 
that it has improved human health at all.
    The Chairman. Dr. Singer?
    Dr. Singer. While we don't have the perfect example here in 
the United States, we can use organic meat production and 
antibiotic-free meat production here in the United States for 
some indication of what we might expect. Research studies do 
show that the antibiotic-free and organic meat production, the 
meat produced in those systems can have higher levels of 
pathogenic bacteria such as Salmonella and Campylobacter on it 
than conventionally reared meat. It also might have less 
antibiotic resistance. So the key here again is a risk-benefit 
type of analysis. It is not good enough for us to say that the 
resistance is the only issue we should be considering. We need 
to weigh both the risks and the benefits.
    The Chairman. Thank you very much.
    Mr. Hayes, do you have any closing remarks?
    Mr. Hayes. I appreciate the participation of the witnesses 
and the willingness of the Chairman and the staff to put this 
together. I think it is very positive.
    The Chairman. I think it has been very productive today. It 
has certainly been an educational process. Just since we have 
been here this morning, Mr. Hayes, I have gotten word that even 
with the statements made by our first panel, and then the 
concerns by the second panel that the FARAD program that you 
and I wrote a letter about is not a priority at USDA, so we may 
have to pursue that a little more. So I think that probably 
could be the reason why we haven't received a response to our 
July letter.
    But anyway, I want to thank everyone who has joined us 
today. I hope everyone found the testimony as informative as I 
have. We have had the opportunity to hear from our regulatory 
agencies, actual producers on the ground and numerous 
veterinarians and researchers. I hope we leave here today with 
resolve to continue to move forward and ensure that consumers 
in the United States have the safest, most plentiful and most 
affordable food supply in the world. I believe that is the case 
because of the work that has gone into it. It is clear from 
today's hearing that antimicrobials play an extremely important 
role in producing healthy animals and even a healthier food 
supply.
    With that, under the rules of the Committee, the record of 
today's hearing will remain open for 10 days to receive 
additional material and supplementary written responses from 
witnesses to any question posed by a Member of the panel.
    This hearing of the Subcommittee of Livestock, Dairy, and 
Poultry is adjourned. Thank you.
    [Whereupon, at 12:20 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
 Submitted Statement of Hon. Louise M. Slaughter, a Representative in 
                         Congress from New York
    Thank you Chairman Boswell and Ranking Member Hayes for allowing me 
to submit testimony on this important public health topic. With 
antibiotic resistance growing at an alarming rate, it is becoming 
harder and more expensive to treat common bacterial infections. The 
problem has become so significant that it has been labeled a ``top 
concern'' by the Centers for Disease Control and Prevention (CDC), and 
the World Health Organization has called it a ``crisis.'' Therefore, it 
is critically important that we act now to protect our current stocks 
of antibiotics.
    Two million Americans acquire bacterial infections during their 
hospital stay every year, and 70 percent of their infections will be 
resistant to the drugs commonly used to treat them. As a result, every 
day 38 patients in our hospitals will 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. Over \1/3\ of all 
diagnoses occur in children under the age of 10. Infants under the age 
of one are ten times more likely than the general population to acquire 
a Salmonella infection. In 1995, 19 percent of Salmonella strains were 
found to be multi-drug resistant. That means that our children are left 
to undergo multiple treatments for otherwise simple infections because 
we have allowed traditional treatments to become ineffective.
    And the cost 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.
    We cannot in good conscience stand by while our life-saving 
antibiotics become obsolete. While overuse of antibiotics among humans 
is certainly a major cause for increasing resistance, there is evidence 
that the widespread nontherapeutic use of antibiotics in animal feed is 
another cause of heightened resistance. A 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 
agriculture as well.''
    Currently, 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. Among 
them are penicillin, tetracyclines, macrolides, lincosamides, 
streptogramins, aminoglycosides, and sulfonamides. These classes of 
antibiotics are among the most critically important in our arsenal of 
defense against potentially fatal human diseases.
    Penincillins, for example, are used to treat infections ranging 
from strep throat to meningitis. Macrolides and Sulfonamides are used 
to prevent secondary infections in patients with AIDS and to treat 
pneumonia in HIV-infected patients. Tetracyclines are used to treat to 
people potentially exposed to anthrax.
    Despite their importance in human medicine, these drugs are added 
to animal feed as growth promotants and for routine disease prevention. 
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. 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, 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.
    Resistant bacteria can be transferred from animals to humans in 
several ways. Antibiotic resistant bacteria can be found in the meat 
and poultry that we purchase in the grocery store. In fact, a New 
England Journal of Medicine study conducted in Washington, D.C. found 
that 20 percent of the meat sampled was contaminated with Salmonella 
and 84 percent of those bacteria 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 on 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, surface water, and soil. Because this manure contains 
resistant bacteria, the resistant bacteria can then be passed on to 
humans that come in contact with the water sources or soil.
    And the problem has been well documented.
    A 2002 analysis of more than 500 scientific articles and published 
in the journal Clinical Infectious Diseases found that ``many lines of 
evidence link antimicrobial resistant human infections to foodborne 
pathogens of animal origin.''
    The Institute of Medicine's 2003 report on Microbial Threats to 
Health concluded ``Clearly, a decrease in the inappropriate use of 
antimicrobials in human medicine alone is not enough. Substantial 
efforts must be made to decrease inappropriate overuse in animals and 
agriculture as well.''
    As recently as last November, in FDA Week, the article below 
entitled ``Study Fuels Call for FDA to Phase Out Antibiotics In Animal 
Feed'' highlighted how methicillin-resistant Staphylococcus aureus 
(MRSA) is prevalent in Canadian pig farms and pig farmers.

  Study Fuels Call for FDA To Phase Out Antibiotics in Animal Feed

    9 November 2007
    FDA Week
    Vol. 13, No. 45

      A new study has found that methicillin-resistant Staphylococcus 
        aureus (MRSA) is prevalent in Canadian pig farms and pig 
        farmers, pointing to animals as a source of the deadly bacteria 
        and raising new questions about the use of human antibiotics in 
        animal feed. Health advocates are using the study's results to 
        drum up support for the Preservation of Antibiotics for Medical 
        Treatment Act, which would phase out the use of antibiotics 
        important in human medicine as animal feed additives within 2 
        years.
      The Veterinary Microbiology study (Khanna et al. 2007) is the 
        first to show that North American pig farms and farmers have 
        carried MRSA. The study looked for MRSA in 285 pigs in 20 
        Ontario farms. It found MRSA at 45 percent of farms (9 of 20) 
        and in nearly one in four pigs (71 of 285). One in five pig 
        farmers studied (5 of 25) also were found to carry MRSA, a much 
        higher rate than in the general North American population, 
        according to the study. The strains of MRSA bacteria found in 
        Ontario pigs and pig farmers included a strain common to human 
        MRSA infections in Canada.
      The study stated MRSA colonization in pigs was first reported in 
        the Netherlands and has also been found in pigs in France, 
        Denmark, and Singapore. In all of these countries, farm and pig 
        workers were found to have been infected with MRSA by pigs.
      The study was published in October.
      Also in October, the Journal of the American Medical Association 
        (Klevens et al. 2007) published a study that estimated almost 
        100,000 MRSA infections in 2005, and nearly 19,000 deaths in 
        the United States. In comparison, HIV/AIDS killed 17,000 people 
        that year, according to the study.
      A pending bill, The Preservation of Antibiotics for Medical 
        Treatment Act, would phase out the use of antibiotics as animal 
        feed additives within 2 years. The Senate version of the 
        legislation is sponsored by Health Committee Chair Edward 
        Kennedy (D-MA) and Sens. Olympia Snowe (R-ME), Susan Collins 
        (R-ME), Sherrod Brown (D-OH) and Jack Reed (D-RI). The House 
        version is sponsored by Rep. Louise Slaughter (D-NY), the only 
        microbiologist in Congress, and 34 other House Members.
      The American Medical Association, the Infectious Diseases Society 
        of America and the American Academy of Pediatrics are among the 
        more than 350 advocacy groups nationwide that have endorsed 
        this bill.
      Until recently, scientists believed MRSA was an infection 
        occurring mainly in hospitals. The JAMA study found that even 
        healthy people are developing MRSA infections. The Veterinary 
        Microbiology study points to pig farms as a possible source of 
        these resistant infections, as have earlier European studies.
      A recent study in the Netherlands found MRSA transmission among 
        pigs, pig farmers and their families.
      Members of the Keep Antibiotics Working coalition, including 
        medical, agriculture and environmental experts, are calling for 
        Congress to compel FDA to study whether the use of human 
        antibiotics in animal agriculture is contributing to the 
        reported surge in MRSA infections and deaths in the United 
        States.
      ``Identifying and controlling community sources of MRSA is a 
        public health priority of the first order,'' said Richard Wood, 
        Executive Director of Food Animal Concerns Trust and Steering 
        Committee Chair of Keep Antibiotics Working. ``Are livestock 
        farmers and farms in the United States also sources? We don't 
        know for sure, because the U.S. Government is not 
        systematically testing U.S. livestock for MRSA.''
      ``Last summer, when we raised the MRSA issue, the FDA told us 
        that it had no plans to sample U.S. livestock to see if they 
        carry MRSA,'' said David Wallinga, Director of the Institute 
        for Agriculture and Trade Policy's Food and Health Program. 
        ``Given the latest science that hog farms may generate MRSA, we 
        need Congress to give FDA and other relevant agencies the 
        necessary funding and a sense of urgency. Sampling needs to be 
        done as soon as possible.''--Inside OSHA.

    As the impact of MRSA continues to unfold, 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 adequately address the effect of the misuse of 
animal antibiotics on the efficacy of human drugs.
    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 for the therapeutic use of 
fluoroquinolones in poultry. The review, and eventual withdraw of 
approval, took 5 years to complete. Under its regulations, the FDA must 
review each class of antibiotics separately.
    In 2003, the Center for Veterinary Medicine at FDA released 
Guidance 152 which provides safety guidelines on how antibiotics should 
be used in agriculture. However, the guidance never established a 
timeframe for FDA to reevaluate existing antibiotics used in animal 
feed and so has rendered these recommendations useless.
    During discussions involving the now-enacted farm bill, I supported 
language which would have provided the farm industry with sound, 
scientific information on production practices that could have helped 
them reduce their dependence on antibiotics and meet the growing 
consumer demand for meat produced without these drugs. The ability to 
grow food animals with fewer antibiotics would have also given U.S. 
exporters an advantage in the international marketplace. This language 
would have also increased research on the movement of antibiotics and 
antibiotic-resistant traits in water to aid public health professionals 
in developing new tools and methods for reducing the spread of 
resistant diseases. Disappointingly, however, industry successfully 
lobbied to strip this language out of the farm bill.
    I am also the sponsor of H.R. 962, the Preservation of Antibiotics 
for Medical Treatment Act (PAMTA). This bill requires three actions to 
accomplish the goal of reducing antibiotic resistance in humans. PAMTA 
would phase out the use of the seven classes of medically significant 
antibiotics that are currently approved for nontherapeutic use in 
animal agriculture. Because the bill defines nontherapeutic use as ``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,'' this bill would in no way infringe upon the 
use of these drugs to treat a sick animal.
    In addition, PAMTA provides that if an antibiotic that is now used 
only in animals also becomes potentially important in human medicine, 
the drug would be automatically restricted from nontherapeutic use in 
agricultural animals unless FDA determines that such use will not 
contribute to development of resistance affecting humans.
    Last, to assist public health officials in tracking implementation 
of the phase out of antibiotics in animal feed, PAMTA requires 
producers of agricultural antibiotics to report the quantity of drugs 
they sell, information on the claimed purpose, and the dosage form of 
those drugs.
    The fundamental solution to the problem of antibiotic resistance is 
to reduce unnecessary use. Then when antibiotics are required, use them 
prudently. Most antibiotics in agriculture are used for growth 
promotion and routine disease prevention--uses that can be reduced, if 
not eliminated, in properly designed animal production systems. Drastic 
reduction of antibiotics uses in animal agriculture, as called for in 
PAMTA, will lessen the encouragement of resistant disease and prolong 
the longevity of vital human drugs.
    As a mother, grandmother, and microbiologist, I cannot stress the 
urgency of this problem enough. When we go to the grocery store to pick 
up dinner, we should be able to buy our food without worrying that 
eating it will expose our family to potentially deadly bacteria that 
will no longer respond to our medial treatments. Unless we act now, we 
will unwittingly permit animals to serve as incubators for resistant 
bacteria.
    It is time for Congress to stand with 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 for our medicines to become obsolete.
    Thank you.
                                 ______
                                 
            Submitted Statement of Keep Antibiotics Working
    Keep Antibiotics Working appreciates this opportunity to provide 
the Committee information regarding the relation between antibiotics 
use in livestock and the growing problem of antibiotic resistance--a 
major health problem for both humans and animals. Keep Antibiotics 
Working is a coalition of health, consumer, agricultural, 
environmental, humane and other advocacy groups with more than ten 
million members dedicated to eliminating a major cause of antibiotic 
resistance: the inappropriate use of antibiotics in food animals.
Antibiotic Resistance: A Major Threat to Public Health
    Antibiotic-resistant disease has been identified by the Centers for 
Disease Control as one of the top public health challenges in the 
United States.\1\ Resistant strains are often more virulent than their 
susceptible counterparts, require longer hospital stays, result in more 
time away from work, and cause dramatically increased human 
suffering.\2\ Resistant diseases, which are on the upswing, are 
increasingly costly to treat--by one estimate adding over $4 billion 
per year to the health care tab in the U.S.\3\
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    \1\ Centers for Disease Control (CDC). 2004. Background on 
antibiotic resistance. Online at http://www.cdc.gov/drugresistance/
community/, accessed on February 9, 2004.
    \2\ Cosgrove S. 2006. The Relationship Between Antimicrobial 
Resistance and Patient Outcomes: Mortality, Length of Hospital Stay, 
and Health Care Costs. Clinical Infectious Diseases 2006 42:s2, S82-
S89. Online at http://www.journals.uchicago.edu/doi/abs/10.1086/499406.
    \3\ National Academy of Sciences Institute of Medicine. 1998. 
Antimicrobial Resistance: Issues and Options. Washington, D.C.: 
National Academies Press, p. 1.
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    The rise of resistant of resistant bacterial diseases is the result 
of over- and misuse of antibiotics in both human and animal medicine. 
The crisis will not be alleviated by the arrival of new drugs. There 
virtually no new drugs in the pipeline. Instead, the solution to the 
crisis will require action in both human medicine and food animal 
agriculture to reduce unnecessary and inappropriate use of our existing 
arsenal. To date, the veterinary and industrial agriculture community 
lags behind the human medical community in taking steps to respond to 
this crisis. Instead it has spent its energies in minimizing or denying 
the problem.
Antibiotic Resistance and Animal Agriculture
    As the ``one health'' concept seeks to emphasize, it is unwise to 
think of animal and human diseases separately. In fact, 60% of known 
human diseases can be transmitted from animals to humans.\4\ In the 
case of antibiotic resistance, the use of the same classes of 
antibiotics in food animal production and human medicine creates 
populations of antibiotic-resistant bacteria carried in or on food 
animals.\5\ These microorganisms can readily travel back and forth 
between humans and animals--on food, on workers handling livestock, or 
through the environment. When resistant bacteria move off the farm, the 
resistance goes with them.
---------------------------------------------------------------------------
    \4\ Taylor L.H., Latham S.M., Woolhouse M.E.J. Risk Factors for 
Human Disease Emergence. Philos. Trans. R. Soc. Lond. B. Biol. Sci. 
Jul. 29, 2001. 356(1411):991-9.
    \5\ McEwen, S., Fedorka-Cray P. 2002. Antimicrobial Use and 
Resistance in Animals. CID 34 (Suppl. 3):S93-106. While many factors 
influence the level of resistance in bacteria in farm animals, the most 
important factor is the use of antimicrobial drugs (Catry et al. 
Antimicrobial resistance in livestock. J. Vet. Pharmacol. Therap. 
26:81-93, 2003.
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    Currently, animal agriculture uses the lion's share of the 
antibiotics in the United States--some 13 million pounds of antibiotics 
every year, about 70 percent of total of all antibiotics used.\6\ The 
majority of these antibiotics are not used for treating sick animals 
but for purposes like growth promotion and prevention. These 
antibiotics used in agriculture are the very same as those used in 
human medicine--penicillin, tetracycline and erythromycin.
---------------------------------------------------------------------------
    \6\ Mellon M., Benbrook C., Benbrook K. 2000. Hogging it!: 
Estimates of Antimicrobial Abuse in Livestock. Cambridge, MA: Union of 
Concerned Scientists, p. 60. Online at http://www.ucsusa.org/food.
---------------------------------------------------------------------------
    As long as this massive use continues, animal agriculture will 
remain a fountain of resistant organisms, dangerous to both animals and 
humans. The straightforward solution to the problem is to reduce the 
use of antibiotics in animal production and thereby the pool of 
resistant organisms they generate.
The Erosion of the Efficacy of Human Use Drugs
    A mountain of scientific studies over the last thirty years 
documents that the overuse of antibiotics in animal agriculture 
undercuts the efficacy of antibiotics. For example, the CDC has found 
that half of all human Campylobacter infections are resistant as are 
one in five Salmonella infections.\7\ These bacteria, which come from 
livestock and poultry, are the two most common foodborne illnesses in 
the U.S. from these two pathogens alone, there are well over a million 
resistant infections in the U.S. each year. Resistance in Campylobacter 
and Salmonella are associated with increased bloodstream infections, 
increased hospitalization, and increased death.\8\ Recent outbreaks of 
foodborne illness in produce like peppers and spinach are likely the 
result of contamination by animal waste containing these bacteria 
during the production and processing of crops.
---------------------------------------------------------------------------
    \7\ CDC. National Antimicrobial Resistance Monitoring System for 
Enteric Bacteria (NARMS): Human Isolates Final Report, 2004. Atlanta, 
Georgia: U.S. Department of Health and Human Services, CDC, 2007. 
Online at http://www.cdc.gov/NARMS/NARMSAnnualReport2004.pdf.
    \8\ Helms M., Simonsen J., Olsen K.E., M 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, 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.''

    As a result of the mounting evidence, the American Medical 
Association, American Academy of Pediatrics, American Nurses 
Association, American Public Health Association, Infectious Diseases 
Society of America, all endorse Federal legislation curtailing the use 
of medically important drugs in animal agriculture.
Antibiotic Use in Healthy Animals Does Not Benefit Human Health
    Despite the overwhelming concern by the medical community about the 
human health, some experts associated with the animal industry, have 
claimed that routine antibiotic use benefits human health by 
suppressing pathogen levels in meat animals.\14\ There is simply no 
evidence that that is the case. European studies have shown that levels 
of foodborne pathogens in human isolates rise and fall independently of 
antibiotic use in healthy food animals.\15\ U.S. experience that 
directly contradicts the claim. from 1995 to 2000 there is documented 
evidence of a significant drop in antimicrobial use on U.S. broiler 
farms.\16\ During this same period, the surveillance by the CDC also 
found a significant drop in the number of Campylobacter infections 
directly contradicting the claims of antibiotic use proponents that any 
reduction in antibiotic use will result in disease increases.\17\ 
Finally, an FDA administrative law judge considered a claim of an 
animal health benefit of antibiotic use made in testimony to the 
administrative law judge during proceedings adjudicating the 
cancellation of Baytil. The judge rejected the claim because of lack of 
evidence.\18\
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    \14\ Cox L.A., Jr. Potential Human Health Benefits of Antibiotics 
Used in Food Animals: A Case Study of Virginiamycin. Cox L.A., Jr. 
Environ. Int. May 31, 2005 (4):549-63. There have been some published 
risk assessments that make this claim. Most of these have as an author 
Dr. Anthony Cox whose testimony was thrown out by the FDA in hearings 
related to the withdrawal of the animal antibiotic Baytril because of 
unreliability and lack of credibility.
    \15\ Evans M.C., Wegener H.C. Antimicrobial Growth Promoters and 
Salmonella spp., Campylobacter spp. in Poultry and Swine. Denmark. 
Emerg. Infect Dis. 2003 April 9 (4):489-92.
    \16\ Chapman H.D., Johnson Z.B. Use of Antibiotics and Roxarsone in 
Broiler Chickens in the USA: Analysis for the Years 1995 to 2000. 
Poult. Sci. March 2002. 81(3):356-64.
    \17\ CDC. Preliminary FoodNet Data on the Incidence of Infection 
with Pathogens Transmitted Commonly Through Food--10 States, 2006. MMWR 
April 13, 2007/56(14); 336-339.
    \18\ FDA. Final Decision of the Commissioner. Docket Number 2000N-
1571. Withdrawal of Approval of the New Animal Drug Application for 
Enrofloxacin in Poultry. On line at http://www.fda.gov/oc/
antimicrobial/baytril.pdf.
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It Is Possible To Raise Livestock and Poultry With Fewer Antibiotics
    The most direct and responsible antibiotic policy is to use 
antibiotics judiciously where they are needed but eliminate uses that 
are unnecessary. In human medicine, for example, physicians have 
established guidelines against the use of antibiotics to treat viral 
diseases, and aggressively seek to reduce prescriptions for those uses.
    Animal agriculture offers an important opportunity to reduce the 
pressure on the microbial ecosystem that creates resistance to 
antibiotics used in animal agriculture. Most of the drugs used in 
animal agriculture are used to promote growth and compensate for 
crowded, stressful conditions characteristic of today's animal 
production facilities. These uses can be reduce or eliminated with 
modern husbandry practices. The viability of these practices has been 
demonstrated in both industrial and alternative agricultural 
operations. On the industrial side, Tyson 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. Many American producers, like Laura's Lean Beef, 
Niman Ranch, Colemen are thriving in the market place selling beef and 
pork produced without antibiotics.
    Finally, the Europeans have shown that even industrial-style hog 
and poultry operations can in ways that dramatically cut antibiotic 
use.
    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 with little or no 
impact on agricultural productivity and animal welfare. 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, so-called ``weaner'' 
pigs, 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.\19\
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    \19\ Wegener. Keynote Presentation. ASM Conferences Antimicrobial 
Resistance in Zoonotic Bacteria and Foodborne Pathogens. June 15-18, 
2008. Copenhagen, Denmark.
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    The EU now has EU wide-ban on non-therapeutic antibiotics.\20\ 
Thailand \21\ and now Korea \22\ also have either enacted or will soon 
enact bans on certain non-therapeutic antibiotic use.
---------------------------------------------------------------------------
    \20\ Ban on Antibiotics as Growth Promoters in Animal Feed Enters 
Into Effect. Europa. December 22, 2005. Online at http://europa.eu/
rapid/pressReleasesAction.do?reference=IP/05/
1687&format=HTML&aged=0&language=EN&guiLanguage=en.
    \21\ Brooks E. Reconciling Scarcity and Demand through Innovation. 
FBA Issue 21. July/August 2008. Online at http://www.efeedlink.com/
ShowDetail/03c885e3-7852-439a-9ef0-a8a0b66a749c.html.
    \22\ Tae-jong K. Antibiotics to Be Banned for Feeding Animals. The 
Korea Times. August 8, 2008. Online at http://www.koreatimes.co.kr/www/
news/nation/2008/09/117_30326.html.
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    The actions taken in other countries are important because they 
validate the public health problem demonstrate that antibiotic can be 
reduced in commercially acceptable ways. In addition, the point to 
potential trade challenges the U.S. may encounter in the future if it 
fails to limit such uses here in the U.S.
    As warned in a GAO report from 2004,\23\ these countries also 
represent potential challenges to the 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.
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    \23\ Antibiotic Resistance: Federal Agencies Need to Better Focus 
Efforts to Address Risk to Humans from Antibiotic Use in Animals, GAO-
04-490, April 22, 2004. Online at http://www.gao.gov/docsearch/
locate?to=http%3A%2F%2Fwww.gao.gov%2Fnew.items%2Fd04490.pdf.
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    And as further noted by the GAO report,\24\ if any major importer 
were to restrict trade from the U.S. because of the use of 
nontherapeutic antibiotics that would override any economic benefits of 
this practice. In addition, the U.S. currently is failing to follow 
Codex recommendations \25\ by continuing the use of antibiotics as 
growth promoters.
---------------------------------------------------------------------------
    \24\ Antibiotic Resistance: Federal Agencies Need to Better Focus 
Efforts to Address Risk to Humans from Antibiotic Use in Animals, GAO-
04-490, April 22, 2004. Online at http://www.gao.gov/docsearch/
locate?to=http%3A%2F%2Fwww.gao.gov%2Fnew.items%2Fd04490.pdf.
    \25\ Code of Practice to Minimize and Contain Antimicrobial 
Resistance. CAC/RCp 61-2005. Online at http://
www.codexalimentarius.net/download/standards/10213/CXP_061e.pdf.
---------------------------------------------------------------------------
    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 animas 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. KAW believes that research, extension, and outreach 
are critically important to helping producers adopt livestock 
management techniques that are less dependant on antibiotic use.
                                 ______
                                 
Submitted Statement of Karen Steuer, Director of Government Operations, 
          Pew Campaign on Human Health and Industrial Farming
    The Campaign on Human Health and Industrial Farming, of the Pew 
Charitable Trusts, appreciates this opportunity to submit testimony for 
the record regarding the use of antimicrobials in the livestock 
industry and important related human health issues.
    As the Subcommittee is aware, food animals in intensive production 
in the United States are commonly treated with antibiotics to prevent 
the transfer of bacteria and infections in the crowded and sometimes 
unhygienic conditions of many industrial farms. Such therapeutic 
treatment of disease is critical to maintaining animal health. However, 
antibiotics are also commonly used in livestock to promote growth and 
rapid weight gain, and to prevent disease in the crowded conditions of 
industrial farms.
    This nontherapeutic administration of antibiotics was studied 
closely by national health and agricultural experts who served on the 
Pew Commission on Industrial Farm Animal Production. In April 2008, the 
Commission issued a final report and called for stricter regulation of 
antibiotic use in industrial farm animals and articulated serious 
concerns about the nontherapeutic application of certain drugs in 
animals. Entire herds or flocks of farm animals are routinely fed 
antibiotics at low levels in their feed or water--a practice that has 
been identified as a major contributor to antibiotic resistance by 
human health professionals and organizations worldwide. For example:

   In the July, 2003, issue of Pediatrics: Official Journal of 
        the American Academy of Pediatrics Dr. Katherine Shea 
        concludes, ``There is a long-standing debate over the exact 
        role that agricultural use of antimicrobials plays in the 
        current antibiotic resistance crisis. Although data gaps 
        complicate the debate somewhat, existing evidence proves that 
        part of the crisis is caused by antimicrobial use in 
        livestock.'' \1\
---------------------------------------------------------------------------
    \1\ Shea, K. (2003). Antibiotic Resistance: What is the Impact of 
Agricultural Uses of Antibiotics on Children's Health? Pediatrics, 112 
(1), 253-258.

   In 2000, the World Health Organization warned, ``National 
        governments should adopt a proactive approach to reduce the 
        need for antimicrobials in animals and their contribution to 
        antimicrobial resistance and to ensure their prudent use 
        (including reducing overuse and misuse), as elements of a 
        national strategy for the containment of antimicrobial 
        resistance,'' and further recommended that ``Use of 
        antimicrobial growth promoters that belong to classes of 
        antimicrobial agents used (or submitted for approval) in humans 
        and animals should be terminated or rapidly phased-out in the 
        absence of risk-based evaluations. The termination or phasing-
        out should be accomplished preferably by voluntary programmes 
        of food animal producers, but by legislation if necessary.'' 
        \2\
---------------------------------------------------------------------------
    \2\ World Health Organization. (2000). WHO Global Principles for 
the Containment of Antimicrobial Resistance in Animals Intended for 
Food. Geneva. At: http://www.who.int/salmsurv/links/en/
GSSGlobalPrinciples2000.pdf.

   The Centers for Disease Control and Prevention (CDC) 
        observed, ``Resistant bacteria may be transferred to humans 
        through the food supply or direct contact with animals. For 
        example, Campylobacter lives in the intestines of chickens. 
        People get Campylobacter diarrhea primarily from eating 
        undercooked chicken. In 1989, none of the Campylobacter strains 
        from ill persons that CDC tested were resistant to 
        fluoroquinolone antibiotics. In 1995, the FDA approved the use 
        of fluoroquinolones in poultry. Soon afterwards, doctors found 
        Campylobacter strains from ill persons that were resistant to 
        fluoroquinolone antibiotics.'' \3\
---------------------------------------------------------------------------
    \3\ Centers for Disease Control and Prevention (CDC). National 
Antimicrobial Resistance Monitoring System (NARMS) Frequently Asked 
Questions (FAQ) About Antibiotic Resistance--How do resistant bacteria 
spread from animals to humans? At: http://www.cdc.gov/narms/faq_pages/
12.htm.

    Many antibiotics that are used in food animal production belong to 
the same classes that are used to treat humans. These include 
tetracyclines, penicillins, cephalosporins, macrolides, and 
fluoroquinolones, among others.\4\ The similarity between human and 
animal drugs frequently means that bacteria resistant to antibiotics 
used in animals also are likely to be resistant to those used in 
humans.
---------------------------------------------------------------------------
    \4\ FDA Center for Veterinary Medicine, Database of Approved Animal 
Drugs, at http://dil.vetmed.vt.edu/NADA/.
---------------------------------------------------------------------------
    The public health implications of antibiotic-resistant bacteria go 
far beyond the immediate threat of infection. Because the infection 
lingers while an effective antibiotic is identified, the potential for 
more severe illnesses and transmission to others is greatly increased. 
This is troubling for our already besieged public health care system 
for a number of reasons. More severe illnesses result in both higher 
frequency and longer duration of hospitalizations, raising the cost of 
health care. In 1998, the Institute of Medicine estimated that 
antibiotic-resistant bacteria generated an estimated $4-$5 billion per 
year in extra costs to the U.S. health care system,\5\ and it is likely 
these costs have increased over time. There is also an overall higher 
risk of complications and death as there are fewer effective drugs 
available to treat serious infections.
---------------------------------------------------------------------------
    \5\ Institute of Medicine. (1998). Antimicrobial Resistance: Issues 
and Options. Workshop Report, Forum on Emerging Infections. (P.F. 
Harrison, & J. Lederberg, Eds.) Washington, D.C.: National Academy 
Press.
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    Corporate food industry representatives have raised concerns that 
any change in antibiotic use will contribute to already increasing food 
prices. However, two recent large-scale studies--one with poultry and 
one with swine--found that the actual economic benefits were miniscule 
to nonexistent, and that the same financial benefits could instead be 
achieved by improving the management of the animals.\6\ Even when 
improvements from growth promoting antibiotics have been observed, 
their benefits are completely offset if costs from increased resistance 
are considered: loss of disease treatment options in humans and 
animals, increased health care costs, and more severe and enduring 
infections. These costs are unfairly externalized to American consumers 
and the health care system at a time when neither can afford it.
---------------------------------------------------------------------------
    \6\ Graham J.P., Boland J.J., Silbergeld E. ``Growth promoting 
antibiotics in food animal production: an economic analysis.'' Public 
Health Rep. 2007; 122:79-87; and Miller G.Y., Algozin K.A., McNamara 
P.E., Bush E.J. ``Productivity and economic effects of antibiotics use 
for growth promotion in U.S. pork production.'' Journal of Agricultural 
and Applied Economics 2003; 35:469-482.
---------------------------------------------------------------------------
    Other countries that are important U.S. trading partners have 
banned or are currently taking steps to phase out the nontherapeutic 
use of antimicrobials in animal agriculture, such as the European 
Union, Denmark, Sweden, and South Korea. Denmark became the first 
country with a large livestock industry to ban antibiotic growth 
promoters in 1998. According to a World Health Organization (WHO) 4 
year review of the impact of the ban, Denmark achieved its goals: total 
antibiotic use in pigs and poultry was down 54% in 2001 from its peak 
in 1994 (despite some initial increase in therapeutic antibiotic use in 
weaner pigs), and drug-resistant strains of bacteria that are harmful 
to human health fell sharply in animals and meat.\7\ As a result, the 
WHO concluded, ``Under conditions similar to those in Denmark, the use 
of antimicrobials for the sole purpose of growth promotion can be 
discontinued.'' \8\
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    \7\ World Health Organization. (2003.) Impacts of antimicrobial 
growth promoter termination in Denmark. Foulum, Denmark. At: http://
www.who.int/salmsurv/en/Expertsreportgrowthpromoterdenmark.pdf.
    \8\ Ibid, p. 8.
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    Action is urgently needed to address emerging antibiotic 
resistance, and should not be weighed in the context of a few pennies 
per chicken breast or pork chop against the growing health risks faced 
by thousands of Americans contracting antibiotic-resistant infections 
annually. According to the Infectious Diseases Society of America, 
90,000 people die each year of a hospital-acquired infectious disease. 
Of these individuals, an estimated 70% have infections that are 
resistant to at least one antibiotic drug.\9\
---------------------------------------------------------------------------
    \9\ Infectious Diseases Society of America. (July 2004). Bad Bugs, 
No Drugs. As Antibiotic Discovery Stagnates . . . A Public Health 
Crisis Brews. Alexandria, VA. At: http://www.idsociety.org/WorkArea/
showcontent.aspx?id=5554.
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    The most critical step to ensure the availability and efficacy of 
antimicrobial drugs is to create policies that drastically reduce their 
use where they are being applied most inappropriately and in the 
greatest numbers: in the production of our food supply. The Pew 
Campaign on Human Health and Industrial Farming supports the Preserving 
Antibiotics for Medical Treatment Act (H.R. 962), which would ban the 
routine, non-therapeutic use of antibiotics in industrial animal 
production unless drug manufacturers can demonstrate that there is no 
harm to human health due to the development of antibiotic resistance.
    Pew is not alone in this approach.

   In 2007 the American Public Health Association (APHA) issued 
        the following policy statement: ``APHA recognizes the urgency 
        of transforming our food system to promote environmental 
        sustainability, improve nutritional health, and ensure social 
        justice, and therefore--Urges Congress to . . . Ban 
        nontherapeutic antimicrobial use and arsenic use and increase 
        funding for surveillance and research on antimicrobial 
        resistance in healthy animals and ensure public health 
        oversight of animal feed ingredients.'' \10\ This policy came 
        upon the heels of an earlier recommendation by the APHA that 
        ``Urges the Center of Veterinary Medicine of the FDA to work 
        for regulations eliminating the non-medical use of antibiotics 
        and limiting the use of antibiotics in animal feeds.'' \11\
---------------------------------------------------------------------------
    \10\ American Public Health Association (APHA). (November 6, 2007.) 
Toward a Healthy, Sustainable Food System. At: http://www.apha.org/
advocacy/policy/policysearch/default.htm?id=1361.
    \11\ APHA. (January 1, 1999.) Addressing the Problem of Bacterial 
Resistance to Antimicrobial Agents and the Need for Surveillance. At: 
http://www.apha.org/advocacy/policy/policysearch/default.htm?id=179. 

   In 2006, the Infectious Diseases Society of America 
        announced their policy of giving ``high priority to the 
        following strategies in the belief that support for these 
        efforts will most rapidly achieve control of the problem of 
        antibiotic resistance and/or provide the scientific basis to 
        manage it in a rational manner. Support for legislation to 
        phase out nontherapeutic use of certain antimicrobial drugs in 
        food animals, including all antimicrobial drugs classified as 
        'critically important' or 'highly important' for human 
        therapeutic use by the Food and Drug Administration.'' \12\
---------------------------------------------------------------------------
    \12\ Infectious Diseases Society of America. (April 24, 2006.) 
Principles and Strategies Intended to Limit the Impact of Antimicrobial 
Resistance. At: http://www.idsociety.org/WorkArea/
downloadasset.aspx?id=4042.

   In 2002, the American College of Preventative Medicine 
        adopted a resolution endorsing ``efforts to curb the growing 
        public health threat of antibiotic resistance by reducing the 
        overuse and misuse of antibiotics in both agriculture and human 
        medicine; phasing out the use in healthy farm animals of 
        antibiotics used in human medicine or closely related to human 
        drugs; efforts to promote sustainable agricultural production 
        methods that provide alternatives to the use of antibiotics in 
        healthy farm animals,'' and to ``Urge companies involved in the 
        production of meat, poultry and fish to voluntarily agree to 
        stop using nontherapeutic antibiotics (i.e., those used for 
        purposes other than treating sick animals), and we urge 
        companies and individuals that purchase meat, poultry and fish 
        products to seek products that have been produced without 
        nontherapeutic antibiotics.'' \13\
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    \13\ American College of Preventive Medicine. (January 23, 2002.) 
Policy Resolution #05-02(A): Principles for Combating Antibiotic 
Resistance. At: http://www.acpm.org/
pol_winter2002res.htm#Principles%20for%20Combating%20Antibiotic%20Resist
ance.

   In 2001, the American Medical Association adopted a policy 
        to ``oppose the use of antimicrobials at non-therapeutic levels 
        in agriculture, or as pesticides or growth promoters, and urge 
        that non-therapeutic use in animals of antimicrobials (that are 
        also used in humans) should be terminated or phased out based 
        on scientifically sound risk assessments . . .'' \14\
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    \14\ American Medical Association. (June 2001). Resolution 508: 
Antimicrobial Use and Resistance, 2001 Annual Meeting Proceedings. At: 
http://www.ama-assn.org/meetings/public/annual01/resolutions.pdf. 

   In 1999 the Council of State and Territorial 
        Epidemiologists, National Association of State Public Health 
        Veterinarians adopted a position recommending ``the 
        discontinuation of antimicrobials used to promote the growth of 
        food animals if they are also used in human medicine. These 
        uses may increase antimicrobial resistance and no longer meet 
        the food safety criteria of reasonable certainty of no harm.'' 
        \15\
---------------------------------------------------------------------------
    \15\ Council of State and Territorial Epidemiologists. (1999.) CSTE 
Position Statement 1999-ID 7: Discontinuation of Antimicrobials Used to 
Promote Growth of Food Animals if they are used in or Select for Cross 
Resistance to Antimicrobials used in Human Therapy. At: http://
www.cste.org/ps/1999/1999-id-07.htm.

    Given the concerns raised by these and other human health 
professionals, it is the view of the Pew Charitable Trusts that 
Congress must address the looming crisis posed by antibiotic 
resistance, and the contribution to that crisis of nontherapeutic 
antibiotic use in industrial animal agriculture. Congress should also 
examine the growing body of evidence indicating that farm workers and 
farm communities are at risk of exposure to resistant bacteria that 
either originate on industrial farms or are carried by the animals on 
those farms.\16\-\18\
---------------------------------------------------------------------------
    \16\ Gilchrist, M.J., C. Greko, D.B. Wallinga, G.W. Beran, D.R. 
Riley, & P.S. Thorne. (February 2007.) The Potential Role of 
Concentrated Animal Feeding Operations in Infectious Disease Epidemics 
and Antibiotic Resistance. Environmental Health Perspectives, 115 (2).
    \17\ van Rijen, M.M.L., P.H. Van Keulen, & J.A. Kluytmans. (January 
2008.) Increase in a Dutch Hospital of Methicillin-Resistant 
Staphylococcus aureus Related to Animal Farming. Clinical Infectious 
Diseases, 46 (2): 261-263.
    \18\ Price, L.B., J.P. Graham, L.G. Lackey, A. Roess, R. Vailes, & 
E. Silbergeld. (December 2007.) Elevated Risk of Carrying Gentamicin-
Resistant Escherichia coli among U.S. Poultry Workers. Environmental 
Health Perspectives 15 (12).
---------------------------------------------------------------------------
    We urge the Agriculture Committee and all Members to take these 
grave health concerns into account and to address this important issue 
in the next Congress, in particular during consideration of important 
legislative initiatives related to food safety and health care reform. 
The Pew Charitable Trusts looks forward to working with the House 
Committee on Agriculture Members and staff to find practical, workable 
solutions to this public health threat, while protecting the necessary 
and valuable therapeutic uses of antimicrobials in order to maintain 
animal wellbeing and human health.
    For additional information, please feel free to contact me at 
[Redacted], or at [Redacted].
                                 ______
                                 
   Submitted Statement of Robert P. Martin, Executive Director, Pew 
            Commission on Industrial Farm Animal Production
    Mr. Chairman and Members of the House Agriculture Subcommittee on 
Livestock, Dairy, and Poultry, my name is Robert Martin and I was the 
Executive Director of the Pew Commission on Industrial Farm Animal 
Production. I appreciate the opportunity to submit a brief statement on 
the Commission's recommendations on antimicrobial use in industrial 
farm animal production.
    The Pew Commission on Industrial Farm Animal Production was a 2 
year study funded by a grant from The Pew Charitable Trusts to 
recommend solutions to the public health, environmental, animal 
welfare, and rural community problems created by industrial animal 
agriculture.
    The Commission released its final report in April of 2008 that 
included 24 primary recommendations, and several secondary 
recommendations, in the four general areas studied. Of those 24 
recommendations, 12 addressed public health problems, and five of those 
addressed antibiotic use in industrial animal agriculture.
    The first recommendation on antimicrobial use is to restrict the 
use of antimicrobials in food animal production to reduce the risk of 
antimicrobial resistance to medically important antibiotics. That is to 
be accomplished by: (1) Phase out and ban use of antimicrobials for 
nontherapeutic use in food in food animals; (2) Immediately ban any new 
approvals of antimicrobials for nontherapeutic uses in food animals and 
retroactively investigate microbials previously approved; (3) 
Strengthen recommendations in the Federal Drug Administration's 
Guidance 152; and (4) Educate producers on how to raise animals without 
the reliance on nontherapeutic use of antibiotics and other 
antimicrobials.
    Perhaps equally important are the Commission's definitions of 
therapeutic, nontherapeutic, and prophylactic use of antimicrobials. 
Present definitions used by the animal agriculture industry blur the 
distinctions between these categories, often calling ``nontherapeutic'' 
use ``prophylactic'' use.
    The Commission defines nontherapeutic use as any use of 
antimicrobials in food animals in the absence of microbial disease or 
documented (known) microbial disease exposure. 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 purposes, is considered nontherapeutic.
    Therapeutic use is defined by the Commission as the use of 
antimicrobials in food animals with diagnosed microbial disease, that 
is, sick animals. This definition is very important given some of the 
inaccurate comments made during the Subcommittee hearing on September 
25, 2008. At no time has the Commission called for banning the use of 
antibiotics in sick animals, as was claimed by witnesses and some 
Members of the Subcommittee. A recommendation banning the medical use 
of antibiotics in food animals would be irresponsible and indefensible.
    The Commission defines prophylactic as the use of antimicrobials in 
healthy animals in advance of an expected exposure to an infectious 
agent or after such an exposure but before the onset of a laboratory-
confirmed clinical disease as determined by a licensed professional.
     Claims that the Commission proposed banning the use of all 
antibiotics in animal agriculture, or that it did not want 
veterinarians to have access to medicine to treat sick animals, do not 
add to the serious discussion of the issue. Nothing is further from the 
truth about the Commission recommendations. The Commission's 
recommendations on antimicrobial use are an attempt to use these 
important live saving drugs--for people and animals--in a more 
appropriate way to help preserve their effectiveness.
    It is commonly accepted now that all use of antibiotics adds to the 
problem of antibiotic resistance. Concern about the prudent, medical 
use of antibiotics in human medicine began at least 30 years ago. It is 
time to do the same in animal agriculture, since estimates indicate 
that as much as 70% of the antibiotics used in the United States are 
used in food animals.
    Thank you.

Robert P. Martin,
PCIFAP.
                                 ______
                                 
   Supplemental Material Submitted By National Pork Producers Council
Introduction
    The National Pork Producers Council is an association of 43 state 
pork producer organizations and serves as their voice in Washington, 
D.C.
    U.S. pork producers appreciate the opportunity to reiterate their 
antibiotic responsible use guidelines and to address statements made 
about Methicillin-resistant Staphylococcus aureus (MRSA) and animal 
agriculture.
Pork Industry Developed Guidelines on Antibiotic Use
    U.S. pork producers take the use of antibiotics very seriously. Our 
ethical principles specifically address animal-health products because 
we believe all producers need to use antibiotics judiciously and 
responsibly to protect pig health, to produce safe pork and manage 
antibiotic use to protect public health.
    This obligation to protect animal health and public health is why 
U.S. pork producers developed our responsible antibiotic use program, 
``Take Care--Use Antibiotics Responsibly.'' It was the first producer 
program outlining principles and guidelines that protect public health, 
animal health and animal well-being through the responsible use of 
antibiotics. ``Take Care'' is the product of cooperation among 
producers, veterinarians, the feed industry, Federal public health 
agencies and food companies. The pork industry's responsible-use 
program has been praised by many Federal agencies, legislators, 
consumer organizations and food supply companies. The U.S. pork 
industry developed this program because it was the right thing to do. 
Like all Americans, pork producers care about animal health and public 
health.
    Initially, ``Take Care'' started as a voluntary program, and many 
producers participated. Today, however, the pork industry understands 
how important it is to use antibiotics responsibly, and ``Take Care'' 
is the way the U.S. pork industry does business. It's good for our 
pigs, it's good for our producers and families, and it's good for the 
bottom line. ``Take Care'' has been incorporated into the industry's 
Pork Quality Assurance (PQA) Plus program, which includes on-farm 
assessments, including reviews of whether the antibiotic-use principles 
are being practiced. Producer PQA Plus certification is required by 
U.S. packing plants as a condition of sale.
    The veterinarians working in the U.S. pork industry also have been 
proactive in the responsible use of antibiotics. The American 
Association of Swine Veterinarians was the first species-specific 
veterinary organization to collaborate with FDA and the American 
Veterinary Medical Association to create and endorse judicious-use 
guidelines for antibiotics.
MRSA
    While MRSA has been found in pigs, it likely has little to do with 
the human epidemic in the U.S. or the use of antibiotics in pig herds. 
It be should be noted that Denmark, a country that has banned 
antibiotics growth promoters in 1999, has a high prevalence of swine 
herds that are positive for MRSA. According to the Centers for Disease 
Control and Prevention (CDC), MRSA in the U.S. is largely human health 
care related. When it comes to community acquired infections, CDC says 
it has investigated numerous outbreaks of community-associated MRSA 
infections in the U.S., and in none of these investigations has animal 
exposure been identified as a risk factor for infection. Although the 
finding of MRSA in retail meat suggests a possible role for foodborne 
transmission, it likely accounts for a very small proportion of human 
infections in the U.S., if the transmission does indeed occur.
    The MRSA found in pigs does not cause illness in these animals and 
does not require pork producers to use antibiotics to control it. The 
presence and further development of antibiotic-resistant strains of 
bacteria is a serious concern for society. The scientific community, 
including physicians and veterinarians, continues to work to understand 
how antibiotic use for humans and on livestock farms, such as swine 
operations, contributes to antibiotic resistance. Once again, the pork 
industry supports judicious use of antibiotics, which are essential to 
the health and well-being of animals.
    A letter from Dr. Julie Gerberding of the CDC to the House 
Committee on Agriculture is submitted along with this statement. (This 
document is located on p. 113.)
Summary
    Pork producers and veterinarians have a moral obligation to use 
antibiotics responsibly to protect human health and provide safe food, 
both of which are paramount concerns to America's pork producers. 
Producers also have an ethical obligation to maintain the health of 
their pigs. Antibiotics are merely one piece to the health care system 
that pigs need. The U.S. pork industry has a long history of being 
proactive and doing the right thing for its pigs and consumers. Pork 
producer developed ``Take Care'' and PQA Plus not because they had to 
but because it was the right thing to do. The U.S. pork industry 
continues to adopt better techniques and new technologies, but it 
cannot lose the tools it already has developed, including antibiotics, 
to protect the well-being of producers' animals and to produce safe 
pork.
                                 ______
                                 
 Supplemental Material Submitted By Richard A. Carnevale, V.M.D., Vice 
  President, Scientific, Regulatory and International Affairs, Animal 
                            Health Institute
October 8, 2008

Hon. Leonard L. Boswell,
Chairman,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.

    Dear Mr. Chairman:

    I am writing to address testimony presented by Representative 
Louise M. Slaughter to this Subcommittee at the hearing on Advances in 
Animal Health within the Livestock Industry on the use of 
antimicrobials in animal agriculture. I am Dr. Richard Carnevale of the 
Animal Health Institute and testified before you at this hearing. I 
greatly appreciated the opportunity to present the views of the animal 
health industry.
    Antibiotic resistance is clearly a public health concern, as 
Representative Slaughter points out. However, it is widely accepted 
that the major resistance problems in human medicine are due to human 
use of antimicrobials and that the contribution from the use of 
antimicrobials in food animals has been greatly exaggerated. The 
majority of diseases in human medicine and those Representative 
Slaughter mentions as important uses for antimicrobials do not come 
from animals. A survey of medical specialists in Europe and the U.S. 
concluded that use of antimicrobials in livestock might contribute to 
only 4-5% of resistance problems encountered in human medicine.\1\ 
Furthermore, we are not aware of any studies that have ``. . . 
conclusively linked non-therapeutic use to a growing number of 
incidents of antimicrobial-resistant infections in humans.'' as Ms. 
Slaughter contends.
---------------------------------------------------------------------------
    \1\ Bywater R. and Casewell M. Assessment of the impact of 
antimicrobial resistance in different bacterial species and of the 
contribution of animal sources to resistance in human infection. 
Journal of Antimicrobial Chemotherapy 2000; 6: 643-645.
---------------------------------------------------------------------------
    AHI surveys of the it's antimicrobial producing member companies 
every year indicates that about 5% of all antimicrobials sold for food 
animals are used for ``non-therapeutic use'' to increase weight gain or 
decrease feed consumption. The vast majority of antimicrobials are used 
to prevent, control, and treat animal diseases which are all considered 
therapeutic uses by the American Veterinary Medical Association and the 
international food standard setting organization, the Codex 
Alimentarius.
    It is also misleading to suggest that the well publicized 
infections in schools and athletic facilities caused by Methicillin 
Resistant Staphylococcus Aureus (MRSA) are due to use of antimicrobials 
in animals. It is true that a strain of MRSA has been isolated from 
pigs in Canada and some European countries , but this strain is not the 
same bacterial pathogen that is responsible for either hospital or 
community MRSA infections in the United States. Dr. Julie Gerberding, 
Director of the Centers for Disease Control and Prevention, recently 
wrote to House Agriculture Committee Chairman Collin Peterson on MRSA 
and its connection to animal agriculture. In none of the investigations 
that CDC has conducted on outbreaks of community-associated MRSA 
infections has animal exposure been identified as a risk factor. 
Furthermore, they have found ``. . . no documented role for meat 
consumption or handling in the transmission of MRSA.'' We have attached 
the CDC letter to the Chairman for your information.
    Two other points in her testimony require comment. In fact, 
language inserted in the farm bill to facilitate research on 
antimicrobial use and resistance was included in the final version. 
Section 7521 of P.L. 110-246, the farm bill, requires the Secretary to 
provide research and education grants to study the development of 
antibiotic resistant bacteria and to ensure the judicious use of 
antibiotics in veterinary and human medicine.
    Second, the Animal Drug User Fee Act of 2008 included a specific 
provision that requires FDA to collect from animal drug application 
sponsors and report on antimicrobial sales data beginning in 2010. The 
industry supported this amendment and provided technical guidance to 
the House Energy and Commerce Committee in developing the necessary 
language in the ADUFA bill.
    Mr. Chairman, the bill that Congresswoman Slaughter endorses, H.R. 
962, the Preservation of Antibiotics for Medical Treatment Act (PAMTA) 
would do nothing to curb antimicrobial resistance problems in human 
medicine but will likely have adverse consequences to animal health and 
food safety, while increasing feed and food costs. As I testified 
before your Subcommittee, FDA already has a rigorous science-based 
process for determining the safety of antimicrobials used in food 
animals and this process has at its foundation, risk assessment. Risk 
assessments have and continue to be conducted on several antimicrobials 
used in food-producing animals. Those assessments have indicated that 
the risks of antimicrobial resistance being transferred to humans and 
impacting public are quite low and certainly do not justify wholesale 
removal of safe and effective products important to animal agriculture.
    I thank you for the opportunity to provide further comment on this 
important topic.
            Sincerely,

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                               Attachment

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Question. In your testimony you outlined human public health 
numbers. How many livestock-bacterial infections are there in the 
United States? What is the percentage of those infections that are 
associated with bacterial pathogens displaying antimicrobial 
resistance?
    Answer. This is a challenging question to attempt to answer, as 
Salmonellae are the only animal bacterial pathogens covered by a 
surveillance program that includes evaluating antimicrobial resistance. 
The National Animal Health Monitoring System (NAHMS) collects 
information through periodic (at 5-10 year intervals) national surveys 
on the occurrence of disease in animal populations on farms. However, 
these data are normally collected without regard to the etiologic agent 
causing the disease. Instead, the program collects data on the 
occurrence of disease syndromes in animal groups (usually specific age 
groups). For example, national estimates are available on the 
proportion of dairy calves prior to weaning that experience a digestive 
disease problem. The program does not differentiate digestive disease 
caused by bacteria (such as Escherichia coli or Salmonella) from 
disease caused by viruses (such as Rotavirus or Corona virus) from 
disease caused by parasites (such as Cryptosporidium).
    So, while we do estimate the number of calves affected by ``a 
digestive disease'' we cannot say how many of these are associated with 
bacterial etiologies let alone how many of these are caused by 
organisms that are resistant to one or more antimicrobial drugs.
    The NAHMS program has some information for Salmonella based on 
samples collected on farm from healthy animals. These samples have been 
collected for some animal species including cattle (beef cow-calf, 
feedlot, and dairy) and swine. Data on other commodities and companion 
animals are lacking. One of the primary benefits of this sampling has 
been to partially characterize the potential risk to food safety. The 
sampling of healthy animals (i.e., those that are likely to end up in 
the food chain) has progressed toward this benefit.
    Veterinary diagnostic laboratories also receive samples collected 
from ill animals on the farm. Which factors affect the decision of the 
producer and/or veterinarian to submit samples to the diagnostic 
laboratory is not clear and therefore it is unknown how this population 
relates to all of the animals that become ill on farms. Factors such as 
the number of animals affected, the severity of the disease, the 
availability and interest of a veterinarian and individual animal 
economic value could all affect the decision to submit a sample to 
obtain a diagnosis. If a bacterial agent is identified from the case 
material it may or may not be tested for susceptibility to 
antimicrobial drugs. The cases from which samples are submitted have 
frequently (though the extent and history is often unknown) been 
treated with antimicrobial drugs. from the above it should be clear 
that the diagnostic laboratory data are not representative of all ill 
animals on farm (though the extent is not known), representing the 
worst case scenario, i.e., animals that have failed to respond to 
standard empirical treatments. In addition to the issues associated 
with sample representativeness and the decision to test for 
susceptibility there is no central repository of information for the 
findings on antimicrobial susceptibility for animal pathogens. Some 
diagnostic laboratories may publish annual summaries for the clientele 
but there is no entity that collates the information, validates it and 
interprets it to produce information for producers, veterinarians or 
diagnosticians.
Response from Stephen R. Mason, Acting Assistant Commissioner for 
        Legislation, Food and Drug Administration, U.S. Department of 
        Health and Human Services
Nov. 20, 2008

Hon. Leonard L. Boswell,
Chairman,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.

    Dear Mr. Chairman:

    Thank you for providing an opportunity for the Food and Drug 
Administration (FDA or the agency) to testify at the September 5,2008, 
hearing before the House Agriculture Committee's Subcommittee on 
Livestock, Dairy and Poultry. The hearing addressed advances of animal 
health within the livestock industry.
    This letter provides responses for the record to questions you 
raised during the hearing. We have reprinted the questions below, 
followed by the agency's response.

    Question 1. What are the costs associated with getting an animal 
drug approved for market?
    Answer. In Fiscal Year (FY) 2007, FDA's organizational components 
spent $49,588,801 in process costs, as described in the Animal Drug 
User Fee Act (ADUFA), associated with the review of new animal drug 
applications. Additional details related to FDA's costs for reviewing 
animal drug applications are provided on page 9 of the enclosed FY 2007 
ADUFA Financial Report.
    If your question relates to industry's developmental, application, 
and other costs associated with animal drug applications, drug sponsors 
are better able than FDA to provide such data.

    Question 2. How many livestock bacterial infections are there in 
the U.S.? What percentage of those infections is associated with 
bacterial pathogens displaying antimicrobial resistance?
    Answer. FDA considers information on bacterial infections in 
livestock and on potential resistance to antimicrobial drugs of the 
pathogens that cause such infections in the context of evaluating 
specific new animal drug applications (NADA). Such information is 
generally supplied by the sponsor of the NADA and is specific to the 
intended use of the drug in question. FDA does not conduct routine 
national surveys of bacterial diseases in livestock. Therefore, we are 
unable to provide data on the overall number of bacterial infections in 
U.S. livestock or on the percentage of those infections displaying 
antimicrobial resistance.
    FDA recognizes that bacterial diseases in livestock are important 
public and animal health challenges. FDA is taking an increasingly 
active role with our partners at the United States Department of 
Agriculture and the Centers for Disease Control and Prevention to study 
livestock bacterial diseases, including Escherichia coli. It is hoped 
that these joint efforts can lead to a greater understanding of the 
diseases themselves and how best to address and control them.
    Thank you again for the opportunity to appear before the 
Subcommittee. Please let us know if you have any further questions or 
concerns.
            Sincerely,

           [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Acting Assistant Commissioner for Legislation.
                              Attachment 1

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


Hon. Leonard L. Boswell,
Chairman,
Subcommittee on Livestock, Dairy, and Poultry,
Committee on Agriculture,
Washington, D.C.

    Dear Mr. Chairman:

    Thank you for your letter of July 10, 2008, cosigned by Ranking 
Member Robin Hayes, Subcommittee on Livestock, Dairy, and Poultry, 
Committee on Agriculture. You wrote to express your concern about the 
potential lack of funding for the Food Animal Residue Avoidance 
Database (FARAD) program. In your letter, you requested that the United 
States Department of Agriculture (USDA) and the Department of Health 
and Human Services (HHS) work together to ensure funding for the 
program's continuation.
    As you know, Title 7 of the United States Code, section 7462 gives 
the Secretary of Agriculture responsibility for the operation of FARAD. 
USDA operates this program through the Cooperative State Research, 
Education, and Extension Service. It is our understanding that, in 
Fiscal Year 2008, there were no appropriated funds available to support 
this program. USDA and HHS have worked together to provide partial 
funding. USDA has agreed to contribute $75,000, and the Food and Drug 
Administration has agreed to contribute $50,000 to support the program.
    Thank you again for your letter. Please call me if you have any 
further questions or concerns. The same letter has been sent to Ranking 
Member Hayes.

            Sincerely,
  
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Acting Assistant Commissioner for Legislation.


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