[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]









                FOOT-AND-MOUTH DISEASE: ARE WE PREPARED?

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

                                HEARING

                               BEFORE THE

           SUBCOMMITTEE ON LIVESTOCK AND FOREIGN AGRICULTURE

                                 OF THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 11, 2016

                               __________

                           Serial No. 114-42


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                        COMMITTEE ON AGRICULTURE

                  K. MICHAEL CONAWAY, Texas, Chairman

RANDY NEUGEBAUER, Texas,             COLLIN C. PETERSON, Minnesota, 
    Vice Chairman                    Ranking Minority Member
BOB GOODLATTE, Virginia              DAVID SCOTT, Georgia
FRANK D. LUCAS, Oklahoma             JIM COSTA, California
STEVE KING, Iowa                     TIMOTHY J. WALZ, Minnesota
MIKE ROGERS, Alabama                 MARCIA L. FUDGE, Ohio
GLENN THOMPSON, Pennsylvania         JAMES P. McGOVERN, Massachusetts
BOB GIBBS, Ohio                      SUZAN K. DelBENE, Washington
AUSTIN SCOTT, Georgia                FILEMON VELA, Texas
ERIC A. ``RICK'' CRAWFORD, Arkansas  MICHELLE LUJAN GRISHAM, New Mexico
SCOTT DesJARLAIS, Tennessee          ANN M. KUSTER, New Hampshire
CHRISTOPHER P. GIBSON, New York      RICHARD M. NOLAN, Minnesota
VICKY HARTZLER, Missouri             CHERI BUSTOS, Illinois
DAN BENISHEK, Michigan               SEAN PATRICK MALONEY, New York
JEFF DENHAM, California              ANN KIRKPATRICK, Arizona
DOUG LaMALFA, California             PETE AGUILAR, California
RODNEY DAVIS, Illinois               STACEY E. PLASKETT, Virgin Islands
TED S. YOHO, Florida                 ALMA S. ADAMS, North Carolina
JACKIE WALORSKI, Indiana             GWEN GRAHAM, Florida
RICK W. ALLEN, Georgia               BRAD ASHFORD, Nebraska
MIKE BOST, Illinois
DAVID ROUZER, North Carolina
RALPH LEE ABRAHAM, Louisiana
JOHN R. MOOLENAAR, Michigan
DAN NEWHOUSE, Washington
TRENT KELLY, Mississippi

                                 ______

                    Scott C. Graves, Staff Director

                Robert L. Larew, Minority Staff Director

                                 ______

           Subcommittee on Livestock and Foreign Agriculture

                 DAVID ROUZER, North Carolina, Chairman

BOB GOODLATTE, Virginia              JIM COSTA, California, Ranking 
STEVE KING, Iowa                     Minority Member
SCOTT DesJARLAIS, Tennessee          STACEY E. PLASKETT, Virgin Islands
VICKY HARTZLER, Missouri             FILEMON VELA, Texas
TED S. YOHO, Florida                 RICHARD M. NOLAN, Minnesota
DAN NEWHOUSE, Washington             CHERI BUSTOS, Illinois
TRENT KELLY, Mississippi

                                  (ii)
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                                  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Costa, Hon. Jim, a Representative in Congress from California, 
  opening statement..............................................     3
Rouzer, Hon. David, a Representative in Congress from North 
  Carolina, opening statement....................................     1
    Prepared statement...........................................     2

                               Witnesses

Roth, D.V.M., Ph.D., James A., Clarence Hartley Covault 
  Distinguished Professor and Director, Center for Food Security 
  and Public Health, College of Veterinary Medicine, Iowa State 
  University, Ames, IA...........................................     5
    Prepared statement...........................................     7
Hill, D.V.M., Ph.D., Howard T., large animal veterinarian, Iowa 
  Falls, IA; on behalf of National Pork Producers Council........    11
    Prepared statement...........................................    12
Parker, William Stephen ``Steve'', Director, Merial Veterinary 
  Public Health, Duluth, GA......................................    15
    Prepared statement...........................................    17
Wolf, D.V.M., Cynthia B., Assistant Professor and Small Ruminant 
  Veterinary Specialist, College of Veterinary Medicine, 
  University of Minnesota, St. Paul, MN; on behalf of American 
  Sheep Industry Association.....................................    28
    Prepared statement...........................................    30
Sjeklocha, D.V.M., David B., Operations Manager of Animal Health 
  & Welfare, Cattle Empire LLC, Satanta, KS; on behalf of 
  National Cattleman's Beef Association..........................    32
    Prepared statement...........................................    33
    Supplementary material.......................................    51

                           Submitted Material

Executive Committee, American Association of Veterinary 
  Laboratory Diagnosticians, submitted letter....................    52
Kansas Department of Agriculture, submitted statement............    53
 
                FOOT-AND-MOUTH DISEASE: ARE WE PREPARED?

                              ----------                              


                      THURSDAY, FEBRUARY 11, 2016

                  House of Representatives,
         Subcommittee on Livestock and Foreign Agriculture,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Subcommittee met, pursuant to call, at 2:01 p.m., in 
Room 1300 of the Longworth House Office Building, Hon. David 
Rouzer [Chairman of the Subcommittee] presiding.
    Members present: Representatives Rouzer, King, Hartzler, 
Yoho, Kelly, Costa, Nolan, and Bustos.
    Staff present: Caleb Crosswhite, Darryl Blakely, John 
Goldberg, Mollie Wilken, Patricia Straughn, Stephanie Addison, 
Mary Knigge, Liz Friedlander, Matthew MacKenzie, Nicole Scott, 
and Carly Reedholm.

  OPENING STATEMENT OF HON. DAVID ROUZER, A REPRESENTATIVE IN 
                  CONGRESS FROM NORTH CAROLINA

    The Chairman. This hearing of the Subcommittee on Livestock 
and Foreign Agriculture of the Committee on Agriculture 
regarding foot-and-mouth disease: are we prepared, will come to 
order. I want to welcome everybody here today, and let me say 
at the outset, I have to pardon myself from our hearing at 
around 2:20 because we have a Transportation and Infrastructure 
Committee markup on the FAA bill and we have votes at 2:30, so 
I will step away temporarily, but I will be back.
    But to begin, let me welcome each of you. Thank you to each 
of our witnesses for being here today. We are going to be 
evaluating our preparation in the event of an introduction of a 
highly contagious animal disease known as foot-and-mouth 
disease, or FMD, and I want to thank everyone for taking their 
time to be here, and in particular, our witnesses for their 
participation and valuable insights that I know they are going 
to provide.
    Now I agree with the sentiment expressed by Chairman 
Conaway last November in the first of the series of hearings on 
American agriculture and national security, that, in fact, our 
national security and agriculture are very closely intertwined. 
The security of our nation depends on our ability to ensure 
that; first, the food coming into our country is disease and 
pest-free; second, on our ability to guarantee that farmers and 
ranchers have the needed policy tools in place to continue 
producing food and fiber; and third, depends on our ability to 
meet the nutritional needs of both those within our border and 
outside of our borders.
    FMD, as you know, is a severe, highly contagious viral 
disease which causes illness in cows, pigs, sheep, goats, deer, 
and other animals with divided hooves. While not a public 
health or food safety threat, FMD remains a worldwide concern 
because of its ability to spread quickly and cause significant 
economic losses.
    I am concerned that an outbreak of FMD in the United States 
would have catastrophic consequences for the multi-billion 
dollar livestock industry, delivering a very harsh economic 
effect that would be felt far beyond just animal agriculture. 
In fact, I have seen a recent estimate focusing on the pork 
industry, estimating an annual impact of $12.8 billion.
    While many countries across the globe are dealing with FMD 
in their livestock populations, fortunately for us, the last 
case in the United States was in 1929. Because FMD is one of 
the most difficult diseases to control, and because it still 
occurs in many parts of the world, the efforts to prevent and 
manage an outbreak here in the U.S. are robust. The USDA, along 
with its partners in the states and the industry, has done 
tremendous work to protect this country from FMD.
    We recognize that the size, structure, efficiency, 
extensive movement inherent to the United States and North 
American livestock industries will present unprecedented 
challenges in the event of an outbreak. If FMD were to have an 
outbreak here, the disease could spread rapidly to all regions 
of the country through routine livestock movements, unless we 
detect it early and eradicate it immediately.
    Homeland Security Presidential Directive 9 issued by former 
President Bush provides for a ``Defense of United States 
Agriculture and Food.'' This directive establishes a national 
policy to defend the agriculture and food system against 
terrorist attacks, major disasters, and other emergencies. HSPD 
9 directs that the Secretary of Agriculture, in coordination 
with the Secretary of Homeland Security, and in consultation 
with the Secretary of Health and Human Services, and the 
Administrator of the Environmental Protection Agency, shall 
work with state and local governments in the private-sector to 
develop a National Veterinary Stockpile containing sufficient 
amount of animal vaccine, antiviral or therapeutic products to 
appropriately respond to the most damaging animal diseases 
affecting human health and the economy, and that will be 
deployable within 24 hours of an outbreak.
    While there has been a considerable amount of work done to 
defend against FMD, today we have asked this distinguished 
panel of witnesses from the industry to talk about the 
progress, the vaccine capabilities we currently hold, and 
possibilities for continued improvement. I look forward to your 
insight.
    In the near future, we will be continuing this series of 
hearings, wherein we will be discussing these and other animal 
and plant health issues with Federal agencies.
    [The prepared statement of Mr. Rouzer follows:]

 Prepared Statement of Hon. David Rouzer, a Representative in Congress 
                          from North Carolina
    Good afternoon and welcome to today's Livestock and Foreign 
Agriculture Subcommittee hearing. Today we will be evaluating our 
preparation in the event of an introduction of a highly contagious 
animal disease: Foot-and-Mouth Disease--or FMD. Thank you to everyone 
for taking the time to be here and I want to thank, in particular, our 
witnesses for their participation and valuable insights.
    I agree with the sentiment expressed by Chairman Conaway last 
November in the first of a series of hearings on American agriculture 
and national security--that, in fact, our national security and 
agriculture are closely intertwined. The security of our nation depends 
on our ability to ensure that (1) the food coming into our country is 
disease and pest free, (2) on our ability to guarantee that farmers and 
ranchers have the needed policy tools in place to continue producing 
food and fiber, and (3) depends on our ability to meet the nutritional 
needs of those both within and outside our own borders.
    FMD is a severe, highly contagious viral disease, which causes 
illness in cows, pigs, sheep, goats, deer, and other animals with 
divided hooves. While not a public health or food safety threat, FMD 
remains a worldwide concern because of its ability to spread quickly 
and cause significant economic losses.
    I'm concerned that an outbreak of FMD in the United States would 
have catastrophic consequences for the multi-billion dollar livestock 
industry, delivering a very harsh economic effect that would be felt 
far beyond animal agriculture. In fact, I have seen a recent estimate 
focusing on the pork industry, estimating an annual impact of $12.8 
billion.
    While many countries across the globe are dealing with FMD in their 
livestock populations, the last case in the United States was in 1929. 
Because FMD is one of the most difficult diseases to control, and 
because it still occurs in many parts of the world, the efforts to 
prevent and manage an outbreak here in the U.S. are robust. The USDA, 
along with its partners in the states and the industry, has done 
tremendous work to protect this country from FMD.
    We recognize that the size, structure, efficiency, and extensive 
movement inherent to the United States and North American livestock 
industries will present unprecedented challenges in the event of an 
outbreak. If an FMD outbreak occurs here, the disease could spread 
rapidly to all regions of the country through routine livestock 
movements--unless we detect it early and eradicate it immediately.
    Homeland Security Presidential Directive 9, issued by former 
President Bush provides for ``Defense of United States Agriculture and 
Food.'' This directive establishes a national policy to defend the 
agriculture and food system against terrorist attacks, major disasters, 
and other emergencies. HSPD 9 directs that ``the Secretary of 
Agriculture, in coordination with the [Secretary] of Homeland Security, 
and in consultation with the Secretary of Health and Human Services and 
the Administrator of the Environmental Protection Agency, shall work 
with state and local governments and the private-sector to develop a 
National Veterinary Stockpile (NVS) containing sufficient amount of 
animal vaccine, antiviral, or therapeutic products to appropriately 
respond to the most damaging animal diseases affecting human health and 
the economy and that will be deployable within 24 hours of an 
outbreak.''
    While there has been a considerable amount of work done to defend 
against FMD, today we've asked this distinguished panel of witnesses 
from the industry to talk about that progress, the vaccine capabilities 
we currently hold, and possibilities for continued improvement. I look 
forward to your insight.
    In the near future, we will be continuing this series of hearings, 
wherein we will be discussing these and other animal and plant health 
issues with Federal agencies.
    I now yield to the Subcommittee Ranking Member, Mr. Costa, for his 
opening remarks.

    The Chairman. I now yield to the Subcommittee Ranking 
Member, Mr. Costa, for any opening remarks.

   OPENING STATEMENT OF HON. JIM COSTA, A REPRESENTATIVE IN 
                    CONGRESS FROM CALIFORNIA

    Mr. Costa. Thank you very much, Mr. Chairman.
    United States agriculture industry, particularly the 
livestock industry, has been fortunate as foot-and-mouth 
disease, otherwise referred to as FMD, has not been a threat 
since 1929. But I think many of our memories are good. We 
clearly know that in 2001 there was an outbreak in Europe, and 
there were challenges and there was fear and concerns as it 
related to what took place, and that is a part of the world in 
which we have close relations and which we have trade that 
takes place on a daily basis. We know it has not been 
eradicated. And for myself, three generations of a farm family 
in California, we have been involved in both the dairy and 
cattle industry for all of those three generations, and I can 
remember stories of my father and my grandfather about the 
fears and the concerns when they first began to try to make it 
work for them, and the lack of protocol and the science and 
technology then that we now have today that makes a big 
difference.
    Foot-and-mouth disease is a very, very serious disease and 
would cripple the U.S. livestock industry as we know it if, in 
fact, such an outbreak were to take place. And therefore, we 
must be prepared throughout the country and in California, 
where we have a very significant cattle industry, as well as a 
dairy industry that last year was over $7 billion in proceeds 
at the farmgate. Clearly, the impacts of both the cattle and 
the dairy industry to California, and to any other part of the 
country, would be very, very damaging.
    The vaccine stockpile is important, but that is only one 
aspect of trying to ensure that the United States is prepared 
to handle foot-and-mouth disease if, in fact, such an outbreak 
were to take place. Several lessons we believe have been 
learned in terms of animal husbandry and the science that is 
contained therein, as we try to prepare and provide prevention 
for other types of contagious issues within our livestock 
industry, whether we are talking about high-path avian 
influenza, otherwise referred to as HPAI, are approaching 
Porcine Epidemic Diarrhea virus, otherwise known as PEDv--I 
always go through this because I give my staff a bad time when 
they use the acronyms and I say people never know what you are 
talking about. Although some of these words might be preferable 
to use the acronyms. So the fact is they are serious, and they 
can be devastating if not controlled.
    I hope the industries that are represented here today by 
these witnesses are prepared to talk about steps that they are 
taking to prevent such outbreaks in ways that we can partner 
with the United States Department of Agriculture. The USDA, for 
farmers, ranchers, and dairymen, for the cattlemen and the 
livestock and pork producers in particular, is a very valued 
partner, and therefore, that hand in glove relationship is 
critical as we look at any current activities and as we look at 
ways to ensure that we protect these industries.
    I think it will take a strong continued public-private 
partnership to ensure that we are adequately prepared to deal 
with this, or any other related issues, should such an outbreak 
occur. We pray not.
    In closing, it is critical that we protect American animal 
agriculture against the threat of foot-and-mouth disease. And 
it is critical that we use fact-based science to ensure that we 
deal with proper risk assessment and risk management that is 
always part of the protocol when we are dealing with these 
issues. Knowing that as many of us grew up the farms, our 
mothers used to tell us an ounce of prevention is worth a pound 
of cure, and we are talking about that prevention here today.
    The producers who are represented and industry stakeholders 
know how critical it is to work collaboratively to identify 
ways to achieve the common goals to detect, control, and 
contain FMD should it reach the United States.
    Thank you, Mr. Chairman. You are quite correct. I think all 
of us on this Committee believe truly that the production of 
food and fiber in America is an issue of national security; and 
therefore, we should treat it as such. So I look forward to 
hearing the testimony of our witnesses, and I yield back the 
balance of my time.
    The Chairman. Thank you, Mr. Costa. The chair would request 
that other Members submit their opening statements for the 
record so the witnesses may begin their testimony, and to 
ensure that there is ample time for questions. The chair would 
like to remind Members that they will be recognized for 
questioning in order of seniority for Members who were present 
at the start of the hearing. After that, Members will be 
recognized in order of their arrival. I appreciate the Members' 
understanding.
    Witnesses are asked to limit their oral presentations to 5 
minutes, and all written statements will be included for the 
record.
    I would like to welcome our witnesses to the table. First, 
we have Dr. Jim Roth, Director of the Center for Food Security 
and Public Health, Iowa State University, College of Veterinary 
Medicine. We have Dr. Howard Hill, large animal veterinarian, 
Iowa Falls, Iowa. Mr. Steve Parker, Director of Merial 
Veterinary Public Health from Duluth, Georgia, and Dr. Cynthia 
Wolf, Assistant Professor, College of Veterinary Medicine, 
University of Minnesota, St. Paul, Minnesota, and Dr. David 
Sjeklocha, did I get that right, Sjeklocha? That is not a 
native North Carolina name, so it takes me a little bit longer. 
Sorry about that. Operations Manager of Animal Health & 
Welfare, Cattle Empire, LLC, Santanta, Kansas, on behalf of 
National Cattleman's Beef Association.
    Dr. Roth, we will begin with you.

  STATEMENT OF JAMES A. ROTH, D.V.M., Ph.D., CLARENCE HARTLEY 
              COVAULT DISTINGUISHED PROFESSOR AND
 DIRECTOR, CENTER FOR FOOD SECURITY AND PUBLIC HEALTH, COLLEGE 
    OF VETERINARY MEDICINE, IOWA STATE UNIVERSITY, AMES, IA

    Dr. Roth. Chairman Rouzer, Ranking Member Costa, and 
Members of the House Committee on Agriculture, Subcommittee on 
Livestock and Foreign Agriculture, as the Chairman mentioned, 
my name is Jim Roth and I am with Iowa State University College 
of Veterinary Medicine. I want to thank you for recognizing the 
importance of foot-and-mouth disease preparation, and for the 
opportunity to speak to you. The introductory comments were 
very accurate on the situation with foot-and-mouth disease, and 
the dangers of foot-and-mouth disease.
    I will first highlight some challenges for control of FMD 
in the U.S., briefly mention some significant progress that has 
been made in preparedness, and then I will discuss the urgent 
need for a sufficient stockpile of FMD vaccine to protect U.S. 
agriculture.
    As has already been mentioned, FMD is the most important 
animal disease in the world. It affects cloven-hoofed animals, 
and we all must remember, it is not a public health or food 
safety concern. This is a livestock disease. It is a bad 
livestock disease, but it is not a human health concern. 
Ninety-six countries in the world have foot-and-mouth disease, 
so more countries have it than don't have it. So our livestock 
industry is always under pressure that this virus could come in 
from one of those countries by many different ways. The U.S. 
has had nine outbreaks of foot-and-mouth disease between 1870 
and 1929, so in a 60 year period, we had nine outbreaks, and we 
haven't had one for 87 years, fortunately.
    All nine of those outbreaks were controlled by stop 
movement and stamping out, so in the affected area, they 
stopped all animal movement. All animals in the infected herd 
are depopulated, and any herds nearby, and you have to do that 
very quickly to stop the virus from spreading.
    It has become apparent that we can't count on a stop 
movement and stamping out if we get into a large outbreak, 
because agriculture has changed quite extensively. We have very 
large herd sizes that are too large to be depopulated within 24 
to 48 hours. If you could depopulate them, carcass disposal 
would be a massive problem. We have extensive animal movement. 
It is estimated there are a million pigs on the road every day 
in trucks, 400,000 to 500,000 cattle, and so there is concern 
that by the time we find it, the virus may have moved 
extensively. And we have to be concerned that wildlife can 
spread this virus. Deer and feral swine, we have 30 million 
deer, five million feral swine in the U.S. that in many cases 
move freely between our livestock herds and could spread the 
disease. So unless an FMD infection is detected very quickly 
and stamped out, there is a great concern it could spread 
relatively widely fairly quickly. And of course, foot-and-mouth 
disease is the main disease limiting trade and livestock and 
livestock products in the world. We would lose our exports 
immediately, and that is about $20 billion a year of beef, 
pork, and milk exported that we would lose, and that is just 
the loss in exports.
    But progress has been made in changing the plans. The USDA 
doesn't plan on counting on only stamping out and stop 
movement. The USDA has been working with states, industry, and 
academia to address the challenges, how would we address an FMD 
outbreak, given modern agriculture? And significant progress 
has been made in developing secure food supply plans to help 
ensure business continuity for livestock producers and 
affiliated industries, and provide a continuous supply of safe 
and wholesome food for our consumers.
    One of the outcomes of that was a document that is called, 
Phases and Types of Foot-and-Mouth Disease Outbreaks, and it 
depends on the magnitude of the outbreak, and the response will 
change depending on the magnitude. But without sufficient foot-
and-mouth disease vaccine, it is likely that we won't be able 
to stop the outbreak at a small outbreak, and it will progress 
to a large outbreak. The North American FMD Vaccine Bank is 
inadequate. It is shared with U.S., Canada, and Mexico, and 
doesn't have enough doses, so we need an adequate stockpile, 
and there are methods for producing an adequate stockpile of 
FMD vaccine. The livestock industry has asked me to draft a 
white paper on how we could have enough vaccine to adequately 
manage an outbreak. You need 23 different vaccines. It is not 
just one vaccine.
    So I urge Congress to provide sufficient funding to enable 
the USDA to work with state officials and livestock industry 
representatives to develop and implement a plan for 
establishing an effective FMD vaccine stockpile to protect 
American agriculture and the food supply. Thank you.
    [The prepared statement of Dr. Roth follows:]

 Prepared Statement of James A. Roth, D.V.M., Ph.D., Clarence Hartley 
Covault Distinguished Professor and Director, Center for Food Security 
     and Public Health, College of Veterinary Medicine, Iowa State
                          University, Ames, IA
Impact of an Outbreak of Foot-and-Mouth Disease (FMD) in the United 
        States and the Urgent Need for an Adequate Stockpile of FMD 
        Vaccine
    Chairman Rouzer, Ranking Member Costa, and Members of the House 
Committee on Agriculture, Subcommittee on Livestock and Foreign 
Agriculture, my name is Jim Roth and I am the Director of the Center 
for Food Security and Public Health at the Iowa State University 
College of Veterinary Medicine. Thank you for the opportunity to speak 
to you about preparedness for the potential introduction of foot-and-
mouth disease (FMD) in the United States. I will first highlight 
challenges for control of FMD and some of the significant progress that 
has been made, then focus on the urgent need for a sufficient stockpile 
of FMD vaccine to protect U.S. agriculture and an approach to begin to 
build that stockpile.
Challenges for Control of FMD in the U.S.
    Foot-and-mouth disease is the most important animal disease in the 
world capable of crossing national boundaries and devastating animal 
agriculture (a transboundary disease). FMD affects cattle, pigs, sheep, 
goats, deer, elk and other wildlife. Ninety-six countries are either 
endemically or sporadically infected with the disease, therefore there 
is a constant threat that it will be introduced into the U.S. either 
accidentally or intentionally. FMD is extremely contagious and can 
spread rapidly with devastating consequences. You probably remember the 
outbreak in the United Kingdom in 2001 which is estimated to have cost 
approximately $6 billion. The number of livestock and the agriculture 
economy is much smaller in the UK than the U.S. We learned from their 
outbreak that we cannot depend on stamping out the disease by killing 
all infected and exposed animals.

    The size, structure, efficiency, and extensive movement inherent in 
the United States livestock industry will present unprecedented 
challenges in the event of an FMD outbreak. No country with a livestock 
industry comparable to that of the U.S. has had to deal with an 
outbreak of FMD, and the impact would extend far beyond animal 
agriculture.
Herd Size
    The U.S. has some very large herds including feedlots with greater 
than 50,000 head of cattle, dairies with greater than 5,000 lactating 
cows, dairy calf ranches with greater than 70,000 head of calves, and 
swine farms with greater than 20,000 sows. These premises are too large 
to rapidly depopulate to stamp out the disease. If it were possible to 
depopulate them, carcass disposal would present enormous environmental 
problems.
Animal Movement
    Once FMD is detected, an essential tool for control is to stop all 
animal movement in the affected area. Livestock production in the U.S. 
depends on extensive movement of animals. Approximately 400,000 cattle 
and one million swine are estimated to be on the road in trucks each 
day, either being delivered to packing plants or to other stages of 
production. Approximately 40 million swine are shipped into a new state 
each year (110,000 each day). Many of those cross multiple state 
lines. In an FMD outbreak, State Animal Health Officials may prohibit 
animals from an FMD positive area from entering their state. Modern 
swine production depends on extensive animal movement on a regular 
basis. If animal movement is stopped, animals will need to be 
euthanized for welfare reasons because facilities will rapidly become 
overcrowded.
    There is also extensive movement of people, feed, manure, and 
equipment on livestock premises each day. Wildlife, including birds, 
can spread disease. There are estimated to be more than five million 
feral swine and 30 million deer in the U.S.; these animals are 
susceptible to FMD and can often move freely between herds of 
livestock. If FMD infection is not detected quickly, it is likely to 
spread rapidly due to extensive animal and related movements.
Diversity of Operations
    The diversity of herd size also presents problems in FMD control. 
In the U.S., 49% of hog operations have fewer than 100 head, whereas 
62% of the inventory of swine is on operations with more than 5,000 
head. Similarly, 18,800 dairy farms have less than 30 cows; however, 
1,800 dairy farms with more than 1000 animals account for nearly 50% of 
the U.S. dairy cow population. An FMD control program will need to 
include operations of all sizes. Federal and state resources will be 
quickly overwhelmed.
Economic Impact of FMD
    An outbreak of FMD will shut down exports of fresh beef, pork or 
dairy products. In 2014, beef exports totaled $7.1 billion, pork 
exports $6.7 billion and dairy exports totaled $7.1 billion. 
Approximately 11% of U.S. beef production and 22% of U.S. pork 
production are exported. In 2003, beef exports dropped due to a single 
case of mad cow disease (BSE); the cumulative loss in U.S. beef trade 
is estimated to have been $16 billion. The increasing export of beef 
and pork products in recent years significantly contributes to the 
value of cattle and swine. As exports increase, the industry becomes 
more vulnerable to the sudden and extended loss of exports that would 
result from an FMD outbreak. The price for pork and beef will drop 
dramatically due to the excess product on the domestic market. That 
will also impact the price of poultry products and the price of grain.
    In 2011, Dr. Dermot Hayes and colleagues at the Center for 
Agricultural and Rural Development at Iowa State University published 
``Economy Wide Impacts of a Foreign Animal Disease in the United 
States'' which had been funded by the National Pork Board. They 
estimated that over 10 years, the cumulative loss due to an 
uncontrolled FMD outbreak would be $199.8 billion. Losses estimated 
include:

    Pork--$57 billion;
    Beef--$71 billion;
    Poultry--$1 billion;
    Corn--$44 billion;
    Soybeans--$25 billion;
    Wheat--$1.8 billion.

    The impact would likely be larger now because of the increase in 
the value of exports since 2011. Agriculture is a critical 
infrastructure in the U.S. and is severely threatened by the potential 
of an FMD outbreak.
Progress That Has Been Made
    Because of the challenges outlined above, it became apparent that 
an FMD outbreak could rapidly get out of control. As a consequence, the 
USDA has been working with states, industry and academia to address 
these challenges. Significant progress has been made in developing 
Secure Food Supply plans to help ensure business continuity for non-
infected poultry and livestock premises and affiliated industries in a 
foreign animal disease outbreak and provide a continuous supply of safe 
and wholesome food to consumers. The Secure Egg Supply and Secure 
Turkey Supply plans are credited with enabling premises in Highly 
Pathogenic Avian Influenza (HPAI) control areas to demonstrate that 
they are not infected so they could continue to move product to market 
in the 2015 outbreak in the Upper Midwest. The Secure Pork, Beef and 
Milk Supply plans are intended to help producers whose farms are not 
infected with FMD stay in business. However, without adequate FMD 
vaccine, it will be nearly impossible to keep farms, especially beef 
and dairy farms, from becoming infected.
    The USDA working with states, industry and academia, developed 
``Guidelines for Classification of Phases and Types of An FMD Outbreak 
and Response''.
Six Types of FMD Outbreak


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    These guidelines were developed to aid rapid decision making as an 
FMD outbreak unfolds. Strategies for the response to, and management 
of, an FMD outbreak will change as the outbreak progresses and will 
depend upon the magnitude, location, and other characteristics of the 
outbreak. The response will shift from an emphasis on stamping out in a 
small outbreak to alternative strategies in larger longer duration 
outbreaks. Vaccine will be an essential tool to control any outbreak 
larger than a small focal outbreak. Without an adequate supply of 
rapidly available FMD vaccine, it will be very difficult to prevent the 
outbreak from progressing to a catastrophic North American outbreak 
(see: FAD PReP Strategy Document: Classification of Phases and Types of 
a Foot-and-Mouth Disease Outbreak and Response available at: 
www.cfsph.iastate.edu/pdf/phases-and-types-of-an-fmd-outbreak).
Lessons Learned from Recent Foreign Animal Disease Outbreaks
    The U.S. has experienced two recent introductions of devastating 
transboundary animal diseases: Porcine epidemic diarrhea virus (PEDv or 
Swine Enteric Coronavirus Disease (SECD)) in 2013 and highly pathogenic 
avian influenza (HPAI) in 2015. Both viruses apparently had origins in 
Asia; FMD is endemic in most countries in Asia. PEDV spread to 27 
states and killed at least eight million baby pigs in the first year. 
HPAI caused the death of 31.5 million poultry in 2 months in Iowa alone 
(including approximately 40% of the laying hens in the state) and cost 
the economy of the state approximately $1.2 billion; the USDA spent 
nearly $1 billion to assist in controlling HPAI. Disposal of the 
poultry carcasses became a serious problem.
    These outbreaks occurred in industries with much more robust 
biosecurity practices than the beef and dairy industries. An FMD 
outbreak would dwarf the PEDV and HPAI outbreaks. No one anticipated 
the introduction of PEDV, so there was no vaccine available. It was 
more than 15 months before vaccine became available. It is not possible 
to have an HPAI vaccine available ahead of a new outbreak because of 
rapid unpredictable changes in HPAI viruses. However, it is possible 
and essential to have vaccine available at the beginning of an FMD 
outbreak. Having an adequate supply of FMD vaccine quickly available 
could greatly limit the extent and duration of an FMD outbreak.
    In summary, the size, structure, efficiency, and extensive movement 
inherent in the United States livestock industry will present 
unprecedented challenges in the event of an FMD outbreak. It will be 
nearly impossible to control an FMD outbreak in livestock dense areas 
without the rapid use of tens of millions of doses of FMD vaccine. At 
this time, those doses are not available for U.S. use and it would take 
many months to obtain the volume of vaccine needed. Without sufficient 
vaccine to aid in the response, FMD could rapidly spread across the 
U.S., resulting in the destruction and need to dispose of potentially 
millions of animals. It would become an endemic disease in livestock 
with spread potentially facilitated by deer, feral swine or other free-
living animals. A long term, very expensive and extensive control 
program would be needed and it could take many years to eradicate.
Requirements for an FMD Vaccine Bank
    The need for FMD vaccine for the U.S. has been recognized for 
decades. The U.S. has shared an FMD vaccine bank with Canada and Mexico 
since 1982 (The North American Foot-and-Mouth Disease Vaccine Bank). 
The USDA has stated that the amount of FMD vaccine available in the 
Bank (which is controlled and shared by the U.S., Canada, and Mexico) 
is far below what would be required for an outbreak in a single 
livestock dense state. Since the need for vaccine in the U.S. is likely 
to be much greater than for Canada or Mexico, additional sources of FMD 
vaccines independent of the North American FMD Vaccine Bank are needed 
to adequately protect U.S. agriculture.
    This was recognized in 2004 in Homeland Security Presidential 
Directive 9. HSPD 9 directed that a National Veterinary Stockpile be 
created. The Stockpile was to contain sufficient amounts of animal 
vaccine, antiviral, or therapeutic products to appropriately respond to 
the most damaging animal diseases affecting human health and the 
economy. The USDA established the National Veterinary Stockpile, 
however the stockpile has never received sufficient funding to 
stockpile FMD vaccines; consequently there are no FMD vaccines in the 
Stockpile.
    The USDA, along with many state and industry officials, recognized 
that the approach of stamping out and stop movement of animals is 
simply not possible given the realities of animal agriculture in the 
U.S. The USDA document ``Foot-and-Mouth Disease Vaccination Policy in 
the United States'' (September 2014) illustrates the current capacity 
of the U.S. to effectively implement vaccination strategy for control 
of different types of FMD outbreaks (available upon request). It 
clearly indicates that there is not sufficient vaccine capacity to 
assist in controlling an FMD outbreak.

    A plan to ensure that adequate supplies of FMD vaccine with 
multiple strains of FMD virus are available in the event of an 
accidental or intentional introduction of FMD virus into the U.S. is 
urgently needed.

    At the request of the National Pork Board, National Cattlemen's 
Beef Association, and National Milk Producers Federation I produced a 
white paper entitled ``FMD Vaccine Surge Capacity for Emergency Use in 
the United States'' outlining a potential plan to develop a National 
Veterinary Stockpile (NVS) with sufficient quantities of FMD vaccine to 
protect U.S. agriculture, food systems, and the economy. The white 
paper is available at: www.cfsph.iastate.edu/pdf/fmd-vaccine-surge-
capacity-for-emergency-use-in-the-US.
    It is possible to have an FMD vaccine stockpile available for 
immediate use. However, establishing and maintaining an FMD vaccine 
bank is complex. There are seven distinct serotypes of the virus that 
are not cross protective and approximately 65 subtypes. Cross-
protection varies between strains within a serotype. The World 
Reference Laboratory for FMD recommends that FMD vaccine banks maintain 
23 strains of FMD virus in the vaccine bank. Once the virus in the 
outbreak is isolated, the serotype can be identified and the correct 
vaccine selected for use. (See: NAHEMS Guidelines: Vaccination for 
Contagious Diseases. Appendix A: Foot-And-Mouth Disease available at: 
www.cfsph.iastate.edu/pdf/fad-prep-nahems-appendix-a-vaccination-for-
foot-and-mouth-disease).
Costs
    The white paper contains recommendations that I hope can be 
considered for implementation and funding to better prepare the U.S. to 
avoid the worst case scenario which is likely to occur if FMD is 
introduced into the U.S. without adequate emergency vaccine supplies.
    I estimated in the white paper that development of a robust FMD 
vaccine stockpile could require an investment of up to $150 million per 
year for 5 years. This number could likely be reduced with additional 
planning, the development of new technology vaccines, and negotiation 
with vaccine companies. The vaccine capability could gradually increase 
during the 5 years, initially focusing on the most common strains of 
FMD virus. By the end of 5 years we could have the capability to 
respond quickly to any strain of FMD virus introduced into the U.S. The 
stockpile could use a rotating inventory strategy so that vaccine would 
not expire and need to be destroyed.
Conclusion
    I urge Congress to provide sufficient funding to enable USDA to 
work with state officials and livestock industry representatives to 
develop and implement a plan for establishing an effective FMD vaccine 
stockpile to protect American agriculture.
    For additional information on FMD see:

    http://www.cfsph.iastate.edu/Factsheets/pdfs/
    foot_and_mouth_disease.pdf
    www.cfsph.iastate.edu/pdf/fmd-vaccine-surge-capacity-for-emergency-
    use-in-the-US
    www.cfsph.iastate.edu/pdf/fad-prep-nahems-appendix-a-vaccination-
    for-foot-and-mouth-disease

    The Chairman. Thank you, Dr. Roth. Dr. Hill.

       STATEMENT OF HOWARD T. HILL, D.V.M., Ph.D., LARGE
       ANIMAL VETERINARIAN, IOWA FALLS, IA; ON BEHALF OF
                NATIONAL PORK PRODUCERS COUNCIL

    Dr. Hill. Good afternoon, Chairman Rouzer, Ranking Member 
Costa, and Members of the Subcommittee. I am Dr. Howard Hill, a 
veterinarian and pork producer from Cambridge, Iowa, and I am 
the immediate past President of the National Pork Producers 
Council.
    As you have heard, foot-and-mouth disease is a very serious 
disease, an outbreak in this country would be economically 
devastating to the U.S. pork producers and other food 
producers. USDA and the livestock industry has been working to 
develop plans to address a foot-and-mouth disease outbreak. We, 
the Federal Government, and the industry must be better 
prepared to deal if we have an outbreak.
    As Dr. Roth pointed out, USDA APHIS has changed its policy 
on managing foot-and-mouth disease from stamping out or 
depopulating to using vaccine in all but the smallest of 
outbreaks to limit the spread of this disease. The U.S. 
livestock industry supported that change, as it is less costly, 
more humane, and more practical, given the enormous size of the 
U.S. herd and the movement of livestock around the country. 
United States simply cannot kill its way out of a foot-and-
mouth disease outbreak. But under the current structure of the 
foot-and-mouth vaccine antigen bank, APHIS does not have the 
quantity of vaccine needed to implement the new policy, and it 
currently can't obtain vaccine in a timely manner if there were 
an outbreak.
    U.S. law prohibits foot-and-mouth disease virus from being 
on the U.S. mainland, so APHIS contracts with foreign vaccine 
production companies to produce finished vaccine from the 
antigen that is stored at Plum Island Animal Disease Center off 
the coast of Long Island. But only a limited number of foot-
and-mouth disease strains are covered by the antigen stored at 
Plum Island. Additionally, based on the current production 
contract, after 3 weeks, it is estimated there would only be 
2.5 million doses of vaccine, and there would be no surge 
capacity to produce more. United States is the only country in 
the world that maintains its own antigen bank, requiring 
shipping of antigen to a foreign manufacturer to have it 
manufactured into a final vaccine, which is complex and time 
consuming.
    The Foot-and-Mouth Disease Vaccine Bank currently is funded 
at $1.9 million, and there have been no requests for a 
substantial increase in the President's budget, despite 
Homeland Security Presidential Directive 9, which requires an 
adequate vaccine stock to be maintained. The livestock industry 
believes fixing the vaccine bank will require; first, an 
offshore vendor maintaining vaccine antigen bank that would be 
available for all 23 strains of the most common foot-and-mouth 
types currently circulating in the world; second, a vendor-
managed inventory of ten million doses, which it is estimated 
to be needed for the first 2 weeks of an outbreak; and then 
third, contracting with an international manufacturer or 
manufacturers for surge capacity to produce at least 40 million 
doses.
    Given the potential economic impact on the livestock 
industry of a foot-and-mouth disease outbreak and the costs of 
dealing with it, APHIS has insisted that the industry share in 
a cost of improving the vaccine bank. From our perspective, it 
is hard to agree to this until we know what the cost is. 
Additionally, the type of outbreak and the location where it is 
will determine which sector of the livestock industry is most 
seriously affected in the initial phase of an outbreak, and 
which sector, therefore, should bear the lion's share of any 
costs.
    While several options have been discussed, none would 
provide significant funds and none have included a way to 
equitably assign costs to each sector of the livestock 
industry. More work needs to be done in this area, and we are 
pleased to hear that APHIS will soon be issuing a request for 
information for improvement of the vaccine bank that should 
give us an idea of the cost.
    The bottom line, though, is that we need to improve the 
preparedness for a foot-and-mouth disease outbreak through the 
development of adequate vaccine bank, and it must be a 
priority, and NPPC urges this Committee and the Congress to 
work with the Administration to do that.
    I thank you, and I would be happy to answer any questions 
at the appropriate time.
    [The prepared statement of Dr. Hill follows:]

   Prepared Statement of Howard T. Hill, D.V.M., Ph.D., Large Animal
   Veterinarian, Iowa Falls, IA; on Behalf of National Pork Producers
                                Council
Introduction
    The National Pork Producers Council (NPPC) is an association of 43 
state pork producer organizations that serves as the global voice in 
Washington. D.C., for the nation's pork producers. The U.S. pork 
industry represents a significant value-added activity in the 
agricultural economy and the overall U.S. economy. Nationwide, more 
than 68,000 pork producers marketed more than 110 million hogs in 2014, 
and those animals provided total gross receipts of $23.4 billion. 
Overall, an estimated $22.3 billion of personal income and $39 billion 
of gross national product are supported by the U.S. pork industry.
    Economists Daniel Otto, Lee Schulz, and Mark Imerman at Iowa State 
University estimate that the U.S. pork industry is directly responsible 
for the creation of more than 37,000 full-time equivalent pork 
producing jobs and generates about 128,000 jobs in the rest of 
agriculture. It is responsible for approximately 102,000 jobs in the 
manufacturing sector, mostly in the packing industry, and 65,000 jobs 
in professional services such as veterinarians, real estate agents and 
bankers. All told, the U.S. pork industry is responsible for nearly 
550,000 mostly rural jobs in the United States. The U.S. pork producers 
today provide 23 billion pounds of safe, wholesome and nutritious meat 
protein to consumers worldwide.
    Exports add significantly to the bottom line of each U.S. pork 
producer. U.S. exports of pork and pork products totaled 2.2 million 
metric tons in 2014, representing more than 26 percent of U.S. 
production, and those exports add more than $62 to the value of each 
hog marketed. Exports supported about 110,000 jobs in the U.S. pork and 
allied industries.
FMD a Growing Threat to North America
    Foot-and-Mouth Disease (FMD) is one of the most economically 
devastating foreign animal diseases affecting animal agriculture. It is 
highly contagious and spreads easily through livestock movement, by 
wind currents, on vehicles that have traveled to and from infected 
farms and even on inanimate objects that have come in contact with the 
virus. It affects all cloven hoofed species, including wildlife such as 
deer and elk.
    Because North America is free of FMD, an outbreak of the disease in 
the United States would immediately shut off all exports of U.S. 
livestock, meat and dairy products, creating a precipitous drop in 
livestock markets. Because U.S. consumers have no knowledge of the 
disease, there also likely would be serious disruptions in the domestic 
market because of decreased demand for those products.
    FMD is endemic in Africa, Asia, South America and the Middle East. 
The FMD virus has seven viral serotypes and more than 60 subtypes, with 
wide strain variability. Managing and ultimately eradicating FMD 
requires strain-specific vaccines, making vaccination challenging and 
very expensive. Sporadic outbreaks with different types continue to pop 
up in countries around the world.
    Increased travel and trade between affected countries make the U.S. 
increasingly vulnerable to introduction of the disease. Now, the United 
States has to confront the possibility of terrorists using FMD as a 
weapon to inflict significant damage to the U.S. economy that could 
also affect food availability.
U.S. Livestock Industry Vulnerable to FADs, Including FMD
    The House Agriculture Committee Nov. 4, 2015, held a hearing on 
American agriculture and national security, which highlighted the 
vulnerability of the U.S. food supply to the potential for foreign 
animal disease introduction by terrorists or by accident.
    While the United States faces an increasing threat, through 
multiple sources, of the introduction of FMD into the U.S. livestock 
herd, there is ample evidence to suggest the safety net in place to 
prevent such an introduction needs to be improved.
    The bipartisan Report of the Blue Ribbon Study Panel on Biodefense, 
co-chaired by former Department of Homeland Security Secretary Tom 
Ridge and former Sen. Joe Lieberman and released Oct. 28, 2015, 
highlighted the need for improvements in the U.S. system for protecting 
the U.S. livestock herd and the nation's food supply from Foreign 
Animal Diseases (FADs).
    Since 2013, several diseases affecting swine have been introduced 
into the U.S. herd, including Porcine Epidemic Diarrhea virus (PEDv), 
Delta Corona Virus and Orthoreovirus. Government officials responsible 
for overseeing port-of-entry inspections and disease risk management 
have been unable to specifically identify the source or means of 
introduction of those viruses even though the U.S. Department of 
Agriculture's Animal and Plant Health Inspection Service (APHIS) 
conducted a root cause investigation. If there is an unidentified gap 
in the U.S. safety net that allowed the recent introduction of these 
new diseases, it also remains open for FMD.
    In USDA's FAD preparation strategy document on the phases and types 
of an FMD outbreak, Dr. James Roth, professor and researcher at Iowa 
State University, identified four phases of the disease: (1) 
confirmation of an outbreak (typically 3 days); (2) surveillance and 
epidemiological work necessary to provide timely evidence of the extent 
of an outbreak to support decision making by government officials; (3) 
recovery from the disease; and (4) freedom from the disease (possibly 
with vaccination).
    He characterized an FMD outbreak as having six types: Type 1, Small 
Focal; Type 2, Moderate Regional; Type 3, Large Regional; Type 4, 
Widespread or National; Type 5, Catastrophic U.S.; and Type 6, 
Catastrophic North American, which includes Canada and Mexico.
    Given the structure of the U.S. livestock industry, the likelihood 
of having a Small Focal or Moderate Regional outbreak is remote. The 
livestock industry estimates there are approximately one million pigs 
and 400,000 cattle moved daily in the United States, some over long 
distances. In addition, there are numerous auctions, fairs and exhibits 
that concentrate large numbers of animals in a single location, 
providing the opportunity for one infected or exposed animal to spread 
disease to many animals. Thus, it seems unlikely that, if the United 
States had an outbreak, it would be a small focal outbreak that could 
be controlled without widespread administration of vaccine.
    The World Organization for Animal Health (OIE) sets standards for 
managing and declaring freedom from FMD. Those standards range from 
``stamping out'' (killing all infected and exposed animals) to being 
free of FMD with vaccination.
Not Enough Vaccine to Address FMD Outbreak
    After watching countries such as the United Kingdom, Korea and 
Japan, whose livestock populations pale in comparison to the United 
States, struggle to manage an FMD outbreak by killing large numbers of 
animals, APHIS changed its existing policy on managing the disease from 
``stamping out'' to using vaccine to limit the spread. This policy 
change was endorsed by the livestock industry as a cheaper and more 
practical alternative given the enormous size of the U.S. livestock 
herd and the rapid movement of livestock around the country. The United 
States simply cannot ``kill'' its way out of an FMD outbreak!
    After reviewing the impacts of the policy change, it became readily 
apparent under the current structure of the FMD vaccine antigen bank 
that APHIS did not have the quantity of vaccine needed to implement 
this new policy, nor could vaccine be obtained in a timely manner in 
the event of an outbreak.
    At APHIS's request, the U.S. livestock industry began a series of 
meetings with its senior officials to develop a strategy for improving 
the vaccine antigen bank and vaccine availability. There has been 
significant progress in FMD preparedness through the development of 
secure supply plans for milk, pork and beef, and APHIS continues to 
work with the livestock industry to improve its preparedness 
capability. Fixing the antigen bank capacity and improving vaccine 
availability must be a priority in future preparedness efforts.
    Current U.S. law prohibits live FMD virus from being introduced 
onto the U.S. mainland, so foreign production companies are the only 
source of finished vaccines. It has been suggested that recombinant DNA 
vaccines that do not use live FMD virus can be produced in the United 
States, thus avoiding the legal prohibition of having live virus on the 
mainland. However, current data is not sufficient to determine how 
quickly, and indeed whether, such vaccines provide protection outside 
of the laboratory environment and for all species.
    The United States likely is years away from the development and 
commercialization of such novel vaccines. But the U.S. livestock 
industry must have vaccines that are protective against the strain of 
FMD that might be in a sample sitting at the Plum Island Animal Disease 
Center (PIADC) for analysis at this very moment!
    The United States is the only country in the world to maintain its 
own antigen bank, located at the PIADC. The bank maintains antigen for 
a limited number of FMD strains. APHIS contracts with foreign vaccine 
production companies to produce finished vaccine from the antigen 
stored at Plum Island. If an outbreak occurs, the antigen is shipped to 
Europe to produce vaccine, and the finished product is shipped back to 
the United States. Based on the current production contract, after 3 
weeks, this process would produce only 2.5 million doses of vaccine, 
and there is no surge capacity to produce more.
    Iowa State's Dr. Roth estimates that the U.S. livestock industry 
would need ten million doses for the first 2 weeks of an outbreak.
    The FMD vaccine bank is currently funded at $1.9 million, and there 
have been no requests for a substantial increase in the President's 
budget despite the fact that Homeland Security Presidential Directive 9 
(HSPD 9) requires an adequate vaccine stockpile to be maintained.
    Although APHIS is the agency charged with managing and controlling 
FADs, there is no logical reason there could not be mutual cooperation 
with the Department of Homeland Security on funding an enhanced vaccine 
bank and improving vaccine availability.
    Another factor complicating upgrades to the vaccine bank is it also 
serves as the North American Bank and thus includes Canada and Mexico. 
NPPC believes it is appropriate to include those neighboring countries, 
but the United States should not wait for negotiations with those 
countries to be completed before making necessary improvements that are 
so critical to the U.S. livestock industry.
    There is concurrence in the livestock industry that fixing the 
vaccine bank will require the following actions: (1) Contract for an 
offshore, vendor-maintained vaccine antigen bank that would have 
available antigen concentrate to protect against all 23 of the most 
common FMD types currently circulating in the world; (2) Contract for a 
vendor-managed inventory of ten million doses (the estimated need for 
the first 2 weeks of an outbreak); and (3) Contract with an 
international manufacturer(s) for the surge capacity to produce at 
least 40 million doses.
    For more than a year, NPPC and others in the livestock industry 
have urged APHIS to identify changes needed to modernize the antigen 
bank and increase vaccine availability by requesting information from 
vaccine producers to identify the cost of fixing the vaccine problem. 
The industry anticipates that the agency soon will make that request.
FMD Outbreak Could Be Economically Devastating
    NPPC knows that fixing the vaccine shortage will require a 
significant increase in budget outlays. However, that cost pales in 
comparison to the cost of an FMD outbreak. Iowa State University 
economist Dermot Hayes estimates revenue losses to just the U.S. pork 
and beef industries from an FMD outbreak at $12.9 billion per year over 
a 10 year period; the corn and soybean industries are estimated to lose 
$44 billion and $24.9 billion, respectively. A recent study by Kansas 
State University estimates cumulative losses to consumers and livestock 
producers at $188 billion, with an added cost to the government of $11 
billion for eradication efforts if vaccination is not employed. 
Depending on the vaccination strategy employed, the study estimates the 
losses to consumers and producers could be cut by 48 percent.
    Given the huge economic impact on the livestock industry of an FMD 
outbreak and the cost of dealing with it, APHIS has insisted that the 
industry must share in the costs associated with making improvements to 
the vaccine bank. While several options have been discussed, none have 
produced a viable method by which equitable contributions from each 
sector of the livestock industry could be made. The type of outbreak 
and its location will determine which sector of the livestock industry 
is most seriously affected in the initial phase of an outbreak.
    None of the options discussed thus far would provide any 
significant funds, and APHIS has not offered any kind of a plan that 
would be equitable among components of the industry. Frankly, the 
industry believes it would be impossible to develop such a plan.
    The history of government involvement in disasters like an FMD 
outbreak is that, once an outbreak occurs, unlimited resources are 
committed to getting control of the situation. In the case of FMD, 
there is a clear opportunity to invest in a robust vaccine bank that 
would limit the economic impact on producers, feed suppliers and 
consumers and reduce the government's cost for control and eradication 
of the disease.
    NPPC urges the Committee and Congress to work with the 
Administration to address the alarming gap in the preparedness for an 
FMD outbreak. Whether the disease introduction is the result of 
terrorism, careless travelers or carried on traded commodities, the 
calamitous result is the same: devastation to the U.S. livestock 
industry.

    Mrs. Hartzler [presiding.] Thank you, Dr. Hill.
    Mr. Parker.

         STATEMENT OF WILLIAM STEPHEN ``STEVE'' PARKER,
     DIRECTOR, MERIAL VETERINARY PUBLIC HEALTH, DULUTH, GA

    Mr. Parker. Chairman Rouzer, Ranking Member Costa, and 
Members of the Subcommittee, thank you for the opportunity to 
provide testimony from the perspective of an FMD vaccine 
manufacturer.
    At Merial, I am responsible for the interface with the 
government on reportable and animal disease management 
programs. Merial strives to align our capabilities with the 
mission of the government to advance solutions against a 
variety of reportable animal diseases. The current North 
America FMD Vaccine Bank stockpile is undersized to respond to 
anything other than a limited scope outbreak. Thoughtful 
consideration should be given to advancing a funding source 
that supports building adequate FMD bank stockpiles that are in 
line with U.S. FMD vaccine use policy.
    Even though the current global FMD vaccine demand grossly 
exceeds the ability of conventional vaccine manufacturers to 
supply, an optimized vaccine need for the U.S. can be addressed 
with advanced planning and investment. Expertise in FMD vaccine 
technology is central to Merial's history. For over 60 years, 
Merial has produced millions of doses of high quality, high 
potent FMD vaccine. This vaccine is made for government clients 
in all regions of the world for epidemic disease control 
efforts, and for government preparedness programs.
    In FMD free countries, vaccine antigen banks are the 
standard model for emergency response to FMD outbreaks. 
Efficient antigen bank models match the quality and quantity of 
bank antigen doses to the disease spread potential in the 
target livestock population, combined with the manufacturer's 
ability to rapidly respond to conversion of antigen to vaccine. 
The North American Bank stores antigen concentrate for 
production of emergency vaccine. The bank does not store 
finished vaccine, mainly due to the difference in shelf life of 
the antigen concentrate, which is 5 years, versus the shelf 
life of finished vaccine at 18 months. FMD antigen banks are 
the referenced solution that allows FMD free countries to 
access rapidly, in outbreak situations, large quantity of 
purified and highly potent vaccine. Within 4 working days of 
activation of the North America Bank, Merial will produce up to 
2.5 million doses of finished vaccine from the North America 
Bank vaccine antigen concentrate, and make the vaccine 
available for shipment to the USDA for field distribution. The 
largest inventory by dose volume and strains in the North 
America Bank are Merial antigens.
    Merial has the broadest world library of FMD vaccine 
strains. These strains are used to produce single strain or 
multiple strain vaccines. This capability provides an insurance 
of protection against the vast majority of strains circulating 
globally.
    As new FMD strains evolve, Merial continues to develop and 
propose inclusion of those new strains into antigen banks. For 
a non-endemic country like the United States, the process of 
constantly updating the library of strains is critical because 
of the unpredictability of strains in an FMD event.
    Merial operates FMD antigen production and vaccine 
finishing facilities in the UK, the Netherlands, France, and 
Brazil. As the world's leader in FMD bank management, we 
maintain vaccine antigen storage facilities in multiple 
locations for our global clients as a risk mitigation service. 
Our bank management services provide the cost effective 
advantages of timely new strain inclusion into banks, perpetual 
inventory rotation management, inventory buyback options, just 
in time antigen to vaccine conversion, and risk mitigation of 
multiple product shipping events.
    FMD banks are only a part of the well-developed FMD 
preparedness plan. Because FMD antigen banks only serve as a 
temporary measure in the face of outbreaks, optimized FMD 
preparedness plans should account for a seamless transition to 
surge production of millions of doses of finished vaccine, once 
the bank inventory is exhausted. The continuous supply of 
vaccine is crucial to achieving control and elimination of the 
disease.
    Mr. Chairman, Members of the Subcommittee, Merial has been 
a partner with the U.S. Government on disease management 
programs for over 20 years. We stand ready to work together to 
explore the time and cost needed to supply gold standard 
conventional FMD vaccines that support continuity of business 
for U.S. livestock producers. Thank you.
    [The prepared statement of Mr. Parker follows:]

   Prepared Statement of William Stephen ``Steve'' Parker, Director, 
              Merial Veterinary Public Health, Duluth, GA
Foot-and-Mouth Disease Industry Preparedness: Vaccine Capabilities
    Testimony Premise Statement: The current North America FMD Vaccine 
Bank (NAFMDVB) stockpile is undersized to respond to anything other 
than a limited scope outbreak. Serious consideration should be given to 
the appropriation amount required for a rightsizing of the stockpiles. 
However, the industrial capacity needed to produce these large volumes, 
is not available today anywhere. Global FMD vaccine demand grossly 
exceeds ability of conventional vaccine manufacturers to supply. This 
issue can be remedied through planning and investment but will take a 
few years to implement.
    Background: Expertise in FMD vaccinology is central to Merial 
history as a company. We have produced multiple millions of doses of 
high quality, high potent FMD vaccines for a multitude of global 
customers for over sixty years. Some countries rely on local production 
of FMD vaccines. However, these locally produced vaccines generally 
cover only regional strains and needs. All past successful examples of 
FMD control and eradication, e.g., Europe in 1991, the Philippines in 
2010, have only been achieved thru application of conventional vaccines 
at international, high quality standards.
    FMD Vaccine Antigen Banks--the solution for emergency situations: 
In FMD-free countries the vaccine antigen bank model has become the 
standard solution for emergency response to the risk of FMD 
introduction.
    Established in 1982, the NAFMDVB stores vaccine antigen concentrate 
for the production of emergency FMD vaccines. The NAFMDVB does not 
store finished vaccine for two reasons, (1) the shelf life of vaccine 
antigen concentrate is 5 years versus finished vaccine shelf life of 18 
months, and, (2) FMD live viruses are on the Federal Select Agent 
Program prohibiting handling of the virus within U.S. territory, with 
the exception of Plum Island.
    FMD antigen banks are the reference solution that allows FMD-free 
countries to access rapidly, in outbreak situations, large quantities 
of purified, highly potent vaccine. The purification of FMD viral 
antigens provides a ``marker'' system that allows monitoring of the FMD 
vaccination program until eradication. The use of highly potent FMD 
vaccines has been demonstrated to induce cross-protection against 
certain heterologous challenge infections of FMD strains.
    Within a week of activation of the NAFMDVB bank, Merial can produce 
up to 2.5 million doses of finished vaccine from the NAFMDVB vaccine 
antigen concentrate, in either single strain or multiple strain vaccine 
formats, and make the vaccine available to the USDA for field 
distribution. The largest inventory by dose volume and strains in the 
NAFMDVB are Merial antigens. Globally, Merial stores more than 120 
million doses of antigens for 14 countries.
    Merial has the world's broadest library of FMD vaccine strains that 
can be used either as monovalent vaccine--containing one strain--or 
polyvalent vaccine--containing several strains. This capability 
provides an insurance of protection against the vast majority of the 
strains that circulate globally and that could be introduced into the 
United States. Merial continues to develop and propose new FMD vaccine 
strains for inclusion in antigen banks, concurrent with the evolution 
of the FMD virus globally. For a non-endemic country, like the United 
States, this is critical because of the unpredictability of an FMD 
event.
    FMD Vaccine Global Industrial Capability Considerations: Merial 
operates FMD antigen production plants at Pirbright in the UK, Lelystad 
in the Netherlands and Paulinia in Brazil, as well as vaccine 
formulation, finishing and packaging facilities in the UK, France and 
Brazil. As the world's leader in FMD bank management, we also maintain 
vaccine antigen storage facilities in multiple locations for multiple 
international clients and countries.
    FMD banks are only a part of a well-developed FMD preparedness 
plan. FMD antigen banks serve as a temporary measure in the face of a 
disease outbreak. FMD preparedness plans should allow for optimized 
bank inventories that supply antigen that support vaccine formulation 
needs for up to 14 to 16 weeks post outbreak. The exhaustion of the 
bank antigen inventory should then be followed by a seamless transition 
to production of finished FMD vaccine and the industrial capacity to 
meet demand capacity. The continuous supply of vaccine is crucial to 
achieve control and elimination of the disease.
                        PowerPoint Presentation
Merial Veterinary Public Health


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          Other Merial U.S. Veterinary Public Health infectious and 
        emerging animal diseases areas: Cervid Bluetongue Virus and 
        Epizootic Hemorrhagic Disease, Rift Valley Fever and other 
        reportable animal diseases. VPH collaborates with other Merial 
        entities on Highly Pathogenic Avian Influenza and Classical 
        Swine Fever as related to USDA Foreign Animal Disease (FAD) 
        Planning.
          Examples of programs that Merial Veterinary Public Health 
        collaborates with USDA on are: (1) the North America Rabies 
        Management Plan through USDA-APHIS-Wildlife Services and the 
        National Rabies Management Program, and (2) the North America 
        FMD Vaccine Bank through USDA-APHIS-Veterinary Services.
Foot-and-Mouth Disease (FMD)
An Old Disease, But a Present Threat



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          Foot-and-Mouth disease (FMD) is an old disease. FMD is a 
        present and persistent threat to the U.S. livestock industry. 
        The last outbreak in the U.S. was in California in 1929. Recent 
        out breaks, in previously non-endemic countries, include the 
        UK, Japan, Taiwan, South Korea, Greece and the Netherlands.
The Importance of FMD

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          One of the most contagious diseases of cloven-hoofed animals.

             Cattle are most susceptible.
             Pigs are very effective in propagating the 
        disease.

          The virus is only present in certain parts of the world
          Rarely lethal, but negatively impacts animal productivity 
        (milk, meat, draft power)
          Disease Control Methods:

             Sanitary: culling/mass slaughter, stop animal 
        movement, disinfection.
             Medical: mass vaccination:
               Need for Inter-governmental and Governmental 
        FMD Control Programs.
FMD--OIE Official Status
OIE Member Countries Official FMD Status Map
Last Update May 2051

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          [http://www.oie.int/en/animal-health-in-the-world/official-
        disease-status/fmd/en-fmd-carte/]
          [OIE 2015.]
          FMD outbreaks in countries previously free from FMD has major 
        effects on the ability to trade animal protein internationally. 
        FMD free countries experiencing outbreaks may respond initially 
        with strict restriction of animal movement and livestock 
        transportation methods.
Virus Transmission Routes

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          The FMD virus is easily transmitted (direct contact, 
        transboundary means of introduction of virus, aerosolized virus 
        transmission introduced via respiratory or oral routes, virus 
        in infected milk, or on clothing, trucks, in feed etc.).
Case Study--The South Korea Outbreak


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          The South Korea FMD outbreak in 2010 was initially addressed 
        by culling animals. The disease was not controlled and the 
        decision was made to mass vaccinate.
Indirect & Direct Impact
Mass Culling and Burial of Pigs in Korea (Nov. 2010-Feb. 11)


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          The South Korean livestock industry suffered massive lose due 
        to culling. The South Korean Government incurred huge direct 
        and indirect costs in the culling effort. Consider this event 
        and compare to cost of what the U.S. has recently been through 
        with HPAI.
The South Korea Outbreak: Vaccine Impact
Nov. 10-Mar. 11--FMD Outbreak Evolution


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          When mass vaccination campaigns were initiated in South 
        Korea, animal outbreaks with FMD were brought under control.
          The South Korea situation, as a case study for the United 
        States, continues to evolve as the introduction of new FMD 
        strains from border countries prove challenging. Merial 
        partners with the South Korean Government on FMD vaccine supply 
        agreements. Merial monitors the local epidemiology of new 
        emerging virus strain to develop vaccines adapted to evolving 
        disease conditions.
FMD Cost of Incursion--Control
FMD Outbreak Economic Impact--Major Incursions Into Disease Free 
        Countries
        
        
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          The UK, in 2001, did not implement a vaccination program of 
        control for disease eradication. Costs associated with the UK 
        FMD outbreak, as compared to countries that used vaccine as 
        part of a control effort, were magnitudes of degree greater.
Epidemiology & Vaccine Recommendations

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FMD Epidemiology Trends Per Pools/June 2015

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           At a global level, seven FMD epidemiologic regions 
        are
            recognized containing specific viral variants (seven 
        ``virus pools''),
            requiring specific vaccines targeted against these 
        variants.

           Vaccine demand is different in each of these regions 
        (no common
            product profile).
Recent FMD Outbreaks (Jan. 14-Sep. 15)

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          Outbreaks reported to OIE. Courtesy WRL.
          Tracking of recent FMD outbreaks show activity in the Middle 
        East, South Africa and East Asia. New FMD strains are emerging 
        in the Middle East and East Asia that warrant strain adaptation 
        for new vaccine development.
FMD Vaccines & Vaccination


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Merial FMD Vaccine Sourcing

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          Merial's industrial capabilities to produce FMD vaccine are 
        broad based and global in scope.
          The global industrial demand for high quality conventional 
        FMD vaccine exceeds manufacturer's ability to supply. It is 
        generally accepted that the industrial capacity to build 
        antigen bank inventories or to supply endemic markets beyond 
        current agreements does not exist at this time.
          Additional to the manufacturing capabilities, Merial 
        maintains FMD Research and Development project in Europe and 
        North America.
FMD Vaccines



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          Merial produces FMD vaccines for specific vaccination program 
        needs.
Merial FMD Vaccine Supply Alternatives

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          Merial offers alternatives, in addition to finished vaccine 
        for endemic disease situations, for FMD vaccine supply. Merial 
        can provide bulk vaccine concentrate for local finishing and 
        packaging. Merial also offers vaccine antigen concentrate banks 
        as a way for disease free countries to build vaccine supply 
        inventory by the stockpiling method.
FMDV Antigen Banks--Storage

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          FMD antigen storage banks provide an efficient means to build 
        stockpiles ahead of potential disease outbreaks.
FMD Antigen Banks Supplied by Merial

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          Merial maintains and manages many antigen bank stockpiles for 
        many countries and NGOs. Merial has been a partner to the North 
        America FMD Vaccine Bank since the 1990s and represents the 
        majority of inventory doses in the NAFMDVB.
Antigen Bank Mobilization Process

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          Typically, once Merial is notified by a country partner of 
        the need to mobilize their bank antigen stockpile, it takes 4 
        days to formulate, fill, label, package and release the 
        finished vaccine for shipment to the country of need.
WRL FMD Bank Recommendations: 7/15

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          The World Reference FMD Bank in the UK updates their FMD 
        antigen bank strain recommendations quarterly.

    Mrs. Hartzler. Thank you, Mr. Parker.
    Dr. Wolf.

        STATEMENT OF CYNTHIA B. WOLF, D.V.M., ASSISTANT
            PROFESSOR AND SMALL RUMINANT VETERINARY
          SPECIALIST, COLLEGE OF VETERINARY MEDICINE,
 UNIVERSITY OF MINNESOTA, ST. PAUL, MN; ON BEHALF OF AMERICAN 
                   SHEEP INDUSTRY ASSOCIATION

    Dr. Wolf. Thank you to this Subcommittee for the 
opportunity to speak with you on behalf of the American Sheep 
Industry regarding preparedness for FMD. My name is Cindy Wolf. 
My family and I raise sheep and beef cattle in Minnesota, and 
we sell direct to a variety of end-users. For the past 32 
years, I have also been employed as a small ruminant 
veterinarian at the College of Veterinary Medicine at the 
University of Minnesota.
    A few things about the sheep industry are important 
relative to FMD, and I would like to point those out. Basically 
in this country, sheep and goats move around the country daily, 
crossing several state lines in about every type of vessel 
made. We hope they have health certificates, but I wouldn't 
count on it. The sheep are sold for human consumption at a wide 
range of body weights and ages, dependent on the custom of the 
end-user. While we have some concentration in our country 
regarding sheep production, we do have a tremendous amount of 
small numbers moving around in the Northeast United States 
processed in a variety of different ways.
    The odd thing about sheep is they are very subtle when they 
are infected with clinical signs. First, you can't really 
notice it. This is in contrast to pigs and cattle. And second, 
for much of the year, sheep are covered with wool, making it 
even harder to see these lesions, and also, their normal 
behavior is that they tend to move with their heads low, so 
seeing these lesions makes that even more difficult.
    So one thing we learned from the UK outbreak in 2001 is 
that sheep carried and distributed the virus around the country 
throughout marketing channels, spreading it to other livestock, 
before the disease was recognized. So the direction we are 
going in this country regarding early detection animal 
traceability, movement restrictions, and vaccination is 
essential to averting a very large outbreak.
    My close friend, Dr. Don Hoenig, who was the State 
Veterinarian in Maine for 27 years, if I could quote him, he 
said, ``A major development in our response planning is the 
acknowledgment that if an outbreak becomes widespread, a large 
scale FMD vaccination strategy will need to be implemented.'' I 
believe that it is imperative that as a country we continue 
along this path, moving away from the singular approach of 
stamping out FMD to one of control that relies upon cooperation 
to produce and deliver timely, effective vaccination, 
communication, and education.
    To accomplish FMD control where business continuity will be 
possible, we will need to adequately fund vaccine banks to 
ensure there is at least one functional FMD vaccine bank at all 
time, if not more, and that that bank is ready to launch into 
production upon a second's notice. Part of such contract will 
need to include making the most likely serotype or serotypes 
available, rapid production of the needed number of doses, and 
preexisting licensure of manufacturing processes so the vaccine 
will be legal to use in the U.S. Also, we--stakeholders and 
government--will need to continue the readiness development 
process so if we need to execute a control plan, we will know 
how to immediately find the herds and flocks that need to be 
vaccinated; we will know how to acquire the ancillary supplies, 
so ten million needles, syringes, special ear tags, the 
handling equipment that we know from other disease examples, we 
don't necessarily have in place; the manpower. How are we going 
to ID these vaccinates? While we have a plan, but can we make 
these 2.5 million ear tags or ten million ear tags in a weeks' 
time? And how are we going to ensure that whole farms are 
vaccinated as rapidly as possible, because sometimes these 
sheep are on thousands of acres at any one time.
    While this will not be a small investment, the cost of not 
having a vaccine preparedness plan in place, given the risk is 
extremely high, and it is essential to the security of U.S. 
agriculture and the country that we are fully prepared and 
ready to produce the potentially needed doses of the 
appropriate serotype in an extremely rapid timeframe.
    And last, it is my holistic approach as a veterinarian, we 
need to continue to bolster our efforts at any and every entry 
point into the U.S. so we rely on improved screening techniques 
and additions to the Beagle Brigade, and we continue to educate 
and remind the public about not bringing in food or other ag 
products from foreign countries, as well as our livestock 
producers to be vigilant and proactive regarding suspect cases.
    Thank you for your support.
    [The prepared statement of Dr. Wolf follows:]

Prepared Statement of Cynthia B. Wolf, D.V.M., Assistant Professor and 
 Small Ruminant Veterinary Specialist, College of Veterinary Medicine, 
   University of Minnesota, St. Paul, MN; on Behalf of American Sheep
                          Industry Association
Impact of an Outbreak of Foot-and-Mouth Disease (FMD) in the United 
        States and the Urgent Need for an Adequate Stockpile of FMD 
        Vaccine
    Chairman Rouzer, Ranking Member Costa, and Members of the House 
Committee on Agriculture, Subcommittee on Livestock and Foreign 
Agriculture, my name is Cindy Wolf. My family and I raise sheep and 
beef cattle in Minnesota. We sell direct to consumers, restaurants, 
auction markets and to a lamb cooperative. For the past thirty-two 
years, I have also been employed as small ruminant veterinarian at the 
College of Veterinary Medicine at the University of Minnesota. Thank 
you for the opportunity to speak to you about our preparedness for the 
potential introduction of foot-and-mouth disease (FMD) into the United 
States.
Sheep Industry Demographics
    I included two images in my written testimony, one showing the 
numbers of sheep by state in the U.S. and the other one roughly shows 
sheep movement. Sheep (and goats) move across the continental U.S. 
daily traversing several state lines in about every type of vessel 
made. We hope that most of them have Certificates of Veterinary 
Inspection but I wouldn't count on it. Sheep sold for human consumption 
have a wide range of bodyweights and ages dependent on the customs of 
the end-user.
    Since FMD transmission can be airborne, there are millions of 
livestock at-risk along routes of commerce if even one animal should be 
infected. Young lambs are generally concentrated for a few weeks to a 
few months while they are being fed prior to processing. The highest 
concentration of these lambs at any given point in time but mostly in 
the fall through the spring is in feedlots or crop aftermath on the 
front range of Colorado, California, Arizona, and Oregon. The larger 
commercial lamb feedlots (including grazing operations) range in size 
from 20,000 to 80,000 head in one-time capacity. Lambs entering 
commercial feedlots tend to come from larger-scale breeding flocks. 
There are approximately 80,000 sheep producers in the U.S. and there 
are sheep in every state. In general terms, 80 percent of the breeding 
ewes are owned by 20 percent of the producers.
All Sheep and Lamb Inventory in the United States: January 1, 2016

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          United States Total: 5.32 million head.
          Source: Sheep and Goats (January 2016), USDA National 
        Agricultural Statistics Service.
Sheep Marketing Channels & FMD Risk
    If FMD were to be found in one or more of the larger commercial 
feedlots, temporary movement restrictions, tracebacks, vaccination, 
etc., would be relatively straight forward because of geographic 
concentration. However, there are sheep in transport every day of the 
year and they are crossing multiple state boundaries through rural 
America much of the time with stops along the way. Nearly all of the 
sheep in traditional interstate commerce are ear-tagged back to their 
flock of origin as required by the cooperative state-Federal national 
scrapie eradication program. Many auction barns that buy and sell sheep 
also have other species in the same facility. This presents a large 
disease exposure risk especially in a species whose FMD clinical signs 
are rather subtle.
Sheep Movement

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Sheep the Silent Carriers and Risk to Other Species
    There are a few things about sheep and goats that are unique 
regarding FMD clinical signs and diagnoses. For example, sheep can be 
infected with FMD and not present remarkable clinical signs as seen 
with pigs and cattle. Besides the clinical signs being more subtle, for 
much of the year many sheep are covered with wool and tend to move with 
their heads low so seeing FMD lesions from any distance would be 
difficult.
Lessons Regarding Sheep and Other Species from the Outbreak in the UK
    One of the lessons learned from the 2001 FMD outbreak in [the] UK 
was that sheep were carrying and distributing the virus across the 
country and throughout marketing channels, spreading it to other 
livestock before the disease was recognized. Therefore early detection, 
animal traceability, movement restrictions and vaccination is essential 
to averting a very large outbreak in the U.S. Veterinarians break down 
the stages of FMD infection into phases that describe virus progression 
with phase one being initial infection and the beginning of clinical 
signs. From a practical standpoint, by the time someone sees a sheep in 
what they believe is phase one, there are other animals somewhere that 
are in stage five or full presentation of clinical signs and all of 
these infected animals have been spreading virus to susceptible 
animals. Immune response to the vaccine takes several days once the 
vaccine is given therefore a large and inclusive vaccination program 
needs to be done very quickly if a case is diagnosed.
Vaccine Needs
    My close friend and colleague who was the State Veterinarian for 
Maine for the 27 years, Dr. Don Hoenig has said the following. ``In the 
past 13 years, I've been involved in national and regional efforts to 
enhance and improve our preparedness and response to FMD. Our response 
plans have been dramatically upgraded. State, Federal, and industry 
stakeholders have held countless meetings and training sessions and 
conducted numerous tabletop and on-farm, functional exercises to test 
our plan. A major development in our response planning is the 
acknowledgement that, if an outbreak becomes widespread, a large-scale 
FMD vaccination strategy will need to be implemented. Unfortunately, 
preemptive vaccination is not feasible or practical since there are 
seven serotypes of FMD virus and over 65 subtypes. Predicting which of 
these viruses might come to the U.S. is impossible.''
    I believe that it is imperative that as a country we continue to 
move away from a singular approach of stamping out regarding FMD 
control to one that relies upon cooperation to produce and deliver 
timely effective vaccination, communication, and education. To 
accomplish FMD control where business continuity will be possible, we 
will need to adequately fund vaccine contracts to ensure there is at 
least one functional FMD vaccine bank(s) maintained and ready to launch 
into production. Part of these contracts will need to include making 
the most likely serotype(s) available, rapid production time of needed 
number of doses, and pre-existing licensure of manufacturing processes 
so vaccine will be legal to use in U.S. Also we (stakeholders and 
government) will want to continue the readiness development process so 
the executors of the control plan know how they will immediately find 
the herds and flocks needing to be vaccinated, acquire ancillary 
supplies (needles, syringes, special ear tags, handling equipment), 
manpower, ID vaccinates, and ensure whole farms are vaccinated as 
rapidly as possible. While this will not be a small investment, the 
cost of not having a vaccine preparedness plan in place given the risk 
is extremely high. It is essential to the security of U.S. agriculture 
and the country that we are fully prepared and ready to produce 
potentially needed doses of the appropriate serotype in an extremely 
rapid timeframe. It is our responsibility to protect agriculture as a 
component of our country's critical infrastructure of which this one 
part.
    Last, we need to continue to bolster our efforts at airports and 
border crossings with improved screening techniques and additions to 
the Beagle Brigade. We must continue to educate and remind the public 
about not bringing in food or other agricultural products from foreign 
countries as well as livestock producers to be vigilant and proactive 
regarding suspect cases.
Conclusion
    The American Sheep Industry appreciates the support of this 
Committee in furthering a plan to bolster our preparedness for a FMD 
outbreak.

    Mrs. Hartzler. Thank you, Doctor.
    Dr. Sjeklocha.

STATEMENT OF DAVID B. SJEKLOCHA, D.V.M., OPERATIONS MANAGER OF 
                ANIMAL HEALTH & WELFARE, CATTLE
EMPIRE LLC, SATANTA, KS; ON BEHALF OF NATIONAL CATTLEMAN'S BEEF 
                          ASSOCIATION

    Dr. Sjeklocha. Mrs. Hartzler, Mr. Chairman, Ranking Member 
Costa, and Members of the Subcommittee, thank you for the 
opportunity to be here today.
    Foot-and-mouth disease is an extremely contagious viral 
disease of cloven hoofed animals and some wildlife species. The 
United States has not experienced an FMD outbreak since 1929, 
yet FMD is still a significant threat to American cattle 
producers. International travel and trade pose a substantial 
risk for FMD by providing pathways for the virus to enter the 
United States. FMD can be transmitted over long distances by 
animal products, people, and other vectors. FMD is considered a 
potential agent for agricultural terrorism. The size, 
structure, efficiency, and extensive movement inherent in the 
United States livestock industry will have unprecedented 
challenges in the event of an FMD outbreak.
    An FMD outbreak in the United States would result in 
immediate closure of most, if not all, of our foreign export 
markets. For the sake of perspective, as the result of a single 
BSE case in 2003, we saw our beef exports decline by 2 billion 
pounds from 2003 to 2004. We still do not have access to 
several critical markets, such as China.
    While international trade is a concern, we also expect to 
see significant impact to U.S. beef producers due to the 
depopulation, restrictions on cattle movements, and a potential 
shutdown of overall cattle trade in the affected regions. 
Models demonstrate that the impact to the beef industry could 
be in excess of $50 billion. Overall, there is a lack of 
capability to rapidly depopulate cattle and dispose of 
carcasses for large feedyards. A 2007 FMD exercise involving 
feedyards in the Texas Panhandle established that it would be a 
logistical challenge to depopulate 50,000 to 75,000 head of 
cattle within 72 hours, and then dispose of them within 96 
hours. With over 3\1/2\ million animals within a 100 mile 
radius of that exercise, 75,000 head of cattle is only a small 
portion of the region's susceptible livestock population.
    Vaccination of cattle against FMD has been practiced with 
relatively positive immunity results. Cattle are considered to 
be the highest priority for emergency FMD vaccine use. If the 
disease is under control in cattle, it should not persist in 
other species. In 2001, rapid vaccination of all the cattle in 
Uruguay brought that FMD outbreak under control rapidly.
    Limitations with FMD vaccinations do exist. Vaccines 
provide only serotype specific protection. There are seven 
distinct serotypes of the FMD virus, and more than 65 strains. 
Vaccination against one serotype may fail to fully protect 
against other strains within the serotype.
    Novel FMD technologies are currently under development, 
using subunit and recombinant DNA. These vaccines do not 
utilize live FMD virus, and can be safely produced on the U.S. 
mainland. ARS scientists at Plum Island have developed 
leaderless FMD vaccines that will allow safe production of FMD 
vaccine on the U.S. mainland, and protect livestock against 
clinical disease, as well as prevent virus shedding and virus 
transmission.
    Although work has started for commercialization of the 
leaderless FMD vaccine, the cost and timeline for vaccine 
production remains highly uncertain. NCBA actively supports a 
development of novel FMD vaccine technologies, and also 
requests immediate steps be taken to update the current FMD 
vaccine supply composed of conventional vaccine technology.
    Established in 1982, the North American FMD Vaccine Bank 
currently holds vaccine antigen concentrate for use by Mexico, 
Canada, and/or the United States. A single livestock dense 
state in the United States would deplete this bank's supply of 
antigen. The funding that USDA has for the supply of FMD 
vaccine in the National Veterinary Stockpile is insufficient to 
provide adequate FMD vaccine supplies. An FMD outbreak in South 
Korea depleted the banks of FMD vaccines from around the world 
in order to vaccinate a population roughly \1/2\ the size of 
the livestock population in Iowa.
    USDA has funded the development of the secure food supply 
plans and incorporated the use of FMD vaccines as an important 
tool. Currently, the beef industry is involved in a 
collaborative effort with USDA, state animal health officials, 
and academic partners to develop a secure beef supply plan to 
manage movements of non-infected cattle in the event of an FMD 
outbreak, provide business continuity for producers, 
transporters, and processors, and to maintain a continuous 
supply of safe and wholesome beef for consumers.
    We request that the Committee work with USDA and encourage 
them to budget the funds needed for the update and 
modernization of the National Veterinary Stockpile of FMD 
vaccine. Thank you for the opportunity to be here today, and we 
look forward to working with you to ensure that the United 
States is prepared for an outbreak of FMD.
    [The prepared statement of Dr. Sjeklocha follows:]

Prepared Statement of David B. Sjeklocha, D.V.M., Operations Manager of 
 Animal Health & Welfare, Cattle Empire LLC, Satanta, KS; on Behalf of 
                 National Cattleman's Beef Association
Foot-and-Mouth Disease Preparedness
    Mr. Chairman, Ranking Member Costa, and Members of the 
Subcommittee, my name is Dr. Dave Sjeklocha. I am a veterinarian and 
the Operations Manager for Animal Health and Welfare for Cattle Empire, 
LLC. Cattle Empire is owned by the Brown family and is located in 
southwest Kansas. The company consists of five feedyards, ranging in 
size from 18,000 head capacity to 87,000 head capacity, for a total 
one-time capacity of approximately 240,000. In addition, there is a 
farming and ranching operation associated with Cattle Empire.
    I grew up on diversified farming and ranching operations in Iowa 
and Missouri and received my degree from Kansas State University's 
College of Veterinary Medicine. Before joining Cattle Empire I spent 
several years as a practicing veterinarian in Nebraska, Colorado, 
Kansas, Texas and Oklahoma with a focus on beef cattle production 
management and medicine. I am an active member of the American 
Veterinary Medical Association, the Academy of Veterinary Consultants 
and the American Association of Bovine Practitioners. In 2011, I was 
recognized as the Beef Cattle Institute's ``Beef Cattle Veterinarian of 
the Year'' from Kansas State University and in 2013 recognized as the 
AVC's Consultant of the Year.
    NCBA is the nation's oldest and largest trade association 
representing America's cattle producers with a strong and united voice 
in our nation's Capital. On behalf of NCBA's membership, I appreciate 
the opportunity to share with you more background on Foot-and-Mouth 
Disease (FMD), our concerns regarding this disease, and our ability to 
respond to a reintroduction of FMD into the United States.
    FMD is an extremely contagious viral disease of cloven hoofed 
animals and some wildlife species. FMD is present in approximately \2/
3\ of the world and endemic in parts of Africa, Asia, Eastern Europe, 
the Middle East, and South America. North America and Central America 
are free of FMD, as is Western Europe, Australia, and New Zealand. The 
United States has not experienced an FMD outbreak since 1929, yet FMD 
is still a significant threat to American cattle producers. 
International travel and trade pose a substantial risk for FMD by 
providing pathways to enter the United States. FMD can be transmitted 
over long distances by animal products, people and other vectors. FMD 
is also considered as a potential agent for agricultural terrorism. The 
size, structure, efficiency, and extensive movement inherent in the 
United States livestock industry will present unprecedented challenges 
in the event of an FMD outbreak. No country with a livestock industry 
comparable to the U.S. has had to deal with an outbreak of FMD.
    FMD presents a great economic threat to U.S. livestock producers 
and is viewed as the most concerning transboundary disease in the 
world. An FMD outbreak in the United States would result in the 
immediate closure of most, if not all, of our foreign export markets. 
To put this into perspective, we need to only look at the economic 
impact of a single case of bovine spongiform encephalopathy (BSE) found 
in a Canadian-born cow located in Washington State on December 23, 
2003. As a result of a single case of BSE, we saw U.S. beef exports 
decline by 2 billion pounds from 2003 to 2004. It took 8 years for U.S. 
beef exports to get back to pre-December 2003 levels. Over a decade 
later we still do not have access to several critical markets, such as 
China, nor do we have full access to every country we were trading with 
prior to December 2003. It's not just the international trade impact 
which concerns us. In addition, we expect to see significant economic 
impact to U.S. beef producers due to depopulation, restrictions on 
cattle movements, and a potential shutdown of overall cattle trade in 
the affected regions. There are many variables which affect how we may 
see introduction of the disease and its spread. These variables include 
the region of the country, the type of operation, the timely reporting 
of the disease, and the response time. In the ``Site-Specific Biosafety 
and Biosecurity Mitigation Risk Assessment'' conducted for the National 
Bio and Agro-Defense Facility, models are used to estimate the economic 
impact of an outbreak of FMD. In scenarios that model the economic 
impact of FMD on cow/calf operations, feedlots, and livestock markets, 
the total economic impact of a case of FMD can reach over $50 billion 
in losses to the U.S. beef industry. Again, we must note that this 
report was based on 2010 cattle prices where the average fed cattle 
price was $95 per hundredweight. Currently, Live Cattle futures are in 
the $135 per hundredweight range. Regardless of the model or scenario 
used, it is obvious from the information above that the reintroduction 
of FMD would cost our industry billions of dollars.
    The goals of USDA's Animal and Plant Health Inspection Service 
(APHIS) in managing an FMD outbreak in the United States are to detect, 
control, and contain the outbreak in order to eradicate FMD from the 
country as quickly as possible. As a result of changes in livestock 
demographics and larger herd sizes, the FMD control paradigm at USDA-
APHIS has shifted from ``stamping out'' or total depopulation, to the 
use of vaccination to achieve control for type 3 outbreaks or larger. 
In September 2014, NCBA joined other animal agricultural stakeholders 
attending a meeting called by USDA-APHIS to develop concrete strategies 
to improve alignment between USDA's response strategies for FMD and our 
current vaccine capabilities. The stakeholders in attendance were 
informed that gaps existed in vaccine preparedness for a type 3, (large 
regional), or greater FMD outbreak. An immediate need was identified at 
this meeting to begin modernization of the current U.S. FMD vaccine 
response capabilities. Budgetary shortfalls at USDA for acquiring 
sufficient supplies of FMD vaccine present a major hurdle to achieving 
modernization of the FMD vaccine capabilities in response to an FMD 
outbreak.
    There are critical reasons for considering vaccination strategies 
in an FMD outbreak. In anything beyond a small, focal FMD outbreak, 
stamping out or rapid depopulation is not viable or sustainable. There 
is a lack of capability and capacity to rapidly depopulate and dispose 
of the large number of carcasses which would be found in feedyards that 
can easily feed 50,000 to 100,000 head of cattle. Even the smaller 
feedyards would pose a challenge for ``stamping out,'' both 
logistically and economically. During the 2007 Palo Duro FMD exercise 
in the Texas Panhandle, rapidly depopulating 50,000 to 75,000 head of 
cattle was deemed a logistical challenge that would not be possible 
within 72 hours for depopulation and within 96 hours for disposal. 
Since the Texas Panhandle is a livestock dense region, 75,000 animals 
constitute only a small portion of the region's total susceptible 
livestock population (over 3.5 million animals in a 100 mile radius). 
If FMD spread rapidly prior to detection, it is clear that a stamping-
out strategy would not be feasible or appropriate.
    Key objectives have been identified by APHIS Veterinary Services in 
regard to FMD vaccine and vaccination policy, and there is definite 
recognition that additional response capabilities will be required. 
There is an immediate need to increase the guaranteed access to FMD 
vaccine. The requirements to achieve response goals include: 
identifying the type of vaccine needed (topotypes and strains); 
establishing multiple sources or manufacturers; establishing which 
vaccines will be used in specified livestock populations; establishing 
a desired quantity of vaccine and determining the necessary time to 
deliver the vaccine.
    Vaccination of cattle against FMD has been practiced with 
relatively positive immunity results. Cattle are considered to be the 
highest priority for emergency FMD vaccine use. If the disease is under 
control in cattle, it should not persist in other species. For example, 
in the 2001 FMD outbreak in Uruguay, the outbreak was brought under 
control by the rapid vaccination of all the cattle in the country. To 
effectively induce immunity in the cattle population, all cattle in the 
affected region should receive two doses of normal potency FMD vaccine 
1 month apart, or a single dose of high potency FMD vaccine as soon as 
possible. Certain limitations of vaccination, however, do exist. 
Vaccines provide only serotype specific protection. There are seven 
immunologically distinct serotypes of the FMD virus and more than 65 
strains. There is a substantial amount of genetic variability in FMD 
viruses, and new strains can occasionally develop spontaneously. Also, 
vaccination against one serotype may fail to protect fully or at all 
against other strains within the serotype. Immunity is not immediate. 
Inactivated FMD vaccines may decrease viral shedding and clinical signs 
in cattle as early as 4 days with protection improving over the next 2 
to 3 weeks. No currently available vaccine provides ``sterilizing 
immunity'' which will prevent subsequent infection. It is possible that 
individual vaccinated cattle which are infected with FMD virus could 
become asymptomatic virus carriers. Differentiating field infected 
animals from vaccinated animals, known as DIVA strategy, is critical to 
emergency vaccination in an FMD outbreak. DIVA diagnostic techniques 
typically use tests for antibodies against viral non-structural 
proteins (NSPs) to differentiate animals that are infected with FMD 
naturally from those animals vaccinated with FMD vaccine. The 
diagnostic DIVA capability of a vaccine is important for an effective 
vaccine campaign, business continuity processes, and FMD surveillance. 
All FMD vaccines should be DIVA compatible unless the animals are 
intended for slaughter.
    Currently, FMD virus is listed by USDA as a ``select agent'' on the 
Select Agent Program registration list. This means that it is currently 
illegal to have FMD virus on the U.S. mainland, even for FMD vaccine 
production purposes. As such, there is no conventional, killed virus 
FMD production (which requires live FMD virus) in the United States. 
The U.S. must rely on the overseas production of FMD vaccine in the 
event of an FMD outbreak.
    Novel FMD vaccine technologies are currently under development 
using subunit and recombinant DNA. These vaccines do not utilize live 
FMD virus and can be safely produced in the U.S. mainland. USDA's 
Agricultural Research Service (ARS) scientists at Plum Island, New 
York, have developed a leaderless FMD vaccine (FMD-LL3B3D) that will 
allow safe production of FMD vaccine on the U.S. mainland and protect 
livestock against clinical disease as well as prevent virus shedding 
and virus transmission. Although work has started for commercialization 
of the leaderless FMD vaccine, the cost and timeline for vaccine 
production remains highly uncertain. NCBA actively supports the 
development of novel FMD vaccine technologies, such as the USDA-ARS 
leaderless FMD vaccine technology, for use in meeting future FMD 
vaccine needs. In addition, NCBA requests immediate steps be taken to 
update the current FMD vaccine supply made up of conventional vaccine 
technology in order to meet surge capacity for emergency use and to 
safeguard the health of the U.S. cattle herd.
    The structure of modern agriculture in the United States, including 
large herd sizes and extensive intra- and interstate movement of cattle 
and cattle products will make it nearly impossible to control an FMD 
outbreak in livestock dense areas without the rapid use of tens of 
millions of doses of FMD vaccine. It is estimated that over 400,000 
head of cattle are in transit daily in the United States. Established 
in 1982, the North American FMD Vaccine Bank currently holds vaccine 
antigen concentrate for use by Mexico, Canada, and/or the United 
States. The amount of antigen in the North American FMD Vaccine Bank is 
far below what would be needed to provide vaccine for a single 
livestock dense state in the United States. The funding that USDA has 
for the supply of FMD vaccine in the National Veterinary Stockpile is 
insufficient to provide adequate FMD vaccine supplies. An outbreak of 
FMD occurring in a livestock dense area, such as Iowa, and which was 
not contained rapidly with ``stamping out'', could easily exhaust the 
world's supply of emergency FMD vaccine. A FMD outbreak in South Korea 
depleted the banks of FMD vaccines from around the world in order to 
vaccinate a population roughly half the size of the livestock 
population in Iowa. For an outbreak in Iowa with over 20 million hogs 
and approximately four million cattle, the amount of vaccine needed 
could easily exceed 50 million doses in a very short time. Insufficient 
vaccination capacity limits the ability of a strategic response to FMD 
by USDA. The need for additional supplies of FMD vaccine, as well as 
new vaccine approaches and technologies, to help meet this need has 
been recognized by USDA and Department of Homeland Security (DHS) 
officials. USDA has funded the development of the Secure Food Supply 
Plans that incorporate the use of FMD vaccines as an important tool. 
Currently, the beef industry is involved in a collaborative effort with 
USDA, state animal health officials, and academic partners to develop a 
Secure Beef Supply Plan to manage movements of non-infected cattle in 
the event of an FMD outbreak; provide business continuity for 
producers, transporters, and processors; and to maintain a continuous 
supply of safe and wholesome beef for consumers.
    NCBA supported the preparation of a white paper by Dr. James Roth, 
distinguished professor and veterinary specialist at the Center for 
Food Security and Public Health at Iowa State University's College of 
Veterinary Medicine entitled: ``FMD Vaccine Surge Capacity for 
Emergency Use in the United States.'' * The objectives of the white 
paper involved securing and providing information concerning FMD 
vaccine that could be used to seek consensus among the stakeholders, 
Federal officials, and state officials on the best mechanisms to ensure 
vaccine availability to minimize the economic, environmental, animal 
welfare, and food security impacts of a large FMD outbreak in the 
United States. In the white paper, Dr. Roth concluded that the funds 
necessary to enable the surge capacity need for FMD vaccine for 
emergency use in the United States would be estimated at $150 million 
per year for 5 years to help to protect a $100 billion a year (cash 
receipts) animal industry. In September of 2013, the World Reference 
Laboratory for FMD at the Pirbright Institute in Pirbright, United 
Kingdom, recommended that national antigen banks for FMD maintain 23 
strains of FMD virus as live master seeds and inactivated antigen 
concentrates.
---------------------------------------------------------------------------
    * Editor's note: the referenced white paper is available at: http:/
/www.cfsph.iastate.edu/pdf/fmd-vaccine-surge-capacity-for-emergency-
use-in-the-US.
---------------------------------------------------------------------------
    Subsequent to the agriculture stakeholder meeting held in September 
2014 with USDA-APHIS to discuss the U.S. FMD vaccination policy for 
response to an outbreak and existing gaps, USDA-APHIS agreed to develop 
a Request for Information or ``RFI'' to companies regularly engaged in 
FMD vaccine production so that an estimated cost to update the current 
FMD vaccine bank for the United States could be determined.
    Homeland Security Presidential Directive 9 (HSPD 9, January 30, 
2004) provides for the ``Defense of United States Agriculture and 
Food.'' This directive establishes a national policy to defend the 
agriculture and food system against terrorist attacks, major disasters, 
and other emergencies. HSPD 9 directs the Secretary of Agriculture, in 
coordination with the Secretary of Homeland Security, and in 
consultation with the Secretary of Health and Human Services and the 
Administrator of the Environmental Protection Agency, to work with 
state and local governments and the private sector to develop a 
National Veterinary Stockpile (NVS) containing sufficient amounts of 
animal vaccine, antiviral, or therapeutic products to appropriately 
respond to the most damaging animal diseases affecting human health and 
the economy and that will be capable of deployment within 24 hours of 
an outbreak. It is urgent to develop a plan to ensure that adequate 
supplies of multiple strains of FMD vaccine are readily available in 
the event of an accidental or intentional introduction of FMD virus 
into the United States. This action is mandated in Homeland Security 
Presidential Directive 9.
    We encourage USDA to consider convening a stakeholder community 
working group of experts capable of evaluating existing and new 
technology FMD vaccines under development to determine the technologies 
which can best meet future as well as immediate needs for emergency 
response FMD vaccination in the United States. Furthermore, the Federal 
Government must conduct research into alternative delivery methods for 
FMD vaccines which have been shown in cattle and in swine to 
significantly reduce the antigenic mass required for each dose of 
vaccine, thus enabling existing and future vaccine antigen concentrate 
to be formulated into significantly more doses of vaccine.
    The current FMD vaccine bank has several problems. Currently, the 
United States does not have access to enough FMD vaccine to handle an 
outbreak beyond a very small, localized disease event. APHIS manages 
the vaccine bank at Plum Island, New York, where vaccine antigen 
concentrate for a limited number of FMD strains is stored. In the event 
of an FMD outbreak, the antigen would need to be shipped to Pirbright, 
United Kingdom, or Lyon, France, to be turned into finished vaccine and 
then shipped back to the United States for use. This bank is currently 
funded at $1.9 million annually. The turnaround time from the onset of 
an outbreak until finished vaccine product can be delivered to the 
field would be weeks for a small FMD event and months for a larger FMD 
outbreak. Of equal concern is the limited number of FMD vaccine antigen 
strains currently maintained at Plum Island and the limited shelf life 
of the vaccine antigen concentrate that would affect the potency of the 
finished vaccine, should the expiring vaccine antigen stock not be 
rotated out of storage. Additionally, worldwide FMD vaccine production 
is limited and there is no surge capacity currently available to 
produce the millions of doses needed in the event of a large-scale FMD 
outbreak in the United States. Manufacturers with contracts in place 
are producing at maximum capacity for their contracted customers and 
will not abandon these established customers to produce vaccine for the 
United States. Furthermore, the FMD vaccine bank is scheduled to move 
in the future to the NBAF facility in Kansas and the storage capacity 
may be limited for FMD vaccine. For these reasons, we recommend 
consideration for establishing a contract for a vendor-managed, 
offshore FMD bank that has the capability to produce vaccine antigen 
concentrate for all FMD strains currently circulating in the world. A 
contracted offshore FMD bank would provide a vendor-managed-inventory 
of vaccine with replacement of outdated product, facilitated vaccine 
finishing, and ultimately increased efficiency in FMD vaccine delivery 
for use in an FMD outbreak.
    Finally, we request that the Committee work with USDA and encourage 
them to budget the funds needed for the update and modernization of the 
National Veterinary Stockpile of FMD vaccine.
    Thank you for the opportunity to be here today, and we look forward 
to working with you to ensure that the United States is prepared for an 
outbreak of FMD.

    Mrs. Hartzler. Thank you, Doctor, and for all of you for 
your testimony. As a former pork producer and someone who 
continues to raise cattle on our farm, this is something that 
is very, very important to me and to Missouri's 4th District, 
and it is important that we get this right. And I am also a 
Member of the Armed Services Committee, and after we go through 
the first round, I might want to come back to agro-terrorism 
and some questions with that.
    But I would like to start off with this question. In a 
recent briefing with USDA, they mention public private 
partnerships as a possible way to address the funding of a 
vaccine stockpile. So has your industry thought about what that 
would look like, and what you could support?
    So I will just open it up to anyone who might want to 
answer that. A public-private partnership to help with the 
funding.
    So the pork producers, the cattle, sheep, you don't want to 
say hey, we will help pay for it? Let's do a show of hands.
    Dr. Hill. I mentioned that in my oral testimony a little 
bit. I guess it is not that our industry and probably the 
livestock industry is opposed to some kind of partnership, but 
we would have to have some kind of a plan and know what the 
cost is before we would want to commit to it. No matter how you 
slice it, this is going to be an expensive program. It is going 
to be, and Dr. Roth can probably give you some idea of what he 
estimates the cost of developing an effective vaccine bank 
would be.
    I don't think the industry is totally opposed to some kind 
of participation, though.
    Mrs. Hartzler. Yes, so let's go to Dr. Roth. You mentioned 
that you need 23 different vaccines, and so can you talk about 
that a little bit, and then what do you anticipate the cost 
would be?
    Dr. Roth. So the World Reference Laboratory for FMD in 
Pirbright, England, puts out a list of the strains that every 
country should maintain in their bank, and there are 23 strains 
that aren't cross protected, and that is based on active 
strains of virus around the world.
    In this white paper that I developed for the commodity 
groups, we estimated that it would cost about $150 million a 
year, and it would take 5 years to build a robust supply for 
all 23 strains, so you would have immediate availability, 
short-term availability, and long-term availability.
    Now I think that can probably be reduced with more people 
engaged in planning and working more with the vaccine industry, 
and looking at some of these new technologies. So I think that 
is a very large number, but if we look at the potential impact 
of FMD, it is not such a big number to protect U.S. 
agriculture.
    Mrs. Hartzler. How long does a vaccine last? What's the 
lifespan of the vaccine, and how often do we have to replenish 
that?
    Dr. Roth. If you have finished vaccine in a bottle ready to 
go, that lasts for 18 to 24 months. The vaccine bank is frozen 
antigen concentrate, and that can last 5, maybe 10 years. But 
in the white paper, we proposed that work with the 
manufacturers to use vendor managed inventory, so they keep 
finished vaccine in their inventory, and when they make a new 
batch, they replace that. So they always might keep 20 million 
doses on hand, and then they sell from that inventory to their 
current customers. And you would have to pay them for that.
    Similarly, with the antigen concentrate, they could 
maintain a rotating stock of antigen concentrate. After it 
begins to age, then they formulate it to vaccine, sell it, and 
replace it with more antigen concentrate. So there would be 
uses for most of these strains. You don't have to destroy it.
    Mrs. Hartzler. So now that we have at least a figure, $150 
million a year, 5 years, so back to the funding thing. One idea 
was a check-off. I'm a big supporter of check-offs for 
promotion and education. So the idea of a check-off for all 
cloven hoofed animals or perhaps a processing fee. So are 
either of these something that your industry would support? I 
will start with the cattle.
    Dr. Sjeklocha. I would say that there are concerns about 
earmarking. If the beef industry would put more money into this 
check-off to develop this vaccine pool, and we had an outbreak 
and there would be some concerns, like if the pork industry 
needed X amount of vaccine, the beef industry needed so much, 
would there be in-fighting or fighting between those two groups 
as to who would get the most vaccine to deal with their 
problems.
    I think overall some industry involvement would be 
acceptable, but that is one of the problems that I think we 
would have to face.
    Mrs. Hartzler. Yes. Dr. Wolf?
    Dr. Wolf. Challenging question, and my thought process is a 
little different in that the sheep producers would be 
cooperating on a scale they have never before cooperated. We 
would be talking about every sheep producer in a large area 
doing something that was not scheduled and time consuming, and 
complying 100 percent.
    And so I look at it as that this isn't just a livestock 
industry problem. This is an all of agriculture problem. If we 
had FMD in our area today, there would be no grain moving to 
all the livestock producers in the area, and think of the 
ripple effect, or hay, or maybe there wouldn't even be fuel 
coming to your farm because of trucks not being allowed to 
move.
    And so I think that the public stands to lose so much that 
the industry groups would step forward, but that they would 
have a difficult time shouldering a majority of the costs, 
because their losses are already going to be huge.
    Mrs. Hartzler. Good point. Quickly, Dr. Hill, do you have 
anything to add for the pork producers?
    Dr. Hill. Yes, and I think when you are referring to a 
check-off, you are referring to mandatory check-off, and under 
the current law, that would not be legal for us to use the 
money for that. Our check-off is for research promotion and 
education, but again, I would agree with Dr. Wolf. I think the 
industry would be willing to participate, but not to the extent 
if the $150 million is right, not to that level.
    Mrs. Hartzler. All right, thank you very much.
    Ranking Member Costa?
    Mr. Costa. Thank you very much.
    Dr. Sjeklocha, to the last question, doesn't that point out 
if there were such an outbreak, that there would need to be 
some sort of a protocol that would be established, and hasn't 
that been thought out in some fashion between the USDA and the 
various industries represented here?
    Dr. Sjeklocha. As far as a check-off?
    Mr. Costa. No, not a check-off. In terms of how the vaccine 
that is in supply that would be readily available and that that 
would have to be developed. What is our supply of vaccine 
today? Dr. Roth, you talked about 23 vaccines. I would like 
some clarification, you are talking about a vaccine or 23 
various vaccines needed to----
    Dr. Roth. To cover all of the potential strains around the 
world, it would take 23 vaccines.
    Mr. Costa. But, if we had a strain that would break out 
here, do we have a particular vaccine for any of those 23 
strains?
    Dr. Roth. My understanding is that the North American 
Vaccine Bank has about 14 strains, perhaps.
    Mr. Costa. Fourteen of the 23?
    Dr. Roth. Yes, and they are the most common strains. They 
have banked the most common strains.
    Mr. Costa. And what is our understanding of the level of 
the supply in the event of it?
    Dr. Roth. My understanding is for most of those strains, it 
is about 2\1/2\ million doses.
    Mr. Costa. I see. The issue of animal husbandry of the 
stakeholders that are involved, I understand there was a 
meeting that began with USDA and APHIS to develop and improve 
the current strategies for an effective response. To what 
extent is industry involved in this preliminary planning and 
implementing for a defense and response program? I mean, it is 
too bad we don't have USDA here to respond, are any of you 
aware of those efforts?
    Dr. Hill. Well, there are ongoing, what do you call them, 
practices or----
    Dr. Wolf. Exercises.
    Dr. Hill. What?
    Dr. Wolf. Exercises.
    Dr. Hill. Yes, exercises. Thank you, Cindy. There are 
exercises, ongoing exercises that the industry cooperates with 
USDA looking at everything from movements to slaughter and that 
sort of thing. Those plans are in place, but----
    Mr. Costa. Do they need to be updated?
    Dr. Hill. Pardon?
    Mr. Costa. Do they need to be updated?
    Dr. Hill. Well, I think they are continually updated.
    Mr. Costa. All right. Do they meet on a regular basis with 
industry?
    Dr. Hill. Pardon?
    Mr. Costa. Does USDA and APHIS meet on a regular basis 
with----
    Dr. Hill. Absolutely.
    Mr. Costa. Okay, so maybe it is a better question that we 
address to the Department.
    In terms of the economic and market concerns, we again know 
about the outbreak with sheep in the UK in 2001. Any 
estimations in terms of the market aspects and export impacts 
to America's livestock industry in the event of an outbreak? 
What sort of constraints and confinements might be put in 
place?
    Dr. Roth. Well, the pork board funded a study using 
economists at Iowa State University in 2011, and they estimated 
that over a 10 year period--because without vaccine, this could 
go on a very long time before we get our FMD free status back, 
that it could cost the pork industry about $57 billion, beef, 
$71 billion, corn, $44 billion, and soybeans, $25 billion, 
because it will impact green markets also.
    Mr. Costa. Well, Madam Chair, I think for the record we 
ought to get an estimate in terms of the economic impacts, so 
we would have a better knowledge of that.
    And it was mentioned here again in terms that a couple of 
you noted in the event of an outbreak, the ability to deal with 
containment. When I chaired the Senate Agriculture and Water 
Committee in California, we had in my district a dairy that had 
an unfortunate circumstance with poison in the feed, and out of 
what is considered a smaller size herd, 500 milking cows, 300 
were lost. Just trying to deal within a 24, 48 hour basis with 
300 carcasses and the disposal and the complications. Dairies 
in California are anywhere from 1,000 to 5,000 head operations 
where you have cattle, 100,000, 50,000, 100,000 head of cattle 
are not unusual. What is the preparation to deal with that 
amount of cattle in the event that you have to deal with the 
eradication and the disposal and all the health and safety 
requirements that come with it?
    Dr. Roth. The new response indicates that when the outbreak 
gets that large, if it gets in a large feedlot or large dairy--
--
    Mr. Costa. Yes, feedlot, large dairy.
    Dr. Roth.--you just can't kill them. It would take too 
long. And if you could kill them, you can't dispose of them. So 
the recommendation is not to kill them, and to let them live 
and we go from stamping out to other strategies hopefully 
involving vaccine to control it. Because most adult cattle will 
recover from FMD, most adult pigs, too. It can be fairly lethal 
in calves and baby pigs.
    Mr. Costa. But at that point, and my time has expired, you 
would have to do some sort of isolation, I would think, from 
those, whether it be pork or livestock of any kind, so that 
they would not contaminate the other herds.
    Dr. Roth. So there would be major efforts made in 
biocontainment, and that is difficult, especially in animals 
outdoors like beef and dairy animals.
    Mr. Costa. Well yes, most of these are outdoors.
    Dr. Roth. Yes, so it would be very, very difficult if it 
gets into those big units to contain it without vaccine.
    Dr. Hill. I might just add, though, in an outbreak 
situation, what you always try to do is you create circles, and 
the circles would be controlling movement but also if we had 
vaccine available, it would be vaccinating those animals in 
that circle, and the vaccine would help with the shedding of 
the virus. It drastically reduces the amount of virus that is 
shed by animals that are exposed or infected. That is part of 
this plan.
    Mr. Costa. So when the animals recover, are they useful?
    Dr. Hill. Yes, many of them do recover.
    Mr. Costa. My time has expired. Do you want to say 
something?
    Dr. Sjeklocha. Yes. I work for Cattle Empire feedyards. Our 
largest feedyard is 87,000 head, and the other end of that is 
that we have to keep in mind that when we are trying to contain 
that area, that 87,000 head feedyard uses about 35 truckloads 
of corn every day. So that is going to be a logistical 
nightmare on top of getting animal health supplies in, and that 
sort of thing. So it is a big issue.
    Mr. Costa. Protocols and preparedness are absolutely 
essential.
    Mrs. Hartzler. Thank you. The gentleman from Iowa, Mr. 
King.
    Mr. King. Thank you, Madam Chair, and I thank the 
witnesses. I would pick up where Mr. Costa was on this, that 
you envision, directly to Dr. Hill first, you turn first to the 
concept of containing this virus in as localized an area as 
possible with concentric circles growing out from that as you 
begin to see how broad it might be growing. What I don't know 
is how quickly the vaccine is effective, and if it is effective 
at all against an infected animal.
    Dr. Hill. Well, the whole thing is based on developing 
immunity, and so immunity takes time. This is a kill vaccine, 
so for maximum production of immunity, you are going to have to 
give two doses. So there is a time delay, but still, I think 
developing that circle and getting out far enough, a lot of 
times an outbreak situation has happened in England, the circle 
was too small. Then all of a sudden you have an outbreak here 
so you make a circle around that, making the circle bigger at 
first if we had enough vaccine to really encompass a large 
population in a bigger circle, we would have a better chance of 
controlling the spread of the disease.
    But you are right, it does take time to develop immunity.
    Mr. King. And just taking that in the picture, let's just 
suggest that we drew the circle big enough to contain the virus 
and I guess it doesn't matter for our discussion purposes how 
broad, but I am just going to say a a 10 mile radius. And if we 
are working within that circle and we have contained the 
livestock within that circle, then if you are not going to 
euthanize the animals, but vaccinate them, there will be an 
infectious spreading period of time until the vaccine might 
begin to contain it. What happens to the animals that are 
infected? Can you ever get them cleaned up where they can go to 
market? Do you allow the infected animals to go to market?
    Dr. Hill. Yes, the adult animals will recover. With pigs, 
your suckling pigs, small pigs are probably more severely 
affected and mortality is going to be higher in those pigs. But 
the adult animals, any finishing pigs, for example, most of 
those would recover and being as it is not a food safety issue, 
could go to market.
    Mr. King. I know that we have done that in the past, like 
pseudo-rabies, for example, can go to market safely. What about 
livestock identification traceability? How much of a factor is 
that in addressing this?
    Dr. Hill. Well, I can speak for the pork industry. We now 
have identification of sows, mandatory identification of sows 
going to slaughter, and we can identify our slaughter pigs by 
batching systems that are very effective. So we do have a good 
identification program in the swine industry, and I will let my 
friends in the cattle and sheep industry speak for themselves.
    Mr. King. I am about to ask him, but first I want to follow 
up on this. From the moment that you might recognize a disease 
and issue an order to quarantine that radius we talked about, 
let's say a 10 mile radius, how long does it take before that 
quarantine order could be effective? And then I am going to ask 
you how far has some of that livestock been hauled in that 
period of time?
    Dr. Hill. Well, I will answer your last part of your 
question first. That is whole rub on this thing. We import a 
lot of pigs into Iowa, as you well know. If we had a shipment 
of pigs that came from North Carolina, for example, or out of 
Canada, they can be in transit for 24 hours. They could spread 
virus all the way across the United States. The first part of 
your question again?
    Mr. King. Was how long does it take to implement a 
quarantine order? How long does it take for the information to 
get out? If you say we are going to stop the transport of pigs 
as quickly as we can, how long would it be before we can expect 
that can happen?
    Dr. Hill. Well, every situation is going to be different, 
and that is probably a question we need to ask APHIS.
    Mr. King. Yes.
    Dr. Hill. But with the state health officers and the 
Federal people, it would be fairly quick, as we had with high 
path AI. And I will just mention, Dr. Roth talked about how to 
get rid of these animals. That was one of the biggest problems 
in Iowa and Minnesota that we had was how to dispose of these 
birds.
    Mr. King. Indeed, and that is a bigger question, of course, 
with livestock, and I wanted to get to that. But I would like 
to direct a question over to Dr. Sjeklocha.
    The question to traceability that I asked Dr. Hill, what 
about traceability of cattle, and what is our capability, and 
how much does that help us address a disease outbreak?
    Dr. Sjeklocha. At this point, I would say traceability of 
cattle: first, traceability of cattle would be helpful. It is 
not widely followed. There is not a real good system ever since 
the eradication program went away. There are some people that 
do have source and age verified cattle in their feedyards. 
Those are usually producers, cow/calf producers that want to, 
for instance, track their carcass data all the way to the 
slaughter plant, that sort of thing.
    There isn't a good traceability system in place right now. 
I would say at our place, we probably receive cattle from ten 
different states just last week, so yes, it would be a big 
issue.
    Mr. King. Let me just submit that when the industry is 
ready, I have a good framework to look at for a traceability 
bill that a lot of the industries looked at and agreed with. I 
don't intend to move it until the industry is ready, but when 
you are, let's talk.
    I appreciate the testimony of all the witnesses, and I 
yield back the balance of my time.
    Mrs. Hartzler. Very good. Now we go to someone who 
certainly knows this, a veterinarian from Florida, Mr. Yoho.
    Mr. Yoho. Thank you, Madam Chair. I appreciate you all 
being here, and I can relate real well with what you are 
talking about. I just want to express how thankful I am that 
you are here bringing this up as the importance of it, how it 
would affect this market. The billions of dollars that it would 
cost production here, the food supply here, plus our export 
markets. It would be hard to really comprehend or tabulate 
that. It would be in the hundreds of billions of dollars from 
what I have seen, just on the beef side. Again, I want to thank 
you for this. The thing I do feel good about in asking fellow 
veterinarians is knowing how rapidly we respond with the 
diagnostics, getting that word out, reporting that, and that is 
imperative that we let all of our associations know that, and 
then on the other side is to make sure that countries that have 
active cases, they don't come in here. Because as you brought 
up, Dr. Hill, did you bring up about the BSE, how that one case 
that happened--or you did over there, Dr. Sjeklocha, how you 
brought up that one case from 2003 and how it cut down $2 
billion worth of exports, which that was one case. And so we 
can imagine the detrimental effect this would have. And so I 
feel good that we would jump on the quarantine. The circle 
would be there. We would vaccinate on the perimeter of that 
first, I would think, and then follow up.
    Mr. Parker, you are with Merial, correct? What is the 
turnaround time if you had the specific serotype diagnosed, 
what is the turnaround time from diagnosis, starting 
production, and getting it out in the vaccine form? Did you say 
4 days for 2\1/2\ million doses?
    Mr. Parker. I am sorry?
    Mr. Yoho. Did you say 4 days for 2\1/2\ million doses?
    Mr. Parker. Yes, sir. Once we receive official notification 
of a confirmation of diagnosis from the USDA, that starts the 
process. We are prepared to begin the gearing up to make our 
production facilities available to receive, as in today's 
situation, they would need to take that antigen that is in Plum 
Island, send it over to us in England or in France, and while 
that is in transit, we are preparing our abilities to convert 
that antigen into----
    Mr. Yoho. Are there any restrictions on that new serovar or 
one you haven't used? Is it already FDA approved? Does it have 
to go through all the regulatory hoops and that, or is it ready 
to go in 4 days?
    Mr. Parker. Not at this time. Anything that is in the North 
America Bank is up to the point of registration, so that there 
is the willingness of the USDA to accept that, because we have 
demonstrated with our outline of production, as with approved 
vaccines here in the United States----
    Mr. Yoho. Okay.
    Mr. Parker. We have gone up just short of the point of 
approval.
    We can convert. Once we receive it in our facility, we can 
convert that antigen within 4 days to finished vaccine.
    Mr. Yoho. And so we have those banks and we have 14 
serovars here that we can--or the antigens stored that we could 
go into and find out pretty quick as soon as diagnostics are 
done, start producing that, and if it is a serovar that is in 
another country, we can bring that over here? There are no 
restrictions as far as you know?
    Mr. Parker. Well if it is not in the bank and we do not 
have the strain, then we have to adapt to that strain to a 
vaccine master seed. So that is a little bit longer process, 
but anything in the bank, we have the ability to turn that 
around within that 4 day time period, once we receive it.
    Mr. Yoho. All right, and then on the new technology with 
the DNA recombinant vaccines, and I know we are looking at the 
leaderless ones, which in my understanding, that would be 
almost like a multivalent type of vaccine, is that correct?
    Mr. Parker. Jim, do you know?
    Dr. Roth. You have to make multiple monovalent vaccines, 
and them combine them with that leaderless. There is also a 
human adenovirus 5 vectored vaccine, too, and those are one 
strain at a time also.
    Mr. Yoho. I was over at the NSF and we were talking to the 
researchers over there, and they are developing a monovalent 
influenza vaccine that they are taking a glycoprotein out for 
the cell wall, and it was for all strains of influenza and that 
is cutting edge. And if that is where we need to go or if that 
is possible with this type of infection, this type of viral 
infection, if that is possible, that is something we need to 
put the R&D in and make sure that is readily available.
    Mr. Parker. Yes, sir, Congressman, as far as I am aware 
right now, there is not that universal vector platform for new 
vaccines; however, that does not mean that there is not work 
being done in that area. There is plenty of effort within many 
company's R&D effort to look at the most optimal solution.
    Mr. Yoho. All right, and then just one last question. I 
know FMD is the one we are most concerned about right now, but 
we have African swine fever and all the ones we haven't thought 
about coming here. I hope the research and development is being 
done on that, and I would like to see a private-public 
partnership done in that so that we are ready, that we are 
never set with a national food security crisis in this county.
    So I appreciate your time here, and I appreciate your 
efforts in bringing this to our attention. Thank you.
    Mrs. Hartzler. I thank the gentleman.
    Now we have the gentleman from Mississippi, Representative 
Kelly.
    Mr. Kelly. And this first question, Mr. Parker, is directed 
to you, and you probably have answered this. I am just trying 
to get it clear in my mind. If you have the antigen, 4 days 
until you can get the vaccine, is that correct?
    Mr. Parker. I am sorry, repeat that?
    Mr. Kelly. If you have the antigen available, it is 4 days 
until you have an effective vaccine that is available to start?
    Mr. Parker. Once we receive it back from USDA, then we can 
turn it around for delivery back to the U.S. within 4 days.
    Mr. Kelly. Okay, and if you don't have an adequate supply 
of antigen, then how long does it take to go, I guess, from 
scratch to a vaccine, if you know the strain?
    Mr. Parker. To characterize the strain and develop a new 
master seed, I would have to check with my industrial ops 
folks. I can't answer that specifically, but it is an extended 
period of time.
    Mr. Kelly. You are not talking days, you are talking at 
least weeks?
    Mr. Parker. Yes, sir. Yes.
    Mr. Kelly. Okay, and then the other question, and this is 
for anybody on the panel, but probably Mr. Parker again, you 
are probably going to be in a better position to answer this. 
When you are counting the number of doses that you have on hand 
or the antigen that you have on hand, is that for the initial 
dose or is that for both doses that an animal will have to 
have?
    Mr. Parker. What is in the bank now, that would be up to 
USDA and the industry to determine what the dose regimen is, 
and in general, swine typically require two doses. There are 
some situations for ruminants where you can get away with a 
single dose, but then again, that is going to be up to APHIS 
and working with the industry to make that determination.
    Mr. Kelly. And again, this is to anyone on the panel. One 
of the things that concerns me most is kind of like with the 
avian flu. It is not so much the trucks that go across this 
country carrying animals, okay, domesticated animals, but the 
actual wildlife, the feral swine and the deer. There are more 
deer in Mississippi than there are people, and there are a lot 
of other states that are like that. What is our plan to deal 
with those which; first, aren't as easy to depopulate. If they 
were, there wouldn't be any deer or wild swine in Mississippi, 
because the feral swine are very destructive in our state. So 
what is the plan to keep those from spreading and to keep them 
in those concentric circles?
    Dr. Roth. That would be very difficult to do, as you can 
imagine. The deer and feral swine, especially the feral swine, 
move pretty freely, and they can be infected with the virus and 
they can also transmit it just as fomites on their feet and so 
forth. So movement of wild animals between herds of livestock 
would be a real risk, and pretty hard to stop.
    Mr. Kelly. And then again, this is probably something I 
should understand, in what way is it passed from one animal to 
another? Is it airborne, is it through mites or mosquitoes or 
ticks? In what ways can it be transmitted from one animal to 
another?
    Dr. Roth. So it's not vector-borne through ticks and 
mosquitoes and that kind of thing. It is mostly direct contact, 
and animals that are infected shed high concentration of virus 
in their saliva and feces, so anything they contaminate that 
another animal touches, they can pick it up.
    Mr. Kelly. And then this is my final question, and it is to 
anyone on the panel. The avian flu hit Minnesota and some other 
states pretty hard. There was a lot of cross talk between the 
spring and the fall when we thought it would come to 
Mississippi or to other southern states with the migratory fowl 
and those things. So I guess my question is have you studied 
the outbreak of the avian flu, and what are the lessons learned 
from the way they handled either well or poorly that we can use 
for this similar foot-and-mouth disease, or for any other 
disease that can be transmitted through our livestock?
    Dr. Roth. We have also worked on the secure egg and turkey 
supply plans, and what we learned is that the biosecurity that 
was adequate for the normal diseases in poultry was not 
adequate for high-path avian influenza. Biosecurity is 
expensive and inconvenient, and we would pretty quickly find 
that the biosecurity we have in the cattle industry isn't 
adequate for foot-and-mouth disease. And to implement enough 
biosecurity in the cattle industry would be pretty difficult 
for animals like yours.
    Dr. Sjeklocha. It would be a monumental task to tackle 
biosecurity in the beef industry.
    Dr. Hill. If you still have some time, I would like to go 
back to your question about vaccines.
    Mr. Kelly. Absolutely.
    Dr. Hill. Okay. So what Mr. Parker was talking about was 
developing this vaccine in 4 days, but he's talking about 
developing 2.5 million doses. We need 40 million doses, okay. 
And the other thing is in regards to the question about 
different DNA types of vaccines, yes, we are working on those. 
The industry is working on them. Do we need more money and 
research to do that? Yes, but those are down the road type 
things. Those are not vaccines that are going to be available 
next year or the next year, or maybe within 5 years. So when we 
are talking about this vaccine bank, we are talking about doing 
something now, rather than waiting for one of these newer 
vaccines. Thank you.
    Mr. Kelly. I thank all you gentlemen and lady for your 
expertise and you coming here to help us with this, and your 
preparation, and Madam Chair, I yield back.
    Mrs. Hartzler. You have good questions. I want to build on 
some of your questions there.
    So how long does the virus last, if it is transmitted 
through saliva and feces?
    Dr. Roth. So an infected animal will shed virus for up to a 
week or so, and if that virus is frozen in the winter, it will 
last a very long time. In the middle of summer with a sunny 
day, it doesn't last very long at all. So it depends on the 
climatic conditions.
    Mrs. Hartzler. Okay, and we have talked about the problem 
with disposal. So how would that typically--if you did do 
that--I know you said we are not going to try to do that 
anymore, but would it be burying them or incinerating them, or 
what types of things?
    Dr. Hill. Well, we wish we had the answer to that question, 
because we did not have the answer to that question with high-
path AI. I mean, there were all kinds of problems. Some people 
didn't want to bury them on the farms. Some of them were taken 
in closed trucks down the interstate to a landfill. I mean, 
there was all kinds of different problems. And that is one of 
the issues that APHIS has addressed is that even if we could 
kill all these animals, how do we dispose of them? It is a 
monumental problem. That is one of the reasons they decided 
that vaccinating and living for another day is the plan of 
choice.
    Mrs. Hartzler. Okay. I wanted to build on what you said 
earlier, Dr. Wolf. I thought that was very insightful about the 
need for in addition to the vaccines, to have a vaccine 
preparedness plan that includes making sure you have enough 
needles and ear tags, and those type of things. So first of 
all, do we have a vaccine preparedness plan? Is there one?
    Dr. Wolf. There is a plan in place that Dr. Roth has with 
him. It is extremely well-written and I encourage all of you to 
go to the Iowa State site and read that, and then APHIS also 
has a published plan. But the challenge is, from my experience, 
for instance, when we had bovine TB in northwest Minnesota, 
when we were ready to enact the TB control plan, we found 
producers didn't have handling facilities, for example, and so 
going back to where we are in today's economy, if all of a 
sudden we order, whether it is 2\1/2\, 10, or 40 million 
needles, I don't think that our suppliers would have that on 
hand.
    Mrs. Hartzler. So is that part of the plan to have those in 
place, in addition to the need for the vaccine itself? Is that 
what Congress potentially--and industry, because you all are 
going to support chipping in--but anyway, is that all something 
that we would fund? Have enough vaccine have enough needles, 
have enough ear tags, all of that, or not? That is just a side 
issue, and by the way, we need these other things.
    Dr. Roth. The National Veterinary Stockpile is stockpiling 
needles and syringes and personal protective equipment, and 
those sorts of things. Their funding has not been adequate to 
have a really robust stockpile, but they are stockpiling a lot 
of equipment that might be needed. They haven't had the funding 
to stockpile the vaccine yet.
    Mrs. Hartzler. Okay, and my last question, and I know Mr. 
Yoho has a question, so back to my statement earlier that I am 
on the Armed Services Committee as well. I am very concerned 
about terrorism and agro-terrorism is certainly involved in 
that. That is why I was trying to get to how is it spread. I 
know this has been talked about. Some are local meetings that 
have been held, don't want to talk too much to give people 
ideas, but how concerned are you of this virus being used 
potentially as a terrorism threat to hurt our economy, just 
like terrorists hijacked airplanes and impacted Wall Street, 
our whole economy with that type of attack. If they were to 
attack our livestock industry in this way, it would have a huge 
detrimental impact on our country. And so how concerned, let's 
say from a scale of 1 to 10, 10 being this is extreme threat to 
0, probably not. How concerned are you of this potentially as a 
terrorism threat?
    Dr. Hill. Twelve.
    Mrs. Hartzler. Wow. Wow.
    Dr. Wolf. I would agree.
    Mr. Parker. I think most terrorists are interested in 
killing people, but yes, it is a huge concern. I would put it 
up there maybe not at 12, but definitely at 10.
    Mrs. Hartzler. Okay. I think that adds impetus to the 
importance of this, not just from important to agriculture, but 
then to our entire economy as well.
    All right, Mr. Yoho?
    Mr. Yoho. Thank you, Madam Chair, and again, I appreciate 
you guys being here.
    That is something I would like to talk to you more about, 
but I would rather not talk about it on the record. You were 
talking about the cost of this, and I want to bring up a couple 
things. The RFID identification tags, I have been kind of 
reluctant with my clients, because you just hate to have a 
mandate or force them into something. But on something like 
this, when we see the potential and the potential damage that 
it could do, it is something as you go back to your industries, 
talk about that and the hog industry just seems to have a lot 
better tracking system, it seems like the way you manage. I 
have complete confidence that we can contain, get our circles 
in there with modern husbandry practices and get the vaccines 
out there. We would have a little lag in there. The thing we 
can't control is the wild movement of animals, and I know in 
Florida there is a feral hog behind every pine tree or oak 
tree, and it is hard to contain all of those. And so when we 
are talking about the cost, and the 2008 Farm Bill established 
a program of plant, pest, and disease management and disaster 
prevention. Mandatory funding has been used very effectively 
through the program for the benefit of the specialty crops. To 
what extent has each of your organizations discussed the 
possibility of creating a similar program within the Animal 
Health Protection Act, and should it be mandatory or would it 
be voluntarily through your associations, and put into a trust 
fund for R&D and let it grow, at some point the best case 
scenario is we don't have to use it for a long, long time, and 
have it becoming self-perpetuating possibly. What are your 
thoughts on that?
    Dr. Hill. Are you referring to the Commodity Credit 
Corporation? Is that what you are talking about?
    Mr. Yoho. The Animal Health Protection Act from the 2008 
Farm Bill.
    Dr. Hill. Yes.
    Mr. Yoho. With plant, pest, and disease management and 
disaster prevention, there was a mandatory funding used in that 
to benefit the specialty crops for research and development.
    Dr. Hill. We would support that, at least in the swine 
industry, and it needs to be mandatory, not just advisory.
    Mr. Yoho. That is right.
    Dr. Hill. And so that money possibly could come from the 
Commodity Credit Corporation.
    Mr. Yoho. Well, that is something. If you take it back 
because nobody wants to put more money into a program like 
that, but the penny a day doubled theory every day, in a 
months' time or 31 days, a penny if you double it every day 
becomes $10.3 million. And if you can come up with some minute 
formula and just put a little bit in there, but we're doing it 
on every head that gets sold on all livestock, not that I am 
mandating or recommending a mandate from the Federal 
Government, because we need less of those in my opinion, but to 
be prepared for that day when it comes, and hopefully we don't 
ever see it. But it is better to be prepared for that, because 
it is hard to play catch up, especially in the situation this 
country is in now economically. And so if we can have that 
lead-in from industry and say, ``You know what, we would like 
to do this, and it could be cross species or animal 
disciplines.'' Just more food for thought, than even an answer, 
but if you have any other different thoughts, let us know.
    Dr. Sjeklocha. I think we would be interested in any and 
all options. We are certainly open to discuss any of that.
    Mr. Yoho. Yes. Worst thing is when you go to a farm and you 
pull out, you see an animal and you don't have the right 
antibiotic or the right vaccine there, and it is like well, 
didn't do much good here. So we don't want to be caught short 
like that. I appreciate your time. Go ahead.
    Mr. Parker. Congressman, just one follow up on some of the 
premise behind your question. It is not just a question of the 
money to do this. There is a time element.
    Mr. Yoho. Yes.
    Mr. Parker. As I stated in my testimony, it is not only my 
company, but any other conventional manufacturer of FMD vaccine 
today. We have no excess capacity. We have to build to meet a 
demand that is the size of the United States. That would be 
larger than anything that we consider, so as of today, there is 
no excess industrial capacity for FMD vaccine manufacturing. If 
we have an outbreak today, it may be 2 to 3 years before we can 
get you the vaccine that you need to address this.
    Mr. Yoho. See, I didn't know that. I mean, that is just 
coming out now. Is it almost like something the Federal 
Government maybe ought to have on hand, ready to go, ready to 
produce something?
    Mr. Parker. That is the vaccine bank. That is in a 
coordinated effort in partnership with the government, we can 
work towards something like this, but we need to know what we 
need to shoot at. Right now, we have not been asked the 
official question, so we don't know what to shoot at, but if we 
are asked the question, we can work with the government to 
achieve some notion of optimization.
    Mr. Yoho. I can't speak for the Chairman, but I would 
recommend you send those recommendations up here to this 
Committee, and I am sure he would be happy to look at those.
    And with that, I yield back, and thank you for your time.
    Mr. Parker. Thank you.
    The Chairman [presiding.] Well, I want to thank everybody 
for attending the hearing. I am sorry that I missed a good 
portion of it. We had a Transportation and Infrastructure FAA 
markup, and had about six amendments to vote on that took a 
little while. But I want to thank all the Members that came, 
and their participation. I want to thank all the witnesses for 
your time and your expertise. I understand that a lot of the 
questions that I had have already been asked, so I am not going 
to go into all of that. I will catch up with it in the record 
myself.
    But I want to thank each of you again for your time and 
your interest in this. I think this is a very, very, very 
important issue to stay out in front of, to stay ahead of the 
curve on, and I really appreciate your time and attention and 
working with the Committee to do everything we can to make sure 
that we don't have an issue in this country.
    Under the rules of the Committee, the record of today's 
hearing will remain open for 10 calendar days to receive 
additional material and supplementary written responses from 
the witnesses to any questions posed by a Member. This hearing 
of the Subcommittee on Livestock and Foreign Agriculture of the 
Committee on Agriculture is now adjourned.
    [Whereupon, at 3:21 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
    Supplementary Material Submitted by David B. Sjeklocha, D.V.M.,
   Operations Manager of Animal Health & Welfare, Cattle Empire LLC, 
    Satanta, KS; on Behalf of National Cattleman's Beef Association
Responses to Questions Raised During the Hearing
    Question 1. In a recent briefing with USDA, they mentioned public-
private partnerships as a possible way to address the funding of a 
vaccine stockpile. Has your industry thought about what that would look 
like and what you could support?
    Answer. The beef industry remains committed to identifying 
solutions to strengthen and improve our country's Foot-and-Mouth 
disease (FMD) preparedness plans. Together with the National Pork Board 
and the National Milk Producers Federation, the National Cattlemen's 
Beef Association financed a white paper, written by Dr. Jim Roth at 
Iowa State University, to explore the FMD vaccine supply for emergency 
use and surge capacity in the United States. The current FMD vaccine 
supply for the United States was found to be inadequate for control of 
a type 3 or larger FMD outbreak. The white paper estimated a financial 
need of $150 million/year for 5 years to acquire the necessary vaccine 
antigen concentrates (VAC) for the most common FMD serotypes viewed as 
potential threats to the United States. In a stakeholder meeting with 
representatives from USDA-APHIS, held in September 2014, discussions 
for financing the needed FMD vaccine included proposals for developing 
funds through the commodity check-off programs or through user fee 
systems. Unfortunately, the Beef Promotion and Research Order (1986) 
does not authorize for Beef Check-off funds to be used to directly 
finance a national FMD vaccine program. Furthermore, the user fee 
vehicle, upon further discussion at the meeting, was believed by many 
in attendance to be inadequate for producing the necessary funding in a 
timely manner. It is our understanding that in order to secure the 
necessary FMD vaccine, working within the current market supplies, a 
significant financial commitment would need to be made by the United 
States Government to a vaccine manufacturer to produce the FMD vaccine 
product and most likely, a new facility for vaccine production would be 
required from the vaccine sponsor to meet the production demands. With 
the knowledge that significant and readily available funding would be 
needed, the animal agriculture industry seeks to increase Congressional 
awareness for FMD vaccine supply problems and requests consideration 
for ways to increase funding at USDA-APHIS to meet the agency mission 
to protect animal health.

    Question 2. What are some of the activities that the livestock 
industry has been involved with to prepare for the event of an FMD 
outbreak? Any focus on consumers or business continuity?
    Answer. The beef cattle industry has been involved in a variety of 
FMD preparedness activities. The beef industry quality assurance 
program, Beef Quality Assurance (BQA), contains biosecurity components 
that are focused at the individual farm level with discussions for 
prevention and control of possible disease agents, biocontainment, and 
managed movements. Individual farms are encouraged to develop 
biosecurity plans. The beef industry is currently working with 
governmental and academic partners to develop a secure food supply plan 
for the beef cattle industry in the event of an FMD outbreak. The 
Secure Beef Supply plan would provide managed movements for non-
infected animals and products in an FMD outbreak situation and would 
function to maintain continuity of business for producers and to ensure 
a safe food supply for consumers. Collaboratively, the beef industry 
works with other commodity groups and state and Federal animal health 
officials to develop FMD preparedness action and communication plans. 
The industry has been involved in a variety of FMD preparedness drills 
which occur in the various states. Additionally, the beef industry is 
actively involved with the Cross Species FMD Communications group, 
whose goals are to create a unified FMD crisis response plan; share FMD 
messaging; and form government partnerships for a coordinated FMD 
response. The group works to prevent supply disruptions to consumers 
and to ensure consumer confidence in meat and milk products during an 
FMD outbreak. Finally, the Cross Species FMD Communications group 
maintains an informational website, www.FootandMouthDiseaseInfo.org.

    Question 3. FMD presents a great economic threat to U.S. livestock 
producers and is viewed as the most concerning transboundary disease in 
the world. If an FMD outbreak were to occur in the United States, what 
would be the result with regards to our export markets?
    Answer. FMD presents a great economic threat to U.S. livestock 
producers and is viewed as the most concerning transboundary disease in 
the world. An FMD outbreak in the United States would result in the 
immediate closure of most, if not all, of our foreign export markets. 
Commodity group exports for 2014 for beef were at $7.1 billion, for 
pork at $6.7 billion, and for dairy at $7.1 billion. To put this into 
perspective, we need to only look at the economic impact of a single 
case of bovine spongiform encephalopathy (BSE) found in a Canadian-born 
cow located in Washington state on December 23, 2003. As a result of a 
single case of BSE, we saw U.S. beef exports decline by 2 billion 
pounds from 2003 to 2004. It took 8 years for U.S. beef exports to get 
back to pre-December 2003 levels. Over a decade later, we still do not 
have access to several critical markets, such as China, nor do we have 
full access to every country we were trading with prior to December 
2003. It's not just the international trade impact which concerns us. 
In addition, we expect to see significant economic impact to U.S. beef 
producers due to depopulation, restrictions on cattle movements, and a 
potential shutdown of overall cattle trade in the affected regions.

    Question 4. USDA has worked with some industries to ensure the flow 
of products and animals in the event of an animal disease outbreak. Can 
you discuss those efforts and at what stage your preparedness plan is 
with USDA?
    Answer. The Secure Beef Supply Plan is intended to identify and 
address issues to better prepare government and industry to enable 
business continuity for the beef industry in the event of a Foot-and-
Mouth Disease outbreak in the United States. A component of the Secure 
Food Supply Plans, the Secure Beef Supply Plan is currently under 
development by a number of partners who are being led by the Center for 
Food Security and Public Health at Iowa State University. Initial work 
on the Secure Beef Supply plan is focused on the feedyard sector of the 
beef industry as well as the transporters and processors. Later, work 
will take place to include planning for the cow/calf sector, dairy beef 
and the stockers/backgrounders. The current work in the feedyard sector 
is being divided among six working groups: biosecurity, surveillance, 
communications, data management, managed movements, and continuity of 
business for infected feedyards. It is important to remember that 
during an FMD outbreak in the United States, it will not be business as 
usual for cattle producers. In addition to meeting specific biosecurity 
performance standards, beef cattle operations within a FMD Control Area 
will need to conduct daily surveillance of cattle and keep records of 
all observations. Since FMD has not occurred in the United States since 
1929, it will be important to train cattlemen to know what clinical 
signs to look for in examining their animals. Early recognition of FMD 
will be critical to preventing disease spread and limiting the negative 
impact on cattle health and performance. One goal of the Secure Beef 
Supply Plan for the feeding and packer/processing sectors is to allow 
feedlots with cattle with no signs of clinical FMD to be able to 
receive a permit to move finished cattle to processing.

    Question 5. On a scale of 1 to 10 with 10 being the greatest risk, 
what does the industry feel is the risk for the use of FMD virus as a 
weapon of bioterrorism?
    Answer. The beef industry believes that FMD virus could easily be 
used by terrorists against this country and would rank the bioterrorism 
risk as being the greatest at 10. Although FMD has no real public 
health consequences, the virus does carry an extreme potential to 
create monumental economic and animal health consequences that could be 
devastating to the United States. FMD virus is viewed by USDA as a 
Select Agent and it is restricted from being present on the U.S. 
mainland. FMD virus is highly contagious among cloven-hoofed livestock 
and some wildlife species and able to persist in the environment for 
significant periods of time as well as being able to be disseminated 
for long distances by wind.

    Question 6. Where is the industry with regard to animal 
identification and traceability in the event of an FMD outbreak?
    Answer. In the feedyard sector of the beef cattle industry, where 
the highest concentration and greatest numbers of animals exist in a 
single location, there is a good system of animal identification in 
place. Cattle 18 months of age and older are moving interstate under 
the guidance and movement regulations for animal disease traceability 
as outlined in phase 1 of the USDA-APHIS ADT rule. Cattle under 18 
months of age will come under phase 2 of the ADT rule when it is 
developed and finalized by APHIS.
                                 ______
                                 
   Submitted Letter by Executive Committee, American Association of 
                  Veterinary Laboratory Diagnosticians
February 19, 2016

  Hon. David Rouzer,
  Chairman,
  Subcommittee on Livestock and Foreign Agriculture,
  House Committee on Agriculture,
  Washington, D.C.

    Dear Congressman Rouzer,

    We would like to comment on testimony before your Committee on 
Thursday February 11, 2016 regarding Foot-and-Mouth Disease (FMD). We 
fully agree with comments on the importance of the National Veterinary 
Stockpile and the urgent need to increase the amount of vaccine for 
FMD. Unfortunately, none of the witnesses commented on the importance 
of early detection of FMD in minimizing the dissemination and impact of 
FMD. Early detection means less spread and less need for vaccine. The 
most important and effective tool we have in the United States for the 
early detection of FMD and other foreign animal diseases is the 
National Animal Health Laboratory Network (NAHLN). The NAHLN, composed 
of Federal, university, and state veterinary diagnostic laboratories, 
is an established surveillance and emergency response system that 
provides critical and ongoing resources for laboratory testing, 
surveillance, information management including data analysis and 
sharing, quality assurance and the development and validation of new 
tests. Member labs of the NAHLN receive thousands of samples on a daily 
basis and perform early analysis and testing for a variety of animal 
diseases and therefore are the most likely point of early 
identification if FMD entered the U.S.
    In addition to vaccination, another important aspect of FMD control 
and recovery will be the need to differentiate animals infected with 
natural virus versus those that have been vaccinated. Current serum 
based tests cannot make this differentiation. However, there has been 
early testing within the NAHLN of methods that will help in 
Differentiating Infected versus Vaccinated Animals (DIVA methods). The 
full development and validation of these methods will be vital in 
recovering from an FMD incursion.
    The NAHLN played a critical role during the 2015 Highly Pathogenic 
Avian Influenza (HPAI) outbreak that devastated the U.S. poultry 
industry. NAHLN laboratories operated 24/7 to test poultry samples 
which provided results needed to allow for rapid depopulation of 
infected flocks, surveillance testing of samples from surrounding areas 
to halt [the] spread of the virus and testing to establish freedom from 
disease to allow continuity of business during the outbreak and 
repopulation of farms and resumption of trade after the outbreak. 
However, in some states the NAHLN was stretched to its maximum and with 
HPAI the labs were only testing poultry. With FMD we will be dealing 
with an agent that is easily transmitted through the air and which 
infects all cloven hoofed livestock--some of which can serve as silent 
amplifiers of the virus.
    When the NAHLN concept was first developed (2004) it was calculated 
that annual Federal funding of $30M would be required to maintain this 
surveillance network. The network has never been funded at this level. 
The American Association of Veterinary Laboratory Diagnosticians 
(AAVLD) has been advocating for full funding of this network for 
several years. Authorization for funding of the NAHLN was included in 
the 2014 Farm Bill but appropriation of the full amount has not been 
forthcoming. More funding for a stronger NAHLN will be critical to the 
success of an effective detection and response to introduction of FMD. 
Current funding for NAHLN is simply not adequate to assure FMD will be 
caught early before it spreads broadly in U.S. livestock and wildlife. 
We respectfully request that the Members of your Committee help secure 
full funding ($30M) of the NAHLN.
            Respectfully,

Executive Committee of the AAVLD
                                 ______
                                 
        Submitted Statement by Kansas Department of Agriculture
    The Kansas Department of Agriculture submits the following 
statement to the U.S. House Subcommittee on Livestock and Foreign 
Agriculture for its February 11, 2016, hearing on foot-and-mouth 
disease (FMD) preparedness. This statement, submitted on behalf of 
Secretary Jackie McClaskey on February 10, 2016, is for consideration 
by the Subcommittee and for inclusion in the printed record of the 
hearing.
Introduction
    The Kansas Department of Agriculture, the nation's oldest 
department of agriculture, is committed to a balanced approach of 
serving the entire agricultural industry and providing an environment 
that enhances and encourages economic growth, advocating for and 
promoting agriculture, while helping ensure a safe food supply and 
protecting natural resources, and human and animal health. This is a 
charge we take seriously, as agriculture is the largest industry, 
employer and economic driver in Kansas, accounting for 43 percent of 
the state's total economy and employing 12 percent of the entire 
workforce.
    Within agriculture, the beef cattle industry is the largest sector, 
with 6.25 million head of cattle and calves on ranches and in feedyards 
as of January 1, 2016, an increase of six percent from a year ago. In 
2014, cattle generated $7.77 billion in cash receipts. Further, our 
state's dairy industry has been one of the fastest growing regions in 
the nation, and we are ranked tenth in the nation in hog production. 
Kansas is also among the nation's top states for red meat production, 
processing more than 5 billion pounds of red meat in 2014 for an 
estimated value of $9.15 billion. Finally, in addition to being a 
leader in raising livestock and processing meat, Kansas, along with our 
neighbors in Missouri, is located within the Kansas City Animal Health 
Corridor, the single largest concentration of animal health and 
nutrition companies in the world. In fact, companies within the Animal 
Health Corridor represent 75 percent, or $19 billion, in worldwide 
animal health sales.
FAD Preparedness
    It is no stretch to say that the health of the Kansas economy is 
dependent upon a healthy and thriving livestock industry. As such, the 
Kansas Department of Agriculture is committed to working alongside our 
partners in the livestock industry and within the Federal Government, 
other state agencies and local entities to be as prepared as possible 
to respond to animal health emergencies, including foreign animal 
diseases like foot-and-mouth disease (FMD). Over the course of the past 
15 years, the department has put an increased focus on FAD preparedness 
and strives to be the best prepared state in the nation when it comes 
to an FAD response.
    This is not a goal arrived at overnight. In the aftermath of the 
September 11, 2001, terrorist attacks and the FMD outbreak in the 
United Kingdom, the department, in cooperation with the Kansas Division 
of Emergency Management and other state agencies, developed the first 
state level food and agriculture response plan, which recognized the 
uniqueness of food and agriculture incidents as compared to other 
``traditional Emergency Support Function 11 Agriculture and Natural 
Resource'' (ESF 11) emergencies.
    While an ESF 11 Function incident focuses on response to natural 
disasters, the root cause of the emergency in a food and agriculture 
incident is food contamination, plant pests and diseases, and livestock 
diseases.
    At that time, the department also joined with other states to form 
the Multi-State Partnership for Security and Agriculture. Between 2001 
and 2008, the department added a Homeland Security Specialist to the 
Office of the Secretary and worked to provide Incident Command System 
(ICS) training for key staff at both the Department of Animal Health 
and the Department of Agriculture. The department's plan recognizes 
that food and agricultural emergency situations are highly complex, 
with jurisdictional issues affecting private industry as well as local, 
state and Federal entities, and that most food and agricultural 
incidents are interstate issues.
    Through our state's work on FAD preparedness, especially in our 
efforts working with neighboring states, we know that, from the state's 
perspective, we will be on the front lines carrying out the response 
plan and that each state's plan must fit their respective industry 
needs. There is no doubt that there will be policy challenges, with 
regard to specific authorities and actions taken to stop the spread of 
FMD or other animal diseases, that will have to be addressed state by 
state. However, it is also incumbent upon states to take their FAD 
preparedness responsibilities seriously and to do their part.
FAD Exercises
    In Kansas, we recognize even the best and most comprehensive 
response plan is without use unless that plan is regularly exercised 
and practiced. While the words on paper may sound good, if we are not 
able to stop the spread of the disease and return to normal business 
operations as quickly as possible, we have not accomplished our goal of 
providing total support to the industry and protecting animal health. 
Further, we also recognize that a response to an FMD outbreak would be 
the most challenging, given the highly contagious nature of the 
disease, its ability to spread rapidly through susceptible species, and 
the complex challenges that could arise with feed and food scenarios as 
well as international trade implications. This is why each time the 
department exercises our plan, we focus on an FMD response, and we 
include as many of our partners outside the department as possible, 
including farmers and ranchers, other state agencies, local partners 
and the Federal Government.
    Beyond the highly complex nature of an FMD response, we also know 
that an introduction of FMD in the United States would be economically 
devastating to the livestock industry. According to a recent study 
published in the Journal of Agricultural and Applied Economics about 
the economic impact of FMD vaccination strategies, without an emergency 
vaccination strategy, producer and consumer losses of an FMD outbreak 
in the Midwestern United States would likely approach $188 billion, and 
government costs would likely exceed $11 billion. Even with a high-
capacity emergency vaccination strategy together with a large 
vaccination zone, producer and consumer losses are projected to reach 
$56 billion, and government costs could reach more than $1 billion.
    According to Kansas policy, the Animal Health Commissioner has 
access to any department staff necessary to response to an animal 
disease incident. The Commissioner can assign personnel to the Division 
of Animal Health until demobilized by the Commissioner. This is a 
policy that has been instrumental in our ability to expand our response 
team. Today, more than 70 department staff have attended ICS training 
and volunteered to serve on the response team. This is a policy model 
that could be replicated in other states to help build a larger 
response team that is prepared and trained to implement each state's 
plan.
    Since 2009, the department has hosted three major, multi-day FMD 
response exercises and more than 20 smaller, tabletop-setting or 
regional response exercises. The first major exercise was in October 
2009, and was focused on movement control at state borders as we know 
that this will be one of the most challenging aspects in an FMD 
response. This exercise included local government, four Kansas counties 
and three Oklahoma counties, seven state-level agencies in both Kansas 
and Oklahoma, the U.S. Department of Agriculture, the FBI, and industry 
association partners and representatives from academia. The goal was to 
evaluate each state's plan for a stop movement order and the 
communication and coordination issues related to the order, to 
determine resource needs, and to achieve consensus from border states 
on the most practical and effective method for routing livestock-
related transports during an FMD outbreak. As a direct result of this 
exercise, Kansas has worked with our neighboring states to establish 
clear plans for which state has authority over checkpoints at each 
state and Federal highway that crosses the state line in order to 
maximize the use of limited resources.
    Between 2009 and the next major exercise in 2013, not only did 
Kansas elect a new governor, but the Department of Animal Health merged 
with the Kansas Department of Agriculture, and the Kansas Department of 
Agriculture moved its headquarters from Topeka to its current location 
in Manhattan. During this time, we also developed a 5 year strategic 
plan to improve our ability to respond to animal disease emergencies, 
with specific goals related to stakeholder engagement, business 
continuity, information management, response readiness, traceability 
and communications. We also made changes to the response plan based on 
learnings in the 2009 exercise regarding the permit management system, 
and the delivery and sharing of data information from the border 
checkpoints to the Incident Command Post, from the Incident Command 
Post to the surveillance branch in a timely fashion, and sharing 
information with border states.
    The 2013 exercise, also based on an outbreak of FMD where the index 
case was in the southeastern United States, was a 2 day exercise with 
more than 250 participants and focused on practicing the new permit 
management system with specific objectives related to the resource 
needs, the development and communication of movement control orders, 
the use of phone banks to respond to public inquiries, and more. This 
exercise also fell during the 2013 Federal Government shutdown. Rather 
than postpone the exercise until that situation was resolved, we 
implemented our plan without immediate Federal assistance. While we 
learned there will be specific information requests and declaration 
requests states will need during an FMD response, we realized we were 
able to implement our plan without a lot of Federal personnel 
assisting.
    In 2014, two regional exercises were held with groups of Kansas 
counties and focused in the local response. In December 2015, the 
department hosted its largest exercises to date, a 4 day functional FMD 
response exercise. Similar to previous exercises, participants included 
industry, local emergency responders, multiple state agencies and the 
Federal Government. From that exercise, we know that challenges remain 
regarding the stop movement of susceptible species. We are currently in 
the process of finalizing the after action response plan and 
identifying key learnings, including challenges and successes, that 
will drive changes and updates to the Kansas response plan. We will 
have an opportunity to exercise those changes in December 2016 at our 
next scheduled FMD exercises.
    Exercises like those we've undertaken in Kansas require time, 
financial resources and cooperation among many different stakeholders. 
But the lessons we have learned in Kansas from regularly exercising our 
plan has resulted in a better plan and has made us better prepared to 
implement our response. It has also helped us identify resource, 
logistic and policy issues, both intrastate and interstate, that need 
resolved.
Resource Challenges
    Whether it was during an exercise setting or during the state's 
actual response to highly pathogenic avian influenza in spring 2015, a 
key challenge we have continually identified is human resources. We 
know that there will simply not be enough local, state and Federal 
personnel to adequately carry out the response plan. This is a 
challenge Kansas is currently working to address.
    Multiple states throughout the country and even USDA have 
veterinary volunteer response corps, which can be activated to assist 
with an animal disease outbreak. It is without doubt that there will be 
a need for additional veterinary support, but we also know there will 
be a need for case specialists, appraisers, manual laborers, 
information technology specialists, communications professionals and 
more. We will need assistance with data entry and record management, 
behavioral health specialists, and other trained volunteers to 
adequately carry out a response. That is why Kansas is working to 
develop a Kansas Agricultural Emergency Response Corps, which will 
recruit volunteers with key skills and training necessary in a 
response. We will provide them with ICS training and education 
regarding the Kansas plan. Then, in the event of an animal disease 
outbreak, we will activate the volunteer corps to work alongside our 
response team to carry out the plan.
    Our goal is to begin recruitment and training of Response Corps 
volunteers later this year and include them in the December 2016 
exercises.
    One factor contributing to our ability to continually improve our 
FAD preparedness is our effort to secure resources in the form of 
grants and cooperative agreements to implement our strategy. 
Preparedness itself takes resources and many states have not been as 
fortunate as Kansas to find the necessary funding to implement their 
own strategies. If the nation is to be prepared for FMD and other 
animal diseases, all states must also be prepared. FMD will not stop at 
the state line, and if Kansas is prepared but our border states are 
not, we will ultimately fail in stopping the spread of FMD and 
protecting our states' livestock industries.
FAD Preparedness in Kansas Feeding Sector
    Kansas has a robust cattle feeding sector, with more than 2.2 
million head of cattle on feed as of January 1, 2016. With the 
transient nature of the cattle feeding sector, with multiple loads 
arriving and leaving individual yards each day, FMD preparedness at the 
feedyard level is critical. The department, in direct collaboration 
with our partners in the industry, met with more than 20 individual 
feedyards in summer 2015 to identify strengths and challenges related 
to FMD preparedness at that level in the industry. Based on those 
meetings, we are working not only with our feedyards, but also with 
veterinarians who work with feedyards, to provide FMD response planning 
resources they can implement.
    Additionally, it is our goal to base the December 2016 exercise on 
the cattle feeding and dairy sectors.
Conclusion
    While the state-level response plan is just one element of FMD 
preparedness in the United States, it is and will continue to be a 
critical component of an overall response and recovery effort. We 
recognize the critical need for a viable FMD vaccination strategy in 
the United States and encourage all efforts in that regard. We also 
cannot stress enough how important our partners in the livestock 
industry have been and continue to be in our state's FAD preparedness 
efforts.
    Finally, we commend the Livestock [and Foreign Agriculture] 
Subcommittee for holding this hearing and we will continue to work 
toward improving FAD preparedness efforts in Kansas.

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