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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 

( 

Printed for the use of the Committee on Agriculture 

agriculture.house.gov 

COMMITTEE ON AGRICULTURE 

K. MICHAEL CONAWAY, Texas, Chairman 

RANDY NEUGEBAUER, Texas, 

Vice Chairman 

BOB GOODLATTE, Virginia 

FRANK D. LUCAS, Oklahoma 

STEVE KING, Iowa 

MIKE ROGERS, Alabama 

GLENN THOMPSON, Pennsylvania 

BOB GIBBS, Ohio 

AUSTIN SCOTT, Georgia 

ERIC A. ‘‘RICK’’ CRAWFORD, Arkansas 

SCOTT DESJARLAIS, Tennessee 

CHRISTOPHER P. GIBSON, New York 

VICKY HARTZLER, Missouri 

DAN BENISHEK, Michigan 

JEFF DENHAM, California 

DOUG LAMALFA, California 

RODNEY DAVIS, Illinois 

TED S. YOHO, Florida 

JACKIE WALORSKI, Indiana 

RICK W. ALLEN, Georgia 

MIKE BOST, Illinois 

DAVID ROUZER, North Carolina 

RALPH LEE ABRAHAM, Louisiana 

JOHN R. MOOLENAAR, Michigan 

DAN NEWHOUSE, Washington 

TRENT KELLY, Mississippi 

COLLIN C. PETERSON, Minnesota, Ranking 

Minority Member 

DAVID SCOTT, Georgia 

JIM COSTA, California 

TIMOTHY J. WALZ, Minnesota 

MARCIA L. FUDGE, Ohio 

JAMES P. MCGOVERN, Massachusetts 

SUZAN K. DELBENE, Washington 

FILEMON VELA, Texas 

MICHELLE LUJAN GRISHAM, New Mexico 

ANN M. KUSTER, New Hampshire 

RICHARD M. NOLAN, Minnesota 

CHERI BUSTOS, Illinois 

SEAN PATRICK MALONEY, New York 

ANN KIRKPATRICK, Arizona 

PETE AGUILAR, California 

STACEY E. PLASKETT, Virgin Islands 

ALMA S. ADAMS, North Carolina 

GWEN GRAHAM, Florida 

BRAD ASHFORD, Nebraska 

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 

STEVE KING, Iowa 

SCOTT DESJARLAIS, Tennessee 

VICKY HARTZLER, Missouri 

TED S. YOHO, Florida 

DAN NEWHOUSE, Washington 

TRENT KELLY, Mississippi 

JIM COSTA, California, Ranking Minority 

Member 

STACEY E. PLASKETT, Virgin Islands 

FILEMON VELA, Texas 

RICHARD M. NOLAN, Minnesota 

CHERI BUSTOS, Illinois 

(II) 

(III) 

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 

(1) 

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. 

2 

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 

3 

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 

4 

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 footand-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 highpath 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. 

5 

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 

6 

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 footand-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 

7 

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 footand-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. 

8 

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’’. 

9 

Six Types of FMD Outbreak 

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-anfmd-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 vacVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00013 Fmt 6633 Sfmt 6621 P:\DOCS\114-42\98682.TXT BRIAN

11442001.eps
10 

cine 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-capacityfor-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-AndMouth Disease available at: www.cfsph.iastate.edu/pdf/fad-prep-nahems-appendixa-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. 

11 

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-theUS 

www.cfsph.iastate.edu/pdf/fad-prep-nahems-appendix-a-vaccination-for-footand-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 PresiVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00015 Fmt 6633 Sfmt 6601 P:\DOCS\114-42\98682.TXT BRIAN
12 

dential 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 

13 

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. 

14 

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 

15 

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 vacVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 P:\DOCS\114-42\98682.TXT BRIAN
16 

cine. 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 nonendemic 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:] 

17 

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. 

18 

POWERPOINT PRESENTATION

Merial Veterinary Public Health 

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. 


11442002.eps
19 

Foot-and-Mouth Disease (FMD) 

An Old Disease, But a Present Threat 

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 

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. 


11442003.eps 11442004.eps
20 

FMD—OIE Official Status 

OIE Member Countries Official FMD Status Map 

Last Update May 2051 

[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 

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.). 


11442005.eps 11442006.eps
21 

Case Study—The South Korea Outbreak 

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) 

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. 


11442007.eps 11442008.eps
22 

The South Korea Outbreak: Vaccine Impact 

Nov. 10–Mar. 11—FMD Outbreak Evolution 

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 

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. 


11442009.eps 11442010.eps
23 

Epidemiology & Vaccine Recommendations 

FMD Epidemiology Trends Per Pools/June 2015 

• 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). 


11442011.eps 11442012.eps
24 

Recent FMD Outbreaks (Jan. 14–Sep. 15) 

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 


11442013.eps 11442014.eps
25 

Merial FMD Vaccine Sourcing 

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 

Merial produces FMD vaccines for specific vaccination program needs. 


11442015.eps 11442016.eps
26 

Merial FMD Vaccine Supply Alternatives 

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 

FMD antigen storage banks provide an efficient means to build stockpiles 

ahead of potential disease outbreaks. 


11442017.eps 11442018.eps
27 

FMD Antigen Banks Supplied by Merial 

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 

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. 


11442019.eps 11442020.eps
28 

WRL FMD Bank Recommendations: 7/15 

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. 


11442021.eps
29 

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 

30 

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 

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. 


11442022.eps
31 

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 

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 investVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00035 Fmt 6633 Sfmt 6621 P:\DOCS\114-42\98682.TXT BRIAN

11442023.eps
32 

ment, 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 31⁄2 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 

33 

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 

34 

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 

35 

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 

36 

* 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. 

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. 

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 

37 

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 indusVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00041 Fmt 6633 Sfmt 6601 P:\DOCS\114-42\98682.TXT BRIAN
38 

try 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 

39 

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. 

40 

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 21⁄2 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 

41 

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. 

42 

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. 

43 

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 

44 

turnaround time from diagnosis, starting production, and getting it 

out in the vaccine form? Did you say 4 days for 21⁄2 million doses? 

Mr. PARKER. I am sorry? 

Mr. YOHO. Did you say 4 days for 21⁄2 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; 

45 

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 

46 

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-andmouth 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. 

47 

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 21⁄2, 

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 

48 

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? 

49 

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 leadin 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 

50 

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:] 

51 

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 

52 

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, 

53 

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 ecoVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00057 Fmt 6621 Sfmt 6621 P:\DOCS\114-42\98682.TXT BRIAN
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nomic 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 AgriculVerDate Mar 15 2010 14:20 Mar 14, 2016 Jkt 041481 PO 00000 Frm 00058 Fmt 6621 Sfmt 6621 P:\DOCS\114-42\98682.TXT BRIAN
55 

tural 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 

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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. 

Æ