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http://www.humanitarian.net/biodefense/fazdc/usaha_fadp.html

U.S. Agricultural and Food Security: Who Will Provide the Leadership?

Floyd P. Horn, PhD
Roger Breeze, BVMS, PhD, MRCVS

Centaur Science Group
Washington DC
2003


A version of this paper appeared in the Proceedings of the 107th Annual Meeting of the U.S. Animal Health Association, San Diego, October 9-16, 2003, pages 79-91. That version was altered before publication without our knowledge in critical respects beyond what might be reasonable as editing of the manuscript: these alterations significantly changed our message. Specifically, the identity of one author was deleted and our ideas of how rapid, on-site test devices should be deployed were completely changed to create the false impression that validation was the next critical step (compare page 87 of USAHA text to page 9 below). The altered text is reproduced here.  The authors leave it to the reader to decide why these changes were made.


Our Text:  Thus far, agricultural agencies in the U.S. and abroad have not deployed rapid detection – or indeed any other modern technologies – to counter foreign animal disease outbreaks.  Other than use of the telephone, control measures still closely follow those introduced by Cardinal Lancisi almost 300 years ago.  Provided with a portable state-of-the-art device that can detect FMD and other viruses on farm within minutes, USDA has reluctantly deployed a handful of machines to fixed sites in a dozen state diagnostic laboratories.  Given the size of the U.S., this does not add significant new capability.  To put this deployment in perspective, the distance between the state diagnostic laboratory in Pullman WA and the dairy industry in Puget Sound is about 300 miles – the same distance as between London and Paris.  Putting a fixed FMD detection machine in Pullman is like providing Great Britain with rapid detection capability by placing a machine in Paris, France. 

On-site detectors should transform disease surveillance and control, not echo history over smaller geographies.  In our view, a federal or state official equipped with an Internet-linked detection device should be on the site of any suspected foreign animal disease outbreak in the U.S. within 4 hours or less of notification so that vigorous informed control measures backed by positive diagnosis can be implemented nationally within 6 hours.  Once the presence of FMD is confirmed, as part of an Internet-based Command and Control system, continuous real-time surveillance must be employed to define the extent of the problem around the initial detection and to predict and track the progress of infection through the national agricultural commerce streams.  And to prevent natural introduction, real time surveillance must also be extended to all commercial flows entering the U.S.  This cannot be achieved by taking samples to a central laboratory.

USAHA version:
Thus far, agricultural agencies in the United States and abroad have not deployed rapid detection, or indeed any other modern technologies, to counter foreign animal disease outbreaks. USDA has, however, deployed a handful of machines to fixed sites in a dozen state diagnostic laboratories that provide a portable state of the art device that can detect FMDV and other viruses on farm within minutes. The question remaining is whether validation is in process.



U.S. Agricultural and Food Security: Who Will Provide the Leadership?

Floyd P. Horn, PhD
Roger G. Breeze, BVMS, PhD, MRCVS

Centaur Science Group
Washington DC

Introduction

Since September 11, 2001, an enormous amount of attention has been paid to the threat of terrorism and the potential for attacks here at home with unconventional radiological, chemical or biological weapons.  During this Annual Meeting of the U.S. Animal Health Association (USAHA) there will be several papers touching on protection against deliberate attacks with foreign animal disease pathogens that could cripple our animal agricultural industries.  And there will be considerable interest in what role the new Department of Homeland Security (DHS) will play in foreign animal disease control – and how Homeland Security, the Federal Bureau of Investigation (FBI), the Department of Agriculture (USDA) and other agencies will work together to prevent, deter, detect, control, investigate and respond to any deliberate attacks.  Floyd Horn recently retired as Administrator of the USDA’s Agricultural Research Service (ARS) and in that role was at the heart of USDA actions to counter terrorism from the mid-1990s.  The purpose of this paper is to inform USAHA of all that has been accomplished thus far, because we did not start to think about this problem on the morning of September 11, 2001.

USDA participated in biological weapons research and development from the Second World War until President Nixon closed the offensive U.S. Biological Weapons programs in 1969.  For the next 20 years, the threat of biological weapons was not really on anyone’s horizon here in America.  But in the late 1980s it became obvious that powerful new genetic engineering technologies and developments in bio-engineering would one day make biological weapons more readily available and deployable by nation states, groups or individuals.  Indeed, new technologies of the late 1980s already allowed creation of novel foreign animal disease viruses – such as foot and mouth disease virus -for which there were no vaccines.  Because the most important threats to U.S. animal agriculture are highly-dangerous foreign diseases caused by viruses, the potential for future deliberate attacks with known or genetically-engineered viruses was particularly important to ARS.  The Nation depended on our agency for new tools and technologies for national defense.

ARS’s Plum Island Animal Disease Center (PIADC) was the principal national site for foreign animal disease research.  In 1989, ARS changed its research program at PIADC to take account of potential biological weapons attacks.  We took a hard look at future threats – both natural and deliberate – and how these might best be countered by new research.  We found that the approach to countering deliberate attacks must necessarily be different from that adopted for accidental disease introductions.  In 2004, many officials still erroneously assert that there is no difference between natural and deliberate disease introductions – and that the traditional federal and state emergency response strategies, perhaps augmented by stocks of vaccines, will suffice to respond to both.  This is a dangerously incorrect assertion.  In fact, these strategies have failed even in modest natural incursions in the U.S., Great Britain, the Netherlands, Taiwan and elsewhere in recent years.

Priorities

There are over 40 foreign disease threats to U.S. animal agriculture.  USDA traditionally prioritizes foreign animal disease threats based on geography and proximity: if a foreign animal disease is in the Caribbean, it’s a crisis.  If the same disease is in Yemen, it’s unimportant.   ARS prioritized the threats based upon the complexity of their solution and the characteristics of the disease pathogen.  Research priorities for natural disease threats (not in order) from 1989 are given in Table 1.

Of course, there is never enough money to study all the potential threats at the same time to the necessary degree, and so the core program at PIADC in the 1990s focused on foot and mouth disease (FMD), African swine fever (ASF) and African horsesickness (AHS).  In addition, there was collaborative work on Rift valley fever (RVF) and Venezuelan equine encephalitis (VEE) viruses with the U.S. Army Medical Research Institute for Infectious Diseases and on Rinderpest with the University of California and Tufts University. 

A commonly asked question is: Which is the most important of the 40 foreign disease threats to U.S. animal agriculture?  The answer is: The next foreign disease that occurs here.  One can prioritize rationally, but still be surprised by the next disease incursion. The core PIADC program recognized this conundrum and was designed to provide essential national expertise in RNA (FMD) and DNA (ASF) virus infections – since most of the animal threats are viruses – and in molecular disease pathogenesis studies in livestock species (this capability provided through the program on AHS – an RNA arbovirus infection).  This core national resource could be built on with external expertise as necessary for other infections – as the AHS group collaborated on RVF and VEE.  Should an unforeseen foreign disease strike, ARS would be ready if it were an RNA or DNA virus and could immediately augment its core animal pathogenesis expertise with bacterial or other specific pathogen experts from academia or industry if it were not a viral problem.

Each disease threat was examined using the steps outlined in Figure 1 to determine the points at which new research might yield useful technological solutions (note that over 10 years ago deliberate introduction was factored into decision making).

In the late 1980s and early 1990s, defectors from the Soviet Union disclosed to British and U.S. Intelligence agencies the existence of a huge, covert offensive biological weapons program that employed tens of thousands of scientists, who had been working for decades to develop biological weapons targeting people, livestock and crops in North America and other countries.  The livestock diseases that Soviet scientists had been studying as weapons included all those listed in Table 1 except AHS and Contagious bovine pleuropneumonia: some of these diseases (RVF, VEE) are zoonotic, that is they infect both people and animals.  ARS was already working to provide new defenses against these same pathogens as a result of the analyses that had been made earlier.

Changing Technologies

It was obvious 15 years ago that one day the established U.S. foreign animal disease control policies – based primarily on quarantine and mass slaughter – would be found inadequate for natural disease outbreaks, given the enormous changes underway in agribusiness and in public opinion on animal welfare, the environment and aerial pesticide applications.  And we realized that a completely new approach would be needed if ever the U.S. faced the threat of deliberate attacks on multiple occasions – when the traditional economic cost-benefit ratios that underlie control policies would be overturned immediately.  It is not the role of ARS to change control policies – this is the responsibility of the USDA’s action and regulatory agencies.  But it is the role of ARS to develop the necessary new technologies that would allow any changes to be made – and preferably before these are needed in a crisis.  There is an old saying that it is better to have a vaccine and no epidemic rather than an epidemic and no vaccine.  For these reasons, ARS began to develop new control technologies in cooperation with other government agencies.

The most important technologies were:


1. Molecular diagnostics based on polymerase chain reaction (PCR) technology.  From the mid-1990s, these diagnostics were moved from performance in a high-containment laboratory to portable, on-site devices that did not require biological containment.

2. A test to discriminate animals that have been vaccinated against FMD from those that have recovered from infection and might still be infectious for others.  Lack of such a test has long been cited as an important economic reason not to use vaccine in the event of an outbreak in disease-free countries (this claim was repeated during the 2001 FMD outbreak in Great Britain). A team of ARS and Animal and Plant Health Inspection Service (APHIS) scientists began to develop such a test in 1990 and the results were presented to USAHA at the annual meeting in 1994.  This technology was completely transferred to APHIS for field deployment in 1995.  APHIS did not pursue the regulatory procedures necessary for validation.  However, in 1999, a private company, United Biomedical, Hauppauge NY, introduced a similar test, which is available commercially for overseas use.

3. Vaccines that can be manufactured in the U.S.  Note that these were for diseases that are both natural and biological weapons threats.

a. Rinderpest – 1989 onwards
b. Rift valley fever - 1990
c. Venezuelan equine encephalitis - 1990
d. Foot and mouth – 1990 onwards


4. An antiviral drug that would block FMD virus infection based on inhibition of the FMD viral polymerase.  Such a drug was needed to block infection by potential biological weapons - genetically-engineered FMD viruses designed to evade all known vaccines.  This work was begun in the early 1990s but stopped after early success for lack of funds.

5. Animals genetically resistant to FMD and ASF virus infection (as models of all RNA and DNA virus infections).  Genetically-resistant animals would completely remove FMD and ASF as biological weapons threats and as natural disease problems. 


Developments 1996 to 2001

From 1996 there was increasing concern in Washington about weapons of mass destruction in the aftermath of the Gulf War and disclosures by Saddam Hussein’s son-in-law and with better understanding of the scope of the former Soviet Union’s offensive biological weapons programs.  The threat of further proliferation of weapons, technologies and skilled personnel from the former Soviet Union was a particular worry.

To this point, Agriculture and the food supply system had been omitted from what national planning had taken place to protect critical U.S. infrastructures against deliberate attack.  The general perception in USDA was that there was no difference between a natural outbreak of a disease like FMD, for example, and one caused deliberately.  And since USDA had apparently been prepared for over 100 years to respond to FMD, the Department felt that it did not need to do anything new to prepare for deliberate attack – or encourage other agencies, such as the FBI, to encroach on USDA turf.  In fact, President Clinton, in a series of Presidential Policy Directives, had already declared that deliberate attacks were different – they were either crimes or acts of war – and that other agencies would then take the lead, specifically the FBI at home and the State Department overseas.  Other entities, such as the Defense Department and the Intelligence Community, were also given key roles.  But USDA as a whole was not a participant in counter-terrorism programs or planning. 

Because ARS had been involved from the very beginnings of modern biological weapons concerns in the late 1980s, we were the most knowledgeable agency in USDA on these issues.  Therefore, from 1996, ARS stimulated internal USDA discussion and provided position papers and information about the broader field of unconventional weapons threats.  This effort culminated in Secretary Glickman establishing a formal USDA Biosecurity Committee (chaired by Floyd Horn) in 1999.  Our efforts to educate other government agencies about threats to agriculture and food also persuaded the National Security Council (NSC) that agriculture and the food supply system were critical infrastructures that should become part of core counter-terrorism planning and preparedness – a NSC subcommittee was formed for this purpose in 1999.  Formal Intelligence Community assessments of foreign biological weapons programs targeting agriculture were also made available.

In 1998, ARS sponsored the first U.S. conference on food and agricultural security.  The proceedings of this conference were later published (1). Subsequently, ARS sponsored an October 2000 conference on Agricultural Bioterrorism at the Banbury Center, Cold Spring Harbor NY and initiated a 2001 National Academies of Science study of biological weapons threats to agriculture and the food supply.  The products of these are well worth studying – if only to appreciate how little has been done to protect agriculture and the food supply system over the past 6 years.

Of course, ARS and other USDA agencies requested funds from the Congress to address the terrorism threat.  After considerable advocacy, these were regularly included in the President’s budget proposals but were not supported by Congress, except for a $500,000 addition in FY 2001.  However, some resources – such as a skilled scientific cadre and specialized biological safety level 3 and 4 (BSL 3 and 4) facilities – cannot be quickly provided in an emergency, even if funds are immediately available.  ARS devoted considerable discretionary resources to establish state-of-the-art genomics and functional genomics capabilities for foreign animal diseases and their livestock hosts so as to maximize productivity and resources of the scientists we already employed.  In addition, vigorous efforts were made to replace the BSL 3 facilities at Plum Island NY, Athens GA, and Ames, IA, and to provide the first BSL 4 facilities for livestock at Plum Island.  We came very close – but suffice it to say that after 6 years of effort there are no modern BSL 3 facilities for agriculture and the nation still has no BSL 4 facility in which to prepare for such dangerous livestock infections as Hendra and Nipah viruses and their cousins yet unknown.  The recent investment of over $1 billion in a national system of BSL 4 labs for human disease threats does not provide any capability to study these infections in livestock species.  Thanks in large part to the action and leadership of USAHA, there is to be a new BSL 3 facility at Ames, but it will be decades before agriculture has all the specialized facilities it needs.

Without new funds, it was impossible to establish unconventional weapons defense programs of the necessary size and scope, but existing investments were sharpened and additional funds obtained from external sources.  For example, we partnered with the State Department on very important activities to prevent further spread of dangerous weapons technologies from the former Soviet Union and with other government agencies on pathogen detection to prepare for attack at home.

Since 1998, ARS has conducted beneficial civilian agricultural research in cooperation with scientists and institutes once engaged in biological weapons research and development in the former Soviet Union.  Work is underway in Russia, Kazakhstan and Uzbekistan and is supported by some $6 million/year from the State Department.  Establishing strong open institutions in the newly-independent states prevents scientists, materials and weapons-related knowledge leaking to other countries and brings these scientists into the world community where they can make useful contributions in both the national and international arenas.  One cooperative venture – between PIADC and the former weapons laboratory and test site at Otar, Kazakhstan - has been exceptionally valuable in international understanding of human and livestock pox viral diseases.

Pathogen Detection

Bacillus anthracis was studied as an offensive biological weapon by several countries because the natural properties of the organism make it highly-suitable for such use.  The organism forms a spore that is highly-resistant to degradation by heat and the forces of an explosive delivery, the spore is optimally sized to penetrate into the human lung, and the growing bacterium produces a series of toxins that produce irreversible lung injury by the time illness first becomes apparent.  Pulmonary anthrax as the disease we have known is terrible enough: fortunately, it is rarely seen naturally because humans are very infrequently exposed to aerosols of spores.

Under the terms of the 1975 Biological Weapons and Toxins Convention, offensive biological weapons programs are illegal.  Defensive programs – development of vaccines, diagnostics and other countermeasures - are fully acceptable.  Scientists of the Former Soviet Union, and perhaps other countries, were engaged in offensive activities, such as studies of how to prepare fine powders of microorganisms that could be dispersed over wide areas by missiles or artillery shells and how to modify the properties of the microorganisms to defeat defensive countermeasures – to overcome vaccination, confuse diagnosis, or create novel patterns of injury.  An advanced biological weapon is one whose biological properties have been modified by genetic engineering or other means to defeat countermeasures.  As an example, Soviet scientists added a novel toxin gene (from another microorganism) to Bacillus anthracis in an attempt to defeat the U.S. vaccine.  There are thus two challenges for detection of biological weapons: 1. to detect the known pathogen, and 2. to detect an advanced pathogen that has been modified genetically (and to understand the nature of the modification for Biodefense).  We seek to defend ourselves against known disease agents and to anticipate and defend against technological surprise through advanced biological weapons with unexpected properties.

Four of the 10 pathogens listed in Table 1 are zoonotic: VEE, RVF, Newcastle disease and avian influenza.  VEE was developed as an advanced biological weapon to target military personnel by the Soviet Union – for delivery as an aerosol with a disease pathogenesis quite different from that of VEE as a mosquito-borne infection.   Newcastle disease – primarily a poultry disease of no clinical significance for public health - produces conjunctivitis in humans – not a fatal disease but certainly a force-incapacitating infection for the pilots of an aircraft carrier.  There were thus commonalities between ARS and agencies charged with human health protection in detection of basic and advanced biological weapons agents.  ARS thus cooperated with other U.S. government agencies to develop standardized means to detect potential biological weapons agents, including advanced biological weapons based on the organisms in Table 1.  Initially, detection focused on samples of soil, water and air because the goal was a standard platform and assay system for military force protection on the battlefield.  Later, this goal expanded to samples from humans and animals under circumstances that might lead to a clinical intervention.

In February 2000, a joint workshop was held between ARS, the FBI and the Department of Health and Human Services (HHS) in Beltsville MD.  Over 30 universities and companies demonstrated detection technologies at this workshop.  An expert inter-agency group assessed these and determined that two portable devices for real time PCR analysis were immediately deployable.  Other government agencies had come to the same conclusion after independent assessments, so ARS implemented a program to develop real time PCR tests to be deployed on these devices for the most important foreign animal and plant disease threats as part of a systematic government activity.  ARS deliberately chose to use devices and test technologies common to other federal agencies involved in national security, law enforcement and public health so that agriculture and the food supply system could take full advantage of tests developed by these other agencies and vice versa.

As explained above, several government agencies were interested customers for this new technology – they needed it for comprehensive detection of biological weapons agents in soil, water and air, and for investigation of potential crime scenes at home and abroad.  But only APHIS (or HHS) might need this technology to detect pathogens in order to diagnose the cause of a disease state in animals, plants (or humans).  The APHIS Administrator’s office – the contact point for biological weapons defense issues – encouraged the ARS detection initiative.  However, APHIS Veterinary Services did not support development of new technologies - the policy was that the first diagnosis of a foreign animal disease would be made by growth and identification of the organism responsible by traditional means at Plum Island under BSL 3 conditions and then subsequent diagnoses would be based on clinical signs or proximity to a known infected herd or flock.   APHIS Veterinary Services opposed transfer of new rapid detection technology to the states.  ARS had no position on APHIS use or non-use of the new technologies, which were primarily directed at other federal customers.

In 2000, ARS scientists developed state-of-the-art PCR tests to detect FMD, classical swine fever, African swine fever, Rinderpest, avian influenza, and Newcastle disease (to complement tests for other pathogens in Table I prepared by other federal agencies).  By state-of-the-art we mean that the PCR target for the assay is based on extensive knowledge of genomic variation to be expected in the pathogen; that the PCR assay distinguishes the pathogen from its near and distant relatives (whether pathogenic or not); and that the test can definably find the pathogen in clinical samples from experimentally infected animals of various target host species at various times before and after clinical disease is apparent.  These tests have not yet been validated or deployed by APHIS.  None of the tests deployed by the Department of Defense or the Department of Health and Human Services have yet been validated by either Department to meet Food and Drug Administration requirements for human clinical use – nevertheless they have been deployed nationally and internationally for years to protect the war fighter and public while validation is being pursued.

These PCR assays were designed to be performed as real time assays outside BSL 3 containment either in a laboratory or on portable devices taken to the site of the problem.  For the latter purpose, there are three machines now available: the RAPID and RAZOR from Idaho Technology Inc. and the Smartcycler from Cepheid Inc.  In time, there will be other devices that are cheaper, faster and more robust.  But all will share the same characteristics.  Assays will be performed by persons of limited training (soldiers, technicians); assays will be performed using quality-controlled standardized reagents and protocols that are internationally consistent; results will be obtained in an hour or less; assays will be reviewed over the Internet as they take place by technical experts located at distant sites; and detection results will flow into an Internet-based Command and Control system that will translate vast amounts of information from the field into current insight for those federal, state and local officials charged with responding to the event.  To permit this, the detectors are connected by wireless to the Internet and contain a global positioning device to allow geographic information systems to be overlaid.

With the ARS test, about 10 particles of FMD virus can be found in a saliva swab from an infected cow within about 90 minutes of arriving at the farm: about 1000 particles are needed to establish an infection in cell culture because not all particles are infectious.  The ARS test is more sensitive than the so-called “gold standard” of cell culture and more accurate in that it detects all FMD virus serotypes and subtypes, including those that may have unusual host cell tropisms (such as Type O1 Taiwan).  The latter is an important characteristic in advanced biological weapons defense.  Most importantly, the ARS test is a pre-clinical test in that it detects infected cattle, swine and small ruminants before clinical signs of disease are apparent.  (The ARS classical swine fever PCR test is also a pre-clinical test.)

In recent years, much has been written about the need for rapid tests.  But very few have asked the question: What could one do differently with a rapid test that one can’t do now by taking samples from the site of the problem to a diagnostic laboratory?  ARS developed this generation of tests primarily for other government agencies charged with countering terrorism and biological weapons.  These agencies have long deployed these portable devices on the battlefield, around military assets, or at high-value targets to acquire real time analytical results to protect military personnel or political leaders.  In such circumstances, a positive test causes personnel in the area to don protective clothing and respiratory devices immediately and to remain protected until the pathogen has been inactivated or they have left the area.  The act of detection is immediately followed by a time-sensitive action to protect those at risk and to minimize or frustrate the impact of the attack.  There is no time to take samples from the site of collection to a state or federal laboratory – time is the precious commodity if catastrophe is to be avoided.

Thus far, agricultural agencies in the U.S. and abroad have not deployed rapid detection – or indeed any other modern technologies – to counter foreign animal disease outbreaks.  Other than use of the telephone, control measures still closely follow those introduced by Cardinal Lancisi almost 300 years ago.  Provided with a portable state-of-the-art device that can detect FMD and other viruses on farm within minutes, USDA has reluctantly deployed a handful of machines to fixed sites in a dozen state diagnostic laboratories.  Given the size of the U.S., this does not add significant new capability.  To put this deployment in perspective, the distance between the state diagnostic laboratory in Pullman WA and the dairy industry in Puget Sound is about 300 miles – the same distance as between London and Paris.  Putting a fixed FMD detection machine in Pullman is like providing Great Britain with rapid detection capability by placing a machine in Paris, France. 

On-site detectors should transform disease surveillance and control, not echo history over smaller geographies.  In our view, a federal or state official equipped with an Internet-linked detection device should be on the site of any suspected foreign animal disease outbreak in the U.S. within 4 hours or less of notification so that vigorous informed control measures backed by positive diagnosis can be implemented nationally within 6 hours.  Once the presence of FMD is confirmed, as part of an Internet-based Command and Control system, continuous real-time surveillance must be employed to define the extent of the problem around the initial detection and to predict and track the progress of infection through the national agricultural commerce streams.  And to prevent natural introduction, real time surveillance must also be extended to all commercial flows entering the U.S.  This cannot be achieved by taking samples to a central laboratory.

Invention of portable, real time PCR machines fundamentally changed who can make a state-of-the-art detection, where that detection takes place, and who controls the information subsequently.  These are the reasons why general field deployment has been delayed.  Until now, detection of foreign animal disease pathogens involved growing live agents in highly-specialized biocontainment laboratories that are exclusively controlled by governments around the world.  Detection could not be de-centralized for biological safety reasons.  Detection thus became a cottage industry employing a handful of specialists in each country.  All this has changed.  Everyday, scores of U.S. soldiers all over the world conduct routine PCR tests for a wide range of highly-dangerous biological weapons agents according to standard methodologies, on uniform devices and with quality-controlled standardized reagents.  In the U.S., the Centers for Disease Control and Prevention have established a nationwide network of hundreds of labs following common protocols for detection of human biological weapons agents.  We look forward to the day when the foreign animal disease threats are detected in the U.S., the rest of North America and overseas using standard methodologies and devices and the same quality-controlled reagents.  In the U.S., this will involve as many personnel as are needed to be on-site in 4 hours or less.

Events of 2001 and 2002

Foot and mouth disease In February 2001, FMD was discovered in Great Britain and quickly spread to become a nationwide epidemic that reached other countries of the European Union.  There was great concern that infection might be brought to the U.S.  ARS immediately demonstrated its real time PCR tests: over the Internet, USDA officials in Washington DC followed real time assays (on samples containing live viruses) in progress at PIADC (for FMD) and Athens GA (for Newcastle disease): they were able to speak directly to the scientists conducting the tests and to ask questions about the results as these were acquired.  Officials also watched tests underway in USDA headquarters.

ARS immediately offered the real time PCR test to British veterinary authorities and later demonstrated it directly in Britain.  The test was declined, although at the time and subsequently there were many pleas by authorities in that country for a rapid, “pen-side” test.

British authorities cited lack of a differential test as a critical reason why vaccine could not be used.  Such a test had been described by ARS and APHIS in 1994 and was available from a commercial source in the U.S. and had been since 1999. 
 
Although the necessary tests were available in 2001, authorities in Great Britain and the U.S. chose not to use them.  What should concern U.S. livestock owners (and perhaps British farmers) more is that in 2004 these tests are still not deployed for their protection – while government money is being wasted to duplicate discoveries already transferred to the private sector.

Anthrax In September and October 2001, Washington DC was paralyzed by postal anthrax attacks.  Federal agencies and businesses were plagued by reports of suspicious white powders.  Mail room workers were very worried about potential exposure to anthrax spores in their workplaces.  The sheer number of samples overwhelmed response capacity.

To meet this challenge, ARS deployed a mobile laboratory equipped with two real time PCR machines to central Washington DC.  Because we had chosen to develop detection platforms common to other federal agencies, we were able to use commercially available anthrax test reagents developed by the Department of Defense.  Suspicious white powders could be examined within minutes and accurate information provided to those who feared exposure.  At the end of each work day, technicians took dust swabs from federal mail rooms all over the Capital and used a military air sampler to capture air-borne dust.  The next morning, before work started, mail room employees were informed of the results of tests performed overnight on their workplaces.  They did not have to wait several days to a week to know if they might have been exposed.  The response to the anthrax attacks demonstrated the value of real time, on-site testing and the value of time gained compared to sending samples to a distant laboratory.

Newcastle disease In fall 2002, Newcastle disease broke out in the Southwestern U.S.  USDA again chose not to deploy the real time PCR test developed and demonstrated 2 years earlier by ARS scientists in Athens, GA.  The stated reason was that this test had not been validated by APHIS – lack of APHIS validation had also been cited as a reason not to deploy the FMD test in 2001.  In fact, in February 2001, APHIS had never validated any of the PCR tests it had long employed for detection of foreign animal disease agents, had never licensed any PCR test for any animal disease in the U.S., and had no protocols for how validation should be conducted.

Some weeks after the State of California developed and deployed its own real time PCR test for Newcastle disease, APHIS allowed states to use the ARS test without validation.  But much critical time had been lost.  


Conclusions

Rinderpest virus and the disease it causes in cattle have probably changed very little since Cardinal Lancisi set out his plan to stem the epidemic in Europe almost 300 years ago.  But commercial agriculture – especially in the U.S. – and public opinion have changed enormously.  And the costs of traditional epidemic control measures are in fact the very factor that makes these diseases attractive as weapons – if FMD did not have a multibillion dollar potential economic impact it would not be a realistic threat.  The control tactics of the past are no longer appropriate and may even encourage attack.  Over the past 15 years, we have provided new tools and technologies to meet today’s needs, including measures to counter deliberate attack.  We believe it is long past time for a radical overhaul of U.S. plans to combat foreign animal disease introductions – accidental or deliberate.  This must start with recognition of the fact that it is not the choice of the U.S. as to whether there is or is not an accidental or deliberate outbreak.  That is not under our control and never will be.  What is under our control is what happens before and after the outbreak is detected – and this depends in turn on our degree of preparedness.  In the long term, the U.S. will mobilize as many thousands of people and spend as much as is necessary to control and eliminate the infection.   But to deter, prevent, minimize, thwart and frustrate attack, what matters most is what we do in the short term – before attack and in the first hours, days and even weeks after disease is detected.  Time is the critical element – the more time, the more options and the more likely that these options will be attractive.

A coordinated national defense should be built upon the following:


1.
Deliberate attack is not about dead cows, swine or sheep; it is about economic harm to the U.S. and terrorizing the public.

2.
Our ability to minimize economic impact depends on knowing what these impacts are – especially outside agriculture – so that specific actions can be taken, probably with international agreement, to limit them.  The lower the economic costs, the less likely there will be an attack in the first place.

3.
The U.S. is the country with the most at risk and the most to lose: we should not copy the failed approaches of others, nor can our protection be based on the lowest common denominator of international animal health.

4.
The public will not accept mass slaughter on the scale of U.S. agribusiness – nor is such slaughter necessary any longer.  Our starting point must be that we will not get into a situation in which slaughter of millions of animals is necessary: this is what terrorists want to see.

5.
Protecting the U.S. begins with eliminating these disease threats overseas where they are prevalent and monitoring commercial streams flowing to the U.S. to ensure they are free of infection.

6.
If we cannot prevent or deter deliberate attack, we must be prepared to snuff out the infection at the site it is first detected and to stem the progress of disease through the national herds and flocks.
   
This is not the place to spell out a new strategy to counter deliberate attacks on U.S. animal agriculture with foreign animal diseases like FMD.  We only point out that such a strategy does not now exist and discussions thus far have not differentiated between accidental introduction of disease and deliberate attack – situations that demand different responses.  When FMD raged in Great Britain in 2001, U.S. veterinary authorities claimed they were prepared to deal with any outbreak here.  Great Britain is a country about the size of Oregon that witnessed a catastrophic debacle in which FMD clearly went beyond control of veterinary authorities and was only stopped when the military took charge.  In that the U.S. has exactly the same control strategies now that Great Britain had in 2001, there must be serious questions about what exactly we are prepared for.  The U.S. has long had the best tools and technologies in the world to counter these threats – now we need to deploy them effectively.

Six years ago (2), we warned U.S. agricultural and food groups that:


1.
The U.S. was not prepared to detect and respond to a biological weapons attack on agriculture and the food supply system – we were unlikely to detect, identify and report; emergency responses were inadequate; working relationships were deficient among the many responders; and the state and federal infrastructure would be overwhelmed.

2.
Certain non-monetary resources cannot be created on demand and may be unavailable in an emergency - such as BSL 3 and 4 facilities and trained personnel.

3.
USDA needs new federal partnerships (FBI, HHS, DOD, Intelligence community – and now DHS) and with the states and private enterprise to counter deliberate multi-state agricultural disease attacks.

4.
The Nation lacks a comprehensive national strategy to prevent and deter the use of unconventional weapons directed against agriculture and the food supply system, or to control, respond to and recover from an attack.

5.
Such a strategy is urgently needed: it will take years to implement and the threats will grow in the meantime.


Regrettably, very little has changed.  As a nation we must do better and the USAHA has a critical role in seeing that we do.  As we look to the future, the words of Edmund Burke are very apt: “The only thing necessary for the triumph of evil is for good men to do nothing.”

References

1. Guarding against Natural Threats and Terrorist Attacks Affecting Health, Food Supplies and Agricultural Economics. Annals of the New York Academy of Sciences, 894, 1999 

2. F.P.Horn and R.G.Breeze. Agricultural and food security. Annals of the New York Academy of Sciences, 894, 9-17, 1999