A GAO report issued on May 22, 2008 (GAO-08-821T, HIGH-CONTAINMENT BIOSAFETY LABORATORIES, DHS Lacks Evidence to Conclude that Foot-and-Mouth Disease Research Can be Done Safely on the U.S. Mainland reviews the background of foot and mouth disease (FMD) research in the U.S. and elsewhere. This report questions the basis for the Department of Homeland Security (DHS) support for the movement of FMD virus and research from the current location at Plum Island Animal Disease Research Center (PIADC) to the newly announced National Bio and Agro-Defense Facility (NBAF) site managed by Kansas State University. In the GAO report, concern was raised regarding a study where DHS relied on a secondary study that the United States of Agriculture (USDA) commissioned and that a contractor conducted in May 2002. This study examined the question of whether it is technically feasible to conduct exotic disease research and diagnostics, including FMD and rinderpest, on the U.S. mainland with adequate biosafety and biosecurity to protect U.S. agriculture? Some significant problems existed in the conduct of this study. Nonetheless, DHS continues to cite to this study as supporting the closing of PIADC, and being the basis of support for the $450 million facility funded to Kansas State University. Various concerns are raised by GAO regarding this USDA study and the readership of this blog is encouraged to read the report in detail and the GAO criticisms.

At the heart of the debate is the question as to what existing laws and statutes govern the site for FMD research in the United States? DHS assumed control of PIADC on June 1, 2003 based on authority granted by the Homeland Security Act of 2002. On January 30, 2004 DHS was instructed by Homeland Security Presidential Directive / HSPD-9 (Defense of United States Agriculture and Food) to undertake several actions to protect United States agriculture and food systems, and improve infrastructure to both natural and intentional acts which would erode U.S. agriculture. DHS has identified PIADC as “reaching the end of its life cycle”, and as lacking critical capabilities to continue as the primary facility for such work. DHS initiated actions to replace PIADC which was judged as antiquated using the following authority, specifically clause (24), cited from HSPD-9.

Research and Development (numbers in parenthesis are paragraph markings as appearing in HSPD-9)

(23) The Secretaries of Homeland Security, Agriculture, and Health and Human Services, the Administrator of the Environmental Protection Agency, and the heads of other appropriate Federal departments and agencies, in consultation with the Director of the Office of Science and Technology Policy, will accelerate and expand development of current and new countermeasures against the intentional introduction or natural occurrence of catastrophic animal, plant, and zoonotic diseases. The Secretary of Homeland Security will coordinate these activities. This effort will include countermeasure research and development of new methods for detection, prevention technologies, agent characterization, and dose response relationships for high-consequence agents in the food and the water supply.

(24) The Secretaries of Agriculture and Homeland Security will develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories that research and develop diagnostic capabilities for foreign animal and zoonotic diseases.

(25) The Secretary of Homeland Security, in consultation with the Secretaries of Agriculture and Health and Human Services, shall establish university-based centers of excellence in agriculture and food security.

The above citation is very important at several levels. Nowhere in HSPD-9 is FMD mentioned directly. However, DHS states authoritatively that FMD virus and research will be housed at the NBAF. The Secretary of Agriculture is directed to assist DHS in plans to upgrade biocontainment and diagnostic capabilities without reference to other legal obligations. Most importantly, nowhere in HSPD-9 is it mentioned that PIADC should be closed and research relocated. This brings us to the point of asking: what exactly is the authority conveyed through a Presidential Directive? These documents are referred to in different ways in Presidential Directives depending on the administration occupying the Executive Office. From the White House briefing room we cite: “PRESIDENTIAL ACTIONS In this section you will find official actions by the President that have a significant impact on how the federal government functions but do not require legislation or Congressional approval . . . ”

Herein is the problem and this problem was referenced, but not detailed, by the GAO study. FAD research and the legal justification to establish and maintain PIADC is well documented in 21 USC 113a. United States Code (U.S.C.) is a compilation and codification of the general and permanent federal law of the United States. Specifically 21 USC 113a states:

“The Secretary of Agriculture is authorized to establish research laboratories, including the acquisition of necessary land, buildings, or facilities, and also the making of research contracts under the authority contained in section 427i(a) of title 7, for research and study, in the United States or elsewhere, of foot-and-mouth disease and other animal diseases which in the opinion of the Secretary constitute a threat to the livestock industry of the United States: Provided, that no live virus of foot-and-mouth disease may be introduced for any purpose into any part of the mainland of the United States (except coastal islands separated therefrom by water navigable for deep-water navigation and which shall not be connected with the mainland by any tunnel) unless the Secretary determines that it is necessary and in the public interest for the conduct of research and study in the United States (except at Brookhaven National Laboratory in Upton, New York) and issues a permit under such rules as the Secretary shall promulgate to protect animal health, except that the Secretary of Agriculture may transport said virus in the original package across the mainland under adequate safeguards, and except further, that in the event of outbreak of foot-and-mouth disease in this country, the Secretary of Agriculture may, at his discretion, permit said virus to be brought into the United States under adequate safeguards.”

The above is literally the law of the land, and violations of this law are punishable through an assortment of penalties including Contempt of Congress. Returning to the topic, where exactly did DHS assume precedent to establish and award the NBAF contract? From the prior discussion the legal precedent is very clear – - only the Secretary of Agriculture or Congress can allow FMD virus to be moved from PIADC onto the mainland. This was established by law in 1949, and this law is still on the books and in effect. With reference to the Secretary of Agriculture, two questions arise. With the erosion of authority over FMD virus research, does USDA, or DHS, assume the obligations of indemnification should FMD escape biocontainment and damage U.S. agriculture? What is the consequence of actions by the current Secretary of Agriculture on binding commitments made by future Secretaries of Agriculture? Should plans for NBAF proceed and the existing PIADC be razed on the basis of “reaching the end of its life cycle”, and as lacking critical capabilities to continue as the primary facility for such work just to have a future Secretary of Agriculture reverse the decision, the ugly reality emerges of “what options exist”? In short, none! And, US agriculture will lack a FMD research program which could assist in vaccine development should this FAD occur at some time in the future.

This leaves open the question of: why has the U.S. Congress not been proactive in the award of the NBAF facility contract, and why is Congress not diligent in the enforcement of existing U.S. Code? Without bias, we assume that FMD research is suitably placed at PIADC consistent with existing law. Moreover, infrastructure upgrades could revitalize this facility, possibly at a fraction the cost of a site based on the mainland. NBAF is currently funded at an estimated cost of $450 million, which is considerable. However, an estimated loss of $1 billion could occur to the economy of the State of Kansas should FMD virus escape containment and impact the State. The latter figure was derived from a Kansas State University publication (Pendell et al., The Economic Impacts of a Foot-and-Mouth Disease Outbreak: A Regional Analysis. J. Agricultural and Applied Economics, 39:19-33. 2007).

In conclusion, a key question remains unanswered – - why is this blog the only source asking these questions?

Introduction

In light of the H1N1 (formerly known as swine flu) virus outbreak, consumers should have an understanding of the influenza virus from a pork producer perspective, and the steps that US swine producers routinely utilize to keep pigs healthy.

Influenza background from the pork industry perspective

• Pork producers have occasionally battled an influenza virus that is transmitted among pigs. Pig influenza within a swine herd generally presents as a relatively mild respiratory disease and treatment is initiated in consultation with the herd veterinarian.

• Very rarely, swine influenza can be transmitted from pigs to humans (zoonotic transmission).

• Although rare, the Centers for Disease Control reports several past cases where an influenza virus originating in swine passed from human to human.

• It appears as if pigs can be infected from humans who are shedding the current H1N1 virus, as evidenced by a case in Canada.

Many routine practices employed by US swine producers prevent, not only swine influenza, but other diseases as well.

• Most animals are housed in like-aged groups to reduce disease transfer from older pigs to younger pigs. Buildings are temperature-controlled and scientifically designed to keep pigs clean, safe and protected from predators, disease and extreme weather.

• Producers utilize all-in-all out production where a building is completely emptied, washed, and disinfected between groups of pigs. This practice serves as a further measure to break disease cycles on pig farms.

• As part of the National Pork Board’s Pork Quality Assurance (PQA) program, pork producers develop and follow a herd health plan in cooperation with a licensed veterinarian. The herd health plan may include influenza vaccine among other disease prevention vaccinations. Most US pork packers require producers to maintain PQA certification.

• Producers practice biosecurity to prevent diseases from traveling into or out of a facility. In the event of a disease outbreak, pigs confined in an enclosed building are much easier to quarantine than are pigs housed in the open.

Conclusion

Contemporary swine production practices and biosecurity measures are well suited to reduce the spread of diseases, including the current H1N1 influenza virus. Confined production greatly reduces the opportunity for conventional and zoonotic disease transfer because of limited animal-to-animal and animal-to-human contact, and serves as an effective disease isolation mechanism when diseases do occur.

I posted a press release on August 3, 2007 from the Department of Environment, Food and Rural Affairs (DEFRA) about a recent outbreak of Foot and Mouth Disease (FMD) in the United Kingdom.

On August, 8, 2007 the Health and Safety Executive (HSE) in the UK posted information that addresses potential breaches in biosecurity that may be linked to the outbreak. The HSE Report is presented below.

As discussed in the HSE Report, the FMD strain identified at the index farm was being worked on at the Institute for Animal Health (IAH) and Merial Animal Health Ltd. The farm is about 16 miles from these facilities. The HSE Report indicates that there is a strong probability that the strain involved in the farm outbreak originated from the IAH or the Merial sites. A question of great importance is whether this was an accidental or intended transfer of the virus from IAH or Merial. IF it is determined that the outbreak was the result of an intentional transfer from IAH or Merial, we will have witnessed a bioterrorism attack. However, in the absence of an admission, establishing this in a definitive way will be extraordinarily difficult, and I encourage readers to not jump to premature conclusions about the cause of the outbreak. However, readers must appreciate that the consequences of a bioterrorism attack(s) on animal agriculture are enormous (see Impact of Bioterrorism on Agriculture in the U.S.).

The Health and Safety Executive Report, August 8, 2007

• An outbreak of foot and mouth disease virus (FMDV) was confirmed at a farm in Surrey on 3 August 2007.
• Preliminary DEFRA investigations indicated that the virus may have originated from the Pirbright site at which two separate organizations are based: the IAH and Merial.
• A multidisciplinary cross-government team with representatives from HSE, DEFRA, the Veterinary Medicines Directorate (VMD) and the Environment Agency (EA) supported by others, conducted on-site investigations on 5, 6 and 7 August.
• This initial report outlines the investigation’s key lines of inquiry and the next steps planned as of 7 August 2007.

Purpose of the Investigation

The Health and Safety Executive was asked by the Government to lead a team to investigate any potential breaches of biosecurity at the IAH and Merial sites; whether such breaches may have led to a release of any specified animal pathogen and whether any such breaches had been rectified to prevent future incidents. A multidisciplinary team was assembled with expertise in a wide range of relevant areas, including in investigation; in working with highly infectious viruses; in engineering control systems relevant to containment; in veterinary medicine production; and in management systems for controlling risk and environmental protection issues.

The Legal Position

The primary legal requirement applying to the site is the Specified Animal Pathogens Order 1998, enforced by DEFRA, which requires licensing of work with FMDV. HSE’s primary remit is to regulate the health and safety of staff at IAH and the Merial sites and to regulate (jointly with DEFRA) human health and environmental risks from work involving genetically modified organisms (GMOs) at the IAH.

What We Did

• We concentrated on biosecurity issues associated with FMDV strain O1BFS67 as this was the strain associated with the outbreak.
• We concentrated on the time frame between 14 and 25 July 2007 as this was advised by DEFRA to be the most likely period of infection.
• We investigated whether or not this strain was in use at the IAH and Merial sites in that time frame and the precise nature of any activities undertaken.
• We investigated whether or not there had been any lapses in control measures which could have led to a breach in biosecurity and whether these could be linked to the outbreak.

To do this we carried out inspections of all facilities of both the IAH and Merial sites where the FMDV strain is handled. This involved checking key biosecurity measures including engineering controls, management systems, working practices and a review of the record logs. We reviewed documents, interviewed staff and visually inspected all the facilities.

What We Found
The following key lines of inquiry were investigated:

Identifying the virus strain

• We confirmed that the FMDV strain found at the outbreak farm was being worked on at both organizations at both the IAH and Merial sites during the period between 14 and 25 July 2007. This involved large scale production at the Merial site (10,000 liters) and a series of small scale experiments (less than 10 ml in each case) at the IAH site.
• We have initiated further studies intended to provide additional molecular information on the virus types in use at both organizations. This requires detailed technical analysis and the results are not available for inclusion in this report but are expected within a week.

Subject to the ongoing work detailed above, the indications are that there is a strong probability that the FMDV strain involved in the farm outbreak originated from the IAH or the Merial sites.

Potential for airborne release from the site

• We found no evidence of any working practices or incidents such as laboratory spillages or leakages from plant or equipment which could have led to a release of the FMDV strain within the contained working environment at either organization.
• We confirmed that all air being discharged to atmosphere from the contained working environments is first passed through a minimum of two high-efficiency particulate (HEPA) air filters.
• We confirmed that there is continuous monitoring of the pressures of the ventilation systems of the facility and that the HEPA filters are routinely integrity-tested in line with regulatory requirements.
• Examination of local wind conditions for the period indicates that there was only a very limited period during which the wind could have acted as a transmission link. This would have had to coincide with a release of virus through the ventilation system. We found no evidence of such a release.

We are further exploring the meteorological data, but at this stage, we consider there to be a negligible combined likelihood that there was an airborne release from the IAH or the Merial sites which was subsequently transferred to the first affected farm between the 14 and 25 July 2007.

Potential for waterborne release from the site

• We established that two separate effluent treatment systems exist on Pirbright site: one services the animal isolation unit at the IAH; the second services both the remainder of the IAH site together with the Merial site.
• We established that the effluent treatment system servicing the IAH animal isolation unit employs a thermal inactivation process. There was no evidence of it operating unsatisfactorily between the 14 and 25 July 2007.
• We established that the effluent treatment system servicing the remainder of the IAH site together with the Merial site employs a chemical inactivation process. Whilst control measures are in place at both premises to require chemical treatment of liquid effluent before it enters the system, a number of biosecurity issues have arisen which are subject to ongoing investigation. These include:
  • the integrity of the system and all associated pipework;
  • the potential for the FMD Virus to have entered this system during the specified time period;
  • whether heavy rain and flooding during the period may have overwhelmed this system;
  • whether any contaminated material could have been transferred between the IAH and Merial sites and the first affected farm.
• For virus to have escaped from the effluent pipe, this would have required a failure in the intermediate inactivation process either at the Merial or IAH site and this would have had to coincide with the flooding.

Waterborne release onto the site remains a possibility. But preliminary investigations into the possibility of whether surface water from flooding from the site could have reached and contaminated the affected farm have indicated that this was negligible due to the distance, topography and direction of flow. These issues are being investigated further.

Potential for Release from the Site by Human Movements

There are various potential routes for accidental or deliberate transfer of material from the site. We have investigated site management systems and records and spoken to a number of employees. As a result we are pursuing lines of inquiry.

Release by human movement must also be considered a real possibility. Further investigation of the above issues is required and is being urgently pursued.

The Next Steps

We will continue with our work and report further as necessary. This report also provides a basis for the independent review of biosecurity arrangements to be led by Professor Spratt of Imperial College. We are briefing Professor Spratt and his team and will also offer him continuing support.

Following an investigation of suspected vesicular disease by Animal Health on a holding near Guildford in Surrey, United Kingdom, laboratory results have this evening indicated that the Foot and Mouth Disease (FMD) virus is present in samples from cattle on the premises.

On the basis of the initial laboratory results Debby Reynolds, UK Chief Veterinary Officer has confirmed Foot and Mouth Disease. In accordance with the legislation and contingency planning arrangements all the cattle on the premises will be culled. A Protection Zone of three kilometers radius and a Surveillance Zone of 10 kilometers has been placed around the premises, and a national movement ban of all ruminants and pigs has been imposed.

Nationally no animal movements are allowed except under license, controls are in place on movement of animal carcasses, animal gatherings, shearing and dipping are restricted, and all farms must increase levels of biosecurity. In both the Protection and Surveillance Zones, there will be requirements for increased levels of biosecurity on farms, movement controls, controls on transportation of dung/manure and treatment of animal products to ensure destruction of the FMD virus.

The farm itself has been under restrictions since late on Thursday evening when symptoms were reported to the local Animal Health office. A 1km temporary restriction zone was placed around the premises earlier today whilst investigations and testing were completed, in line with domestic and EU legislation.

The vulnerability of agriculture in the United States to attack has been the subject of numerous reviews, especially since the terrorist attacks of September 11, 2001.

However, a large proportion of the public remains unaware of the complexities and scale of agriculture from “farm to fork” in the U.S., and clearly does not appreciate the vulnerability of our agricultural assets. Agriculture in the U.S. is remarkably robust from a standpoint of productivity and efficiency in the food distribution chain but dangerously fragile because of countless vulnerabilities that could be exploited. There are few events that would cause more economic damage than a widespread attack on the agriculture infrastructure in the U.S. This article will address some of those vulnerabilities and provide a brief overview of the impact that a targeted bioterrorism act(s) might have that exploits those vulnerabilities in agriculture.

Nature as a Terrorist

Nature acts in a reoccurring way as a “terrorist”. There are numerous examples throughout recorded history that have involved an array of human, animal and plant diseases. An example to illustrate the point is the foot-and-mouth disease (FMD) outbreak in the United Kingdom in 2001 which had an economic impact of over £8 billion (about $10 billion); more than six million animals were slaughtered: four million for disease control and over two million for welfare reasons. An outbreak of FMD in the pig population in Taiwan in 1997 resulted in the virtual depopulation of domestic pigs on the island with huge economic costs including the loss of an estimated 50,000 job. A part of the economic impact is that Taiwan no longer has a viable pork export business. The economic impact of a positive diagnosis of BSE in a single cow in Washington in December 2003 impacted exports by about $2 billion. An outbreak of Nipah virus among pigs in Southeast Asia during 1999 resulted in large scale slaughter of animals to control disease spread. Nipah is a zoonotic disease that can be spread from pigs to humans. In humans, Nipha infection causes severe encephalitis. There was a 40% mortality rate among infected patients in Malaysia and Singapore with at least 109 fatalities. The virulent H5N1 avian influenza strain circulating in Asia and Central Europe has potential to create a $5 billion impact should this pathogen enter the U.S. poultry production environment, independent of the potential as a human disease pandemic pathogen. A significant portion of the impact would result from the collapse of export trade. Based on the foregoing brief overview, it must be emphasized that a bioterrorism attack on agriculture in the U.S. would have catastrophic impacts.

Foreign Animal Diseases (FAD)

Diseases and biological toxins have been used as weapons of war throughout recorded history. Several diseases of livestock species are so dangerous to the economy of disease–free trading partners as to warrant extraordinary measures. Among these diseases are the familiar names: Foot and Mouth Disease, African Swine Fever, Bovine Spongioform Encephalopathy, Rinderpest, Highly Pathogenic Avian Influenza and many others (a detailed list can be found on the Select Agent and Toxin List maintained by APHIS). Use of any of these causative agents for these diseases represents a serious threat to livestock populations as the result of an asymmetric biological attack.

Asymmetric Biological Attack on Agricultural Assets

The Department of Defense defines asymmetric strategies as attacks on vulnerabilities not appreciated by the target or that capitalize on limited preparation against the threat. Intended introduction of a biological agent(s) that targets food production in the U.S. is designed to create fear, societal chaos, and have a destabilizing effect on the economy and the functionality of government. No elaborate delivery technology would be needed for such an attack. Samples of infectious material obtained or cultured from infected animals or carcasses are all that would be required. Virulent contagious diseases are still common in a number of countries and accessible. There is evidence that terrorist groups have given strong consideration to this strategy. A document captured at Tarnak Farms in Afghanistan in 2001 revealed that al Q’aida aspired to develop biological agents as weapons to advance their agenda. Apparent in reviewing this document is that the food supply was envisioned as a delivery mechanism. This example is significant because awareness to this level of detail is indicative of sophisticated program planning. It is evident that the intentional introduction of a disease pathogen that targets animal agriculture and the subsequent effects on food production systems and export trade could be devastating. More important is that attribution would be extremely difficult, if not impossible, to prove.

A recent example of an asymmetric attack occurred in New Zealand where a small group of farmers intentionally introduced a virulent rabbit pathogen (rabbit calicivirus disease) as a strategy to control the population of wild rabbits. This introduction was so effective that the disease is epizootic in New Zealand and threatens to spread beyond Oceana. The significance of this event is that a group of motivated individuals without much scientific training managed to research, acquire a source of the pathogen, and penetrate one of the best biosecurity systems in the world to unleash a hemorrhagic disease virus on the rabbit population in New Zealand.

Summary

The use of foreign animal disease pathogens to inflict economic damage to an adversary’s agricultural productivity, either through a State-sponsored initiative (biological warfare) or through several terrorism models would have potentially catastrophic effects. The possibility of preventing an asymmetric attack(s) is at best daunting. Regional and local consequences would have Katrina-like similarities; large numbers of individuals applying for unemployment insurance, rise in health care costs due to treatment for mental illness, inability to meet mortgage payments, possibly closing of all public services and facilities due to movement restrictions, and the news media broadcasting to the entire U.S. population in near real-time every detail and attempt at disaster plan execution including large scale slaughter of animals to control disease spread. It is not easy to answer the questions of how bad an agricultural bioterrorist event would be in the U.S. However, the preponderance of evidence is that it would be potentially devastating to agribusiness and likely challenging to national security. A huge challenge will be to find ways to reduce the likelihood of an attack and the subsequent impact on society.