BioResearch: The Risk/Reward Ratio
Examining Hazards and Benefits of Biological Defense Facilities And Associated Research
By Jay Fraser
In the field of science and technology research, the stakes are usually a lot higher than the athletic platitude of “no pain, no gain.” In S&T, the risk/reward ratio becomes a guiding consideration when evaluating the merits of an effort. Speaking from my personal experience in research and development of technology, every effort contains a ratio of risk and reward. The question is whether the projected or envisioned end result is worth the time and effort expended. At the same time, considering issues surrounding the Global War on Terror, it is absolutely essential that the unimaginable be imagined. The question is whether the consequences of doing (or not doing) something is worth the risk. Without question, unpredictable events can and will occur. Thus, we have to be prepared for a wide range of possibilities.
Since 1954 when Plum Island was given by the US Army to the Department of Agriculture to study Foot and Mouth Disease following disease outbreaks in Mexico and Canada, the Plum Island Animal Disease Center (PIADC) has operated as a bio-safety level-3 (BSL-3) laboratory. According to the Department of Homeland Security web site, a BSL-3 is a laboratory that studies and thus stores “[m]icroorganisms present in the United States, and foreign and emerging agents that may cause serious consequences in livestock but are not harmful to human beings because of available protective measures.”
But it isn’t really that simple or simplistic. The ownership of the Plum Island facility was transferred from the Department of Agriculture to the Department of Homeland Security as one of the provisions of the Homeland Security Act of 2002. What followed was Homeland Security Presidential Directive 9 (HSPD-9) that brought into motion the creation of a facility that would conduct not only research and development on mitigation strategies for the animal diseases previously studied by the Plum Island facility, but to also expand its scope to study zoonotic diseases (those diseases that impact both animals and human beings). This raised the specter of the need to require a facility that could study not only BSL-3, but also BSL-4 diseases. According the the DHS reference cited above, BSL-4 diseases are “[m]icroorganisms that pose a high risk of life-threatening disease and for which there is no known vaccine or therapy.”
A number of BSL-4 laboratories already exist in the United States performing various types of high-risk research. There have been few known accidents or critical releases from a level 4 facility in the U.S. (One exception was the escaped baboon from the Southwest Foundation for Biomedical Research (SFBR) in San Antonio Texas in July 2006, but not known to be from the Level 4 part of the lab. It should also be noted that the escapee was never out of the sight of his keepers, and that it was the first breach in 16 years at the SFBR.) Nevertheless, there is an undercurrent of conspiracy theorists and doomsayers that argue strenuously against the creation of any National Bio and Agro-Defense facility. Without differentiating between BSL-3 and BSL-4 laboratories, and further, without actually substantiating the hazard, those in strident objection are vehemently opposed to the establishment of the NBAF anywhere beyond that which could be rebuilt on Plum Island (noting that there is limited if any support from the community for this to occur).
Two anti-research organizations of note have existed; the Sunshine Project (which inexplicably suspended operations in February 2008) and a less subtle organization called Stop the NBAF (specifically anti-NBAF in North Carolina), both of which have publicized the mistakes and accidents that have occurred. Make no mistake about it, however, there have been other accidents that have occurred and became visible because of the pending decisions about the NBAF. These included:
• the power outage at the Center for Disease Control Level 4 facility in the Summer of 2007, but the lab was not operational at the time of the outage.
• the unreported accidental exposure of workers at Texas A&M’s Level 3 laboratory to brucellosis during an experiment (BSL-3).
Some very dangerous and virile diseases will be studied at both the BSL-3 and BSL-4 elements of the new NBAF. The real question lies in whether the risk (that has been mitigated in the security and safeguards parts of the plans to build the facility) outweighs the benefits of studying and potentially solving the puzzles of how to tame these viruses before they become threats to the human populations.
Diseases Studied in BSL-3 Facilities
• Foot and Mouth Disease (FMD)
• Classical Swine Fever (CSF)
• African Swine Fever (ASF)
• Rift Valley Fever (RVF)
• Contagious Bovine Pleuropneumonia (CBPP)Diseases Studied in BSL-4 Facilities
• Japanese Encephalitis (JE) Virus
• Nipah Virus
• Hendra Virus
It should be recognized that 10.9% of the space allocated at the new NBAF will be used for BSL-4 research, with nearly ¾ of the space being used for BSL-3 work. Some of the other issues are discussed below.
The result of HSPD-9 was the initiation of a program, the National Agro and Bio-Defense Facility with the objective of replacing and upgrading the animal research center on Plum Island.
HSPD-9 tasked the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To partially meet these obligations, DHS has requested Congress to appropriate funds to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would house high-containment laboratories able to handle the pathogens currently under investigation at PIADC, as well as other pathogens of interest.
The Federal Register of January 18, 2006 was the first moment in a mad and expensive dash by almost 2-dozen locations to respond to the Request for an Expression of Interest.
This Request for Expressions of Interest resulted in submissions by 29 different sites from which the DHS then selected 12 Consortia that comprised 18 potential sites for follow-on evaluations. When the second down-selection decision was made on July 11, 2007, various groups in the finalist areas became sensitized the possibility that their community might be the “winner” in the NBAF lottery. It is on this background that the questions of research and the risk/reward ratio can be discussed.
There are five finalist cities plus the so-called “no-decision, decision” in which the NBAF could be re-built on Plum Island. The finalist areas are South Milledge Avenue Site, Athens, Georgia; Manhattan Campus Site, Manhattan, Kansas; Flora Industrial Park Site, Flora, Mississippi; Plum Island Site, Plum Island, New York; Umstead Research Farm Site, Butner, North Carolina; Texas Research Park Site, San Antonio, Texas. Just a couple of weeks ago, the Department of Homeland Security published its much awaited Environmental Impact Statement (EIS).
On September 11, 2007, an open public forum was held in San Antonio, Texas. Other, similar public forums were held in each of the down-selected areas. At these open meetings, people from the communities had the opportunity to voice their support or outrage at the possible locating of the NBAF in their city. I attended only the meeting in my city. At the time, there were very few negative statements made, while I’m told that in other areas, especially in North Carolina and in Georgia, there was an outspoken opposition. Since that time, even before the release of the EIS, a number of issues have come to the surface.
Since the release of the EIS, the most substantial issue that has been raised is the use of a mainland facility that might increase the risk of a release of foot and mouth disease. Related, sub-issues were:
• It is now argued, following the release of a report from the Government Accountability Office (GAO) that risk assessments of moving a laboratory studying animal diseases near cattle herds have not been done. Further, it is being used by opponents that the DHS supposedly did not have the “right” data available when they made the decision to move the Plum Island replacement on-shore.
• A mainland facility will be at a higher risk of terrorism than a facility on an island.
Both arguments are compelling, yet should be seen through a number of filters. These “filters” would include whether the research community has learned nothing about risk mitigation, safety and security safeguards around such facilities. Additionally, there truly needs to be a question raised as to whether or not an island or a mainland facility is more or less vulnerable to a terrorist attack. Logically, if a terrorist wanted to attack an island facility, its ability to do so exists (the attacks of September 11th, I believe, prove that virtually anything is possible, and that if we do not imagine the unimaginable, then events even more unimaginable may occur).
Further to these, it is also worthy to note that currently, legislation exists that bans the study of Foot and Mouth Disease on the mainland. Therefore locating the NBAF on the mainland would require permission from the Department of Agriculture to do so. This is a result of the circumstance that when the ownership of Plum Island was transferred from the Department of Agriculture to the Department of Homeland Security, the Secretary of agriculture retained the authority to prevent Foot and Mouth Disease research from being conducted on the mainland. Legislation is pending in Congress to allow this to occur. It has been estimated that a leak of Foot and Mouth Disease from the facility could result in $2.8 billion to $4.2 billion in economic losses.
By law, research on live foot and mouth disease (FMD) virus is not permitted on the U.S. mainland. This policy would need to be changed before DHS could conduct FMD research at NBAF if it were sited on the U.S. mainland. The conference agreement to the 2008 farm bill, H.R. 2419, as well as H.R. 1717, address possession of live FMD virus by DHS.
So the question remains, are the levels of risk associated with the NBAF in general, and the location of the facility on the mainland instead of an off-shore island facility in or out of balance with the reward of developing effective countermeasures to the diseases? I could, but will not, draw upon course work that I recently completed for Department Homeland Security certification in “Enhanced Threats and Risk Assessment” to show how land-based versus island locations have relatively similar risk levels for terrorism. But then, it would also hold that an assessment for man-made or natural disasters would also need to be provided. As Hurricane Rita approached the Texas coast in 2005, University of Texas Medical Branch (UTMB) went through a series of shutdowns in both their BSL-3 and BSL-4 laboratories as a preventative measure, and actually relocated many of their high risk experiments to the Southwest Foundation for Biomedical Research in San Antonio (including research on such viruses as that which causes hemorrhagic fever).
Why is it important that a National Bio Agro Defense Facility exist? Setting aside for a moment any possible man-made or terrorist release of a zoonotic disease, over the 4th of July weekend, it was reported that another outbreak of brucellosis (which causes pregnant cattle to abort their young) occurred in the bison her in Yellowstone Park.
There is no effective brucellosis vaccine for wildlife, and cattle vaccines are only 60 to 70 percent effective. Humans are susceptible to the disease, but cases are rare and usually limited to those who work with infected cattle. Eradicated everywhere else in the nation, brucellosis surfaced seven times in the Yellowstone area this decade, including twice since mid-June. With the recent cases, Montana ranchers near Yellowstone face severe restrictions on out-of-state cattle sales, and Wyoming ranchers could face a similar fate if another cow in the state tests positive for brucellosis in the next two years.
In summary, yes there are risks associated with performing research on high risk zoonotic diseases. And yes, there are risks associated with performing Foot and Mouth Disease on the mainland. Protecting the U.S. food supply requires elite scientists devoting attention to detecting and countering outbreaks of foreign animal diseases such as foot-and-mouth disease. In addition to potential threats that could devastate livestock herds, the scientists will work on others diseases that can jump from animals to people. How likely is it that hundreds of world class scientists will want to travel to work each day to an off-shore island laboratory? Or still, how likely is it that they will want to house themselves and their families in an off-shore location?
However, on May 22 in his testimony before the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, Gary Voogt, President-elect of the National Cattlemen’s Beef Association not only called for and supported the creation of a state of the art research facility to study the effect of potentially devastating outbreak of foot-and-mouth disease to our cattle population he is confident we have adequate technological containment ability already. Perhaps most importantly in the context of this current debate was his statement that “[w]e believe modern bio-containment technology is adequate to protect our industry and to allow for safe research and diagnostics, regardless of location.”
The establishment of a National Bio and Agro-Defense Facility (NBAF) is both necessary and wise, and should be supported. The risks of inaction on this front far outweigh the mitigated risks associated with such a facility. Though no facility of any type - in any industry or science - can be guaranteed absolute infallibility, we have the technological means to reasonably assure the safe operation of such a facility today, and we likewise clearly have the need for the benefits a National Bio and Agro-Defense Facility would provide.