Background: Common to all fields of science and engaged scientists is their willingness to participate in the free exchange of ideas. This blog often posts such ideas in the form of existing citable scientific contributions and news items. In recent conversations among like-minded individuals regarding contemporary topics in livestock production agriculture and biotechnology, the issue of U.S. animal disease research was raised. No factor in livestock production can impact production efficiency and profitability more than a disease issue. And, in the case of a highly contagious foreign animal disease (FAD) where the U.S. would change from disease-free status to one of a FAD positive diagnosis, livestock production could be decimated in quick order.
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?