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Security and Researching High-Consequence Biological Threats

For most of the country, the process of selecting a replacement for the Plum Island Animal Disease Center has been off radar. The chances are that unless you are involved in homeland security activities, or are veterinarian or a cattle rancher, you wouldn't know (or maybe even care) what Plum Island did, or why it needed to be replaced.

Perhaps you remember that following September 11th there were concerns about the threat of crop-dusters being flown by terrorists to poison our food supply. Our food supply continues to be one of the "soft" targets of concern. In the same way, animal diseases that can transfer to humans represents a serious potential problem. Its not just any concern about H5N1 Avian Flu because these diseases include such as Salmonella and plague that can be spread by wild rodents in Southwestern U.S (a recent outbreak of Yersinia Pestis in Northern Arizona is an example).

In January 2006, the Department of Homeland Security began looking for a replacement for Plum Island - the site would be called the National Bio and Agro Defense Lab, and would be designated as a Level 4 Biohazard facility. Plum Island had been transferred from Department of Agriculture to the DHS in 2004 under Homeland Security President Directive 9 - Defense of United States Agriculture and Food.

Twenty-nine locations submitted Expressions of Interest (EOI) and 18 sites were selected for review under the Selection Process. After conducting site visits in the Second Quarter 2007, the list was narrowed to five locations.

* Flora Industrial Park, Madison County, Miss.
* Kansas State University, Manhattan, Kan.
* Texas Research Park, San Antonio, Texas
* Umstead Research Farm, Granville County, N.C.
* University of Georgia/South Milledge Ave., Athens, Ga.

This new lab facility will research high-consequence biological threats involving zoonotic (i.e., transmitted from animals to humans) and foreign animal diseases. It will also allow basic research; diagnostic development, testing, and validation; advanced countermeasure development; and training for high-consequence livestock diseases.

The new and unique government biocontainment infrastructure will:

* integrate those aspects of public and animal health research that have been determined to be central to national security;
* assess and research evolving bioterrorism threats over the next five decades; and
* enable the Departments of Homeland Security and Agriculture (USDA) to fulfill their related homeland defense research, development, testing, and evaluation (RDT&E) responsibilities.

Starting in August, the DHS visited these five sites and held Public Forums as part of developing the Environmental Impact Statements. I attended the one in Texas and had an opportunity to speak in favor of the facility being located here. From what I've read, the Public Forums in North Carolina and Georgia didn't "go very well."

All of this is backdrop to a recent report about U.S. labs mishandling deadly germs. According to this article, there have been more than 100 accidents and missing shipments since 2003. Even though there were no deaths or risk to the public as a result of these incidents, the question of procedures and oversight at these high-security facilities has been raised.

According to a review by The Associated Press of confidential reports submitted to federal regulators. They describe accidents involving anthrax, bird flu virus, monkeypox and plague-causing bacteria at 44 labs in 24 states. More than two-dozen incidents were still under investigation. The number of accidents has risen steadily. Through August, the most recent period covered in the reports obtained by the AP, labs reported 36 accidents and lost shipments during 2007 — nearly double the number reported during all of 2004.

This is not intended to overstate the risk to public safety from the new NBAF. No one involved would be so oblivious to the hazard and to previous accidents and breaches to not recognize them in the security plans for the new facility. And yet, the concern is a valid one, especially considering how many incidents have actually gone unreported. One "watchdog" organization, The Sunshine Project provides frequent, if not highly critical coverage on issues relating to biologicla weapons and biotechnology. Some of the more recent ones are quite startling actually.

Ebola Error in Wisconsin Shows Lax Federal Biodefense Oversight ( 19 September 2007)

Anthrax and Tularemia Bioweapons Bungling in Texas (18 Sep 2007)

Texas A&M More the Norm than the Exception (26 Jun 2007)

The Bird Flu Lab Accident that Officially Didn't Happen (26 Jan 2007)

As always, it is the cover-up that makes an incident worse. It is possible that the unreported accident at Texas A&M contributed to its being dropped from the short list. Additional "unreported incidents" are listed in the first article.

All of this having been said, a GAO Report released last week, "HIGH-CONTAINMENT BIOSAFETY LABORATORIES - Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States" identified six lessons from three recent incidents: failure to report to CDC exposures to select agents by Texas A&M University (TAMU); power outage at CDC’s new BSL-4 lab in Atlanta, Georgia; and a release of foot-and-mouth disease virus at Pirbright in the United Kingdom (U.K.). These lessons highlight the importance of:

(1) identifying and overcoming barriers to reporting in order to enhance biosafety through shared learning from mistakes and to assure the public that accidents are examined and contained; (2) training lab staff in general biosafety, as well as in specific agents being used in the labs to ensure maximum protection; (3) developing mechanisms for informing medical providers about all the agents that lab staff work with to ensure quick diagnosis and effective treatment; (4) addressing confusion over the definition of exposure to aid in the consistency of reporting; (5) ensuring that BSL-4 labs’ safety and security measures are commensurate with the level of risk these labs present; and (6) maintenance of high-containment labs to ensure integrity of physical infrastructure over time.

Against this backdrop, is the outbreak of Hoof and Mouth Disease in the United Kingdom that was discovered in August. As far as I know, the suspicions that the outbreak spurred from a break at private testing lab have not been totally discounted.

Even though Hoof and Mouth Disease was eradicated in the United States in 1929, the British outbreak raises concerns. In fact, Ross Wilson, CEO of the Texas Cattle Feeders Association, said his group has been rethinking its support since the British outbreaks.

"The recent situation at Pirbright does give us some concerns," Wilson said. His group represents 5,000 cattle feeders in Texas, New Mexico and Oklahoma, an area that the group says is the largest cattle feeding region in America. The region markets more than 7 million cattle who eat at feedlots each year, about a third of the nation's fed cattle population. Texas ranks first in the country in fed cattle population.

That, in itself, is interesting considering that the Hoof and Mouth outbreak was made public more than a month before the Texas Public Forum for comments on September 11, 2007. No one from the Texas Cattle Feeders Association appeared that night to voice objection. And maybe even more "odd" is that San Antonio already has a Level 4 and Level 3 bio-hazard facilities at the Southwest Foundation for Biomedical Research (SFBR). SFBR was just awarded a $1.5 million grant from the Department of Homeland Security to study Marburg virus, a hemorrhagic fever virus.

All of this is a matter of National and Homeland Security. Its important work and frankly, San Antonio is a perfect place. Then again, I'm a "little biased."



I did not know that the Plum Island facility was scheduled for replacement.

As much as I am also biased in favor of a Texas site, I also believe that the site should either be on an island which is a good distance from the continental U.S., or in an arid desert surrounded by a large, uninhabited and controlled reserve.

I don't think that I'm particularly paranoid: I'd have no qualms about living outside the fence surrounding a nuclear power plant, and currently live in an area where Hantavirus and Y.Pestis (bubonic plague) are concerns. But I do believe the risk-times-consequences factor for any such bio research lab requires very significant isolation to buy time in the event of a problem. Quite frankly, of the five locations on the short list, San Antonio best meets the biological isolation requirement. More precisely, it is the least bad at violating it.

CBI: Hanta and Y.Pestis are in fact two of the "nasties" under the umbrella of the NBAF. A couple of clarifying points however.

1) While I agree with the concept of "R x C," San Antonio is today the 7th largest city in the county, so I don't see how it deals with biological isolation (nor was biological isolation one of the site requirements est. by DHS).

2) None of the proposed sites, except for the remote possibility of leaving the facility on Plum Island (actually very unlikely), are on an island. In fact, one of the questions raised by DHS in the process is existing infrastructure. One of the "unmentioned" issues is bringing 350 toplevel scientists to an area is whether they'll have the "necessaries" that they need for life (an isolated area is not conducive).