Containment Lab Confidential
Keeping Tabs on the Biosafety Labs at Fort Detrick – And Those Private Research Facilities Beyond the Gates That Could Be Right in Your BackyardBy G.M. Corrigan Photographs by Casey Martin
Lawyer-activist and local columnist Barry J.C. Kissin — tall, intense, ripcord lean but with a coiled, anaconda-like strength about him — sits at a dining room table growing increasingly exercised as he goes on about the perceived inadequacy of local first-responder plans for the infectious nightmares he worries could escape the biodefense labs at Fort Detrick.
“See, part of the problem is that these labs are not acknowledging what the threat is,” he flares. “So, you can’t effectively manage emergencies in advance if you don’t know what the threat is — and the local responders really don’t.”
Reportedly on a government watch list for his anti-biodefense activities, Kissin, unlike the FBI, doesn’t believe USAMRIID (the germ-studying U.S. Army Medical Research Institute of Infectious Diseases, which, officials say, conducts only defensive bio-work) scientist Bruce Ivins perpetrated the 2001 anthrax attacks. Kissin has been monitoring biodefense developments at the 8,500-population, 50-tenant army base since the program received a multibillion dollar booster shot in the wake of the attacks.
As part of a confederation of citizens concerned about local health and safety implications of the build up — which includes an additional USAMRIID complex (810,000 gross square feet), the Department of Homeland Security’s National Biodefense Analysis and Countermeasures Center (NBACC, 160,000 gross square feet) and the National Institutes of Health’s (NIH) Integrated Research Facility (IRF, 144,000 gross square feet) — Kissin and others focused on the required environmental impact statements (EISs) associated with the new government construction. It, after all, included a significant ramping up of the most controversial of workspaces, the so-called Biosafety Level (BSL)-4 labs, which handle the meanest of microbes.
“I think the biggest threat from these labs is what’s called a laboratory-acquired infection, OK?” he adds, leaning emphatically across the table. “We have it on solid authority — and I’m talking USAMRIID medical doctors — that in as many as 80 percent of these cases, the individual who is infected neither knows when nor how.
“Now, let’s introduce plague into this scenario, for example, which they’re playing with big time at Fort Detrick,” Kissin proposes softly, pausing in a way that piques one’s interest in a bug that killed tens of millions of people in medieval Europe. “It’s contagious …!” he yells. “You could be communicating the disease without knowing it.”
Many county residents may also be unaware of several private BSL-3 labs quietly conducting research with highly infectious viruses behind the walls of nondescript office buildings in neighborhoods beyond the controlled gates of Fort Detrick.
Frederick Citizens for Bio-lab Safety
Deeming the risk assessments of these EISs inadequate, the residents eventually lobbied against construction of the new USAMRIID facility, slated for completion in 2015. In 2008, a kindred, formal group, called Frederick Citizens for Bio-lab Safety, joined the fray, but failed to get the Frederick Board of County Commissioners to enjoin the army in court against breaking ground.
It did, however, get the National Academy of Sciences National Research Council to formally review the USAMRIID EIS.
“Basically, the 2010 NRC [National Research Council] study found the EIS to be inadequate,” says Beth Willis, a former medical social worker and chairperson of the Containment Laboratory Community Advisory Committee (CLCAC), a city-county, bio-labs information clearing house and liaison body formed as a result of the NRC’s findings. “But it also said that USAMRIID has terrific procedures in place, so there was no reason to recommend that the lab not go forward.”
She adds that “to its tremendous credit, however, USAMRIID embraced” the NRC’s committee-forming recommendation, and offered its full support “recommending that the liaison committee be independent.”
As a result, the seven-member committee — not including alternate member, the Frederick County Board of County Commissioners (BOCC), Board of Aldermen, Fort Detrick and USAMRIID representatives — launched its monthly meetings in early 2011. It’s now where all the community bio buzz is centered.
“The labs are concerned that we’re trying to get into their business and tell them how to do science,” Willis says of the partnership’s growing pains. “But we really want to work toward better, more free-flowing communications — and that’s hard, because we’re talking about large institutions that are not accustomed to informal communications.”
A first order of business for the new, expertise-rich committee was to write its own purpose and scope statements, which, after much discussion, adopted an advisory role and a purview that included the “planning, design, construction, operation and disposition” of Fort Detrick’s three BSL-3 and -4 labs, its BSL-3 Department of Agriculture lab, a BSL-2 Navy facility there and “any other government or private laboratories operating within Frederick County,” according to Willis.
The CLCAC, however, doesn’t concern itself with other tenants on the 1,127-acre base, its Area B environmental issues or garrison matters unrelated to the bio-lab complex.
But the committee does concern itself with a relatively peripheral matter — considering the 1.1 million gross square feet of new or under construction high-containment space there — that lately has seized the public’s attention: the number and location of private, BSL-3 labs in the community that, because of security reasons or regulatory gaps, can work with pernicious pathogens without revealing their presence in the neighborhood.
Not Allowed to Know?
According to a 2009 U.S. Government Accountability Office (GAO) report, there were 13 BSL-4 laboratory entities either in operation, or in the planning or construction stage in the country in 2008. There were 242 BSL-3 entities (1,362 actual labs) registered either with the Centers for Disease Control and Prevention (CDC) or the U.S. Department of Agriculture’s (USDA) “select agent” programs. In 2004, there were only five BSL-4 and 150 BSL-3 entities (415 labs) nationwide.
In states such as Maryland, with local, emergency management-related disclosure agreements with the CDC and USDA, nonfederal select agent custodians must also register with the confidential Biological Agent Registry (BAR) program in their respective states.
Statewide, Maryland has 22 laboratory entities on the BAR, according to Maryland Department of Health and Mental Hygiene (DHMH) Deputy Secretary Fran Phillips. Four of those are in Frederick County.
At least two of the four are Fort Detrick’s USAMRIID and Homeland Security’s NBACC, which work with BSL-3 and BSL-4 select agents, and whose spokespersons told the Gorilla they voluntarily registered with the state BAR program. The USDA lab is not registered with the BAR.
That leaves two, private BSL-3 entities in the county authorized to work with select agents and possibly an unknown number of private, BSL-3 entities working with still-dangerous — if not “select” — agents or toxins, such as severe acute respiratory syndrome (SARS) or drug-resistant tuberculosis. Neither category’s members — the first because of state and federal anti-terrorism legislation and the second because its members are relatively unregulated — have to reveal their presence to the public. And it’s against the law for the BAR program or CDC officials to say almost anything about registrants outside their tight bioresearch brotherhood.
“It became clear we’re not allowed to know,” Willis explains, acknowledging that these private labs are more vulnerable to “bad actor” attacks than those behind Fort Detrick’s gates. She says the committee verified that nobody regulates any nonclinical or non-NIH-affiliated BSL-3 labs that work with dangerous but non-select agent pathogens. “We’re certainly not implying that they’re not safe. But there’s no oversight of them by any government, anywhere.”
Dr. Robert Myers, director of laboratories administration for the Maryland Public Health Service, as well as the 2009 U.S. GAO report, agrees with Willis.
“They don’t even have to disclose their identities to the state,” Myers says of the nonselect agent, BSL-3 labs that are neither clinical nor NIH-related. “That’s the issue the committee brought up, and that’s the issue we’re going to address with a working group — to find out exactly where the gaps are in the regulation.”
It’s also an issue the CLCAC tried to remedy with legislation proposed in 2011 by Maryland State Sen. Ron Young. Senate Bill 758, fiercely opposed by Maryland bioscience and biotech lobbies, died in committee. Calling the legislation “BAR on steroids,” Myers observes the bill likely failed because it wanted the state health department to approve laboratory design and do CDC-like annual inspections, thus duplicating that requirement for some.
Young plans to reintroduce a revised version of the bill in the next session, according to a staff person in his office.
Some Secret Labs Exposed
“In the business, you just don’t want to talk about it,” a highly informed, but confidential, source told the Gorilla of the private labs’ secrecy habits. “It’s a public relations thing.”
The source, who came to light when a Gorilla reporter reviewed the websites of the 75 biotech companies listed with Frederick County and then queried likely candidates about their labs’ BSL status, says that one of the “secret” BSL-3 labs here is Lonza-Walkersville. Another was Life Technologies Corporation on Executive Way, where a BSL-3 laboratory was located until at least early 2000.
Contacted for comment, a spokesperson for Life Technologies, who spoke on condition of anonymity, initially stated it never had a BSL-3 lab in Frederick. When confronted with the source’s claim, however, that spokesperson says the Frederick branch had once “prepared” to become a BSL-3 lab but never actually elevated itself to that biosafety level.
“Yeah, bull,” replies the source, who concedes that Life Technologies’ capability may have lapsed when the company was bought out by Invitrogen Corporation in 2000. “I have done BSL-3 level work in the past while with Life Technologies and Lonza-Walkersville,” the source notes. After being informed of its former employee’s claim, a Lonza spokesperson acknowledged having BSL-3 facilities at its Walkersville location, where in the 1990s it treated “viruses that were not classified as BSL-3, but
which [were] treated as BSL-3 for greater safety precaution.” The spokesperson added that the lab is not currently working with BSL-3 pathogens.
Even though Lonza-Walkersville — and, possibly, Life Technologies — is equipped with BSL-3 facilities, there still may be other local candidates for the distinction. At least half of the biotech firms queried for this story — but only six or seven likely ones — did not respond to the Gorilla’s email seeking comment.
“These high-containment labs serve a critical function in the protection of public health,” asserts Rhonda Jung, spokesperson for Birmingham, Alabama-based Southern Research Institute’s (SRI) life sciences laboratory in Frederick city. SRI is a self-professed BSL-3 lab registered with the BAR program. “If physicians, scientists and public health officials don’t understand
viruses like Avian Influenza, SARS and West Nile, for example, we won’t know how to prevent them or treat them should they become a public health threat,” she says.
Employing 70 people at its sleek building on Aviation Way, Southern Research-Frederick, currently works on HIV, Hepatitis C, West Nile (encephalitis), Western Equine Encephalitis and “something called St. Louis Encephalitis” at its BSL-3 lab, according to Jung.
The local facility also once worked on the anthrax bacillus, which ultimately brought about the lab’s unveiling as a BSL-3 site. In 2005, SRI accidentally shipped a quantity of the pathogen in its live, instead of its “dead” or weakened, form to a research hospital in California, and the incident became public.
“The anthrax event we experienced in 2005, while very unpleasant to go through, actually became a great teaching experience for us,” Jung says. “We took a self-imposed, timeout from doing high containment work there … conducted a thorough internal investigation, and even brought in external resources to review our policies, procedures and training.”
And, in an exceptional gesture of public-private cooperation, it shared those policies, procedures and training with a subcommittee of the CLCAC at an on-site briefing last November.
“It was indeed an excellent presentation,” states Willis, who had been asked not to relay specifics of the meeting. “CLCAC’s experience, however, is that secrecy backfires; it breeds mistrust. Southern Research-Frederick has a good story to tell, but the last big story in the press was … the live anthrax incident.”
Safety, Security and Emergency Management
Except for the unknown number of private BSL-3 research labs operating outside the auspices of the NIH (National Institutes of Health), the arcane world of high containment work is not only extensively regulated, but it may also be disparately overregulated, as the GAO report indicated.
As well it should be, some concerned citizens might say, given the virulence of the agents and toxins under investigation — sometimes in densely populated areas — and the various vectors of their release, which includes laboratory-acquired infection, animal or insect escape, accidental venting (such as what reportedly happened at a Soviet, offensive bioweapons plant in Sverdlosvk in 1979, killing 68) and “insider threat,” such as may have occurred in the 2001 anthrax attacks. Then, there is the issue of increasing incident probability due to lab proliferation.
Military and other federal government labs housed at Fort Detrick, for example, not only must comply with lab-related regulations of their agencies or service branches (for example, USAMRIID labs voluntarily shut down several years ago to revamp inventory procedures) but also with the CDC’s or USDA’s select agent programs — all of which apply the principles and best practices of the Department of Health and Human Services’ Biosafety in Microbiological and Biomedical Laboratories, the biosafety Bible.
Private labs, for their part, depending on the kind of select agent work they are performing, must comply with regulations of either the CDC or the USDA, and one or more of the following: the U.S. Food and Drug Administration (FDA), NIH, the DHMH’s Office of Health Care Quality (if a clinical lab), the U.S. Department of Transportation (select agent shipping and receiving), the FBI (background checks and investigations) and any state BAR programs.
Though mostly a “passive” regulatory regime, requiring only minimal information on a private laboratory’s select agent work for local emergency management purposes, the state BAR program does require the registrant to file its incident response plan with its local emergency management director for reference and with the state for its review.
“This is not a program that is underregulated,” DHMH’s Phillips said at the November CLCAC meeting.
For its part, the Centers for Disease Control and Prevention (CDC), the big daddy of biocontainment regulation, which has responsibility for 49 of 80 select agents or toxins on the list, is anything but passive. Of the 363 entities in the federal select agent program nationwide as of July 2012, the CDC oversees 313 of them, all of which must register their address; the select agents in use, possession or undergoing transfer; the names of employees with access to the select agents (11,000 nationwide) and the “responsible officers” charged with the lab’s biosafety and security programs.
In addition, and most importantly, these entities must comply with the CDC’s reporting, training and incident response requirements, a compliance that is checked annually on site, or during incident-initiating or surprise inspections.
Finally, there are the local responders — the city and county emergency management personnel, the hospitals and the frontline doctors and health care providers — that comprise another piece of the public safety puzzle should contagion erupt or containment be breached at a BSL-3 or -4 lab. Local nurses and doctors have a responsibility to report any condition symptomatic of a select agent-related disorder immediately to county public health officials. Either that scenario or a lab breach affecting the public sets in motion a chain of events that may involve the combined assets of local government’s emergency management team.
“Part of our responsibility … is to make sure we’re bringing the many layers of our government together to benefit the citizens,” says Frederick County’s Director of Emergency Management John (Jack) Markey. With 14 city-county emergency drills conducted since 2005, he is confident of the collective agencies’ ability to respond effectively as a team to any select agent-related release. “It’s one of the things Frederick has gotten right over the years,” he says.
Kissin, however, remains skeptical of any such confidence in light of the poisonous pathogens penned up at Fort Detrick and at the private labs. “USAMRIID labs shut down three years ago because their inventory was haywire and it has had hundreds of mishaps since the breach of [anthrax] containment in December of 2001. And the public didn’t learn about that breach until April of 2002.
“They don’t belong here in the middle of a densely populated area,” he fumes about the labs. “It’s that simple.”
Containment by the Numbers
BIOSAFETY LEVEL 1 (BSL-1) a basic level of protection appropriate for agents that are not known to cause disease in normal, healthy humans.
BIOSAFETY LEVEL 2 (BSL-2) appropriate for handling moderate-risk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure.
BIOSAFETY LEVEL 3 (BSL-3) appropriate for agents with a known potential for aerosol transmission, for agents that may cause serious and potentially lethal infections and that are indigenous or exotic in origin.
BIOSAFETY LEVEL 4 (BSL-4) appropriate for exotic agents that pose a high individual risk of life-threatening disease by infectious aerosols and for which no treatment is available.
What Is a Select Agent?
A “SELECT AGENT” is an air-transmissible subset of dangerous pathogens, such as anthrax and, at the BSL-4 level, Ebola, that lends itself to bioterrorism. Its custodians must comply with select agent regulations of either the CDC or, where animal or plant matters are concerned, the USDA to prevent theft, loss or accidental release.
See the CLCAC in Action
On Tuesday, Sept. 11, at 7 p.m., the Containment Laboratory Community Advisory Committee (CLCAC) will hold a public meeting in Frederick’s city hall on local emergency response and bio-lab safety. Representatives from county emergency management, public health, police and Fort Detrick will be on hand to conduct a discussion and answer questions.