Fort Detrick Lab Shut Down after Failed Safety Inspection; All Research Halted Indefinitely
Heather Mongilio / The Frederick News-Post
Fort Detrick’s research agenda — modifying and dispersing lethal and genetically modified organisms — has “unmistakable hallmarks of an offensive weapons program … in essence creating new threats that we’re going to have to defend ourselves against” — threats from accidents, theft of organisms and stimulus of a bioarms race.
FORT DETRICK, Maryland (August 2, 2019) — All research at a Fort Detrick laboratory that handles high-level disease-causing material, such as Ebola, is on hold indefinitely after the Centers for Disease Control and Prevention found the organization failed to meet biosafety standards.
No infectious pathogens, or disease-causing material, have been found outside authorized areas at the US Army Medical Research Institute of Infectious Diseases.
The CDC inspected the military research institute in June and inspectors found several areas of concern in standard operating procedures, which are in place to protect workers in biosafety level 3 and 4 laboratories, spokeswoman Caree Vander Linden confirmed in an email Friday.
The CDC sent a cease and desist order in July.
After USAMRIID received the order from the CDC, its registration with the Federal Select Agent Program, which oversees disease-causing material use and possession, was suspended. That suspension effectively halted all biological select agents and toxin research at USAMRIID, Vander Linden said in her email.
The Federal Select Agent Program does not comment on whether a program such as USAMRIID is registered and cannot comment on action taken to enforce regulations, Kathryn Harben, a spokeswoman for the CDC, wrote in an email.
Fort Detrick community cancer map.
“As situations warrant, [Federal Select Agent Program] will take whatever appropriate action is necessary to resolve any departures from regulatory compliance in order to help ensure the safety and security of work with select agents and toxins,” Harben said in the email.
The suspension was due to multiple causes, including failure to follow local procedures and a lack of periodic recertification training for workers in the biocontainment laboratories, according to Vander Linden. The wastewater decontamination system also failed to meet standards set by the Federal Select Agent Program, Vander Linden said in a follow-up email.
“To maximize the safety of our employees, there are multiple layers of protective equipment and validated processes,” she said.
Vander Linden could not say when the laboratory would be able to continue research.
“USAMRIID will return to fully operational status upon meeting benchmark requirements for biosafety,” she said in an email. “We will resume operations when the Army and the CDC are satisfied that USAMRIID can safely and consistently meet all standards.”
USAMRIID has been working on modified biosafety level 3 procedures and a new decontamination system since flooding in May 2018. This “increased the operational complexity of bio-containment laboratory research activities within the Institute,” she said.
At the time of the cease and desist order, USAMRIID scientists were working with agents known to cause tularemia, also called deer fly or rabbit fever, the plague and Venezuelan equine encephalitis, all of which were worked on in a biosafety level 3 laboratory. Researchers were also working with the Ebola virus in a biosafety level 4 lab, Vander Linden said.
Of the pathogens, Ebola, bacteria Yersinia pestis (plague), and bacterium Francisella tularensis (tularemia) are on the list of the Health and Human Services select agents and toxins. The three are considered Tier 1 agents, which pose a severe public health and safety threat.
Venezuelan equine encephalitis also falls under the Federal Select Agent Program, according to the Code of Federal Regulations.
The military research institute is looking at each of its contracts to see what will be affected by the shutdown. USARMIID work outside the lab is not expected to be affected, including on Ebola, Vander Linden said.
“We are coordinating closely with the CDC to ensure that critical, ongoing studies within bio-containment laboratories are completed under appropriate oversight and that research animals will continue to be cared for in accordance with all regulations,” she said in an email. “Although much of USAMRIID’s research is currently on hold, the Institute will continue its critical clinical diagnostic mission and will still be able to provide medical and subject matter expertise as needed to support the response to an infectious disease threat or other contingency.”
According to the Code of Federal Regulations, which also lists required training, records and biosafety plans, Federal Select Agents Program registration can be suspended to protect public health and safety. It is not clear if this is why the USAMRIID registration was suspended.
The code also gives the Department of Health and Human Services, under which the CDC falls, the right to inspect any site and records, without prior notifications. Vander Linden said in the email that the CDC inspected USAMRIID several times over the past year, both unannounced and on a regularly scheduled basis.
USAMRIID will work to meet requirements set by the Army and the CDC and have its suspension lifted, Vander Linden said.
“While the Institute’s research mission is critical, the safety of the workforce and community is paramount,” she said. “USAMRIID is taking the opportunity to correct deficiencies, build upon strengths, and create a stronger and safer foundation for the future.”
Heather Mongilio is the health and Fort Detrick reporter for the Frederick News-Post. She can be reached at hmongilio@newspost.com.
Posted in accordance with Title 17, Section 107, US Code, for noncommercial, educational purposes/
Biological Weapons: Bargaining With the Devil
(August 18, 2011) — The earliest recorded use of biological warfare was that of Romans putting dead horses into an enemy’s water supply. Other documented examples include combatants hurling plague-ridden human corpses into enemy garrisons; giving blankets contaminated with smallpox to hostile forces; infecting enemy livestock with anthrax and the equine disease, glanders; and poisoning an adversary’s water supply with intestinal typhoid bacteria.
These heinous war practices may seem pre-modern; yet, readiness for biological warfare continues, aggressively and in extreme secrecy, today. Up to a dozen countries are suspected of offensive, or “first use,” biological weapons programs, chief among them the United States.
From 1942 until the late ’60s, a highly secretive, offensive, biological weapons research program, begun at the US Army’s research facility at Fort Detrick in Frederick, Maryland, gained momentum in the United States. World War II German and Japanese scientists (whose war crimes were overlooked for their expertise in bacteria and viruses capable of sickening and killing livestock, plants and humans) were recruited and employed in it.
In 1969, President Nixon learned of the large-scale biowarfare program and halted it, given its gruesome risks and the already existing overkill capacity of the US nuclear weapons arsenal. (1) Soon after, the US government signed and ratified the 1972 UN International Biological and Toxin Weapons Convention that outlaws all offensive biological weapons programs, that is, programs with first-strike intent and capability.
In late 2001, the US Department of Homeland Security rapidly resurrected research on biological warfare agents. The new agency seized upon the anthrax attack in October of that year, in which inhalable anthrax was sent through the US mail to certain Congressional politicians and journalists (but ultimately killed five postal workers), to warrant and market a bioweapons research agenda. The FBI alleged (yet never proved with direct evidence) that the source of the anthrax letters was Fort Detrick biodefense scientist, Bruce Ivins, who committed suicide as federal agents were pursuing him.
The resurgence of biowarfare research in 2001 is one of the many militaristic actions taken under the banner of fighting terrorism, and it is strongly suspected to be in violation of the biological weapons convention. Some have suggested that this domestic terrorism was a deliberate act to pre-dispose the public for a new wave of biological warfare research. (2)
The bullish climate of the “war on terrorism” set off a massive flow of federal funding for research on live, virulent bioweapons’ organisms (also referred to as biodefense, bioterrorism and biosafety organisms) to federal, university and private laboratories in rural, suburban and urban areas. Among the federal agencies building or expanding biodefense laboratories are the Departments of Defense (DoD), Homeland Security, State and Agriculture; the Environmental Protection Agency; and the National Institutes of Health (NIH).
A new network, comprised of two large national biowarfare laboratories at BU and University of Texas, Galveston medical centers, more than a dozen small regional laboratories and ten Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research, was designed for funding by the National Institute for Allergy and Infectious Diseases, a division of NIH. The validation offered by the federal health research agency for ramped-up biological warfare research is the dual use of the research results: “better vaccines, diagnostics and therapeutics against bioterrorist agents but also for coping with naturally occurring disease.”
Today, in dozens of newly sprung laboratories, research on the most lethal bacteria and viruses with no known cure is being conducted in an atmosphere of secrecy, with hand-picked internal review boards and little, if any, public oversight or accountability. Fort Detrick, Maryland, a longstanding military base and major government research facility, is the site of the largest biodefense lab being built in the United States.
Here, biowarfare pathogens will be created, including new genetically engineered viruses and bacteria, in order to simulate potential bioweapons attacks by terrorist groups. Novel, lethal organisms and methods of delivery in biowarfare will be tested, all rationalized by the national security need to study them and develop a figurative bioshield against them. In fact, Fort Detrick’s research agenda — modifying and dispersing lethal and genetically modified organisms — has “unmistakable hallmarks of an offensive weapons program” … “in essence creating new threats that we’re going to have to defend ourselves against” — threats from accidents, theft of organisms and stimulus of a bioarms race. (3)
Between 2002 and 2009, approximately 400 facilities and 15,000 people were handling biological weapons agents in sites throughout the country, in many cases unbeknownst to the local community. The marathon to spend nearly $60 billion since 2002 on biological weapons research has raised serious concerns for numerous scientists and informed public critics. Among these are:
• runaway biodefense research without an assessment of biowarfare threat and the need for this research; (See the Sunshine Project web site for the most comprehensive map of biodefense research sites through 2008 in the United States )
• militarization of biological research and the risk of provoking a biological arms race;
• neglect of vital public health research as a tradeoff for enhanced biodefense research;
• lack of standardized safety and security procedures for high-risk laboratories;
• increased risk of accident and intentional release of lethal organisms with the proliferation of facilities and researchers in residential communities;
• lack of transparency and citizen participation in the decision-making process; and
• vulnerability of environmental justice (i.e., low income and minority) communities to being selected for the location of these high-risk facilities.
Is this federal research agenda “the biological equivalent of our misadventure in Iraq?” An expert on biological weapons at the University of California Davis, Mark Wheelis, contends that a “mass-casualty bioterrorist attack” is unlikely and that “plastering the country” with bioweapons laboratories leaves the country with a weakened public health research infrastructure and, thus, less secure. The Government Accounting Office (GAO) and many others have drawn the same conclusion. In May 2009, a study of security in DoD biodefense laboratories determined that the security systems of high biocontainment laboratories cannot protect against theft of bioweapons agents.
Soon after, a Washington Post story revealed that an inventory of potentially deadly pathogens at the government’s premier bioweapons research laboratory at Fort Detrick, Maryland, uncovered that more than 9,000 vials were missing. In testimony to a House Committee hearing on the proliferation of bioweapons laboratories, Nancy Kingsbury of the GAO revealed that expansion of bioweapons laboratories has been “so uncoordinated that no federal agency knows how many exist”; nor, she added, is there any sense among federal agencies of how many are needed, of their operational safety and of the cumulative risks they pose to the public.
Keith Rhodes, the GAO’s chief technologist, testified in the same October 2007 Congressional hearing “’we are at greater risk today’ of an infectious disease epidemic because of the great increase in biolaboratories and the absence of oversight they receive.” As many have gravely observed, the biodefense build-up means a huge number of people has access to extremely lethal material.
No Realistic Assessment of Need for Growth in Biodefense/Bioweapons Labs
Between 1900 and 2000, one person died in the United States from the deliberate use of a biological weapon (altogether six died by 2011, given the five anthrax deaths in 2001). This contrasts with more than 100,000 deaths per year from three public health causes, namely firearms, air pollution and food-borne disease. The other documented deliberate use of a pathogen involved the contamination of salad bar food with salmonella in 1984, which sickened 751 people.
This contrasts with the annual incidence of comparable intestinal infections suffered by American tourists in Mexico, Africa, the Middle East and South Asia, which must reach hundreds of thousands, if not millions of cases. Most historical threats of bioweapon use were hoaxes and most intended uses were personal, according to Milton Leitenberg of the Center for International Studies at the University of Maryland.
Contrary to popular and public official statements, weaponizing biological agents is extremely difficult, requiring immense research money, effort and expertise. Thus, the threat of biological terrorism with mass casualties — a threat that government has elevated without a basis in fact and without any rational threat assessment — confounds public awareness and siphons resources from true public health needs, such as gun control, reducing air pollution and research on TB resistance.
In March 2005, 750 top microbiologists, comprising the majority of US scientists studying bacterial and fungal diseases, wrote their major funding agency, the NIH, to claim that the agency’s emphasis on biodefense research had diverted research away from germs that cause much more significant disease and death.
Between 1998 and 2005, grants for researching potential bioweapons such as the bacteria that cause anthrax, plague and tularemia and viruses such as Ebola, Marburg and smallpox increased by 1,500 percent. During the same period, grants to support non-biodefense germs that cause major sickness and death (such as TB-resistant microbes and influenza) dropped 27 percent.
Lynn Klotz, a fellow at the Center for Arms Control and Non-Proliferation, calls for a combined risk assessment, which includes the risks of infectious diseases such as HIV/AIDS and staph infections, a potential influenza epidemic and the risk of a bioweapons attack in order to apportion health resources where they are most needed. Such an assessment, he argues, will support prioritizing public health needs over the political hype that creates an “overblown fear of a big bioweapons attack.”
Toothless Biological and Toxin Weapons Convention (BTWC)
The 1925 Geneva Protocol, the oldest international agreement on biological weapons, prohibits the use of biological weapons in war by parties to the protocol. Many states have historically interpreted this prohibition to mean “offensive” or first use and have reserved the right to use bioweapons in self-defense. (4)
The 1972 UN Biological and Toxin Weapons (BTWC) Convention prohibits all offensive biological weapons research, production and stockpiling programs, that is programs intended for first use of biological warfare and also proscribes the export or transfer of these weapons. However, signatory countries are not prohibited from developing defensive bioweapons for use in response to a bioweapon attack.
The Convention also permits bioweapons-related research for medical and “other peaceful purposes.” Thus, the weakness of this convention is that it allows bioweapons programs that may purport to be defensive or for medical and/or other peaceful purposes, but which can serve offensive purposes. Simply put, the convention does not protect against militarized biological and toxic weapons research, development and production.
A second central flaw of this convention is that, unlike the 1993 UN Chemical Weapons Convention, it has no provision for a Verification Protocol (5) to assure compliance with the convention, nor does it provide for establishing an independent UN-based organization to monitor compliance. At most, signatory parties are expected to meet every five years to review voluntary implementation reports — with desultory results, thus far. Further, no United States administration has shown interest or leadership in achieving a strong Verification Protocol to the BWTC , a persistent policy neglect which increases the likelihood of a wider international resurgence of interest in biological weapons.
Under the Bush administration, the United States resisted and derailed international NGO and signatory states’ attempts to craft protocols for the BWTC that would provide for bioweapons’ inspections and an organization responsible to do them.
The US opposition to inspections stems from perceived risks to — the oft cited, yet never parsed — “national security interests.” Of the US animus toward bioweapons’ research inspection, Jackie Cabasso of the Western States Legal Foundation, noted, “With biological weapons, the line between offense and defense is exceedingly difficult to draw … Secrecy is the greatest enemy of safety.” Given the massive US bioweapons research buildup, secrecy will raise the suspicion of other countries. “This bodes badly for the future of biological weapons control.”
Environmental Justice: A Case Study of Community Activism against the BU Bioweapons Laboratory
“As a nation … we are still in the grips of the military industrial complexfor whom projects such as the Boston Biolab are as much meat and potatoes as any multi-billion dollar weapon system, no matter how dubious the need.”
In February 2003, Boston University (BU) submitted a proposal to the NIH to construct a facility with the highest-risk level bioweapons research laboratory (called a BSL-4 laboratory) that would be sited within the BU Medical Center. The medical center is located in a dense, urban neighborhood with a majority of low-income and minority residents nearby.
The process of proposal development, site selection and subsequent approval for funding took place in secret, without informing and consulting the local community. The site selected for the laboratory was pre-determined prior to BU undertaking a National Environmental Policy Act (NEPA) mandated environmental impact review and without involving the surrounding residential and working community — all in violation of federal policy. Nonetheless, NIH approved BU Medical Center’s proposal for $128 million.
The fall out has been a classic struggle between an environmental justice community (6) — a community that is overburdened with health disparities, waste facilities, bus depots and that is home to the majority of social institutions, such as the county prison, homeless shelters, mental health facilities and a heroin detox center that other neighborhoods have rejected — and a powerful academic medical institution in a well-glued alliance with a federal agency and the majority of municipal and federal politicians.
The community protest strategies included persistent community organizing spearheaded by Roxbury Safety Net, a premier community organizing coalition; public protest and strategic use of media; coalition building between the community and other nearby municipalities and interest groups; ongoing meetings with local politicians; enlisting numerous legal and science experts; and undertaking two community-initiated lawsuits.
The neighborhood, in which the bioweapons laboratory was slated for siting, was comprised of very poor and predominantly minority populations living in public and subsidized housing, with the children attending nearby public schools. Many used the Medical Center for health services, thus, their access would be jeopardized by a biodefense laboratory-related transport accident, fire, release of toxic organism, or terrorist act.
Within a few blocks of the laboratory site are three of the largest shelters in Boston for the hungry and homeless. A fire, release of an insect vector, or other emergency at the laboratory would put the most vulnerable residents at disproportionate risk. Neither the NIH nor BU Medical Center took a hard-eyed look at salient local emergency preparedness considerations. A fire or other emergency at the laboratory would paralyze traffic in the area, render the city’s emergency evacuation plan useless and trap the most vulnerable of the city’s people.
Inexplicably, the density of the surrounding neighborhood was not factored into the potential impacts of a high-risk laboratory, especially given this laboratory would be located in a much more densely populated area than any other BSL-4 lab in the country. Hamilton County, Montana, the location of the Bitterroot biodefense laboratory, has a population of 15 per square mile, whereas Suffolk County, where the BU Medical Center laboratory would be sited, has a population density of 11,788 people per square mile.
The county population density of the area surrounding the proposed BU laboratory is four times that of the Centers for Disease Control Atlanta facility; ten times that of the San Antonio, Texas, facility; almost 20 times that of the Galveston, Texas, facility; and about 40 times that of Fort Detrick, Maryland, facility.
One can only conclude that NIH and BU see the local predominantly low-income and minority community as a convenient “sacrifice zone” for a high-risk research facility that would otherwise be rejected by more affluent and politically connected communities that have the power, money and connections to keep high-risk facilities — whether prisons or bioweapons labs — out of their backyards.
Legal Action
NIH and BU’s private gentlemen’s agreement to site this biodefense laboratory in the BU medical center has been brilliantly challenged by community activists on both state and federal law grounds, with notable legal support from nonprofit and private law firms. At both the state and federal levels, the activist resident plaintiffs charged that the Environmental Impact Reports prepared by BU and the NIH were insufficient because they: 1) did not provide an adequate “worst-case” scenario of a biodefense laboratory accident and 2) did not conduct a comparison of a biodefense laboratory accident in less dense suburban and rural locations.
The citizen lawsuit against NIH also charged the agency with failure to conduct an environmental review of the entire national biodefense laboratory program, before awarding research grants, specifically to identify and address disproportionate impacts on minority and low-income communities, as prescribed in President Clinton’s Executive Order 12898.
What followed was a succession of disingenuous risk assessment reports designed by consultants to give BU and NIH the results they wanted — low to almost no risk to the local communities from lab spill and infected worker scenarios. The pathogens chosen for their risk scenarios were either non-contagious or merely mildly contagious, with no more than one lab worker infected, or they involved risks to farm animals, which are non-existent in Boston’s inner city. Even when the highly contagious lethal virus which causes severe acute respiratory syndrome (SARS) was analyzed after the risk assessors were sent back to work, they again used small risk scenarios and, naturally, found miniscule risk of community infection.
They avoided a damning SARS scenario, such as: a lab researcher unknowingly infected with SARS has lunch with and infects colleagues, most of whom take public transportation home at rush hour after work, a few of whom go to evening meetings and one of whom leaves on a crowded 747 from Logan Airport for a conference in New York City. All cough in their respective work, public and home environments. With this scenario in mind, scientist Lynn Klotz, who worked with other scientists and community activists to propose an alternative vision for the BU lab, wrote recently:
An escape of a highly contagious pathogen from a lab in a city is more likely to seed an epidemic … What if a lab researcher is infected with a highly contagious deadly disease that is transmitted by casual contact, a victim’s cough or from contaminated surfaces? Besides SARS, the 1918 pandemic flu also comes to mind. The BU [BSL4] Laboratory likely will research SARS and the 1918 pandemic flu. … Research on deadly, highly contagious pathogens should be conducted in BSL4 laboratories in isolated locations … never in populated areas …
The community-driven legal action has had positive, yet limited, effect in its efforts to promote environmental justice. For seven years, the courts have not permitted BU to open the BSL-4 laboratory while the sham environmental impact assessments continue to be reworked for a third time. However, the courts did approve the construction of the building that was to house the biodefense laboratory; it stands tall, arrogant, empty, yet entitled, as if expecting to outlast the critics.
At the same time, the protracted state and federal lawsuits have given the undaunted community the opportunity to keep the issue of environmental injustice in the media and the public eye, functioning like a hair shirt for BU. Their resistance recently included proposing creative alternatives to bioweapon research, while biding time for the next reworked risk assessment. The activists and scientist partners designed an alternative vision for the BU laboratory, one that proposes a focus on developing new technologies, preventatives and cures for the infectious diseases of substantial public health concern.
The World Health Organization has identified antibiotic resistance as one of the greatest threats to human health. The coalition’s alternative vision for infectious disease research in the BU BSL-4 advocates investing the NIH funding in countermeasures for infectious bacteria where many strains are now resistant to multiple antibiotics.
In July 2011, emails began circulating from the Safety Net coalition organizers and legal team to ready for the public review comment period for risk assessment No. 3 of the impact of the bioweapons laboratory on the community, which may begin in fall 2011. Both the federal and state governments will conduct public review and comment processes on the risk study.
This singular, remarkably cohesive and long-lived environmental justice struggle against a national bioweapons laboratory fires up again. Less long lived is the Principal Investigator and Director of the BU Biodefense Laboratory, Dr. Mark Klempner, who resigned as director effective September 1, 2011.
On August 12, 2011, BU announced that they are deferring their plans to operate the highest-risk level research in the still empty laboratory building and are, instead, seeking a waiver from the state of Massachusetts to begin lower-risk research. Another gain for the community, whose heat has singed the biodefense Goliath.
Additional Resources on the Biological and Toxin Weapons Convention
“Trust But Verify? Not This Time: For Biological Security, Transparency Is Best Policy”
The Biological and Toxin Weapons Convention (BTWC) Web Site
Perspective on and analysis of the BTWC
Information on NGO action to improve the BTWC, see the Biological Weapons Prevention Project
“Biodefense Research and Development Policy in 2009: A Citizen Perspective”
Footnotes:
1. Guillemin, Jeanne, (2005) “Biological Weapons: From the Invention of State-sponsored Programs to Contemporary Bioterrorism,” New York: Columbia University Press.
2. Boyle, Francis, (2005) “Biowarfare and Terrorism,” Atlanta, Georgia: Clarity Press, Inc.
3. Michael Carroll’s rigorous investigation, “Lab 257: The Disturbing Story of the Government’s Secret Plum Island Germ Laboratory,” uncovered careless laboratory procedures with some of the deadliest of animal diseases, OSHA and EPA violations, worker infections and lax federal oversight. He lays out the facts and circumstantial evidence that suggest a connection between the USDA germ warfare research facility and the initial outbreaks of Lyme disease in 1975 and West Nile Virus in 1999.
4. Boudewijn de Jonge, “Institutional governance and reform,” University of Amsterdam, January 2006.
5. Ibid.
6. H. Patricia Hynes, Klare Allen and Eloise Lawrence, “The Boston University Biolab: A Case of Environmental Injustice.” Proceedings of The State of Environmental Justice in America 2007 Conference, Howard University Law School, March 29-31, 2007.
H. Patricia Hynes is a retired professor of environmental health from the Boston University School of Public Health. She directs the Traprock Center for Peace and Justice and is a member of Nuclear Free Future.
Posted in accordance with Title 17, Section 107, US Code, for noncommercial, educational purposes
