April 17 2020
A neat and orderly laboratory is unlikely. It is, after all, so much a place of false starts and multiple attempts.
Isaac Asimov
The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is a United States Army Medical Command installation located in Frederick, Maryland. It is a Biosafety Level 4 (BCL-4) laboratory. Historically, Fort Detrick was the center of the U.S. biological weapons program from 1943 to 1969.
On Veterans Day, November 11, 1969, President Richard M. Nixon asked the Senate to ratify the 1925 Geneva Protocol prohibiting the use of chemical and biological weapons. Nixon assured Fort Detrick its research would continue. On November 25, 1969, Nixon made a statement outlawing offensive biological research in the United States. Since that time any research done at Fort Detrick has been purely defensive in nature, focusing on diagnostics, preventives and treatments for biowarfare infections.
Since the discontinuation of that program, it has hosted most elements of the United States biological defense program. Fort Detrick also houses the National Cancer Institute-Frederick (NCI-Frederick) and is home to the National Interagency Confederation for Biological Research (NICBR) and National Interagency Biodefense Campus (NIBC).
The modern history of accidents originating at Fort Detrick started in 2001, when Anthrax attacks infected 22 people and killed five. FBI took almost 7 years to identify potential perpetrator - Bruce Evan Ivins, a top scientist who worked for the institution for 18 years. In July 2008, he committed suicide, just as the FBI was about to lay charges relating to the incidents. He was told about the impending prosecution.
In 2010, National Research Council (US) Committee published evaluation of the health and safety risks of the new USAMRIID facilities undergoing expansion. Earlier in 2006, as part of the decision process for the expansion, and to comply with the National Environmental Policy Act (NEPA) of 1969 and associated regulations, the Army prepared an Environmental Impact Statement (EIS).
Analysis of the EIS produced the following findings:
The analyses in the EIS of the risks and the mitigation measures to address them were not comprehensive and there was insufficient documentation for a fully comprehensive independent assessment of the risks to the community posed by biological agents. The problem was compounded by the fact that the MCE (Maximum Credible Event) scenarios were not reasonably foreseeable accidents;
The epidemiological characteristics, including transmission pathways, natural reservoirs, geographic distributions, and clinical outcomes of the pathogens, were not systematically documented;
There was incomplete consideration of some of the possible routes through which the general public might be exposed to pathogens.
Although USAMRIID has sought to set high standards for biosurety and biosafety, recent examples of laboratory-acquired infections (glanders and tularemia) and breaches in containment (Bacillus anthracis spores) point to human error or deliberate misuse. The committee recommends further formalized training in responsibility and accountability at USAMRIID, similar to that required for NIH-sponsored training programs. The circumstances surrounding the laboratory-acquired infections also should be carefully evaluated to determine what lessons can be learned for preventing future cases.
The committee recommended that the Army consider developing detailed and practical guidance for conducting hazard assessments of infectious agents for inclusion in its guidance for implementing NEPA to improve future EIS processes and products.
MEDICAL AND EMERGENCY MANAGEMENT RESPONSE
The committee findings
USAMRIID has a special immunizations program (SIP) clinic that serves as the occupational health provider for laboratory personnel and an outpatient research facility for investigational vaccines;
In the event of an incident requiring medical care, a formal agreement is in place between USAMRIID and Frederick Memorial Hospital for patients to be transported and treated at the hospital;
However, there is no guarantee that USAMRIID workers will report incidents or seek medical care at the base;
Since 2000, there have been two known cases in which USAMRIID workers failed to seek medical attention at the SIP clinic and also appeared to have failed to disclose that they were USAMRIID employees to the off-base physicians from whom they sought medical care. These failures delayed prompt diagnosis and treatment, and have raised community concerns about the potential for secondary transmission (that is, infection of others through contact);
A primary concern of the committee focuses on medical response and whether clinicians with specialized training in the clinical diagnosis and treatment of unusual infectious diseases are readily available. The committee was informed that, at present, there are only a few physicians in the community who regularly consult on infectious disease problems and none are believed to have had substantial training in dealing with diseases caused by the organisms being studied at USAMRIID;
Efforts have been made by USAMRIID to provide education to some of the Frederick Memorial Hospital physicians through quarterly training. However, it is unrealistic to expect many of the physicians in the county to avail themselves of such educational efforts or to know when and whom to consult when confronted;
The primary concern is the lack of readily available clinicians with the necessary specialized training to consult on the clinical diagnosis and treatment of unusual infectious diseases or with an unknown infectious disease.
Recommendations:
Given the unique nature of USAMRIID’s mission in dealing with special pathogens, additional measures should be taken to provide assurance that experienced medical professionals are readily available to consult on unusual infectious diseases. Serious consideration should be given to support an initiative that would provide experienced specialist physicians knowledgeable of diseases caused by organisms studied at the laboratories.
This would include consultation as needed on a 24/7 schedule to see patients from the community. Such physicians should also serve to provide continuing communication and coordination between USAMRIID scientists and community physicians and public health personnel;
For medical and emergency response mechanisms, a senior authoritative management system is needed to ensure that USAMRIID works effectively with county government agencies, the local medical community, emergency preparedness and response initiatives, and Frederick Memorial Hospital. Such a system would include a clear chain of command with designated personnel to work directly with partners in the county and community.
The Army should consider the use of permanent civilian staff for these positions to ensure continuity of relationships.
COMMUNICATION AND COOPERATION WITH THE PUBLIC
Findings:
A segment of the local population around Fort Detrick is not satisfied that the Army is doing everything it can to protect them from infection by pathogens being studied at USAMRIID;
Communication between USAMRIID and the Frederick community has not been adequate to address community concerns. The community has not been made aware of the details of the many safeguards already in place at USAMRIID, the requirements governing the operation of biocontainment facilities, and the Army’s ongoing commitment to improving safety and security.
Recommendations:
USAMRIID should expand its two-way communications with the public. Examples of possible communication efforts are:
Promptly disclosing laboratory incidents to the public;
Providing fact sheets about pathogens being studied, to include information on their natural reservoirs and how they are transmitted, and
Holding an open house prior to activation of the new USAMRIID facility or opening a visitors’ center.
Fast-forward to 2015-2020
In May 2015, the U.S. Department of Defense discovered that one of its laboratories at Dugway Proving Ground, Utah, had inadvertently shipped incompletely inactivated Bacillus anthracis to 194 laboratories and contractors worldwide over the course of 12 years;
Deputy Secretary of Defense Bob Work in a press briefing on 23 July 2015 announced the findings of the investigative committee and calling the Defense Department’s inadvertent delivery of live anthrax to commercial labs “a massive institutional failure.”
In July 2015, the Committee on Energy and Commerce of the US Congress initiated inquiry into safety practices at the bacteriologic labs;
On 28 July 2015, testimony was given on the DoD live anthrax shipments before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, U.S. House of Representatives;
Dr. Daniel M. Sosin, Deputy Director and Chief Medical Officer with the Office of Public Health Preparedness and Response at the Centers for Disease Control and Prevention (CDC) testified on CDC’s role in the investigation as the Federal Select Agent program authority;
The U.S. Army announced on 3 Sep 2015 an immediate safety review at all DoD labs and facilities involved in the production, shipment, and handling of live and inactivated select agents and toxins.
In December 2015, the Army issued an investigation report on its findings which, among other things, determined that although the inadvertent shipment of incompletely inactivated Bacillus anthracis was a serious breach of regulations and raised biosecurity concerns, it did not pose a public health risk. The investigation also determined that there was insufficient evidence to establish a single failure as the cause for the inadvertent shipments of incompletely inactivated Bacillus anthracis.
However, the report cited scientific and institutional issues and said that senior management at Dugway Proving Ground had contributed to “a culture of complacency, resulting in laboratory personnel not always following rules, regulations, and procedures.”
The Army’s 2015 investigation report resulted in recommendations to the Army to improve scientific knowledge gaps on irradiation and viability testing processes, address institutional concerns to reduce the risk of future mishaps involving biological material, and address individual accountability for the failures that contributed to the inadvertent shipment of incompletely inactivated Bacillus anthracis;
In January 2016, DoD conducted Press Briefing: Reorganization of Critical Reagents Program, New Biological Inspection Program;
In April 2016, OIG Report Released: Evaluation of DoD Biological Safety and Security Implementation. Key findings:
DoD had not maintained biosafety and biosecurity program management, oversight, and inspections of its BSAT laboratories according to applicable Federal regulations;
BSAT laboratories in Military Services were inspected according to different guidance, standards, and procedures, risking dangerous lapses in biosafety practices;
Lack of coordinated oversight of DoD laboratories led to multiple, missing, and duplicative inspections, and, therefore, an excessive administrative burden that could interfere with scientific research performance;
Inspection quality varied as inspection team members sometimes lacked necessary training or sufficient experience and expertise, or a combination of each;
DoD did not require that deficiencies identified by inspections were tracked and remain corrected after they were initially closed;
DoD lacked a single coordinating entity to oversee and manage biosafety and biosecurity deficiencies in high risk BSAT laboratories.
In July 2016, Army Directive 2016-24 Issued for Biological Select Agent and Toxins (BSAT) Biosafety Program. The directive established policy and assigned responsibilities for the Department of Defense (DoD) Biological Select Agent and Toxins (BSAT) Biosafety Program;
In September 2016, Congressional Hearing on Inactivation Procedures for Dangerous Pathogens. The Subcommittee on Oversight and Investigations held a hearing on 27 Sep 2016 entitled “Bioresearch Labs and Inactivation of Dangerous Pathogens.”
In June 2018, USAMRIID has suspended Biosafety Level 3 (BSL-3) and Biosafety Level 4 (BSL-4) operations while conducting repairs to its waste treatment plant. Unprecedented heavy rainfall in the Fort Detrick area created flooding issues in the Steam Sterilization Plant (SSP);
In September 2018, GAO Outlines Progress and Shortcomings in DoD’s Biosafety and Biosecurity Program;
During a site visit to USAMRIID in June 2019, CDC inspectors identified several deviations in Standard Operating Procedures designed to safeguard laboratory workers in Biosafety Level-3 and BSL-4 containment laboratories;
In July 2019, USAMRIID received a formal Cease and Desist Order from the CDC for failing to have sufficient systems in place to decontaminate wastewater generated by BSL-3 and BSL-4 laboratory operations. That notice was followed by a formal suspension of USAMRIID’s registration by the Federal Select Agent Program, effectively halting all BSAT work in registered laboratory areas;
In August 2019, USAMRIID has ceased research operations on high-risk pathogens after failing to meet Federal biosafety requirements. The move resulted from several actions recently taken by the Centers for Disease Control and Prevention in response to concerns about USAMRIID’s past management of its Biological Select Agents and Toxins (BSAT) research program.
In November 2019 CDC approved Partial Resumption of USAMRIID Select Agent Research;
The CDC provided additional conditions for research to gradually resume, which include allowing a limited number of studies to be performed. Work on these studies will be conducted in specified laboratories only, by select personnel who have undergone extensive training. These limited activities will afford USAMRIID and DSAT the opportunity to evaluate the newly implemented processes and procedures.
The CDC will continue to conduct on-site evaluations to observe laboratory personnel. Real-time observations will be conducted at all supervisory levels in order to ensure that practices are in compliance with the revised biosafety plan and that any deviation is corrected on the spot.