By Michelle Grundahl, Biodefense MS Student
The 6th International Biosafety and Biocontainment Symposium, presented by the US Department of Agriculture’s Agricultural Research Service (USDA ARS), brought together experts from government, academia, and industry to discuss emerging biorisk challenges in agriculture. Speakers highlighted how the convergence of food, agricultural, and natural resource challenges require coordination and intensification of food safety, nutrition, and food security efforts to mitigate risks.
I attended this virtual conference along with my GMU Biodefense Program colleagues Ms. Stevie Kiesel and Ms. Rachel-Paige Casey. You can find their discussions of other symposium sessions here. This report provides an overview and commentary on Session II – Applied Biosafety Research: An International Effort.
Session II: “Applied Biosafety Research: An international Effort”
Applied biorisk research is the “systematic, scientific investigation into and study of materials, tools, and practices to provide for the safe handling and containment of infectious microorganisms and hazardous biological substances.” This is a bit more specific than the biorisk management practices that one might be familiar with; this type of research informs the procedures that laboratories should implement. Applied biorisk research is important because it provides assurances to researchers, and the public, that sound practices are in place. This is of domestic and international importance in universities, government laboratories, industry and diagnostic labs (all who might work with unknown risks). This focused research is relevant even to non-traditional labs, such as DIY community science spaces and in global settings that may have low resources.
Overview of 2019 US Workshop: What is Applied Biosafety Research, Who’s Doing It and How Might We Do It Better?
Applied Biosafety Research is not a new field of research. A presentation by Joseph Kozlovac, an Agency Biological Safety Engineer for the Agricultural Research Service (ARS) of the USDA, remined us that there were programs for this in the 1960s. These past programs resulted in guidance such as those published by the National Institutes of Health (NIH) in 1976. Mr. Kozlovac states that currently there are no great efforts researching the topics of facility design, personal protective equipment, bioengineering controls, and more. In October 2007, the House Committee on Energy and Commerce held a congressional hearing: “Germs, Viruses and Secrets” and determined that a task force would consider the ongoing proliferation of biolabs in the United States. Their Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight aimed to ensure oversight of labs involved in handling toxins and infectious agents. A 2009 report suggested the research agenda for this. The Federal Experts Security Advisory Panel provided recommendations in 2014 for biosafety and biosecurity to be improved (there had been a few incidents). The panel specifically suggested a program of applied biosafety research, one that used evidence-based information. Eventually, the 2018 National Biodefense Strategy made these directives clear, emphasized that mitigating lab risks was imperative, and asserted that conducting applied research would provide evidence.
The outcome of a September 2019 “Federal Stakeholders Applied Biosafety Research Workshop” identified five categories with gaps in need of research. One of those gaps in need of further research is the evidence based “hierarchy of controls,” which represents eliminating risks as a top effector. Substituting risks, or engineering to control the risk, is more effective than altering how workers perform, or use protective equipment. Managing the risk of preventing pathogen exposure (and infection) also requires data on the agent, including evidence of the known exposures, morbidity rates, characterization and validation of the pathogens. Potential mitigation strategies require prior information of work-related incidents (such as needle sticks and equipment failures). Identifying the errors that cause incidents in the lab is just a starting point. Another factor to explore are the actual methods used to evaluate hazard mitigation. These efforts aim to identify the appropriate risk assessment methods that should be used. The most interesting research category identified by the Federal Stakeholders Applied Biosafety Research Workshop: where intangible human factors insert into laboratory science. Creating a safety minded culture is not done via protocol. Studying the sociology of laboratory biorisk management makes attempts to tease apart issues such as non-compliance, attitudes, training, and communication.
Dr. Danielle Lohman, Foreign Affairs Officer for US Department of State, provided a review of the stakeholders. There are numerous implementations where applied biorisk research protects workers, agriculture, and the environment. The people who can benefit are funders (government, private), researchers (federal, university and private lab workers), disseminators of knowledge (institutions, journals and organizations), and the end-users (regulators, biosafety professionals). An excellent example of coordination and collaboration of these applied research activities, Dr. Lohman explained, is the example of COVID-19. We saw rapid international scientific effort to quickly understand an unknown pathogen. The promotion of scientifically sound action is a collaborative effort. The US Department of State is promoting this idea, too. In October 2020, they hosted an invitation only G7 Expert’s meeting on Strengthening Laboratory Biorisk Management to improve the research process internationally.
Applied biorisk research is a critical discipline that can benefit from more professional attention. While some might equate safe laboratory practices with mundane tasks and added duties, others see this field as immensely important in creating standards with great impact. In fact, the Biorisk management standards and their role in BTWC implementation working paper (from the most recent Meetings of Experts of the Biological Weapons Convention) clearly shows the need for greater applied biorisk research.
Department of Defense (DOD) Biological Select Agents and Toxins (BSAT) Scientific Gaps in Biorisk Research Program (SGBRP)
Dr. Cristine Lawson, Deputy Director for Biosecurity for the Department of Defense (DOD) Biological Select Agents and Toxins (BSAT) Biorisk program Office (BBPO) and manager of the DOD BSAT Scientific Gaps in Biorisk Research Program (SGBRP), provided an enlightening overview of the program. Apparently, the DOD is very active in BSAT applied biorisk research. They are contributing to the knowledge base of biorisk practices as applied to Biological Select Agents and Toxins. Some people might recall May 2015 when we learned that the DOD shipped residual live spores of Bacillus anthracis(Anthrax) to 88 sites and that 194 labs received these spores. DOD took this very seriously and they executed comprehensive reviews of their procedures, protocols and accountability. Among the findings revealed was that there was insufficient information to inform and develop B. anthracis inactivation protocols. The 2016 Government Accountability Office report High Containment Laboratories: Improved Oversight of Dangerous Pathogens Needed to Mitigate Risk; a 2018 report expands upon this. As a result, the DOD has changed its guidelines, created centralized oversight for its BSAT-registered laboratories, and updated its procedures (for more than just their Anthrax research).
The DOD’s creation of the Scientific Gaps in Biorisk Research Program (SGBRP) is intended to fund research in the pursuit of increased scientific knowledge for BSAT procedures. Their review panel assesses the risk of procedures at DOD facilities, and assesses the available scientific evidence that can be used for mitigation. As part of a proactive approach, proposals are solicited. Some proposal categories examples include viability, inactivation, decontamination, environmental sampling, monitoring, and other similar biorisk topics. These proposals are ranked, selected, and then granted funding. One issue in this initiative, Dr. Lawson explained, is the challenge of funding. Funding, of course, is always a concern, but the program focuses on ensuring that senior DOD leadership is aware of the importance of applied biorisk research in order to maintain funding for closing knowledge gaps. It would be ideal for DOD to remain as the lead agency in the efforts to close the gaps of scientific knowledge for BSAT protocols. There is room for improvement here, as noted in the Inspector General’s 2020 report, but most would agree that the DOD has had great success with their BSAT program. Another area Dr. Lawson believes the biorisk community should engage on is encouraging scientists and biorisk experts to engage on policy development. When the federal registrar asks for input, the program encourages feedback from its experts and scientists, and that should be encouraged throughout the entire regulated community.
Biosafety and Chemical Safety Research
Do you wear your safety goggles every single time you step foot into your laboratory so that you can avoid an accident? Two safety researchers, Dr. Dana Ménard, Assistant Professor of Psychopathology at the University of Windsor, and Dr. John Trant, Assistant Professor of Bioorganic and Medicinal Chemistry at the University of Windsor, described their research, “A review and critique of academic lab safety research,” regarding academic chemical laboratory safety. It involves more than just posting safety protocols at eye wash stations. Enhancement of research laboratory safety requires collaboration from the entire laboratory community. The true number of laboratory accidents is largely unknown. The data on incidents and deaths in laboratories are sparse, in Canada and in the US. Safety practices and policies tend toward industry in regard to regulations. Academic institutions do not have the same regulatory framework as industry laboratories. A UCLA study (sample size of 2400) reported that 30% of the researchers surveyed had been involved in a laboratory accident. A 2017 study showed that 32% of 261 students had a lab accident. The presenters of this session asserted that the numbers could be higher, as they expect that under-reporting happens frequently. One major concern with surveys like these is that respondents tend answer questions in a way they think is socially acceptable. Social desirability is an issue: we know and report what we should do but we might actually act differently.
Many injuries are likely unreported, for a variety of reasons. Dr. Ménard noted that lab accidents in academia are handled quite different than in industry. Industry workers seem not to keep quiet about accidents and they are usually obligated to report accidents at work. Conversely, academic investigators tend to have low consequences after major incidents in their labs, and student researchers have little-to-no recourse. Dr. Ménard summarized a Canadian study of 104 participants that showed 56.7% were involved in at least one laboratory accident; and around half of those involved (or should have received) medical attention. Around 30% did not report the accident at all. Some of the reasons given for not reporting accidents include “not too serious” and “shame.”
One gap in our knowledge of this area is the lack of understanding on what training is received by people who work in research labs. Dr. Trant discussed revealed one example where 70% of lab workers received training but only 25% received it before they had started experiments. Even though studies describe interventions, there is often little baseline data for these laboratory interventions, per Dr. Ménard. Some training and intervention efforts that labs can use are self-study programs, quizzes, handouts, black lights and games/scavenger hunts as part of training efforts. Training is necessary but perhaps some of our colleagues complain about losing “academic freedom”, or that there are too many rules and too much regulatory compliance. For some principal investigators (and their competing priorities), safety actions can be seen as a “hassle”. Dr. Trant warns that the lax attitude toward safety is currently normalized in academia and that good leadership is necessary.
Understanding Human Reliability in the Laboratory: Implications for Biosafety
In high consequence laboratory environments, we depend on data to support critical decisions that inform policy. Dr. Rocco Casagrande, Managing Director at Gryphon Scientific, presented his risk assessment for the National Bio and Ago Defense Facility (NBAF). This laboratory is the US’s only large animal BSL-4 facility (and will contain agents such as Foot and Mouth disease). Doing this type of research in the middle of the United States is a new endeavor. The Gryphon Scientific group has also performed a risk-benefit analysis of researching modified agents with pandemic potential (such as influenza and coronavirus). Developing standards at facilities is critical; even more critical is the prior decision making before standards are created. So, why should human behavior be a major part of this research? Containment and facility design is the usual focus, but what people are actually doing in the lab is just as important. A lab can be perfectly built, but we still depend on humans for operation.
Data are needed for this as existing data are lacking. Fatigue, motor skills, and protocol violations play a part in the points of failure in laboratory safety. Dr. Casagrande looked at other industries to inform this data gap. He examined the mistakes that pilots make, and he examined seemingly insignificant events (like dropping vials) to see how much material could escape. As the Gryphon team considered how laboratory accidents happen, they found that the workers themselves are frequently who initiate accidents. The actions of workers can mitigate or exacerbate an incident. Knowing how mistakes happen can help mitigate outcomes like lab acquired infections. These types of mistakes may inform the types of mitigation needed for high consequence laboratories.
The Open Philanthropy Project provided a grant for biosafety research in order to improve high-level decision making for critical science policies. A culture of biosafety is the goal. Since the data do not exist, Casagrande’s team is filling the gap on human reliability. The goal is to have researchers ready to do this type of research, build a community, publish data, and build a culture of biosafety. These data can be generated by inserting dummy pathogens into the workflow of a lab. How challenging will it be to find data on large animal laboratory workers in high containment laboratories? We can only compare Plum Island (since NBAF is not yet open). Testing ‘real’ work versus an experimental environment might also be useful for low- and middle-income countries who frequently have constrained resources. They are identifying innovative practices. Some labs already have unique practices that might be useful to others, and an upcoming workshop plans to find the barriers for implementation of best practices.
This talk did not broach the subject of human reliability in an expected way. I hoped to hear about identifying potentially malicious actors, discussing dual-use research, and learning about the other risks of opening a BSL facility with many new workers. These topics will be useful to explore; it was not clear if this was already included in Gryphon Scientific’s work. Brand new laboratories provide a unique opportunity for starting new practices, collecting data on worker training, and conducting applied safety research. This opportunity should not be wasted as NBAF becomes operational.
Challenges and Innovations in Personal Protective Equipment (PPE) Decontamination During the COVID-19 Pandemic
Dr. Antony Schwartz, the Director of the Occupational and Environmental Safety Office at Duke University, presented his experience with ensuring a recycled supply of personal protective equipment (PPE) at his institution this past year. Their innovative approach at their biosafety level 3 (BSL-3) lab used vaporized hydrogen peroxide (VHP) to decontaminate face masks and powered air-purifying respirators (PAPRs). They validated this method for multiple types of N95 masks. Other methods are possible, too, but some of them are not recommended since fit and filtration degrade after multiple decontamination cycles. Dr. Schwartz suggested that other interested researchers should review this website showing the various methods that have been considered. Future innovations might result in sustainable PPE. Under development are textiles with filtering materials, reusable N95s, removable filters with a valve that filters in both directions. These decontamination procedures and sustainable innovations may have many applications in healthcare, emergency response, high containment research, law enforcement, and military activities. An important takeaway from this presentation was that gear can now be used more than once. In my opinion, this could have huge implications for training activities. Single use items can be a challenge to incorporate into training regimens. Reusable protective gear could support more frequent and realistic training activities for health care workers and first responders.
How do we manage biorisk? We learned what the current research has uncovered in this field, and its application to high containment laboratories as well as academic spaces. Through applied research for biosafety, we can develop robust procedures, we can decrease accidents, and we can even consider sustainable personnel protective equipment. The efforts of these professionals can make laboratory workers safer; and they will build better practices, training, equipment and data. The studies and procedures shared during this conference encourage all professionals, and students, to use (and generate) reliable biosafety data as they continue to build a culture of laboratory safety. A missing topic from this conference was the consideration of biosecurity and dual-use risks, or the potential need for oversight of the growing number of high containment laboratories around the world.