Biosafety and Biosecurity: The Role of Public Health, Law Enforcement, and Research

Omar Mukhlis, Biodefense PhD Student


Milwaukee, Wisconsin, the land of cheese curds and breweries, is no stranger to fermentation and pasteurization, making it the perfect location to host the 65th Annual Biosafety and Biosecurity (ABSA) Conference; the first ABSA conference with an in-person option since 2019. Held from October 17-19, 2022, the scientific program was three full days of keynote presentations and panels of biosafety and biosecurity best practices and hands-on skills.

The following are a select few synopses from the chock-full 3-day ABSA conference.

  • Session IX Biorisk Program Management
  • Session X Eagleson Lecture Award: The Growing Threat of Lyme Disease: Where Do We Stand?
  • Session XII: Public Health

Additional details about the ABSA 65th conference scientific program can be found here.

Session IX Biorisk Program Management:

This session on biorisk program management started with a talk by Robin Tobias, MPH (University of Minnesota) on ABSA International Biosafety and Biosecurity Month celebrated annually each October. Now in its 9th iteration, the month is used to spotlight ethical research, transparency, training, engagement, and stewardship of biosafety and biosecurity. Rather than embracing a specific theme for 2022, ABSA decided to return to the core components of biosafety and biosecurity. This portion of the session closed with a call to share your Biosafety and Biosecurity Month activities on social media using the hashtag #biosafety_biosecuritymonth.

Second on the session docket was Rachel Gamble, DrPH from Merrick & Company discussing the importance of operations and maintenance (O&M) personnel in facility biosafety. O&M are the heart of the facility, directly supporting lab functions, and without proper functioning of lab systems safe science cannot occur. This is especially true as the biosafety containment level increases, as the intersection between biosafety and O&M becomes increasingly more important. Currently, many O&M personnel only receive a sprinkle of biosafety training. This is an issue because O&M personnel need to understand how their job and biosafety intersect.

The key to addressing this is integrated facility training, which shows personnel how O&M operations directly tie into biosafety, allows for O&M personnel to step into researchers’ shoes, increases understanding of the regulatory compliance role that O&M plays, and facilitates the sharing of lessons learned. The benefits of this are numerous, to include greater cohesion in facility operations, better retention of personnel, and sharing of expertise between O&M and biosafety professionals. Most importantly, increased collaboration and integrated training with operations and maintenance personnel will improve facility management and operations, ultimately resulting in safer science.

The final speaker of session IX was Special Agent Scott Mahloch from the Federal Bureau of Investigation (FBI) providing an overview of the FBI weapons of mass destruction (WMD) investigation of Wyndham Lathem as an insider threat case study. An Associate Professor of Microbiology-Immunology at Northwestern University (2007-2017), Dr. Lathem was a leading researcher of Yersinia pestis, the causative agent of bubonic plague. Two of his research accolades include discovering a gene in Y. pestis that allows the bacterium to replicate quickly in air-filled areas causing pneumonia and research he conducted on the evolution of plague with Yersinia pseudotuberculosis and gut pathogens. In late July 2017 Lathem and an accomplice fatally stabbed Lathem’s boyfriend in his Chicago high-rise condominium, leading to his arrest by Chicago Police Department in late August 2017.

Not publicly known at the time was the fact there was a simultaneous but separate FBI WMD investigation into Dr. Lathem due to a confluence of factors including: 1) the withdrawal of an offer from the Pasteur Institute in France for Lathem to open a lab in March 2017; 2) a concerning email sent by Lathem to Northwestern’s University Select Agent Facility Responsible Official while on the run from authorities in August 2017; 3) the recovery of unknown substances in Lathem’s apartment during the homicide investigation; and 4) and a statement from Lathem to a jail staffer while incarcerated that he had ingested genetically modified Y. pestis and that millions of people would die due to his actions.  All of this led to a thorough investigation by the FBI to assess the credibility of the threat looking at the technical feasibility, adversarial intent, and operational practicality of the case. Specific details on the FBI’s conclusions were not shared during the course of the presentation, but Special Agent Mahloch assured the ABSA audience the FBI had taken the threat seriously, as evidenced by the three-pronged credibility test.

Special Agent Mahloch concluded his talk by highlighting the specific insider threat indicators within this Wyndham Lathem case study. Lathem exhibited noticeable behavioral changes in both his professional and personal life following his rejection from the Pasteur Institute. On a professional level, Lathem began exhibiting narcissistic tendencies, his colleagues noticed more frequent absences, and he appeared to be more checked out from his work.  In his personal endeavors, Latham’s relationship with his partner was described as “abusive and controlling,” he had increased his consumption of alcohol, and had stopped taking his antidepressant medication  These indicators, when combined with Lathem’s access to a select agent facility provide a textbook example of an insider threat.

Session X Eagleson Lecture Award: The Growing Threat of Lyme Disease: Where Do We Stand?

Richard Marconi, PhD, Virginia Commonwealth University Medical Center, Richmond, VA

Dr. Richard Marconi from Virginia Commonwealth University (VCU) Medical Center delivered the Eagleson Lecture to ABSA this year. The talk focused on the growing threat of Lyme disease and where we stand in regard to prevention and treatment. Dr. Marconi, who has spent nearly 30 years conducting research on Lyme Disease at VCU, started his lecture by providing an overview of Lyme disease, its causative agent (Borrelia burgdorferi), and the essential life cycle stages alternating between tick and reservoir host. Dr. Marconi stressed that the tick population is both increasing and spreading into parts of the country that previously have not seen ticks. This trend is not isolated to the United States, with similar reports coming from part of Europe and China. All of this suggests that we should anticipate seeing an increase in the rates of Lyme disease and other tick-borne diseases.

The second part of the lecture transitioned to look at Lyme disease prevention, specifically a deep dive into the work Dr. Marconi and VCU have done to successfully get a canine vaccine to market and the ongoing efforts to build on that to develop a human vaccine against Lyme disease. There are two formulations of vaccines for Lyme disease: 1) Lyme bacterin vaccines and 2) Lyme sub-unit vaccines. The former relies on whole cell lysates-“bacterial soups” as dubbed by Dr. Marconi. The issue with these vaccines is that most of the proteins present don’t provide protection, as only a small percentage actually elicit an immune response. The second category of vaccines, the type VCU works on, uses highly purified recombinant proteins that produce a protected antibody response. Vanguard® crLyme, the canine vaccine Dr. Marconi helped spearhead, uses two outer surface proteins (Osp) to generate immune response.

The first outer surface protein is OspA, which was used in predecessor vaccines including the short-lived Lyme Rix (1998-2001); the only Lyme disease human vaccine ever brought to market in the United States, but it was ultimately pulled from the market due to concerns about auto-immune reactions. The second protein, OspC, was far more difficult to develop as it is dissimilar to OspA in that there are around 30 variants of OspC. Through research they found that the use of OspC variant cocktails simply did not work. To get around this Dr. Marconi’s team worked to identify the epitopic regions of the OspC genome and identified two small parts of the genome (L5 & H5 fragments). Using these two identified epitopes they created a new protein, called a chimeritope. They tested to see if their approach worked, and it did. Fast forwarding through subsequent laboratory and field studies, Vanguard® crLyme was ultimately approved by the U.S. Department of Agriculture (USDA) for use in canines early 2016. Since then, Dr. Marconi has pivoted to the development of a human vaccine for Lyme disease, striving to use the same chimeritope approach he used for the canine vaccine. One major difference? He’s seeking to avoid the use of OspA due to the perceived human auto-immune issues associated with the protein as mentioned above.

Dr. Marconi’s Eagleson lecture closed with a question-and-answer session where most of the audience was interested in what to do if you find an 8-legged parasite. The best way to remove a tick? Patiently with a pair of forceps or tweezers. How long does it take to transmit the infection? If it is still crawling, you are good. It takes about 36-48 hours of feeding for transmission to occurs; simply put no engorgement, no transmission. In summary, this was an insightful and engaging lecture on the growing threat of Lyme disease and a peek into the groundbreaking vaccine work Dr. Marconi and his VCU colleagues are doing to counter this spirochete using protein sub-units.

Session XII: Public Health

This session on public health started with a presentation from Gabrielle Essix, MS from Nuclear Threat Initiative (NTI) on the 2021 Global Health Security (GHS) Index. The GHS Index is a joint effort between NTI ,Johns Hopkins Center for Health Security, and Economist Impact to assess security and related capabilities globally. The Index strives to clearly and transparently identify gaps in national-level capabilities to prevent and respond to high consequence biological events and drive accountability for filling those identified gaps. More specifically, the goals of the index are to 1) Accelerate progress in building capacity to prevent detect and respond to pandemics; 2) help national governments identify and address gaps; 3) provide data for evidence-based decision making by donors; and 4) set a standard for pandemic preparedness. The key finding of the report? All countries remain dangerously unprepared for meeting future epidemics and pandemic threats. NTI will publish the next GHS report in 2024 and is looking to improve the index through expert consultations and engagement with forums like ABSA.

Dana Krauss from Georgetown University Center for Global Health Science and Security was up next in the session with her talk looking at the intersections of personal scientific responsibility and public health through the lens of the SARS-CoV-2 pandemic.  Combining (lab) biosafety and public heath she defined public biosafety as “the application of biosafety principles, practices, and technologies by an informed individual and informed governing bodies in a community health setting to successfully reduce agent exposure to and continued release in the general public”. Examples of public biosafety principles, practices, and technologies include at-home and public testing, cleaning of contaminated personal items (e.g., computer keyboards, doorknobs), coughing into your coat sleeve, and general scientific fluency/comprehension. The key concept as presented by Ms. Krauss is that within public biosafety, there is a balance between responsibility and tools available. This was seen with the widespread “responsibility” to wear masks early in the pandemic when there were not tests available. Now we find ourselves in a situation where tests are widely available, and in turn masks are less prevalent here in the United States. The tool of self-testing is used, but there is now a decrease in responsibility to report and as such infection data is often not being shared with relevant public health authorities. Overall, Ms. Krauss provided an insightful presentation of her research conclusions looking at the  intersection of public health and personal responsibility.

The third speaker in session XII was Michael Marsico, MS from the Association of Public Health Laboratories (APHL) who presented on building biosafety across non-traditional testing site during covid-19 and beyond. APHL works in the intersection between policy, science, and practice and, in March 2021, they reached out to labs inquiring about biosafety training needs. The response received? More training for non-traditional testing sites was desperately needed. APHL addressed this by developing technical resources (e.g., COVID-19 Antigen Testing Biosafety Guidance, Potential Hazards and Recommended Mitigation Procedures for COVID-19) and providing training in the form of COVID-19 webinars and workshops. The delivery of these Biosafety Preparedness Workshop(s) for non-traditional testing sites was the focus of Mr. Marsico’s remarks. The workshop project was launched in July 2021 through APHL and the CDC, with the first workshop training being delivered in Colorado with the help of a contractor in June 2022. The second and final workshop was held in Michigan in late October. These trainings sought to provide biosafety preparedness training by describing biosafety and biosecurity concepts, explaining the fundamental principles of biological waste management, personal protective equipment and quality management related to point-of-care testing, and provide scenario-driven exercises to outline safer point-of-care testing. With the completion of the second workshop, APHL will continue to engage non-traditional testing sites, providing support and guidance as needed to foster safer practices and quality testing of patient specimens.

The final talk of the session was from Rocco Casagrande, PhD from Gryphon Scientific who presented on empirical studies in biosafety. Over the past 15 years Gryphon Scientific in conjunction with a plethora of academic and private sector partners have performed studies on biosafety and biosecurity to develop approaches to support critical decision making processess. Using findings from those studies they identified that most of the data available were dose-response data or stability data, and that data for accident causes and source terms were lacking in the life sciences. To address this identified gap, Gryphon received a grant from the Open Philanthropy Project to undertake critical research in biosafety along three lines of research: 1) conduct failure analysis to determine how laboratory accidents generate hazards; 2) conduct human reliability research to determine how/how frequently researchers create incidents; and 3) gather data on innovations in biosafety to learn from the measures that have already been implanted but are not widely known. Preliminary findings from these three lines of research were provided to the audience with official publication of the data and findings expected for the not so distant future. Dr. Casagrande closed the presentation by letting the audience know that if anyone is interested in continuing the research presented to reach out to Gryphon, and they will happily share all of their data.  

Closing Thoughts: This provides a select sampling of the of thought-provoking and insightful ABSA scientific agenda from the 65th conference. If interested, the 66th Annual Biosafety and Biosecurity Conference will be held from October 13-18, 2023 in Omaha, Nebraska.

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