Recent mishaps at laboratories that mishandled potentially dangerous biological substances and the transmission of the ebola virus in a US hospital are examples of failures at bioscience facilities that two researchers at Sandia National Laboratories think could be prevented by implementing the practices described in a new book on biorisk management.

Laboratory Biorisk Management: Biosafety and Biosecurity was edited by two Sandia senior managers, Reynolds M. Salerno, PhD, of the biological sciences and technologies program, and Jennifer Gaudioso, PhD, of the international biological and chemical threat reduction program.1 The researchers have worked for years to improve safety and security at bioscience facilities worldwide.

Gaudioso Salerno

Jennifer Gaudioso, PhD (left), and Reynolds M. Salerno, PhD, Sandia National Laboratories. Photo by Randy Montoya, courtesy Sandia National Laboratories.

“This is the first full-length manuscript on the detailed implementation of biorisk management,” says Salerno. “Laboratory biorisk management is fundamentally a culture of rigorously assessing risks, deciding how to mitigate those risks deemed to be unacceptable, and establishing mechanisms to constantly evaluate the effectiveness of the control measures.”

Salerno, Gaudioso, and the other authors advocate a cultural shift in how laboratories, hospitals, and other bioscience facilities approach safety and security. Biorisk management should:

  • Prioritize an intellectually sound, evidence-based decisionmaking process using substantive risk assessments to evaluate a facility’s risk, based on its unique operating environment.
  • Require implementation of mitigation measures according to the risks of specific activities, experiments, or projects.
  • Constantly assess performance.
  • Emphasize more meaningful roles and responsibilities for all personnel within a facility.
  • Assign ultimate responsibility for safety or security performance to top management.
  • Be scalable from the smallest hospital or clinical lab to the largest research institution.

About a dozen other Sandia experts in the field paired with international counterparts to develop and advance a relevant and practical set of concepts capable of being implemented by labs worldwide, says Gaudioso.

In addition to explaining and providing a model of biorisk management, the book includes chapters on risk assessment, facility design and controls, training, operations and maintenance, how to evaluate biorisk management performance, communications issues, case studies, and future directions and challenges for biorisk management.


Because the scope, scale, and sophistication of bioscience fields have expanded dramatically over the past 15 years, the time to rethink the safety and security of bioscience facilities is now, says Salerno. Examples of bioscience expansion include the rapid advance of synthetic biology and, following the 2001 anthrax attacks on the White House and Congress, the deep integration of the biosciences within the nation’s security and research agencies.

“What we have never done in the biosafety community is take a good hard look at why we do what we do, and ask ourselves if the system needs to be radically reshaped in light of all the changes in biology,” Salerno says. “From our perspective, this is way overdue.”

Today’s biosafety guidelines were created in the early 1980s. The Centers for Disease Control and Prevention partners with the National Institutes of Health to publish biosafety guidelines to protect workers and prevent exposures in biological laboratories, Salerno says.

The current guidelines designate biological agents as belonging to one of four tiered risk groups, and assign work with those agents into one of four corresponding biosafety levels. But use of the guidelines has become perfunctory, and many personnel in bioscience facilities do not understand their nuances, says Salerno. For example, it has become common practice to share risk assessments and material safety data sheets among facilities, so that they no longer take into account the unique circumstances of each facility, including its location, the type of work done there, and the expertise and training of the facility’s personnel.

“The events of the last year in this field demonstrate exactly what we’ve argued: that the current system is broken. It’s a systemic problem,” says Salerno. “We’ve created an administrative-based safety culture in biology that is way too simplistic for the level of complexity of today’s science.”


Over the past 15 years, Sandia scientists have become increasingly aware of the issues involved in biosafety through their work with laboratories around the globe.

In 2008, the European Committee for Standardization (CEN) hosted an international workshop that provided attendees with an introductory overview of biorisk management and resulted in a published agreement on biorisk management among 24 countries. The World Health Organization (WHO) quickly adopted the biorisk management framework, and asked Sandia and other technical advisers to create a 2-week advanced training program on biorisk management. Sandia experts helped to teach courses in the program in 2010 and 2011.

“We were barely scratching the surface and everybody wanted more information, more detail, and wanted to understand how to implement the concept,” says Salerno. “That’s when we began talking about the need for a manuscript.”

In addition to preparing the new book, Sandia staff also curate the Global Biorisk Management Curriculum, which contains 47 separate courses developed by Sandia and others and is being taught by 500 trainers worldwide, says Gaudioso.


The book promotes the idea that a good biorisk management system determines ahead of time the metrics needed to demonstrate that a project, experiment, or activity is being done safely and securely.

The risk assessment completed before an activity has begun sets leading safety and security performance indicators. Then, regular monitoring and documentation will show whether the activity is achieving its safety and security goals—enabling scientists to identify things that are working fairly well, but perhaps not perfectly—while the activity is in progress.

“In other words, by evaluating performance you can adjust your safety measures before something happens,” says Salerno. “You don’t want a bad thing to happen to determine whether or not your system is working.”

Some might view biorisk management as merely added paperwork. But Salerno and Gaudioso point out that experience in other high-consequence industries shows that when an effective safety system is in place processes are more effective and efficient, in turn leading to decreased costs and improved productivity.

A lot of the risk assessment and mitigation processes described in the book should help institutions solidify good practices and fill in the gaps in their procedures, Gaudioso explains.

“The burden should be proportionate to the risk, so that you’re not asking too much from people who are carrying out activities that don’t present a lot of risk to themselves or the community,” Gaudioso says. “But for people whose activities carry more significant risk, then yes, they have to do a little bit more to make sure they are managing those risks appropriately. I don’t think that’s an unreasonable thing to ask.”


Salerno recognizes that the system outlined in the book won’t work unless stakeholders in the biosciences community buy into the concepts.

“If someone takes this book, agrees that the performance chapter makes some good points, but then adds a large number of additional and perhaps arbitrary requirements, the system will look like yet another administrative checklist,” he says. “That would be counterproductive.”

In the final chapter of the book, Sandia researcher Benjamin Brodsky, PhD, and coauthor Uwe Müeller-Doblies, Dr med Vet, a veterinary public health consultant and president of the European Biosafety Association, write that biorisk management is a relatively young strategy that faces challenges to being implemented broadly. More evidence is needed to show that biorisk management works, so they call on more organizations to develop ways to measure the performance of biorisk management and to show how it benefits an organization.

“This will enable the biorisk management community to continue creating tangible benefits for the bioscience community, including keeping society and the environment safe while more efficiently facilitating the delivery of science,” they write.

With main facilities in Albuquerque, NM, and Livermore, Calif, Sandia National Laboratories is a multiprogram laboratory operated by Sandia Corp, a wholly owned subsidiary of Lockheed Martin Corp, for the National Nuclear Security Administration of the US Department of Energy. For further information, visit Sandia National Laboratories.


  1. Salerno RM, Gaudioso J, eds. Laboratory Biorisk Management: Biosafety and Biosecurity. Boca Raton, Fla: CRC Press, 2015.