New book details safety, security methods for biosciences sites

“The times are changing and 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,” he said. “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 said.

The current guidelines tier biological agents into four risk groups and designate work with those agents into one of four biosafety levels. Salerno says use of the guidelines has become perfunctory and their nuances are not widely understood by many personnel at bioscience facilities. For example, he said, it has become common practice in the field is to share risk assessments or material safety data sheets between facilities, so that they no longer take into account the unique circumstances of each facility, including location, the type of work done there and the expertise and training of its personnel.

“I believe 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,” Salerno said. “We’ve created an administrative-based safety culture in biology that is way too simplistic for the level of complexity of today’s science.”

Global assistance in laboratory security brings issues to light
Sandia scientists became more aware of the issues through their work over the past fiftee years with laboratories around the globe.

In 2008, the European Committee for Standardization hosted an international workshop that published an agreement among 24 countries, introducing an overview of biorisk management. The World Health Organization (WHO), which quickly adopted the biorisk management framework, asked Sandia and other technical advisers to create a two-week Biorisk Management Advanced Trainer Programme, which Sandia experts helped teach in 2010-2011.

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

In addition to the book, Sandia also curates the Global Biorisk Management Curriculum, which contains forty-seven separate courses developed by Sandia and others and is being taught by 500 trainers worldwide, Gaudioso said.

Focus on performance can prevent problems before they happen
Salerno said the book promotes the idea that a good biorisk management system determines ahead of time the metrics that will show 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 the safety and security goals, enabling scientists to identify things that are working fairly well, but perhaps not perfectly, while the activity is in progress, he said.

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

Some might view this as added paperwork, but Salerno and Gaudioso point out that experience in other high-consequence industries shows that when processes are more effective and efficient, a more effective safety system is the result, which in turn leads to decreased costs and improved productivity.

Gaudioso explains that a lot of the risk assessment and mitigation work in the book should help institutions solidify good practices and fill in gaps in their procedures.

“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,” she said. “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.”

Culture change in biosciences required for biorisk management
Salerno recognizes that the system outlined in the book will not 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. That would be counterproductive,” he said.

In the final chapter, Sandia researcher Ben Brodsky and a co-author write that biorisk management is a relatively young approach that faces challenges to being implemented broadly.

More evidence is needed to show whether 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 wrote.