Can Biosecurity Go Global?

Outside the U.S., biological labs follow few if any security regulations. A Sandia National Laboratory team works to help those labs prevent deadly microbe releases, accidental and deliberate.
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A tall, modest academic with graying temples, Ren Salerno was happily toiling away in obscurity at a small biological threat research program at Sandia National Laboratory in Albuquerque, N.M., "studying issues nobody really cared about," he recalls. Then the attacks on Sept. 11 burst his academic bubble. As one of the few experts on the security of biological agents, Salerno was called to Washington, where, as soon as he arrived, he met with Deputy Secretary of Agriculture James Moseley, a man with a lot to worry about.

Some of the greatest bioterror threats are zoonotic pathogens — microbes that can be transmitted from other animals to humans and vice versa, including the plague, anthrax, Ebola and more. According to a 2001 study from researchers at the University of Edinburgh, 61 percent of the more than 1,400 pathogens that infect humans are zoonotic, and U.S. Department of Agriculture animal health laboratories are littered with them. The USDA, in fact, has more biocontainment labs in the U.S. than either the Centers for Disease Control or the National Institutes of Health.

For days, Washington officials peppered Salerno with questions about national biosecurity infrastructure and the possibility of bio-terrorist attacks, especially with microbes stolen from U.S. facilities. Within a month, Salerno and his team at Sandia had contracts with the USDA to assess and design security solutions for biocontainment labs around the country. Contracts with CDC and the Department of the Army soon followed.

But the stakes were about to rise again. Only weeks after 9/11, letters containing a suspicious white powder were mailed to media companies and two U.S. senators. People started dying. Bioterrorism was no longer a possibility. It was happening.

Before 2001, life scientists were familiar with biosafety — that is, working safely — but biosecurity, or keeping laboratory agents from being misused, was not really part of the scientific conversation outside of the military. "The prospect of somebody choosing to misuse biological agents was quite new and fairly controversial," Salerno says. "The idea of threats and bad guys doing bad things is anathema to most scientists."

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Following 9/11 and the ensuing anthrax attacks, the Congress worked with what is lightning speed for the government, passing the Patriot Act at the end of 2001, restricting who was allowed to work with biological agents, and the Bioterrorism Act in 2002, improving the government's ability to prepare for and respond to bioterrorism events. The latter law included a registration program for facilities and people who handle toxins and biological agents — in the U.S.

But even now, anywhere around the world, someone can build a laboratory to work with the most dangerous pathogens and be subject to no construction standards, no operating standards and no safety or security standards, Salerno says. It's a situation that several international organizations are trying to address, and Salerno has helped put together trial biosecurity training programs around the world. But so far, the trials have not been expanded or institutionalized.

"It's just the beginning, I hope," Salerno says. "We're trying to change the paradigm."

After the 2001 anthrax maillings and implementation of the federal legislation they spawned, working with bacterial agents in the U.S. became a "major investment in training and infrastructure," says Paul Keim, a biologist at Northern Arizona University and senior scientist of the lab that identified the anthrax strains used in the 2001 attacks. "A response to the security fears was to raise the biosafety levels, because we didn't really know how to raise security, because we had no standards," Keim says.

Researchers studying anthrax, for example, at biosafety level 2 — which required basic safety precautions like goggles and specialized cabinets with air filters — were suddenly required to fulfill the restrictions of a biosafety level 3 lab. This meant that expensive respiratory equipment, waste decontamination procedures and closed airflow systems were required, suddenly, in hundreds of labs scattered across the country. "It changed so fast; it's been very difficult to keep up with the regulations," he says.

In addition, labs rushed to get security systems. Laboratory managers hired security companies out of the Yellow Pages; they installed locks on doors and windows, put cameras and lights in parking lots and sat security guards at front desks. Many scientists considered the efforts ridiculous and a huge waste of money. If someone broke in, how would the would-be thief know how to identify and transport a pathogen?

"The likelihood of a terrorist commando team attacking a facility with helicopters and grappling guns is extremely low," Salerno says, laughing. The probability of a scientist going rogue is significantly higher, but scientists were even less happy to discuss that idea. So when Salerno and his team arrived at lab doorsteps to talk about internal security, they met resistance.

"This just wasn't a topic that life scientists thought about," recalls Jennifer Gaudioso, a staff member at the International Biological Threat Reduction program at Sandia. "You wouldn't necessarily think about opening a door for someone with an armful of books beforehand, and now you have to stop and think, 'Should this person be allowed in here?'"

After an initial evaluation to assess the biological materials in the labs and their basic vulnerabilities, Salerno and the Sandia team — usually three to five members — got down to less glamorous work. With help from human resources personnel, they set up systems to monitor and limit access to the lab, implemented tracking systems to follow the movement of pathogens from room to room and trained lab staffers to look for behavioral changes in colleagues. Overall, Salerno's team visited dozens of labs around the country. The effort lasted until 2003.

Then, with the largest national labs secure, Salerno and the U.S. government turned to look beyond the country's borders.

Over the last 20 years, as laboratory tools and technologies have become cheaper, biocontainment labs, once rare, have become numerous. Scientists in countries around the world study pathogens of varying levels of danger — and with varying degrees of security.

For most intents and purposes, international standards or accreditations for bioscience facilities don't exist. There is a World Health Organization manual on laboratory biosafety that includes tips like, "Children should not be authorized or allowed to enter laboratory working areas," and, "Labels must not be licked."

"Today," Salerno says, "that 100-page document is just woefully inadequate."

International biosecurity standards are important not only for the prevention of deliberate biological attacks but for the reduction of biological accidents. In 2004, nine cases of severe acute respiratory syndrome, or SARS, were linked to procedural lapses at China's National Institute of Virology. One infected individual died. In 2006, a lab worker at Texas A&M University became sick with brucellosis, an infectious disease carried by cattle and dogs, after cleaning a chamber containing Brucella bacteria. All select-agent research at the school was suspended. In August 2007, some 60 cattle in Surrey, England, were infected with foot-and-mouth disease after the virus leaked from broken pipes running from a nearby infectious disease laboratory. The list goes on.

"An outbreak anywhere, deliberate or natural, is a threat everywhere," says Andrew Weber, the assistant secretary of defense for nuclear, chemical and biological defense programs. "It's not something we can just deal with within our own borders."

Beginning in 2006, professionals in the biological community, especially biocontainment laboratory managers in North America and Europe, began discussing the need for international standards. In February 2008, the European Committee for Standardization published the first international biorisk management standards, developed by 76 participants from 24 countries. This standard, though still voluntary, includes both bio-security information — guidelines that restrict access to agents and toxins, for instance — and practical biosafety measures, such as details of the process of inventorying and disposing of hazardous materials.

"It represented an evolution in thought," says Salerno, who participated in the formation of the guidelines. "The previously distinct fields of biosafety and biosecurity came together."

Shortly after the International Biorisk Standards were published, Salerno was contacted by Nicoletta Previsani, head of biosafety and laboratory biosecurity at the World Health Organization in Geneva, about creating a hands-on risk management course to be taught to people involved in biological labs around the world. "Biosafety is not anymore an issue that only concerns the worker at the bench," Previsani says. "Instead of just teaching biosafety, we thought we needed a different approach that addresses the management of big risks."

Biologists are not typically mathematicians or modelers, nor are they taught to assess risk while getting a doctorate in microbiology or virology. "It becomes more of a management problem than simply a technical problem," Salerno says.

Previsani corralled Salerno and Stefan Wagener, director for biosafety at the Canadian Science Centre for Human and Animal Health in Winnipeg, Canada, to serve as experts for the course and invited Pamela Lupton-Bowers, a professional adult educator, to integrate teaching techniques. The four professionals locked themselves in a room for five days, and in January 2010, the WHO premiered the first-ever international biosecurity training program. The two-week course trains laboratory leaders in assessing and mitigating the risk of deadly agents in the laboratory. Perhaps more important, the course trains those leaders to train others.

Workshops were held in Jordan, Ecuador, Sweden, the Maldives, Kenya and Thailand, and participants have already begun teaching biosecurity workshops in their own countries: After attending the WHO course, Rafiq Saleh, head of the public health laboratory at the Ministry of Health in Amman, Jordan, went on to teach two biosecurity courses of his own, training more than 30 lab technicians in Jordan. "We really feel that it's been useful to our country," he says.

Still, Salerno says, the program is limited by numbers. Overall, it has trained just 60 participants, not all of whom have gone on to train others. "If [the course] is a one-time extravaganza, it won't mean very much because we've touched so very few people," Salerno says. "On the other hand, if the powers that be can recognize it as a precedent-setting, paradigm-shifting event, and can leverage it and build from it explicitly, then I think hopefully five or 10 years from now, we'll look back on it and say, 'Wow, that was really formative.'

"But the jury's still out on that."

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