"Personnel reliability" counterproductive in bio-labs
Security in bio-labs is a subject that has risen in the public and political consciousness in the last few years. It is now understood in the US that security threats do not only come from overseas, but that they can be 'home-grown'. It has also been recognised that a major threat to the US peoples' way of life is bioterrorism. Therefore securing bio-labs, which house some of the deadliest pathogens known to man, from threats both within and without is vital. But the knee-jerk reaction of imposing protocols such as the “personnel reliability principle", which has been very effective at nuclear installations, may actually reduce the effectiveness of other security measures while at the same time hindering scientific development.
Discussing this topic is not new, and the subject has been raised in various fora repeatedly over last decade. But a consistent approach to biosecurity and biosafety (because the two are inextricably linked) is still lacking, and the more time that passes without coherent policies and practices increases the risk that a catastrophic event will be precipitated, either through malice or incompetence.
There is precedentConcerns about both security and safety at research laboratories have been highlighted by a handful of worrying incidents. In 2009 a scientist working in laboratory in Germany had an accident with a needle containing the Ebola virus. In 2008 investigators revealed that the perpetrator of the 2001 anthrax letters attacks (often known as Amerithrax), which resulted in exposures that killed five people and infected another 17, was a trusted scientist at a US military laboratory.
This fear about the 'insider threat' led to a Presidential Order, given in January 2009, which called for a full inter-agency review of laboratory bio-security practices, including personnel reliability. Part of this review consisted of an experts' workshop, run by the American Association for the Advancement of Science (AAAS), designed to document existing biosafety training programmes, provide recommendations for developing future programmes, and highlight the challenges facing biosafety initiatives.
The resulting report recommended that professionals from across the scientific community, including scientists and administrators, be involved in reviewing and improving safety in their institutions. It stressed that experts from different areas of competence should be involved in the process to ensure that bio-safety standards are realistic.
Mark Frankel, director of the AAAS Program on Scientific Freedom, explained that many scientists in the USA are unaware of the stringent protocols under which they could find themselves working, and about the security vetting they may soon have to undergo. “Clearly one of the main things we wanted to do is to draw attention to the issue of personnel reliability," he said, “which I do not think is well-recognised by life scientists out there in the field. They have absolutely no idea what's coming."
The authors of the report concluded that measures based solely on the personnel reliability principle, which calls for vetting all personnel expected to come into contact with agents that could be used for malicious purposes, cannot address questions of bio-safety on their own. Instead, they argue, improved training is the answer, combined with organizational learning.
It reads: “Many of these security-oriented policy discussions have not engaged the greater life science community or considered existing practices that address some of the security concerns_Biosafety training is a cornerstone for preparing anyone entering a high-containment laboratory, and biosafety professionals generally act as gatekeepers to those laboratories."
Alternative measuresOne way to mitigate the risk of accidental contact with dangerous disease agents might be to set up an anonymous database of possible exposures, so the whole scientific community can learn from genuine mistakes without anyone fearing recrimination. Lessons learnt from past incidents can then be used to develop and improve safety protocols. The Select Agent Program and Biosafety Improvement Act already makes provisions for such a database, but only if it is run by the government. This might be unacceptable to private laboratories, where intellectual property concerns could make them reluctant to participate.
One of the chief criticisms of the personnel reliability principle as it applies to bio-labs is that while it would be effective for ensuring the people handling the agents are suitably qualified and competent, there are questions about its usefulness for preventing malicious actors or unstable personnel from gaining authorised access to high-containment laboratories. While personnel reliability assessments have been implemented effectively at some government laboratories, there are doubts about how well they can be used in academic institutions. Alternative, more flexible programmes adapted to these settings are still being discussed.
Fears about overly stringent security protocols hampering the work of US laboratories may be well founded. When the unusual cases of influenza later recognised as 'swine flu' were first seen in Mexico, virus samples needed to be sent to expert laboratories for testing to identify the virus behind the infections. But due to a time delay caused by security controls, samples had to be sent to Winnipeg in Canada instead of an equipped lab much closer, in Atlanta.
“The labs are fine in Canada," said Kavita Berger of the AAAS in a press release, “but the point is that we are basically cutting ourselves out of the game for global health as well as the global research enterprise, and that's not good."
Elsewhere in the WestQuestions over the correct bio-security strategy to adopt are not unique to the USA. A report published by the UK's Royal Academy of Engineering (RAE) predicts that scientific exploration in synthetic biology will escalate rapidly.
The RAE defines synthetic biology as the branch of engineering concerned with redesigning existing, natural biological systems, and making novel biologically based parts, devices and systems that could be used as biological or chemical sensors, for example. These basic building blocks could also lead to the development of new drugs quickly, or could provide the raw material for more efficient bio-fuels. However, the report cautions that synthetic organisms could also be created for malevolent purposes.
“Bio-security concerns were triggered by the synthesis of several pathogenic viruses, including the 1918 influenza virus and an infectious poliovirus that was synthesised using only published DNA sequence information and mail-ordered raw materials" warn RAE scientists. “Such developments have led to concerns that 'biohackers' [hobbyists who experiment with DNA and other aspects of genetics] could recreate known pathogens and perhaps even make them more virulent."
This demonstrates an additional difficulty with legislating for biosecurity, which is not present in the nuclear arena. It is extraordinarily unlikely that someone could build a functioning nuclear device in their garage, but biosecurity measures must take into account that agents can be stored and manipulated beyond the laboratory walls.
Personnel reliability may have a role to play, but it must be placed in context. It may be unhelpful to employ them in lieu of, instead of alongside, existing measures which include proficiency testing, mentorship, and didactic training.
Points to watch *** If strict protocols are brought in for all laboratories expect to see protests and complaints from life-scientists, complaining that they are unable to work effectively. *** As measures are implemented to vet scientists with access to select agents more carefully, expect to see sackings of personnel deemed to be unsuitable under new regulations. Both extreme and borderline cases are likely to reach the mainstream media. |