The Revolving Door of Biosafety

By Scott McAlister

Have you ever seen a science fiction movie that starts with a lab accident? A scientist drops a vile with the biohazard label on it and next thing you know, boom, the zombie apocalypse is in full force.  In the real world, lab accidents probably won’t lead to a zombie outbreak, but the reality is still pretty concerning.  We have seen accidents in the last couple years that should lead to some uneasy feelings about the biosafety and biosecurity protocols and practices we have in this country.  In response to these incidents, the White House released issued a memorandum to highlight recommendations and implementation timelines to fix these problems.  This report, however, looks eerily similar to a report filed by the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight in 2009.  The failure of the 2009 report to include concrete implementation made it all too easy to overlook.  Hopefully, the more prominent report released by the White House, including the implementation timelines, will be effective in curbing future lab accidents and improving biosafety.

The memorandum, released by Lisa Monaco, Assistant to the President for Homeland Security and Counterterrorism, and John Holdren, Assistant to the President for Science and Technology, was a response to incidents and accidents that have occurred over the last two years at high profile labs at the Centers for Disease Control, National Institutes of Health, and Dugway Proving Groud Centers for Disease Control and Prevention, National Institute of Health,and Dugway that.  At 187 pages long, the memo highlights recommendations for avoiding future laboratory incidents and establishes timeframes for the implementation of these recommendations.  With the explicit mission of enhancing biosafety and biosecurity in the United States, the memo recommends increased transparency of the nation’s laboratory system for public safety and security, increased incident reporting and accountability to the public, material stewardship, and applicability to other biological agents that could pose serious threats to public health.   Included in the report is a memo from 2014, which called for specific recommendations to strengthen the Federal government’s biosafety and biosecurity practices and oversight system.[1]  This memo, lays out both immediate and long term steps on how to enhance safety and security of research to minimize the potential for future incidents.  It also includes implementation plans and timelines, which have been endorsed by the Interagency Policy Committee on Biological Select Agents and Toxins.  Notable recommendations include changes to the culture of responsibility, oversight, outreach and education, applied biosafety research, incident reporting, material accountability, inspection processes, and regulations and guidelines, all by the end of 2016.  The National Security Council staff and Office of Science and Technology Policy will review implementation of these recommendations on semi-annual basis.

The report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight, released in July of 2009, attempted to optimize biosafety and biocontainment oversight and research by developing a coordinated and synergistic approach that did not impede scientific enterprise.[2]  The report focuses on enhancing the framework for oversight, creating a culture of accountability and compliance, a structure for training and competency, incident reporting and information sharing, infrastructure maintenance, and public outreach and transparency.  The report stressed that research on hazardous agents is vital for ensuring public and agricultural health and thatlocal oversight was the key to biosafety.  Transparency, as they saw it, was critical to the success of research in high biocontainment labs and periodic evaluations were necessary to ensure effective oversight.  The major weakness of the report are its lack of implementation timelines and concrete ways to put the recommendations into effect.

Both reports were created for similar reasons, mainly to prevent laboratory accidents and incidents in facilities that work with dangerous pathogens.  It is not surprising then, that many of their recommendations are similar as well.  Recommendations regarding culture of responsibility, proper oversight, incident reporting, and outreach and education are prominent in both reports.   For example, the first recommendation of the 2015 White House memo focuses on strengthening aculture of responsibility at both the individual and institutional levels.  Compare this to a main objective of the 2009 Task Force report whichfocused on encouraging a robust culture of accountability in biosafety and biocontainment measures at both the institutional and individual levels.  The 2009 biosafety task force report explored whether to establish a new voluntary, non-punitive incident-reporting system for high and maximum labs that would ensure the protection of sensitive and private information.  The White House memo ordered the establishment of a new voluntary incident reporting system that would increase transparency and oversight while  protecting private information.  The recommendations of both reports, however, are are hamstrung  byvague language like “improve”, “support”, “enhance,” and “optimize”.  This language can be interpreted differently depending on how much of an improvement is wanted, or how much support is needed.  The lack of follow-up to the 2009 report illustrates the danger of good recommendations being ignored  The White House memoresolves this problem somewhat with its timelines for  implementations, although some parts are still relatively unclear.  Separated by more than five years, why do these two reports share the same fundamental message?  Without proper implementation, the 2009 report, regardless of how well thought-out the recommendations were, had no power to change the state of laboratory safety.  With all due respect, who has actually heard of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight or could even pronounce its name in a single breadth?  A report with no concrete methods for change put out by an entity that many people don’t know about isn’t exactly a recipe for success.  With the release of this new call for change by a much better-known and powerful entity, hopefully history will not repeat itself.

Even if all of the recommendations of the October 2015 White House memo are implemented, however, its impact on biosafety practices will likely be limited. Important issues such as laboratory culture, including aspects like leadership style and technician accountability, is not something that can necessarily be completely controlled by federal oversight.  There are 347 entities that work with Select Agents in the United States.  Many of them are private laboratories, which makes it hard for federal oversight to be effective.  Also, a broad recommendation to create a culture that values responsibility and material stewardship will resonate differently with each lab.  Each laboratory head will react to these recommendations in a different way.  Increased oversight in one lab may be seen as a hindrance and slow the process of the science, whereas in another, the same oversight might help to fix protocols.  This brings up to the idea of top-down management.  How much can someone in Washington really understand how to regulate laboratory culture, especially if he or she has never worked in a lab before?  Are laboratory managers or principle investigators really supposed to follow the direction of people who have little to no experience in a laboratory setting?

Another important aspect to consider in a laboratory environment is tacit knowledge.  As someone who has spent time in a professional laboratory setting, I know from first-hand experience that protocols aren’t always followed as directed.  Tacit knowledge plays a large role in the success of some experiments; from something as small as changing a reagent by a minuscule amount to changing the specific ways components are stored.  It also plays a large role in how certain labs, or parts of the lab, interact with each other.  Social organization at each lab is different, based on previous interactions with management and faculty.  How will rigid sets of broad implementations for increased laboratory safety interplay with the ever-evolving concept of tacit knowledge in the lab?  Regardless of the proposed semi-annual inspections, at what point does a lackadaisical reporting and inspection method retake the environment and things revert back?  Also, lets say that the implementation timeline does spur a change in laboratories; how are these changes being measured?  Does each lab reach the same level of safety, or is it relative depending on the nature of the work being done in the lab?  The broad and sometimes vague language used in the recent report leads to interpretation issues in different labs.

Overall, the similarity of these reports stem from the failure to implement changes recommended in the 2009 report.  The lack of specifically drawn out implementation procedures provided an all too easy escape for heeding the warnings and recommendations of the 2009 Task Force.  Perhaps if some of these changes had been put into place in subsequent years, some of the recent incidents could have been avoided.  The fact that a prominent source such as the White House put out a memo about this topic could help bring the issue to the forefront of discussion and increase the likelihood of actual changes being made. Looking ahead, do the implementation timelines from the recent memorandum have the power to actually change the laboratory environment?  A lack of concrete consequences for laboratories not following the timeline was absent in the new memo.  With relatively little incentive to change in the way the federal government sees fit, will we see another report in a couple of years mirroring the two discussed in this article? Or even worse, another high-profile lab accident which further erodes the public’s confidence in the ability of researchers to handle these dangerous pathogens responsibly?

2015 White House memo: https://www.whitehouse.gov/sites/default/files/docs/10-2015_biosafety_and_biosecurity_memo.pdf

2009 Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight report: http://www.ars.usda.gov/is/br/bbotaskforce/biosafety-FINAL-REPORT-092009.pdf

[1] Monaco, Lisa and Holdren, John, “Enhancing Biosaftey and Biosecurity in the United States” pg.1.

Click to access 10-2015_biosafety_and_biosecurity_memo.pdf

[2] “Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight.” July 2009, pg. 4. Print.