Laboratory Biorisk Management

Biosafety and Biosecurity

Reynolds M. Salerno, Jennifer Gaudioso, Reynolds M. Salerno, Jennifer Gaudioso

• Publisher: CRC Press
• Year: 2015
• ISBN:
  9781498749749
• Edition: 1
• Topic: Medicine
• Subtopic: Infectious Diseases

Over the past two decades bioscience facilities worldwide have experienced multiple safety and security incidents, including many notable incidents at so-called "sophisticated facilities" in North America and Western Europe. This demonstrates that a system based solely on biosafety levels and security regulations may not be sufficient.Setting the s

Chapter 1

Introduction

The Case for Biorisk Management

Reynolds M. Salerno and Jennifer Gaudioso

Abstract

This introductory chapter recounts the history of laboratory biosafety and biosecurity in an attempt to explain the origins of the current paradigm that relies on pre-defined biosafety levels, agent risk groups, and biosecurity regulations. This history reveals that the fundamental concepts of biorisk management were articulated well before the current paradigm came into existence, but unfortunately have been lost by a community that has expanded significantly. After summarizing many safety and security incidents at bioscience laboratories in the 1990s and 2000s, demonstrating the weakness of the current paradigm, this chapter argues that the rapid technological advances of the biosciences compel the community to reconsider the traditional methods of ensuring safety and security. The chapter then reviews a series of catastrophic accidents that occurred in many different industries, and shows, as a result, how generic, rule-based, administrative systems have been abandoned in favor of a performance-based, holistic, risk-management systems approach. The implementation of substantive risk management policies, standards, and expectations has dramatically decreased both the number and severity of accidents in these industries. The bioscience community should not wait for a calamity to occur in its field before learning these fundamental lessons.

Laboratory Biosafety and Biosecurity

Biorisk management encompasses both laboratory biosafety and biosecurity. The laboratory biosafety community has relied on predefined biosafety levels * for more than 30 years. Laboratory biosecurity has a much shorter history than biosafety, but it has been predominantly based on prescriptive regulations. In both cases, biosafety and biosecurity practices have generally relied on generic biological agent risk groups, biosafety levels, or regulations that, de facto, assume that all work with the same agent presents the same degree of risk—regardless of the nature of the work, where it takes place, or by whom. Diagnostic work with avian influenza should take place in essentially the same laboratory in Minneapolis as in Jakarta, and if the laboratories physically look the same, the risk of accidental release will be essentially the same. Of course, anyone with any substantive experience in the biological research and diagnostics field, particularly biosafety experts, will recognize the absurd simplicity of that statement, but for many who want to build a new bioscience facility, the published guidance leads them to believe that achieving the prescribed biosafety level equates to biological safety in that facility.

The situation is arguably worse for laboratory biosecurity. Because most professionals in the bioscience community have little experience or expertise in law enforcement or counterterrorism, policy makers with scant bioscience background have enacted regulations that define the technical security systems for every facility that works with specific agents or toxins. The unique circumstances of the facility or its personnel, its location, the agents, and the nature of the work with those agents seem not to matter. From the perspective of the regulators, all the facilities that work with certain dangerous agents in their jurisdiction should employ the same security approach. Not only does this simplified approach inevitably lead to wasted security resources in some facilities, and significant gaps in security at other facilities, but most disturbingly, it discourages the scientific leadership to engage intellectually on the subject of security. Such an attitude inevitably leads to complacency and increases a facility’s vulnerabilities over time.

A Short History of Laboratory Biosafety

It is instructive to understand the history of laboratory biosafety and biosecurity. Much of the published history is rooted in North America and Western Europe. Biosafety as an intellectual field can trace at least many of its origins to the US biological weapons program, which was active during the Cold War and finally terminated by President Nixon in 1969. In 1943, Ira L. Baldwin became the first scientific director of Camp Detrick (which eventually became Fort Detrick), and was tasked with establishing the biological weapons program (US Department of Army 2014). The US development of biological weapons was explicitly for defensive purposes: to enable the United States to respond in kind if attacked by such weapons. After the Second World War ended, Camp Detrick was designated a permanent installation for biological research and development. Baldwin understood from the very beginning that the program had to establish specific measures to protect Camp Detrick personnel and the surrounding community from the dangers of the highly infectious agents that the program would work with on a daily basis. Biosafety was necessarily an inherent component of biological weapons development. † Baldwin immediately assigned Newell A. Johnson to design any needed modifications for safety. Johnson engaged some of Camp Detrick’s leading scientists about the nature of their work, and developed specific technical solutions—such as Class III safety cabinets and laminar flow hoods—to address their specific risks (US Department of Army 2014). Over time, Johnson and his colleagues recognized the need to share their technical challenges and solutions with other facilities that were also part of the US biological weapons program, and in 1955 they began to meet annually to discuss biosafety issues. This annual meeting eventually led to the formation of the American Biological Safety Association (ABSA) in 1984, and the annual meeting soon became the ABSA annual conference (Barbeito and Kruse 2014).

Although the US biological weapons offensive and defensive programs are among the most documented contributions to a systematic approach to developing biosafety, these pioneers recognized the contributions of others to the field. For example, Arnold Wedum cites descriptions of the use of mechanical pipettors to prevent laboratory-acquired infections in German scientific journals that date back to 1907 and 1908 (Wedum 1997). Ventilated cabinets, early progenitors to the nearly ubiquitous engineered control now known as the biological safety cabinet, were also first documented outside of the US biological weapons program. A pharmaceutical company in Pennsylvania developed a ventilated cabinet for work with Mycobacterium tuberculosis in 1909 (Kruse et al. 1991). In 1954, tuberculosis was the driving factor that led to the adoption of similar ventilated cabinets at the Goteborg Bacteriological Laboratory (Lind 1957). These early efforts helped the bioscience community begin to more broadly adopt principles of this nascent field of biosafety.

At approximately the same time as the United States formally abandoned its biological weapons program, the international community aggressively pursued the eradication of smallpox (Colle...