Reynolds Mathewson Salerno

Laboratory Biosecurity Handbook

INTRODUCTION Laboratory Biosecurity and the Risks of Bioterrorism Laboratory Biosecurity and International Obligations Laboratory Biosecurity and National Regulations Approach/Objectives of this Book RISK ASSESSMENT Overview of Biosecurity Risk Assessment Methodology Characterize Assets and Threats Evaluate Scenarios Characterize the Risk Risk Reduction COMPONENTS OF BIOSECURITY Physical Security Personnel Security Material Control and Accountability Transport Security Information Security PROGRAM MANAGEMENT Role and Responsibilities Biosecurity System Design Response Force Performance Testing Documentation Assessments and Audits Training and Exercises SPECIFIC BIOSECURITY RECOMMENDATIONS Low-Risk Facility Moderate-Risk Facility High-Risk Facility Extreme Risk Facility Specific Biosecurity Recommendations - Low-Risk Facility Specific Biosecurity Recommendations - Moderate-Risk Facility Specific Biosecurity Recommendations - High-Risk Facility Specific Biosecurity Recommendations - Extreme High-Rick Facility CONCLUSIONS List of Acronyms Glossary Appendix A-Vulnerability Assessment Questionnaires Appendix B-Example Biosecurity Risk Assessment Methodology Appendix C-Biosecurity Plan Template Appendix D-Example Memorandum of Understanding with Local Law Enforcement Appendix E-SOP for Testing Access Control Systems Appendix F-Biosecurity Guidance and Regulations

A BW risk assessment: Historical and technical perspectives

The use of pathogens and toxins as weapons is not new and is certainly not a creation of recent biotechnical advances. Documented use of biological weapons (BW) dates at least as far back as the Middle Ages, when plague-infected cadavers were catapulted over the city walls of Kaffa. However, it was not until the fall 2001 anthrax attacks along the East Coast of the United States that BW use—especially in the form of bioterrorism—was brought to the forefront of the U.S. national security debate. Unfortunately, the risk of BW use or bioterrorism is not well understood, and the rapid advances of and accessibility to biotechnology have only served to increase confusion. This article aims to provide a comprehensive assessment of the risk of the use of biological weapons by combining a historical overview of past BW activities with an analysis of the technical requirements necessary to develop and deploy such weapons.

Developing a Risk Assessment and Management Approach to Laboratory Biosecurity

A growing awareness in the microbiological research and policy communities centers on the need to increase the protection of dangerous biological agents from theft. However, existing security literature and regulatory requirements do not present a comprehensive approach or clear model for biosecurity, nor do they wholly recognize the operational issues within laboratory environments. The modern laboratory operating environment needs to be defined by both biosafety and biosecurity considerations. In addition to being a component of the operating environment, biosafety can serve as a model for biosecurity. Both of these paradigms should be implemented in a graded manner, with increased protection based on the results of a risk assessment. This article proposes a preliminary framework for assessing biosecurity considerations and provides examples that address specific biological materials. The bio can be divided into several fundamental steps: (1) assessing the materials based on their weaponization potential and potential consequences, (2) assessing the potential adversaries, and (3) analyzing security scenarios. The results of the risk assessment form the foundation for risk management and the design of a biosecurity program. By prioritizing risks, the assessment provides a rational basis for allocating scarce security resources.

Historical precedence and technical requirements of biological weapons use : a threat assessment.

The threat from biological weapons is assessed through both a comparative historical analysis of the patterns of biological weapons use and an assessment of the technological hurdles to proliferation and use that must be overcome. The history of biological weapons is studied to learn how agents have been acquired and what types of states and substate actors have used agents. Substate actors have generally been more willing than states to use pathogens and toxins and they have focused on those agents that are more readily available. There has been an increasing trend of bioterrorism incidents over the past century, but states and substate actors have struggled with one or more of the necessary technological steps. These steps include acquisition of a suitable agent, production of an appropriate quantity and form, and effective deployment. The technological hurdles associated with the steps present a real barrier to producing a high consequence event. However, the ever increasing technological sophistication of society continually lowers the barriers, resulting in a low but increasing probability of a high consequence bioterrorism event.

Biosafety Risk Assessment Methodology

Laboratories that work with biological agents need to manage their safety risks to persons working the laboratories and the human and animal community in the surrounding areas. Accepted biosafety best practices and international guidance span a wide variety of biosafety risk mitigation measures, which can be categorized as engineering controls, procedural and administrative controls, and the use of personal protective equipment. The determination of which mitigation measures should be used to address the specific laboratory risks should be dependent upon a risk assessment. Ideally, a risk assessment should be conducted in a manner which is standardized and systematic allowing it to be repeatable and comparable. A risk assessment should clearly define the risk being assessed and avoid over complication.

Biological Risk Assessment in the Laboratory: Report of the Second Biorisk Management Workshop

The Biorisk Management Workshop is held annually at the Canadian Science Centre for Human and Animal Health and organized by the National Microbiology Laboratory’s Office of Biorisk Management (OBM), which is part of the Public Health Agency of Canada. Each year experts are invited to discuss important aspects of biosafety and biosecurity and to provide ideas and concepts for advancing biorisk management. The outcomes of the workshop are generally made available to the biosafety community at large. During the 2007 five-day meeting, the group was charged with discussing and, if possible, developing a common approach to biological risk assessment for the laboratory. Three of the five days were used to discuss individual parts of the risk assessment process, while the remaining time was spent developing a draft conceptual model of a unified risk assessment process. The risk assessment process is a critical step in determining the appropriate biosafety and biosecurity measures for the safe and secure handling of biological agents in the laboratory setting. The risk assessment is also an integral part of a biosafety management system, serving as the basis for both implementing and reviewing a performance-oriented biosafety system. Typical outcomes of such a biological risk assessment are the identification of risks that require immediate attention and management, as well as the determination of appropriate biosafety levels, which by definition are a combination of different controls and not limited to the physical barriers, practices, and/or the use of personal protective equipment. Although the biosafety community has been exposed to this process for decades and is apparently practicing it, there has not been a true consensus-building effort on documenting the actual procedures and outcomes of risk assessments. To make matters worse, the process is often viewed as too cumbersome, not quantifiable, and just not practical. Recent review of postings on the ABSA “Biosafety Mailing” list, a common information exchange forum for biosafety professionals, revealed some dangerous trends. Too many in the community are just asking for copies of existing procedures, often lacking a clear understanding of the fundamental differences between “Risk Groups” and “Biosafety Levels” and/or seeking a quick and easy alignment between certain biological agents and their proposed biosafety level. Although risk assessments are currently performed, the lack of a unified approach and appropriate tools makes such assessments unnecessarily difficult. The current lack of clearly quantifiable processes makes the biological risk assessment a predominantly qualitative approach and, as such, potentially highly subjective, variable, and inconsistent. At the same time, as the biosafety community is struggling with a necessary and useful process, we see an overall increasing tendency towards a zero-risk mentality based on perception as it relates to containment facilities. This tendency is compounded by the fact that we are currently experiencing an unprecedented growth in new facilities within communities that are questioning the facility’s safety, management, and research, which are essential foundations of successful work with infectious agents.

Biosecurity: Progress and Challenges

Bioscience facilities are essential to the efforts to combat both naturally occurring infectious diseases and bioterrorism. But both the general public and policy makers are questioning how bioscience institutions address the safety and security risks of handling infectious disease causing organisms. As a result, new regulations at the national level in many countries and international initiatives from the United Nations, World Health Organization, and others are having direct consequences for the operation of bioscience. In particular, laboratory biosecurity is a relatively new and evolving paradigm for bioscience facilities, which have an obligation to ensure their facilities operate safely and securely. However, although progress has been made in these areas, numerous challenges remain throughout the world, and much work remains. It is the responsibility of both the scientific community and policy makers to work collaboratively to ensure responsible use of pathogens and toxins, equipment, and expertise.

Laboratory Biosecurity: A Survey of the U.S. Bioscience Community

Laboratory biosecurity practices, or measures to prevent the theft or sabotage of biological research materials, must coexist with biosafety. Within the United States, laboratory biosecurity, for a list of select agents, has been regulated through several Codes of Federal Regulation. In 2004 and 2005, Sandia National Laboratories conducted a survey of the U.S. bioscience community in conjunction with Reed Research Group, to assess the extent biosecurity is implemented in laboratories and the relationship between biosecurity and biosafety and good laboratory practices in regulated select and non-select agent laboratories. This paper describes the results of this survey.

Material control and accountability for laboratory biosecurity

Laboratory biosecurity refers to a suite of measures to protect legitimate stocks of dangerous pathogens and toxins from being acquired by individuals with malicious intent. Intentional misuse presents a different problem than accidental misuse, which is the subject of laboratory biosafety. In particular, the material control and accountability (MC&A) component of laboratory biosecurity addresses an insider threat. MC&A directly involves the personnel who work with pathogens and toxins that could be attractive to bioterrorists. Control of material comprises both procedural and physical measures for both material and MC&A-relevant information. Accountability requires a one-to-one correspondence between materials and people, together with a system of records, reporting and audit. Key elements of MC&A should be understood intellectually, rather than being applied simply as a prescriptive list of security measures. MC&A measures reflect an additional stewardship responsibility that technical people accept in working with material that could harm others if used improperly.

Development of Self-Remediating Packaging for Safe and Secure Transport of Infectious Substances.

As George W. Bush recognized in November 2001, %22Infectious diseases make no distinctions among people and recognize no borders.%22 By their very nature, infectious diseases of natural or intentional (bioterrorist) origins are capable of threatening regional health systems and economies. The best mechanism for minimizing the spread and impact of infectious disease is rapid disease detection and diagnosis. For rapid diagnosis to occur, infectious substances (IS) must be transported very quickly to appropriate laboratories, sometimes located across the world. Shipment of IS is problematic since many carriers, concerned about leaking packages, refuse to ship this material. The current packaging does not have any ability to neutralize or kill leaking IS. The technology described here was developed by Sandia National Laboratories to provide a fail-safe packaging system for shipment of IS that will increase the likelihood that critical material can be shipped to appropriate laboratories following a bioterrorism event or the outbreak of an infectious disease. This safe and secure packaging method contains a novel decontaminating material that will kill or neutralize any leaking infectious organisms; this feature will decrease the risk associated with shipping IS, making transport more efficient. 3 DRAFT4