PROGRAM
ALL PRECONFERENCE COURSES
Preconference Courses
Sunday, October 21, 2012
8:00 am - 5:00 pm
19. Risk Assessment and Containment for Plant-based Recombinant DNA Research
M. Malendia Maccree, University of California—Davis, Davis, CA
This course will provide an overview of plant-based recombinant DNA research conducted with a focus on biological
safety and containment. The course will include basic knowledge of plant molecular biology, plant-microbe
interactions, and plant pathology which is critical to successful risk assessments for plant-based experiments
involving recombinant DNA. Additional considerations such as greenhouse operations, seasonal cycles, environmental
release of recombinant organisms, and the perspective of plant researchers will be discussed. Applicable regulations
and guidelines will be reviewed. Examples and applications of common controls and best practices will be described
and examined. Participants will be asked to synthesize basic botany and molecular biology concepts in order to apply
principles of risk assessment and containment to plant-based research. Interactive exercises will provide case-study
examples for participants to identify stakeholders, perform a risk assessment, cite applicable jurisdictions and
regulatory requirements, and suggest appropriate controls and best practices to address identified risks.
Objectives:
- Identify and understand common types of plant-based experiments which involve recombinant DNA
- Apply biological risk assessment methodology and identify appropriate containment levels for plant-based experiments
- Identify regulations, guidelines, and jurisdictions which pertain to plant-based research with recombinant DNA
- Recognize and respond to unique biological safety programmatic challenges presented by BSL-1 and plant-based microbiological research
Suggested Background: Risk Assessment, Micro/Molecular Biology 101, Principles and Practices of Biosafety
Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, Biosafety Professionals
Working with Plant Pathologists (BSL-1, BL-1-3P), and Plant Scientists (BSL-1)
Audience Level: Intermediate
8:00 am - 5:00 pm
20. The Role of Threat Assessment in Biosecurity Programs
Ben Perman, PhD, RBP, Booz Allen Hamilton, Inc., Washington, DC
Jason Griffeth, Booz Allen Hamilton, Inc., Herndon, VA
Lindsay Odell, PhD, Booz Allen Hamilton, Inc., McLean, VA
Nanda Gudderra, PhD, Northern Arizona University, Flagstaff, AZ
Patricia Delarosa, PhD, RBP, CBSP, Booz Allen Hamilton, Inc., McLean, VA
This course will train administrators, management, and researchers the basic principles of threat assessment and
introduce participants to the role of threat assessment in biosecurity programs. The course will provide participants
with a basic tool-kit that will allow implementation of successful insider threat mitigation strategies using threat
assessment at their home institutions and to convey concepts in threat assessment to their colleagues. This course
will follow established criminal psychology techniques in the personal protection field that are used to identify,
assess, and manage dangerous threats. Participants will be presented with relevant case studies in order to learn
about basic threat indicators and threatening behaviors. Through an analysis of relevant case studies, participants will
learn how to recognize specific personal security vulnerabilities and how to link these vulnerabilities to threats. The
course will focus on the requirements of a biosecurity program and the role of threat assessment in the management
of effective personal security and personal suitability or reliability components of biosecurity programs. Regulatory
issues relevant to threat assessment and the implementation of personnel management programs will also be
discussed. Theoretical concepts will be put into practice in a tabletop exercise devised around a realistic laboratory
security problem that draws on the material presented in the lecture and case studies.
Objectives:
- Describe the basic principles of threat assessment in a biosecurity program and how threat assessment can be implemented in a successful insider threat mitigation program
- Recognize specific personal security vulnerabilities and how to link these vulnerabilities to threats
- Discuss the purpose and requirements of basic suitability or reliability and threat assessment programs and their roles in laboratory biosecurity management
- Identify resources and the legal and regulatory controls relevant to threat assessment and the implementation of a laboratory biosecurity program
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, Security Professionals
Audience Level: Basic
8:00 am - 5:00 pm
21. Designing a Resilient Civilian Biosurety Program for Biosafety Level 3 Laboratories
Jessica McCormick, PhD, RBP, University of Medicine and Dentistry of New Jersey, Newark, NJ
Marta Figueroa, University of Medicine and Dentistry of New Jersey, Newark, NJ
Brendan McCluskey, MPA, JD, University of Medicine and Dentistry of New Jersey, Newark, NJ
A strong biosurety program encompassing physical security, biosafety, agent accountability, and personnel reliability
is key to running a successful, safe, and secure BSL-3 facility. Laboratory support and biosafety staff must be
knowledgeable on the implementation of security measures; prepared to deal with exposure incidents, natural
disasters, and other incidents that may affect workers in and outside of the BSL-3 laboratory; and have a mechanism
to account for agent stock, equipment, and other materials. Ensuring BSL-3 laboratory staff is capable of dealing with
the pressures of working in containment space and maintaining a level of trust is particularly problematic. The
biosurety program for a BSL-3 laboratory must be designed to prevent events, reduce the impact should an incident
occur, address any vulnerabilities present, and prepare staff to handle incidents that may occur in the facility.
Objectives:
- Identify strategies, policies, plans, training programs, and exercises that will prepare staff members for incidents affecting the BSL-3 laboratory
- Develop a program and policies for risk assessment and continued verification, including security, biological protocols, and personnel
- Define a training program to ensure staff members demonstrate competence to work in and around a BSL-3 laboratory
- Recognize policies designed to prevent laboratory incidents at BSL-3 laboratories
Suggested Background: None
Target Audience: New Biosafety Professionals, Laboratory Workers
Audience Level: Basic
8:00 am - 12:00 pm
22. The Physics Behind Biocontainment—Part I
Juan Osorio, National Institutes of Health, Bethesda, MD
Keith Ashe, National Institutes of Health, Bethesda, MD
Theodore J. Traum, PE, National Institutes of Health, Bethesda, MD
Diego Osorio, National Biosafety & Biocontainment Training Program, Bethesda, MD
Many principles in physics can be applied to the proper operation of a biocontainment laboratory. Concepts such as
directional airflow, pressure, temperature, and humidity are needed to make a biocontainment facility run effectively
and efficiently. Some biosafety professionals may not be aware that these concepts can impact their work and
research. The objective of this course is to explain these physics concepts using basic real-life examples and how they
apply to biocontainment laboratories. Throughout the course, examples of basic physics concepts will be
demonstrated to add a visual dimension that formulas and definitions cannot accomplish. Physics visual aids will be
used to demonstrate actual engineering principles relating to biocontainment laboratories. Building upon the physics
concept, static pressure as it relates to an exhaust system and fan selection will be explained. A hands-on activity will
be conducted following the explanation of each physics concept. This course will not be driven by formulas but will
integrate examples that show cause and effect in real-life scenarios. Building on this information, there will be a step-by-step presentation on how these examples are relevant to planning a laboratory, validation, certification,
maintenance, and operations.
Objectives:
- Apply physics concepts and formulas to control variables that impact daily work and eliminate disruption
- Interpret and understand data that is used for measuring pressure, temperature, humidity, and airflow
- Recognize how a building's system is affected by variables such as barometric pressure and temperature
Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Basic
8:00 am - 12:00 pm
23. High Speed Cell Sorter Selection, Biosafety, and Aerosol Containment
Geoffrey Lyon, MPH, Yale University, New Haven, CT
High speed cell sorting is a very common research tool utilized by universities, biotechnology companies, and
hospitals. High speed cell sorters allow users to separate tens of millions of cells per hour with purities of > 99%. This
makes cell sorting one of the most effective method of separating cell populations from a heterogeneous mixture. High
speed cell sorters are also capable of generating massive aerosols in the event of a clog or deflection. This course will
help biosafety professionals understand the potential risk associated with cell sorters. We will discuss safety features
of various machines and highlight aspects of each that should be considered when purchasing. High speed cell sorting
is also utilized by people who want to sort cells that are infected with various agents and pathogens. This course will
focus on the safety considerations that are required when creating a BSL-3 cell sorting facility. It will look at the
creation of SOPs, facility requirements, and risk assessment process for sorting BSL-3 materials. Different methods
used in assessing the containment of aerosols for cell sorters will also be examined. The overall goal of this class is to
provide biosafety professionals with a background to help them make decisions on safety and containment for high
speed cell sorters, particularly in a BSL-3 setting.
Objectives:
- Provide a brief background on the differences between flow cytometry and high speed cell sorting
- Determine the level of containment needed for high speed cell sorters and guidelines to use in evaluating cell sorters for RG3 cell sorting
- Identify the variety of different methods used in evaluating and testing the aerosol containment of high speed cell sorters
- Explain the topics needed to develop emergency response to catastrophic failures of high speed cell sorters
- Identify the topics needed to develop SOPs and risk assessments for cell sorters
Suggested Background: Fundamentals of Biosafety, Risk Assessment, Biosafety Level 3 Operations, Principles and
Practices of Biosafety
Target Audience: All Safety Professionals, Laboratory Workers, Experienced Biosafety Professionals
Audience Level: Basic
8:00 am - 12:00 pm
24. Fundamentals of Microbiology and Infectious Disease
James Klenner, MS, RBP, CBSP, Indiana University—Purdue University Indianapolis, Indianapolis, IN
This course is intended for those professionals that participate in protocol review, facilities planning, and any other
risk assessment activities but are unsure as to the actual nature of the disease risks of microbiological agents.
Biological safety and risk assessment will not be covered in this course. The proposed topics will cover infectious
agents, virulence factors, pathogenicities, host-microbe interactions, susceptibility, modes of transmission, and the
changes seen in the microbial world. If you don't know the difference between a TCID50, PFU, or ID50; or why HBV is
stable in dried blood and HIV isn't; or why influenza is an inhalation hazard; or why public health officials advocate flu
shots each year, then this class is for you.
Objectives:
- Define different microorganisms and their pathogenicity
- Restate the various modes of transmission of microbial pathogens
- Correlate the host response to microbial infections
- Develop a basis for various environmental survival trends
Suggested Background: None
Target Audience: New Biosafety Professionals, All Safety Professionals
Audience Level: Basic
1:00 - 5:00 pm
25. The Physics Behind Biocontainment—Part II
Juan Osorio, National Institutes of Health, Bethesda, MD
Keith Ashe, National Institutes of Health, Bethesda, MD
Theodore J. Traum, PE, National Institutes of Health, Bethesda, MD
Diego Osorio, National Biosafety & Biocontainment Training Program, Bethesda, MD
The second part of this course is built upon in physics principles covered in "The Physics Behind Biocontainment—
Part I." The concepts learned in the first part of the course will be applied to scenarios that take place in a BSL-3
laboratory. Concepts such as how to achieve directional airflow, calculating pressure differentials, and understanding
how the laboratory HVAC system works will be discussed. Real-life examples of physics concepts will be applied to
biocontainment laboratories. These physics concepts will be presented through hands-on exercises that easily explain
formulas and definitions that can be difficult to understand. Physics visual aids will be used to demonstrate actual
engineering principles relating to biocontainment laboratories. A hands-on activity will be conducted following the
explanation of each physics concept. This course will not be driven by formulas but will integrate examples that show
cause and effect in biocontainment laboratories. Realistic scenarios will also be presented that are relevant to
planning a laboratory, validation, certification, maintenance, and operations.
Objectives:
- Calculate, interpret, and understand pressure differentials for biocontainment laboratories
- Recognize how a biocontainment laboratory's HVAC system works
Suggested Background: Physics Behind Biocontainment—Part I or Physics Behind Biocontainment (ABSA 2011)
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Intermediate
1:00 - 5:00 pm
26. Preparing for, Conducting, and Responding to Regulatory Agency Inspections/Audits
Barbara Fox Nellis, SM(NRCM) RBP, CBSP, Barb Nellis Consulting, Sarasota, FL
This course will prepare the biosafety and other safety professionals, the entity, and laboratories for onsite regulatory
inspections. Information will be provided to help participants identify what the different regulators are looking for,
what they want in advance of their visit, and what to do with a surprise inspection. This course will also address how
onsite audits vary and what is similar between CDC, USDA/APHIS, DHS, DOD, DOT, FDA, AAALAC, FAA, NIH, DEA,
OSHA, NRC, EPA, and other regulatory agencies; steps to take in preparing the facility, documentation and personnel
as well as the management team, for the onsite audit. Participants will learn why OSHA regulation compliance and
training records are important; what you can and should control, and tips for training the visiting auditors if they
expect to enter hazardous chemical, biological, or radiation areas. Other topics covered include worker interviews and
stumbling blocks, training records and verification of training, individual training records for various work and
containment environments, what should the auditors present and what should the facility present; how to word the
follow-up report, presenting timelines for completion, and thoughtful challenges to the auditor's findings. Exercises
will be completed in a small group breakout, checklists used by the various regulatory agencies will be shared and
internal checklists for the facility created from templates to cover various types of facilities.
Objectives:
- Identify what agencies can and will inspect your entity
- Define the proper documentation and training necessary for an audit
- Identify the follow-up that is required and the level of detail that is necessary to respond to an audit
Suggested Background: Fundamentals of Biosafety
Target Audience: All Safety Professionals, Experienced Biosafety Professionals, Administrators of
Containment Facilities
Audience Level: Basic
1:00 - 5:00 pm
27. Molecular Biology 101
James Klenner, MS, RBP, CBSP, Indiana University—Purdue University Indianapolis, Indianapolis, IN
This course is intended for those professionals that participate in protocol review, facilities planning, and other risk
assessment activities but lack a basic understanding of molecular biology and techniques. Following this course,
attendees will be able to do more than regurgitate facts and use the new understanding of the principles of molecular
biology in various situations at their institution. This course will cover topics such as the chemistry of nucleic acids,
DNA replication, RNA transcription, and protein translation, the Central Dogma of Biology, DNA cloning, transfection
of prokaryotic and eukaryotic cells, restriction enzymes, and recombinant DNA lab methodologies (including PCR,
DNA fingerprinting, sequencing, and detection protocols). While this course will not turn you into a molecular
biologist, it will give you enough background information to understand the nature and manipulation of genetic
material and hopefully unveil the mystery of deoxyribonucleic acid.
Objectives:
- Explain the differences and chemistry of nucleic acids
- Define general molecular biology techniques
- Demonstrate an understanding of the principles of molecular biology used to develop recombinant DNA technology and to show how these technologies are used to study biological phenomena
Suggested Background: None
Target Audience: New Biosafety Professionals, All Safety Professionals
Audience Level: Basic