Preconference Courses Please visit our web site for course availability.

www.absaconference.org _____________________________________________________________________________________________________________________________________

Thursday, October 17, 2013 _____________________________________________________________________________________________________________________________________ 8:00 am - 5:00 pm 1. Working Safely and Ethically With Animals Robert Heckert, DVM, PhD, CBSP, Robert Heckert Consulting, Desert Hot Springs, CA Animals have been used in research for many years which has led to discoveries that have advanced human and animal health. Working with animals safely and ethically is challenging and potentially dangerous if workers are unprepared. In order to work safely, maintaining animals in a vivarium requires good procedures, safety equipment, and facilities. This course will cover the risks, risk mitigation techniques, safe working practices, and housing options. Using good biosafety practices whenever handling animals is important in order to provide a safe working environment. This can be done by screening incoming animals for potential infections, using careful work practices to prevent respiratory, percutaneous, oral and mucus membrane exposure to the pathogens; utilizing safety equipment (as needed), and using facilities that are correctly designed (contained rooms/animal cages, hand wash sinks, directional airflow, etc.). To complement these, institutions should provide training in the proper use of personal protective equipment, animal handling training, well written standard operation procedures, and a medical monitoring program. When working with large animals infected with highly dangerous pathogens, environmental protections become equally or more important and require further elaborate secondary containment features. This course will cover all the above aspects of working safely and ethically with animals. Objectives: Recognize the risks of working with animals Explain to mitigate the risks of working with animals Restate how to protect the environment from the escape of highly dangerous animal pathogens from the vivarium Identify a variety of housing options for biocontainment of infected animals Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles and Practices of Biosafety Target Audience: All Safety Professionals, Animal Caretakers, All Biosafety Professionals Audience Level: Intermediate 8:00 am - 5:00 pm 2. The Safe Transport of Infectious and Biological Substances Francine Rogers, MS, RBP, SM(NRCM), CBSP, University of Tennessee, Memphis, TN This course will provide an in-depth outline of the regulatory requirements for shipping biological and infectious materials, including related materials such as shipping with dry ice. Numerous hands-on exercises using compliant packaging will establish comfort and confidence working with the proper packaging. Each attendee will receive a 2013 reference manual with the most current regulations, both nationally and internationally. Objectives: Express the transport regulations and have the confidence to offer correctly prepared shipments Establish training programs at their own facilities based on a solid foundation and support system Paraphrase the current understanding of the recent past and potential future changes to the transport regulations Suggested Background: None Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, Laboratory Workers Audience Level: Basic 8:00 am - 5:00 pm 3. BSL-3 Operations and Management J. Paul Jennette, MS, PE, RBP, Cornell College of Veterinary Medicine, Ithaca, NY Domenica Zimmerman, University of Texas Medical Branch, Galveston, TX This course will review the important aspects of the daily operation of a BSL-3 facility from two points of view; management of the facility and daily operations. This assumes that you already have a facility built and have all required authorizations to work in it. The course will cover the different aspects you need to consider to operate a BSL-3 facility such as approval of a worker, training of workers and maintenance support, occupational health issues, managing waste, maintenance of the HVAC and physical facility, periodic checks on the facility’s systems, and emergencies of different types. It will also cover daily operations in a BSL-3 such as understanding when it is safe to

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enter and when you need to evacuate the facility, what to do when the ventilation fails, practical aspects of entry and exit procedures, practical tips on selection and use of PPE, safety considerations within the experimental SOPs, waste handling, facility’s cleaning, and how to have equipment repaired or serviced. This course will be conducted in a way that allows for interaction and exchange of experiences between participants and instructors. This course will not cover regulatory aspects from specific countries. Objectives: Describe elements of annual verification, emergency response, etc. Recognize institutional responsibilities from management to user Describe methods to develop manuals, SOPs, and training Suggested Background: Basic understanding of risk assessment and biosafety principles Target Audience: All Safety Professionals Audience Level: Basic 8:00 am - 5:00 pm 4. Managing Infection Risk Paul Huntly, PhD, Riskren, Singapore, Singapore Biorisk management is equally relevant to hospital acquired infections and other areas where the principal hazards are biological agents as it is in laboratories. A comprehensive framework has been developed for managing infection risk based upon a proactive risk assessment methodology. This course will describe the principles underlying this approach, specifically designed to cover all aspects of hospital infection control from a biorisk management perspective. Interactive exercises will be conducted to help attendees better understand proactive risk based tools and to assist in the mitigation of infection risk. Although this course is relevant to dedicated laboratory personnel, the topic is primarily geared towards how healthcare organizations manage infection risk in the wider context, using principles and practices which are rooted in laboratory biorisk management. Objectives: Restate the practices and principles on biorisk management as applied to infection control in a healthcare setting Describe the rationale for risk based thinking and standardization as applied to healthcare Paraphrase the 18 elements that describe a comprehensive managing infection risk program Summarize the practical experiences and views in relation to the challenges faced by healthcare workers in

managing infection risk Suggested Background: Fundamentals of Biosafety, Risk Assessment, Infection Control and Prevention, Quality

Management in Healthcare Target Audience: All Safety Professionals, Laboratory Workers, Healthcare and Infection Control

Professionals Audience Level: Intermediate _____________________________________________________________________________________________________________________________________

Friday, October 18, 2013 _____________________________________________________________________________________________________________________________________ 8:00 am - 5:00 pm 5. Threat Assessment Approaches for Laboratory 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 Patricia Delarosa, PhD, RBP, CBSP, Booz Allen Hamilton, Inc., McLean, VA With the recent inclusion of suitability and reliability measures to the Select Agent Program, laboratories are recognizing the need to take proactive measures in ensuring their facilities and staff operate in a secure manner. This course will educate laboratory staff on basic threat assessment concepts so they can build a program that identifies and addresses personnel vulnerabilities and effectively implements biosecurity procedures to protect facility and staff. Attendees will be provided with a basic tool-kit that will allow them to implement successful insider threat mitigation strategies using threat assessment approaches at their home institutions and to convey concepts in threat assessment to their colleagues. Through an analysis of relevant case studies, attendees will learn how to recognize specific personal security vulnerabilities and how to link these vulnerabilities to threats. Discussion will be held regarding the regulatory issues relevant to threat assessment and to the implementation of personnel management programs, specifically the changes to the Select Agent Regulations pertaining to Tier 1 agents. Theoretical concepts

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will be put into practice in a 3-hour 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 laboratory 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 legal/regulatory controls relevant to threat assessment and the implementation of

laboratory biosecurity programs Suggested Background: None Target Audience: All Safety Professionals, Laboratory Workers, Animal Caretakers Audience Level: Basic 8:00 am - 5:00 pm 6. Developing and Maintaining Roles & Responsibilities for Risk-Based Access to, Control of, and

Accountability for Biological Agents and Toxins Cecelia Williams, PhD, Sandia National Laboratories, Albuquerque, NM Linda Winona, PhD, Sandia National Laboratories, Albuquerque, NM This course will provide introductory information on developing and communicating policies and procedures related to laboratory access and material control, and accountability issues. The course will focus on management’s role in determining personnel accountability for biological material and how it is determined, implemented, transferred, communicated, and evaluated. Specific laboratory biosecurity issues, including physical access control systems, operational details of material control and accountability systems, personnel screening approaches, information security, and incident response will not be addressed. Objectives: Compare and contrast different groups of people who require laboratory access and the risks associated with

each Identify access opportunities to biological agents and assess the competence level and reliability of

countermeasures State how biorisk influences the access and accountability determinations Explain how access privileges are evaluated and the circumstances in which access would be revoked Develop a process for assigning, modifying, and transferring access and accountability for biological agents and

toxins Suggested Background: Fundamentals of Biosafety, Risk Assessment, Principles and Practices of Biosafety Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals Audience Level: Basic 8:00 am - 5:00 pm 7. Biorisk Assessment of Emergency Scenarios Paul Huntly, PhD, Riskren, Singapore, Singapore This course will present an overview of issues surrounding the principles required for effectively understanding and controlling risks associated with potential emergency scenarios in containment laboratories. Issues discussed will include when formal risk assessments should be conducted, simple risk assessment philosophies, and models. Interactive group exercises will discuss the practical challenges in relation to what are the real vs. perceived risks in such situations, together with what may constitute reasonable and proportionate mitigation measures. Information, examples, and scenarios will be drawn from experience of conducting risk assessments and audits in a wide range of facilities around the world. This course will inform and stimulate discussion and challenge attendees to question the realities of such situations, by considering risk holistically from a very practical perspective. Objectives: Recall some basic structures and philosophies of risk assessment as applied to emergency planning Develop an awareness of the range of emergency scenarios that may be encountered and how these can be

assessed, plans can be developed and tested Recognize the complexities of managing emergency situations and the requirements of basic planning and the

need to be able to reliably respond in a practical and logical manner Clarify experiences and views in relation to emergency situations and discuss different stakeholder risk

perceptions and how these can impact the ability to respond effectively

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Suggested Background: Fundamentals of Biosafety, Risk Assessment Target Audience: All Safety Professionals, Laboratory Workers, Animal Caretakers, Supervisors Audience Level: Intermediate 8:00 am - 5:00 pm 8. Laboratory Design Best Practices and Process Mark Fitzgerald, HDR, Inc., Atlanta, GA Jeff Owens, MPH, CSP, CBSP, SM(NRCM), HDR, Inc., Atlanta, GA Jennifer Gaudioso, PhD, Sandia National Laboratories, Albuquerque, NM Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM This course will offer an understanding of key principles underlying the design of research and diagnostics laboratories. Attendees will be introduced to laboratory design best practices as they relate to building zoning, operational efficiency, biosafety and biosecurity factors, supporting good lab protocols, and flexibility. Attendees will participate in guided discussions, develop diagrams to illustrate best practice concepts, and analyze existing plans with respect to the design principles under discussion. Attendees will work in small groups to produce conceptual diagrams and building plans for their facility and present their solutions to the class. Instructors will guide attendees through the process, providing critical feedback on the designs as they progress and offer brief presentations on some of the most pertinent design drivers. This course will increase student’s awareness of laboratory design issues and analytical processes, and provide examples of well-designed laboratory buildings and spaces. The course is intended for those who want to be able to lead or aid in the creation of safe and efficient laboratory designs, providing attendees with a methodology for developing, analyzing, and refining laboratory designs. Objectives: Describe the range of issues or “design drivers” that must be considered when undertaking a laboratory design Identify how good design practices work to enhance both biosafety and biosecurity Demonstrate how efficiency in laboratory layouts reduces labor, reduces energy and water consumption Demonstrate how laboratory designs should be developed in conjunction with the protocols followed when

personnel, materials, or animals move from one space to another Suggested Background: Fundamentals of Biosafety, Principles and Practices of Biosafety Target Audience: All Safety Professionals, Laboratory Workers, Architects, Project Managers, Facility

Engineers Audience Level: Intermediate 8:00 am - 5:00 pm 9. Advanced Risk Assessment Patrick Condreay, PhD, GlaxoSmithKline, Research Triangle Park, NC Anne-Sophie Brocard, RBP, University of Texas Medical Branch, Galveston, TX Elizabeth Weirich, MS, CBSP, SM(NRCM), Center for Disease Control and Prevention, Atlanta, GA In this new, advanced, and interactive course, attendees will follow a single research project as it evolves over time from basic to multifaceted in vitro and in vivo scenarios based upon actual research protocol submissions. Attendees will work together to conduct risk assessments that build upon each other from the discovery of a novel virus to determining the efficacy of experimental vaccines in humans. Multiple systems used in the research progress from cell culture to small animal models using recombinant viral vectors, to macaques, and finally clinical trials. Risk assessments will focus on the likelihood of exposure and the severity of consequences from exposure to the multitude of hazards encountered in the increasingly complex research. Course attendees should have a thorough understanding of rDNA work and the linkage between biosafety, risk assessment and risk mitigation. Objectives: Analyze complex scenarios by identifying hazards associated with component parts of the plan Prioritize risks based on the likelihood and consequences of occurrence Assess the overall risk and determine mitigation strategies to minimize the risk Evaluate mitigation strategies for effectiveness, adjust strategies as warranted Suggested Background: Fundamentals of Biosafety, Risk Assessment, Micro/Molecular Biology 101, Principles and

Practices of Biosafety Target Audience: Experienced Biosafety Professionals, Laboratory Workers Audience Level: Advanced

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8:00 am - 12:00 pm 10. Preparing for, Conducting and Responding to Regulatory Agency Inspections/Audits Barbara Fox Nellis, RBP, CBSP, SM(NRCM), Barb Nellis Consulting, Crossville, TN This course will prepare biosafety professionals, the entity, and laboratories for onsite regulatory inspections. Information will be provided to help participants understand what the different regulators are looking for and what they want in advance of their visit, what to do with a surprise inspection, how onsite audits vary and what is similar between CDC, USDA/APHIS, DOD, DOT, FDA, FAA, NIH, DEA, OSHA, NRC, EPA, and other regulatory agencies, steps to take in preparing the facility, documentation, personnel, and management team for the onsite audit. Attendees will learn why OSHA regulation compliance and training records are important, how to conduct oneself during an audit, what you can and should control, and tips for training the visiting auditors if they expect to enter hazardous chemical, biological, or radiation areas. Additional information will include worker interviews and stumbling blocks, training records and verification of training, individual training records for various work and containment environments. This course will provide information on what auditors should present and what should the site present, how to word the follow-up report including presenting time-lines for completion and thoughtful challenges to the auditor's finding. Exercises will be completed in small group break-out, 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 Identify the follow-up that is required and the level of detail that is necessary Suggested Background: Fundamentals of Biosafety Target Audience: All Safety Professionals, Experienced Biosafety Professionals, Facility Managers Audience Level: Intermediate 1:00 pm - 5:00 pm 11. NIH OBA and Select Agent Incident Reporting: A Practical Guide Bruce Whitney, PhD, Texas A&M University System, College Station, TX This course is designed to assist Responsible Officials, biological safety officers, administrators, and management in the process of reporting incidents under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) and the Select Agent Regulations. This course will review the regulatory requirements and process for reporting, offer practical guidance for incident investigation (including root cause analysis), and writing both immediate and follow-up incident reports. The course will be highly interactive and end with real-world, scenario-based exercises. Attendees are encouraged to bring their own scenarios for discussion and practice. Objectives: Explain federal reporting requirements and process Identify incidents that require reporting and those that do not Apply root cause analysis in the incident investigation process Write immediate and follow-up incident reports for submission to federal regulators Suggested Background: None Target Audience: All Biosafety Professionals, IBC Chairs/Administrators/Management Audience Level: Intermediate _____________________________________________________________________________________________________________________________________

Saturday, October 19, 2013 _____________________________________________________________________________________________________________________________________ 8:00 am - 5:00 pm 12. Biosafety Management Techniques for Improving Organizational Program Understanding and Support Robert Emery, DrPH, RBP, CBSP, University of Texas Health and Science Center at Houston, Houston, TX Rachel Gamble, CBSP, University of Texas Health and Science Center at Houston, Houston, TX A recurrent challenge for biosafety professionals is the ability to garner necessary program resources. This difficulty lies in the fact that on a good day in the world of biosafety, nothing happens. Upper management may not fully appreciate or understand all of the effort that goes into making nothing happen. Biosafety professionals in particular experience difficulty in this regard because many in the profession have received intensive training in the biological sciences, but little or no training in the area of program management. This course will focus on key management

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techniques that can be used within biosafety programs to help improve stakeholder understanding of the program and its activities. Real-world examples of successful applications will be discussed. Objectives: Identify various biosafety programmatic measures and metrics that can be easily captured and communicated Define the techniques that can be used for displaying biosafety data in ways that others can readily understand

and appreciate Describe how biosafety programs can assist with other basic safety program needs to help avoid the notion of

program duplication of efforts and to improve safety and client satisfaction levels Employ various commonly used sales methods to improve the visibly and support for their biosafety programs Suggested Background: None Target Audience: All Safety Professionals, New Biosafety Professionals, Experienced Biosafety Professionals Audience Level: Intermediate 8:00 am - 5:00 pm 13. Advance BSL-3 Facility Operations Miguel A. Grimaldo, M. Eng, University of Texas Medical Branch, Galveston, TX J. Paul Jennette, MS, PE, RBP, Cornell College of Veterinary Medicine, Ithaca, NY This course is a follow up to the BSL-3 Facility Operations and Management course. This advanced course will focus on detailed aspects of biocontainment operations of BSL-3, ABSL-3 and enhanced BSL-3 laboratories. It will cover risk assessments for biocontainment equipment; facility operations and maintenance SOPs; maintenance personnel training requirements; solid and liquid waste decontamination equipment; procedures, validations and cycle developments; area decontamination methodologies; procedures and validations; filtration systems and their validation and testing processes; ventilation control methodologies and ventilation equipment configurations; facility testing during normal and failure conditions of the ventilation system; test documentation; and record keeping. Objectives: Explain the facility verification process in detail, including recommended test methodologies Restate the training requirements for facility personnel accessing the biocontainment areas Identify methodologies for decontamination of areas, equipment, filters and waste Describe elements of biocontainment equipment risk assessments Suggested Background: Principles and Practices of Biosafety, BSL-3 Operations and Management Target Audience: All Safety Professionals, Experienced Biosafety Professionals Audience Level: Intermediate 8:00 am - 5:00 pm 14. Engineering for the Biosafety Professional—Part I Juan Osorio, IE, World BioHazTec Corporation, Rockville, MD Theodore Traum, PE, World BioHazTec Corporation, Rockville, MD Brynte Johnson, MS, RBP, CBSP, SM(NRCM), World BioHazTec Corporation, Rockville, MD Diego Osorio, CE, World BioHazTec Corporation, Rockville, MD Proactive biosafety professionals need to be involved and knowledgeable in the operation, maintenance, and certification of containment facilities and building systems. The biosafety professional may be called upon to participate in the planning, design, and validation of a new biocontainment laboratory or renovation of an existing facility. This course will equip attendees with the basic knowledge to understand the process for planning, design, construction, maintenance, and operation of a high-containment laboratory. For the biosafety professional to participate in these activities, it’s important to understand engineering fundamentals, develop skills to ask questions in engineering terms, and have the confidence to question the answers. This introductory course will provide information relevant to BSL-3 facilities to determine air change rates, define HVAC containment boundaries, interpret design drawings, understand HEPA filtration, provide an introduction in determining room heat loads and ventilation rates, directional airflow concepts and room pressure differentials, as well as an introduction to HVAC components (i.e., isolation valves, control valves, fast acting actuators etc.). Building on this information, there will be a step-by-step presentation on planning, design, construction oversight, commissioning, certification/validation/ANSI Z9.14 standard, maintenance, and operation. Attendees will gain a better understanding of engineering issues in the planning, design, construction, commissioning, certification/validation, and post occupancy of biocontainment facilities, be able to formulate informed questions, be able to interact with maintenance personnel and integrate facility operations with the biosafety program. Objectives:

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Recognize engineering issues in the planning, design, construction, commissioning, certification/validation and post occupancy of biocontainment facilities

Name the components of an HVAC system Analyze a laboratory layout to establish its HVAC boundaries Explain HEPA filters operation, decontamination, and testing Calculate Air Change Rates (ACR) and measure with architectural scales Interact with maintenance personnel and integrate facility operations with the biosafety program Suggested Background: None Target Audience: All Safety Professionals, Experienced Biosafety Professionals, New Biosafety Professionals Audience Level: Basic 8:00 am - 5:00 pm 15. Surviving Biosafety Sean Kaufman, MPH, CHES, CPH, CIC, Emory University, Atlanta, GA Long hours, short deadlines, lack of control, and limited resources are challenges most biosafety officers face today. Unfortunately, if these challenges are not adequately managed, biosafety officers may face burn-out, become depressed, and even begin experiencing issues within their personal lives. This course will provide those serving the biosafety profession with perspectives, resources, and skill-building exercises aimed at mitigating occupational effects of the biosafety profession. Objectives: List the 4 primary controls of biosafety Discuss the process of risk mitigation Assess risk perceptions of laboratory staff Facilitate innovative training sessions Utilize MBTI personality classification instruments Discuss risks associated with serving the biosafety profession Suggested Background: None Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, Audience Level: Intermediate 8:00 am - 5:00 pm 16. Think Before You Act! A Realistic Approach to Sustainable Lab Practices Debra Sharpe, MPH, CCHO, RBP, The WorkingBuildings Companies, Atlanta, GA Paul Huntly, PhD, Riskren, Singapore, Singapore Trevor Powers, PE, CCP, CEM, LEED AP, The WorkingBuildings Companies, Atlanta, GA Tiffini Lovelace, AIA, NCARB, The WorkingBuildings Companies, Atlanta, GA Operating a biomedical laboratory is a tremendous challenge that must balance risk, scientific technique, budget, and safety while adhering to the many aspects of regulatory compliance. Laboratories may be tasked with processes that are regulated by a multitude of agencies. These parameters add to the complexity of decisions required to attain safe and efficient operations that lead to reliable scientific results. Considering that most biomedical laboratories can consume more than 5 times the energy of a standard commercial office building, sustainable environments and operations within these settings become more complex to implement without compromising safety and testing accuracy. The use of sustainable guidelines and rating systems such as those provided by USGBC’s LEED, BREEAM, ASHRAE, and LABS21 have allowed for tremendous progress toward educating the public on sustainability and creating an avenue to implement sustainable practices. When discussing laboratory operations, much more consideration must be given to risk assessments and operational parameters that are not addressed in many of the sustainability guidelines and rating systems. This course will focus on aspects for a realistic approach to using sustainable practices in a biomedical laboratory design and operations. The course instructors will discuss sustainable technologies with the pros and cons of each, using risk assessment as a tool when pursuing appropriate sustainable technologies, and how laboratory building operations impact sustainability goals. Objectives: Review the sustainable technologies and design techniques appropriate for use in laboratory buildings Discuss risk assessment and how it can be a tool for determining which sustainable technologies are appropriate

for your lab Cite real world information regarding sustainable laboratory building operations Suggested Background: Fundamentals of Biosafety, Risk Assessment, Biosafety Level 3-Design and Operations

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Target Audience: All Safety Professionals, Operations and Management Personnel, anyone involved in facility design

Audience Level: Intermediate 8:00 am - 12:00 pm 17. Fundamentals of Microbiology and Infectious Disease James Klenner, MSc, MPH, MPA, 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 is not; or why influenza is an inhalation hazard; or why public health officials advocate flu shots each year, then this course is for you. Objectives: Defining 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, Laboratory Workers Audience Level: Basic 8:00 am - 12:00 pm 18. Concepts of Virology Patrick Condreay, PhD, GlaxoSmithKline, Research Triangle Park, NC This course will briefly review gene expression in eukaryotes then go on to examine several concepts of virology. Characteristics of different viral families will be presented as well as general replication strategies employed by different viruses. Mechanisms of viral pathogenesis and strategies for anti-viral intervention will also be explored. Attendees should have a familiarity with molecular biology. The course is targeted for the biosafety professional who does not actively conduct laboratory research, yet wishes to acquire a basic knowledge of virology. Objectives: Define the nature of viruses Clarify how viruses are classified into families Recognize strategies employed by viruses to multiply in a host Discuss concepts underlying viral pathogenesis Describe methods used to interfere with viral infection and replication Suggested Background: Micro/Molecular Biology 101 Target Audience: Laboratory Workers, Experienced Biosafety Professionals Audience Level: Intermediate/Advanced 8:00 am - 12:00 pm 19. Implementing Personnel Security Programs in Biomedical and Microbiological Laboratories Ben Perman, PhD, RBP, Booz Allen Hamilton, Inc., Washington, DC Lindsay Odell, PhD, Booz Allen Hamilton, Inc., McLean, VA With the growing focus on Dual Use Research of Concern and recent inclusion of suitability and reliability measures to the Select Agent Program, laboratories are recognizing the need to take proactive measures in ensuring their facilities and staff operate in a secure manner. The purpose of this course is to educate laboratory staff of basic threat assessment concepts so they can identify vulnerabilities and effectively implement biosecurity procedures among their facility and staff. This course will provide attendees with a basic tool-kit that will allow them to implement successful comprehensive insider threat mitigation strategies using personnel security approaches at their home institutions and to convey concepts in personnel security to their colleagues. Through an analysis of case studies, attendees will learn how to identify threats, link threats to vulnerabilities and, most importantly, address specific personnel security vulnerabilities. Attendees will learn about all aspects of personnel security including: suitability, reliability, training, peer and self reporting strategies, threat assessment, operation security, information security, and an introduction to elicitation, manipulation, and surveillance awareness. Regulatory issues relevant to implementation of personnel security management programs, in particular biosecurity changes to the Select Agent

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Regulations pertaining to Tier 1 agents, will be discussed. Theoretical concepts will be put into practice in a conceptual personnel security program developed through direct attendee input using a realistic laboratory security problem that draws on the material presented in the lecture and case studies. Objectives: Restate the types of threats posed to biomedical research, public health, and clinical diagnostic facilities and

institutions and describe some of the tools that can be used to assess these threats Summarize the main components of laboratory security programs, describe how each mitigates the threats above,

and describe the unique role that personnel security programs play in insider threat mitigation Explain the purpose, requirements, and major components of personnel security programs Identify resources and legal/regulatory controls relevant to personnel security programs and the implementation

of successful insider threat mitigation techniques Suggested Background: None Target Audience: All Safety Professionals, Laboratory Workers, Animal Caretakers, Responsible Officials,

Biosecurity Managers Audience Level: Basic 1:00 pm - 5:00 pm 20. Molecular Biology 101 James Klenner, MSc, MPH, MPA, 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: Summarize the central dogma of molecular biology 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, Laboratory Workers, All Safety Professionals Audience Level: Basic 1:00 pm - 5:00 pm 21. Virus-based Gene Transfer Vectors Patrick Condreay, PhD, GlaxoSmithKline, Research Triangle Park, NC This intermediate course will examine the molecules, processes, and techniques involved in recombinant gene expression. We will explore the technology of how viruses are converted into vector systems for the transfer of gene expression constructs. Common viral vector systems, including retroviruses, lentiviruses, adenoviruses, poxviruses, herpesviruses, alphaviruses, and baculoviruses will be discussed with an emphasis on the biosafety characteristics of the vectors derived from these viruses. The course is targeted for the biosafety professional who is not actively conducting laboratory research, yet requires a basic understanding of recombinant DNA methodology. Objectives: Describe processes of recombinant gene expression Discuss concepts of viral vector technology and biosafety features Recognize characteristics of vector systems unique to specific viruses Apply knowledge of recombinant gene expression and viral vector principles to risk assessments Suggested Background: Micro/Molecular Biology 101 Target Audience: All Safety Professionals, Laboratory Workers Audience Level: Intermediate

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1:00 pm - 5:00 pm 22. Bioterrorism Awareness for the Animal Health Community John Page, MS, Federal Bureau of Investigation, Washington, DC Ben Perman, PhD, RBP, Booz Allen Hamilton, Inc., Washington, DC Animal health is a key aspect of biosecurity. Animals can serve as vectors and reservoirs of zoonotic and human disease and direct impact on animal populations can threaten the contribution to domestic economy from the agriculture sector. This course will provide awareness to the animal health communities (agriculture, veterinary, vivarium staff) in potential bioterrorism events and increase cooperation among the law enforcement agencies in the mitigation of these events. Objectives: Identify potential foreign animal disease introduction avenues to private/commercial farms, other agriculture

industry-related sites, and veterinary schools Describe indicators of a potential bioterror event and discuss animal biological agents, vulnerabilities of the

agricultural, veterinary industry, vivarium, and unique methods of attack that a bioterrorist may use in targeting livestock

Identify regional institutional characteristics of animal health community bioterror events and bioterrorism criminal investigations

Restate the biosecurity roles and responsibilities of research institutions, biosecurity of the animal biological agents (select agents), and the people in contact with them

Explain the benefits and potential obstacles to improve cooperation among law enforcement agencies and animal public health research institutions regarding biosecurity

Suggested Background: None Target Audience: Animal Caretakers, Laboratory Workers, Experienced Biosafety Professionals Audience Level: Basic _____________________________________________________________________________________________________________________________________

Sunday, October 20, 2013 _____________________________________________________________________________________________________________________________________ 8:00 am - 5:00 pm 23. How to Develop an Export Management and Compliance Program Including the I-129 for Deemed

Exports Deborah Howard, CBSP, University of North Carolina at Chapel Hill, Chapel Hill, NC The I-129 for Deemed Exports and the H1B Visa—How are you handling the certification regarding the release of controlled technology or technical data to foreign person in the United States? Learn about the fundamental research exclusion and the impact deemed exports have on your organization. If you answer yes to the following questions, this course is for you! Do you have foreign nationals in the workplace? Ship biological materials (or genetic elements) out of the U.S.? Export select agents (or their genetic material)? Ship items that cost more than $2,500 out of the U.S.? Is your software controlled? Do you have controlled “development” technical research? Learn to understand the six terms of use as it relates to foreign nationals in the workplace. This course is intended for professionals who manage the shipping/exporting program including deemed exports at their university. There is more to shipping than classification, labeling, and marking; there are licensing, under-invoicing, and ITN numbers from the U.S. Census Bureau to consider when shipping anywhere outside the U.S. including Puerto Rico. Join us to learn about the SNAP-R program, visual compliance and how the International Traffic and Arms (ITAR) Regulations fit into exporting. Troublesome clauses in contracts will also be covered. The course will discuss which pathogens and lab equipment require a license when exporting, how to obtain a license, Census Bureau requirements, recordkeeping, and much more. Objectives: Describe the exporting agencies and what items/technology they regulate Recommend strategies for implementing an export management plan Discuss the I-129 Deemed Export Attestation and how it affects your organization Recognize situations where export controls will apply Suggested Background: None Target Audience: All Safety Professionals, Experienced Biosafety Professionals, New Biosafety Professionals Audience Level: Intermediate

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8:00 am - 5:00 pm 24. Engineering for the Biosafety Professional—Part II Juan Osorio, IE, World BioHazTec Corporation, Rockville, MD Theodore Traum, PE, World BioHazTec Corporation, Rockville, MD Brynte Johnson, MS, RBP, CBSP, SM(NRCM), World BioHazTec Corporation, Rockville, MD Diego Osorio, CE, World BioHazTec Corporation, Rockville, MD In follow-up to Engineering for the Biosafety Professional—Part I, this course demonstrates biocontainment engineering principles and their application to the proper operation and sustainability of a biocontainment laboratory. Concepts such as understanding various types of traditional HVAC design and emerging green design, comprehension of the purpose and information available from a building automation system, troubleshooting airflow reversals, understanding HVAC schematics, identifying redundancy needs, determining methodology for HVAC decontamination, deconstruction, and decommissioning. These basic concepts assist the biosafety professional in interacting with facility personnel and designers for new construction, renovations, and ceasing of BSL-3 facility operations. The objective of this course is to explain these engineering concepts using basic, real-life examples and how they apply to biocontainment laboratories. More advanced engineering fundamentals will be discussed including HVAC sequence of operations, ventilation risk assessment, developing failure scenarios, and integration of energy conservation into the laboratory. Group exercises will be conducted for practical application of principles presented. Building on Engineering for the Biosafety Professional Part I, this course will not be driven by theory but will integrate examples that show cause and effect in real-life scenarios. Objectives: Interpret HVAC schematics Identify the basics of HVAC control systems Restate the decommissioning and deconstruction process Explain decontamination at the room level and HVAC system level Summarize the methodology for troubleshooting HVAC systems Analyze test data and develop a risk assessment for an airflow reversal Suggested Background: Engineering for the Biosafety Professional—Part I or Engineering for the Biosafety

Professional (2012) Target Audience: New Biosafety Professionals, Experienced Biosafety Professionals, All Safety Professionals Audience Level: Intermediate 8:00 am - 5:00 pm 25. Advanced Principles and Practices of Working in an ABSL-3 Belinda Rivera, BS, University of Texas Medical Branch, Galveston, TX This course will introduce information to individuals that are currently working, plan on working, or audit ABSL-3 facilities. Working in an ABSL-3 facility has unique hazards. Personnel working in these facilities need to be informed of these hazards and trained to work safely and appropriately with the species being handled. Topics will include personal protective equipment, animal handling procedures, husbandry procedures, caging options, waste management, and emergency response procedures. Institutions with ABSL-3 facilities need to involve safety personnel, animal care staff, and researchers to ensure proper work procedures and safety protocols are in place and followed to maintain a safe and productive work environment. Objectives: Identify proper PPE and disinfection practices Restate the techniques used to manipulate animals safely Explain the processes on waste management Summarize the knowledge gained regarding emergency and exposure response Suggested Background: None Target Audience: New Biosafety Professionals, All Safety Professionals, Animal Caretakers Audience Level: Advanced 8:00 am - 5:00 pm 26. Designing Training Programs for a Biosafety Environment Lora Grainger, PhD, Sandia National Laboratories, Albuquerque, NM Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM This course will provide attendees the theoretical basis for tailoring a training program for their respective institutions. The focus will be on overcoming the unique challenges involved with teaching adults including an

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introduction to the theory and psychology behind effective training for adult learners. The course will cover strategies for working with different levels of pre-existing knowledge and educational levels. Different training methods will be utilized and discussed while addressing learning preferences (visual, auditory, and kinesthetic) with the purpose of understanding each method. Discussions will be held regarding methods suitable for large or small groups, learning retention, and the overall usability for the biosafety and biosecurity field. The instructors will emphasize how a mix of theoretical case studies, incidents, accidents, and other experiences provide a basis for an ongoing, engaging, and interesting training program. The course consists of a mixture of theoretical lessons and facilitated adult learning using group discussions and presentations giving insight into the psychological background for how training can either be a success or a failure. Objectives: Express an understanding of why we train, training topic drivers, and development of clear training objectives Summarize the ADDIE training design cycle, the Jensen Model for Brain-Based Teaching, and the Principals of

Learning Restate different learning styles including Kolb’s Cycle and Bloom’s Taxonomy of Cognitive Domains Differentiate between training, teaching, coaching, and facilitating Distinguish the pros and cons for different teaching styles and the costs and resources needed for different types

of training programs Determine the suitability of different training methods for different types of staff/employees depending on skills,

education, personality type, and learning preference Suggested Background: None Target Audience: All Safety Professionals, New Biosafety Professionals Audience Level: Basic 8:00 am - 5:00 pm 27. Implementation of Programs and Procedures for an Effective Biosurety Program for BSL-3 Laboratories Jessica McCormick-Ell, PhD, RBP, University of Medicine and Dentistry of New Jersey, Newark, NJ Brendan McCluskey, MPA, JD, University of Medicine and Dentistry of New Jersey, Newark, NJ Marta Figueroa, PhD, CIH, University of Medicine and Dentistry of New Jersey, Newark, NJ A strong biosurety program encompassing physical security, biosafety, agent accountability, and personnel reliability is essential to running a successful, safe, and secure biosafety level three facility. Laboratory support and biosafety staff must be knowledgeable on and implement physical security measures; be 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 stocks, equipment, and other materials. Ensuring the BSL-3 laboratory staff is capable of dealing with the pressures of working in containment space, and maintaining a level of trust to be able to work in these environments is particularly problematic. The cycle of risk management, policy development, training, and exercises is key to the implementation of these components. Biosurety programs are complex, involving many parties within an institution and must prevent events, where possible, reduce the amount of harm should an incident occur, decrease the total number of and consequences of potential hazards, address any vulnerabilities present, and prepare staff to handle incidents that may occur in the facility. This course will build on the foundation of developing a biosurety program, provide suggestions, and provide opportunities to discuss implementation of physical security systems and policies, mechanisms for agent accountability and personnel reliability programs for biosafety level three laboratories. Objectives: Design effective policies, plans, and procedures in regards to physical security, agent accountability, and

personnel reliability programs in order to be compliant with the current CDC/USDA Select Agent Regulations Evaluate programs and plans through effective exercises Explain how to implement effective training programs to ensure understanding and competence for those

working with select agents at BSL-3 Suggested Background: None Target Audience: New Biosafety Professionals, All Safety Professionals Audience Level: Basic 8:00 am - 12:00 pm 28. Biosafety with RNA Interference (RNAi): MicroRNAs with Microbes & siRNA Therapeutics Thomas Cremer, PhD, University of Louisville, Louisville, KY RNA interference is a field of study within molecular biology that has only been known since the mid-1990s. Since then it has expanded into numerous areas of biomedical research with major advances in the mid- to late-2000s.

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While the research has rapidly advanced, little is reported about the biosafety implications associated with this work; there is a lack of guidance on how to approach risk assessments. This course will cover microRNAs and small interfering RNAs (siRNAs). MicroRNAs have been shown to be important for immunity and for viral fitness. Particular emphasis will be on the risk assessment of manipulating microRNAs in viruses by cases studies of recent published reports. siRNAs have been used in basic research, though are being advanced into clinical trials as novel antimicrobials. The course will provide a fundamental understanding of RNAi and highlight tools that can be used to facilitate risk assessment of work done in this field. Objectives: Explain emerging topics of molecular biology within the biosafety community Develop a working knowledge of the fundamental concepts in the emerging field of RNA interference (RNAi) Recognize biosafety concerns for work with RNAi in microbes Identify tools and resources for facilitating risk assessment of RNAi biosafety concerns Describe novel therapeutics based on RNAi technology Suggested Background: Risk Assessment, Micro/Molecular Biology 101 Target Audience: Experienced Biosafety Professionals, New Biosafety Professionals, Laboratory Workers Audience Level: Intermediate 8:00 am - 12:00 pm 29. Biocontainment Myths Explored Jack Keene, RBP, CBSP, DrPH, Global Biohazard Technologies, Inc., Midlothian, VA Ronald Trower, RBP, Global Biohazard Technologies, Inc., Midlothian, VA There are many misconceptions or myths being circulated regarding the requirements for biocontainment laboratory operation, maintenance, and personal protective equipment (PPE). This course is designed to assist biosafety officers and management personnel to identify those requirements that are appropriate and those that are unnecessary and costly. Operation of biocontainment laboratories can and should be simplified to reduce costs and to provide the best possible working conditions for those that use these facilities. Objectives: Identify what mechanical features are absolutely necessary and which are of questionable utility in

biocontainment facilities Select appropriate PPE for use in the BSL-3 laboratory and to eliminate the use of unnecessary and cumbersome

PPE Evaluate the cost versus benefits to some commonly recommended biocontainment practices and equipment Suggested Background: Risk Assessment, Biosafety Level 3-Design and Operations Target Audience: Experienced Biosafety Professionals, New Biosafety Professionals, Laboratory Workers Audience Level: Intermediate 8:00 am - 12:00 pm 30. Biowaste Management for Biocontainment Facilities Joe Wilson, Bio-Response Solutions, Inc., Pittsboro, IN Rich Apolinar, Astell, Inc., Harrisburg, NC This course will address common issues of system requirements that do not consider the impact of improperly specified autoclaves, autoclave installation, or the amounts of effluents emanating from autoclaves and other sources in the facility. Effluent Decontamination Systems (EDS) equipment is almost always specified as high temperature batch technology when a number of lower cost or more efficient systems could be specified; technologies that use dramatically less energy (sometimes over 50 times less). All of the EDS options will be described along with capital and operational costs. Tissue digester (TD) equipment is also commonly specified for biocontainment facilities in questionable technological formats, expensive configurations, or challenging interfaces. Proven options of TD equipment design, features, and interface options will be discussed along with cost impacts on capital acquisition and operation. The interrelationships between these biowaste systems and the facility will be discussed in detail. Objectives: Articulate the different types of EDS options, pros and cons, relative capital costs, and costs of operation and

maintenance Describe the different types of TD technology and articulate the configuration options for biocontainment facility

operations Summarize TD interface options with the barrier, and operational and maintenance issues each type of interface

poses Restate the proper autoclave technology and features for biocontainment facilities

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Explain the interface of autoclave technology with the facility; plumbing of the effluents properly to minimize the impacts of cost and other issues on the facility

Describe problems caused by improper autoclave, EDS, and TD implementation of facilities by examples Suggested Background: None Target Audience: Architects, Engineers, Biosafety Officers, Consultants and others involved in

biocontainment facility design and/or specification of equipment for the facility Audience Level: Intermediate 1:00 pm - 5:00 pm 31. Overview of the Certification Review/Advanced Biosafety Training Series Marian Downing, RBP, CBSP, Alliance Biosciences, Kemah, TX Chris Thompson, RBP, CBSP, Alliance Biosciences, Greenfield, IN This is an overview of the ABSA Certification Review Course which has been divided into seven online on-demand modules. Each module corresponds with the domains addressed in the National Registry of Certified Microbiologists Specialist Microbiologist in Biological Safety SM(NRCM) exam. This series of modules, Advanced Biosafety Training Series, is an intermediate to advanced online offering, designed for those studying for the SM(NRCM) exam, as well as those biological safety professionals who are interested in advanced training. This course will provide an overview of the SM(NRCM) exam domains included in each of the modules. Participants will gain insight into the exam logistics (qualifications, how to apply, exam administration) and structure. Exam prep strategies, test taking tips, reference lists, and other useful study aides for preparing for the exam will be provided. Participants will take part in a readiness assessment for the exam and be able to participate in a Q&A session with the instructors. Participants will be polled ahead of time for any questions regarding the exam and answers will be discussed during the course. ABSA credentialing programs, Certified Biological Safety Professional (CBSP) and Registered Biosafety Professional (RBP), eligibility, administration, and application for each and how it relates to the SM(NRCM) exam will also be discussed. Objectives: Explain the eligibility, application requirements, and deadlines for the NRCM exam List the domains tested on the SM(NRCM) exam Recognize key study aides useful for SM(NRCM) exam preparation Describe the content of the online Advanced Biosafety Training Series Modules Restate the eligibility and application requirements for the CBSP and RBP credentials Suggested Background: A working knowledge of basic biosafety Target Audience: Anyone considering or preparing for the SM(NRCM) exam Audience Level: Intermediate