October 13-18, 2017

October 13-18, 2017

Albuquerque, New Mexico

Albuquerque, New Mexico

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2015 Preconference Course Agenda 2016-12-11T23:13:40+00:00
[icon icon=”0273.png”]Presenter Bios available where indicated.[/icon]

Friday, October 9, 2015

8am-5pm: 1. Building a Select Agent Program: Safety, Compliance, and Efficiency
Amy Vogler, PhD, RBP, Northern Arizona University, Flagstaff, AZ; Shelley Jones, MS, RBP, Northern Arizona University, Flagstaff, AZ
A successful Select Agent Program depends on ensuring personnel safety and maintaining regulatory compliance in an efficient manner. In the absence of efficiency, research can be unnecessarily hindered and regulatory compliance may become overly burdensome, which could lead to lapses that affect the success or failure of an entity’s Select Agent Program. This course will explore strategies for implementing a successful Select Agent and/or Tier 1 Select Agent Program based upon the instructors’ experience with their institution’s Select Agent (including Tier 1) BSL-3 Program. Topics will include identifying site-specific needs; developing and reviewing plans and SOPs; promoting a safety and compliance culture; organizing and tracking inventory; training methods and recordkeeping; providing effective oversight; and preparing for, facilitating, and responding to inspections. Strategies presented will focus on organization, resource management, flexibility, and efficiency. This course will consist of presentations, group discussions, and exercises to assist participants in applying the strategies to the needs of their entities.

Objectives:

  • Evaluate site-specific needs and expectations
  • Design and implement effective and efficient policies, plans, and procedures compliant with the current CDC/USDA Select Agent Regulations
  • Identify strategies for streamlining and integrating required documentation
  • Describe inventory management techniques to ensure current and accurate inventory records

Suggested Background: None
Target Audience: Safety Professionals dealing with Select Agent Programs
Audience Level: Basic

8am-5pm: 2. The Essentials of Health and Safety at the Boundaries of Biosafety
Robert Emery, DrPH, RBP, CBSP, University of Texas Health Science Center—Houston, Houston, TX; Bruce Brown, DrPH, CBSP, University of Texas Southwestern Medical Center, Dallas, TX; Rachel Gamble, DrPH, CBSP, University of Texas Health Science Center—Houston, Houston, TX; Scott Patlovich, DrPH, CBSP, University of Texas Health Science Center—Houston, Houston, TX
In actual practice, there is virtually no work setting where occupational risks are limited solely to biological agents. Fire safety, occupational safety, and chemical safety risks are ubiquitous in laboratory and production settings, and sources of radiation can be regularly encountered. Issues regarding insurance coverage and policy limitations can also arise. Given this diversity of possible risks, it is prudent for biosafety professionals to familiarize themselves with the essential aspects of these other specialty areas of loss control. This course is designed specifically to provide a baseline orientation to a series of parallel health and safety professions with which a biosafety professional commonly interacts. Each section begins with a discussion of the relative public health impact of a specialty area and ends with a description of the simple things a biosafety professional can do to assist in keeping the overall organization safe and compliant.

Objectives:

  • Describe the 5 recognized steps of risk management process and why this is important for the biosafety profession
  • Identify the basic elements of a fire and life system program, a chemical safety program, radiation safety program, and a comprehensive hazardous waste management program that can be easily accessed by a biosafety professional
  • Summarize the risk represented by insider threats

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate

8am-5pm: 3. Basic Risk Assessment
Patrick Condreay, PhD, Biosafety Consultant Services, Carrboro, NC; Anne-Sophie Brocard, PhD, RBP, CBSP, University of Texas Medical Branch—Galveston, Galveston, TX; Betsy weirich, MS, CBSP, SM(NRCM)[icon icon=”0273.png”][/icon], Centers for Disease Control and Prevention, Atlanta, GA
Rapid scientific and technological advances continue to challenge the biosafety community in determining and establishing the appropriate practices and containment necessary to avoid exposure to the wide array of hazardous biological agents and materials found in the laboratory. This introductory course will provide an opportunity to incorporate the basic knowledge and skills necessary in order to perform risk assessments for working safely with pathogens (human and animal) and rDNA (genetically modified organisms or viral vectors). Using case studies, participants will work together to conduct risk assessments by determining the hazards involved; the appropriate questions to ask to address the potential risks associated with the intended activities; and make recommendations on appropriate containment and practices required to work safely. The conclusions of the groups will be presented.

Objectives:

  • Identify and list determinants for assessing risk (host, environment, agent)
  • Complete the steps of a risk assessment
  • Determine steps to manage risk (mitigation)
  • Identify resources and references for risk assessment/management

Suggested Background: Fundamentals of Biosafety
Target Audience: New Biosafety Professionals, Laboratory Workers
Audience Level: Basic

8am-5pm: 4. Shipping Infectious Substances Certification Course
Eric Cook, MPH, CBSP, Sandia National Laboratories, Albuquerque, NM
This course is appropriate for those who have some experience with infectious substance handling or shipping, but may not have been certified within the past 3 years. The course utilizes group discussions and interactive exercises focused on the essential areas of infectious substance shipping. Participants will have the opportunity to mark, label, package, and complete documentation for a variety of infectious substances shipments (Category A, Category B, and Exempt Patient Specimens). Participants will review applicable regulations with a focus on IATA. This course is appropriate for those responsible for packaging, marking, and labeling shipments of all categories of infectious substances, dry ice, and liquid nitrogen. A final written certification exam will be administered. Participants must score at least 80% in order to be certified.

Objectives:

  • Summarize the various regulations that impact the shipment of infectious substances
  • Using principles of risk assessment, classify biological materials for shipping purposes as either Category A, Category B, Exempt or not regulated
  • Demonstrate how to package, mark, label, and document shipments of infectious substances, Category A, Category B, and dry ice
  • Complete a written exam to qualify for infectious substance shipping certification

Suggested Background: None
Target Audience: All Safety Professionals, Laboratory Workers, New Biosafety Professionals
Audience Level: Basic

8am-5pm: 5. BSL-3 Design Commissioning Basics
Paul Langevin, PEng, Merrick & Company, Ottawa, Ontario, Canada; Gilles Tremblay, Merrick & Company, Ottawa, Ontario, Canada; Art Wyatt, PEng, Merrick & Company, Atlanta, GA
This course will offer participants a comprehensive design understanding of BSL-3 facilities. This compact design-based course will cover all aspects from planning to commission and will provide the participants an understanding how a biocontainment facility is logically designed and built. The basic steps involved in planning, design, construction, acceptance, and operation that each facility should go through to be effective in primary and secondary containment will be reviewed. Participants will be able to participate in the BSL-3 design processes and understand the influences that vary for BSL-3 facilities through interactive discussions.

Objectives:

  • Recognize how to participate with BSL-3 design projects
  • Restate the influences of BSL-3 facility design
  • State the operational influences for design criteria
  • Explain BSL-3 project variations and delivery options

Course Requirement: Participants must bring a laptop or tablet with a USB port
Suggested Background: Fundamentals of Biosafety, Risk Assessment, BSL-3—Design and Operations, Principles and Practices of Biosafety
Target Audience: All Biosafety Professionals, Facility Managers, Inspectors, Designers, BSL-3 Facility Building Operators
Audience Level: Intermediate

8am- 12:00 pm: 6. 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:

  • 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: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
Audience Level: Basic

1pm-5pm: 7. Biosafety Considerations with Human Gene Transfer
Christopher Jenkins, PhD, RBP, WIRB-Copernicus Group, Princeton, NJ; David Emery, PhD, WIRB-Copernicus Group, Puyallup, WA
Since the late 1990s, human gene transfer research has teased the community with the promise of medical breakthroughs using targeted clinical applications with biological materials. Despite setbacks along the way, the field of human gene therapy has made significant advances. This course will provide an overview of human gene transfer research, risk assessment considerations for biosafety professionals and Institutional Biosafety Committees, and outline the regulatory environment for human gene transfer research. Case studies and group discussion will be used to amplify the take home messages.

Objectives:

  • Recall the challenges past and present with human gene transfer research into human subjects
  • Generate risk assessments with biological materials used in clinical environments
  • Review the regulatory environment from the FDA and NIH perspectives for human gene transfer research

Suggested Background: Risk Assessment, Micro/Molecular Biology 101
Target Audience: All Biosafety Professionals, Clinical Professionals
Audience Level: Intermediate

Saturday, October 10, 2015

8am-5pm: 8. Techniques for Improving Support for Your Biosafety Program
Robert Emery, DrPH, RBP, CBSP, University of Texas Health Science Center—Houston, Houston, TX; Bruce Brown, DrPH, CBSP, University of Texas Southwestern Medical Center, Dallas, TX; Rachel Gamble, DrPH, CBSP, University of Texas Health Science Center—Houston, Houston, TX; Scott Patlovich, DrPH, CBSP, University of Texas Health Science Center—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 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 techniques used for displaying biosafety data in ways that others can readily understand
  • Describe how biosafety programs can assist with other basic safety program needs to avoid duplication of efforts and improve safety and client satisfaction levels
  • Employ various commonly used sales methods to improve the visibly and support for biosafety programs

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate

8am-5pm: 9. Engineering for the Biosafety Professional—Part I
Juan Osorio, IE, 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; Theodore Traum, PE, 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 (e.g., 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 from planning to 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:

  • Recognize engineering issues in planning, design, construction, commissioning, certification/validation, and post-occupancy of biocontainment facilities
  • Analyze a laboratory layout to establish its HVAC boundaries
  • Explain HEPA filters operation, decontamination, and testing
  • Formulate informed questions in engineering terms and have the confidence to question the answers
  • Interact with maintenance personnel and integrate facility operations with the biosafety program

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic

8am-5pm: 10. Infectious Substance Shipping Train the Trainer
Eric Cook, MPH, CBSP, Sandia National Laboratories, Albuquerque, NM
This course is appropriate for those who need more in-depth knowledge of regulations and are responsible for training others in shipping infectious substances. Come learn how to apply brain friendly learning techniques to become a master trainer. Learn techniques to turn a boring infectious substance shipping seminar into something memorable. Participants should have completed an infectious substance shipping training course within the past three years and are familiar with shipping regulations. A portion of the course will be spent in reviewing details of both IATA and DOT regulations. IATA DGR and 49 CFR regulations will not be provided. Participants must bring their own copy of the IATA DGR regulations and a copy of 49 CFR for marking and discussion.

Objectives:

  • Apply adult learning theory, brain-friendly strategies into an infectious substance shipping course
  • Discuss details of shipping regulations and be prepared to answer FAQs related to infectious substance shipping regulations that go beyond the typical, basic shipping course
  • Demonstrate expertise in infectious substance shipping regulations through an open book exam
  • Evaluate and coach others in the proper application of infectious substance shipping regulations
  • Demonstrate the new IATA qualification requirements for instructors of dangerous goods shipping

Course Requirement: Participants must provide their own copy of the IATA DGR regulations and a copy of 49 CFR
Suggested Background: Previous Certification Training in Infectious Substance Shipping
Target Audience: Experienced Biosafety Professionals, Trainers
Audience Level: Advanced

8am-5pm: 11. Basic Threat Assessment for Laboratory Biosecurity Programs
Ben Perman, PhD, RBP, Booz Allen Hamilton, Inc., Washington, DC; Tricia Delarosa, PhD, RBP, CBSP, National Institute of Allergy and Infectious Disease, Rockville, MD; Lindsay Odell, PhD, Booz Allen Hamilton, Inc., McLean, VA; Maureen O’Leary, PhD, CBSP, Dartmouth College, Hanover, NH
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. Participants will be provided with a basic tool-kit that will allow implementation of successful insider threat mitigation strategies using threat assessment at their home institutions. The course will follow established techniques in the personal protection field that are used to identify, assess, and manage dangerous threats. Participants will be presented with relevant case studies on basic threat indicators, approaches to make threats, threatening behaviors, how to recognize specific personal security vulnerabilities, and how to link these vulnerabilities to threats. The course will focus on the purposes and 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, in particular changes to the Select Agent Regulations pertaining to Tier 1 agents, will be discussed. Theoretical concepts will be put into practice in a 2-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 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

8am-5pm: 12. Introduction to Synthetic Biology
David Gillum, MS, RBP[icon icon=”0273.png”][/icon], Arizona State University, Tempe, AZ; Zsuzsi Kovacs, MS, Arizona State University, Tempe, AZ; Irene Mendoza, MS, Arizona State University, Tempe, AZ; Giorgio Scarpellini, MS, Arizona State University, Tempe, AZ
This course will cover biosafety and biosecurity issues pertinent to the emerging field of synthetic biology. Participants will be provided with a general and historical overview of synthetic biology and a glimpse into the current trends and potential future of the field. Instructors will focus on core concepts in synthetic biology and a current level of understanding as they pertain to biosafety and biosecurity. Implications for staff training, personal protective equipment (PPE), engineering controls, lab design, material transportation, waste disposal, regulations, ecological impacts, and ethical considerations will be discussed. As the field of synthetic biology continues to play a bigger role in industry, research, and pharmaceuticals, this course will be timely and will help move conversation forward to allow biosafety professionals an opportunity to become current with trends and positively impact policies, procedures, and guidelines.

Objectives:

  • Recall the history of synthetic biology, the motivation for making biology easier to engineer, and a few common applications of synthetic biology
  • Identify the core concepts and tools to make synthetic biology including: RNA, DNA, and proteins
  • Discuss the major foundational technologies for synthetic biology and aspects of biotechnology that enable the reprogramming of natural systems
  • Recognize the biosafety and biosecurity concerns for individuals and institutions working with synthetic biology and the basic laboratory techniques used in synthetic biology applications
  • Summarize the ethical, environmental, and ecological considerations regarding synthetic biology and its current and future applications

Suggested Background: Micro/Molecular Biology 101
Target Audience: All Safety Professionals, New Biosafety Professionals, Laboratory Workers
Audience Level: Basic

8am-5pm: 13. Brain-friendly Biorisk Management Training Strategies
LouAnn Burnett, MS, CBSP, Sandia National Laboratories, Albuquerque, NM
We have all attended training sessions that we liked and we’ve attended training sessions that we didn’t like. Some training sticks and some doesn’t. Much of this good/bad, stick/don’t stick is based on how our brains function. Creating memorable training is imperative in creating a solid biorisk management culture. This course will examine “brain-friendly” strategies that can be used in biorisk management training. The course will be highly interactive and students will design and teach-back a short brain-friendly activity.

Objectives:

  • Know why certain training strategies are more brain-friendly than others
  • Demonstrate confidence in using participant-driven, interactive techniques
  • Utilize validated brain-friendly techniques to create and teach a short activity

Suggested Background: None
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate

8am-12pm: 14. Biocontainment Myths Explored
John Keene, DrPH, RBP, CBSP, Global Biohazard Technologies, Inc., Midlothian, VA; Ronald Trower, RBP, Global Biohazard Technologies, Inc., Midlothian, VA
There is considerable confusion and misunderstanding when it comes to interpretation of the BMBL and requirements for containment. Such misunderstanding can increase the cost of operation of biocontainment facilities and cause undue hardship on research personnel. This presentation will highlight some of the most common misinterpretations of the guidelines and will provide guidance on how to avoid the pitfalls of misinformation.

Objectives:

  • Identify potential problems in containment practices
  • Recognize the differences between true requirements and fictional requirements
  • Apply the concepts presented to establish a cost effective, user friendly biocontainment procedure process

Suggested Background: Fundamentals of Biosafety, BSL-3—Design and Operations, Principles and Practices of Biosafety
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate

1pm-5pm: 15. Biocontainment Laboratory Operations: Applying Lessons Learned from the Planning Stage to Facility Startup
John R. Henneman, MS, RBP, Pennsylvania State University, University Park, PA; Miguel A. Grimaldo, MEng[icon icon=”0273.png”][/icon], University of Texas Medical Branch—Galveston, Galveston, TX; J. Paul Jennette, MS, PE, RBP, Cornell College of Veterinary Medicine, Ithaca, NY
This course offers participants key insight and sharing of experiences in biocontainment facility construction and start-up from the operations point of view. Often we hear about containment facilities being built simply by transplanting concepts used at other institutions without consideration of the site-specific needs and resources. In this course, lessons learned and the questions to ask during all the stages of building or renovating biocontainment facilities will be shared by instructors with over 50-years of combined experience. The course will focus on establishing the need for high-containment including the level required; the long-term need; and ideas for flexibility. Selecting the right architect, engineer, and construction manager who understands the design and purpose of the facility selecting the proper operations staff; selecting the right commissioning agent; and initiating safe scientific operations will be discussed. The course will consist of interactive, group discussions facilitated by the instructors.

Objectives:

  • Restate lessons learned in the design/construction and start-up process of a biocontainment facility
  • Identify the questions to ask when selecting the facility design, construction, and operations teams
  • Describe the plans and procedures needed to initiate scientific operations

Suggested Background: Fundamentals of Biosafety, BSL-3—Design and Operations
Target Audience: All Safety Professionals, Laboratory Workers, Laboratory Management
Audience Level: Basic

Sunday, October 11, 2015

8am-5pm: 16. BSL-3 Operations and Management
J. Paul Jennette, MS, PE, RBP, Cornell College of Veterinary Medicine, Ithaca, NY; Dee Zimmerman, University of Texas Medical Branch—Galveston, 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 the 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 and training of a worker; 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. Daily operations in a BSL-3 such as: understanding when it is safe to enter and when you need to evacuate; what to do when the ventilation fails; practical aspects of entry and exit procedures; practical tips on selection and use of personal protective equipment (PPE); safety considerations within the experimental SOPs; waste handling; facility cleaning; and how to have equipment repaired or serviced will be discussed. 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 any specific country.

Objectives:

  • Describe the elements of annual verification, emergency response, etc.
  • Recognize institutional responsibilities from management to user
  • Summarize the methods used to develop manuals, SOPs, and training

Suggested Background: Basic Risk Assessment and Biosafety Knowledge
Target Audience: All Safety Professionals, All Biosafety Professionals
Audience Level: Basic

8am-5pm: 17. Integrating Your Biosafety Program into a Biorisk Management System
LouAnn Burnett, MS, CBSP, Sandia National Laboratories, Albuquerque, NM; Ben Brodsky, PhD, Sandia National Laboratories, Albuquerque, NM; Patricia Olinger, RBP[icon icon=”0273.png”][/icon], Emory University, Atlanta, GA; Kalpana Rengarajan, PhD, RBP[icon icon=”0273.png”][/icon], Emory University, Atlanta, GA
The function of most biosafety programs is driven by the need to comply with various local and federal requirements. This approach can result in a program that is compliant, but still does not address all areas where biorisk exists. A management system approach can assist an institution assure compliance and address both the breadth of all the functional aspects biosafety and biosecurity across all the roles at an institution, from the top management downwards. Provisions for a Biorisk Management System have been developed in the CEN Workshop Agreement (CWA) documents 15793 and 16393. This course will allow participants to begin to integrate the biorisk management system approach into their current biosafety program by using the CWA documents to identify gaps, establish goals, objectives, roles, and responsibilities to address priority gaps. This course will be very interactive and hands-on, using tools, tips, and lessons-learned from the facilitators and the students.

Objectives:

  • Identify key components of management systems and how those can apply to and enhance a biosafety program
  • Recognize gaps in your current biosafety program and to plan a risk-based strategy to address those gaps
  • Utilize existing tools and resources to guide implementation of a biorisk management system approach
  • Develop a communication strategy to enhance involvement from all personnel, including management

Suggested Background: None
Target Audience: All Biosafety Professionals, Laboratory Workers
Audience Level: Intermediate

8am-5pm: 18. Advanced Principles and Practices of Working in an ABSL-3
Belinda Rivera, BS, University of Texas Medical Branch—Galveston, Galveston, TX
Institutions with ABSL-3 facilities need to involve animal care and research staff along with safety personnel to ensure that proper work procedures and safety protocols are in place and followed to maintain a safe and productive work environment. This course will provide information to individuals who audit or train personnel to work in ABSL-3 facilities. ABSL-3 facilities have unique hazards and require input from animal care staff, researchers, and biosafety professionals to perform collaborative risk assessments. Personnel working in these facilities need to be informed of the hazards and trained to work safely and appropriately with the species and agents being handled. Discussions will include proper personal protective equipment (PPE), animal handling procedures using pictures and videos, husbandry procedures, caging options, waste management, and emergency response procedures.

Objectives:

  • Identify proper PPE and disinfection practices
  • Restate examples of techniques used to manipulate animals safely
  • Explain the process of waste (cages, carcasses) management
  • Summarize emergency and exposure response

Suggested Background: None
Target Audience: All Safety Professionals, Animal Caretakers, Veterinarians
Audience Level: Advanced

8am-5pm: 19. A BSO’s Guide for Understanding Research Compliance Regulations
Ted Myatt, ScD, RBP, University of Rhode Island, Kingston, RI
This course will enhance the participant’s range of understanding in research compliance areas, regulations, and the guidance that underpins these areas which can be beneficial to biosafety officers and environmental health and safety (EH&S) professionals. For example, research typically encountered by biosafety officers, Institutional Biosafety Committees (IBC), and EH&S groups may also require Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) review and oversight. In order to develop strategies for dealing with these areas of overlap, it is helpful to have a solid understanding of IRB and IACUC regulations and guidance. Comprehension of the regulations and guidance governing research involving human and animal subjects, export controls, and financial conflicts of interest will expand the participant’s area of expertise, potentially leading to new opportunities within an institution’s overall research compliance structure. This knowledge can be used to develop best practices and reduce the regulatory burden on investigators. This course will consist of a mixture of didactic lecture, case studies, and interactive exercises.

Objectives:

  • Describe the major regulations and guidance governing research involving human subjects (IRB) and animal subjects (IACUC)
  • Compare and contrast IBC governance with IRB and IACUC governance
  • Summarize when review by both the IRB and/or IACUC are required for research requiring IBC review
  • Discuss other compliance issues, such as export controls, financial conflicts of interest, research misconduct, and their potential relation to research reviewed by an IBC
  • Develop an understanding of federal grant management policy, including requirements for review and oversight of research involving recombinant DNA human and animal subjects
  • Identify strategies to effectively manage IBCs and best practices for coordination of review and oversight for research requiring review from multiple committees

Suggested Background: None
Target Audience: All Biosafety Professionals, All Safety Professionals
Audience Level: Intermediate

8am-12pm: 20. IBC Basics
Kathryn L. Harris, PhD, RBP[icon icon=”0273.png”][/icon], National Institutes of Health, Bethesda, MD
This course will present the history, function, and administration of the Institutional Biosafety Committee (IBC). Delivered by expert staff from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA), IBC Basics will promote the professional development of those associated with the IBC by providing an opportunity to learn about the NIH OBA, the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (NIH Guidelines), the history of the IBC, and understand the range of responsibilities that the IBC has under the NIH Guidelines.

Objectives:

  • Summarize the content of the NIH Guidelines
  • Restate the requirements for the IBC under the NIH Guidelines
  • Recognize the partnership between NIH OBA, IBC, and Recombinant DNA Advisory Committees and learn about the NIH OBA IBC site visit program
  • Describe how to implement an effective program of oversight for research subject to the NIH Guidelines, learn about common challenges, and possible solutions

Suggested Background: None
Target Audience: New Biosafety Professionals, All IBC Members
Audience Level: Basic

8am-12pm: 21. NIH Design Requirements Manual Update
Alamelu Ramesh, PE, LEED AP, National Institutes of Health, Bethesda, MD; Steven Breslin, PE, LEED AP, National Institutes of Health, Bethesda, MD; Rajiv Chainani, PE, LEED AP, National Institutes of Health, Bethesda, MD; Scott Taylor, PE, CEM, LEED AP, National Institutes of Health, Bethesda, MD
This course will provide participants with the salient points discussed in the NIH Design Requirements Manual (DRM). Subject matter experts will discuss planning, architectural, structural, mechanical, plumbing, and electrical design criteria for biomedical and animal research facilities designed and constructed on NIH property and other entities where the design and construction is funded by NIH. This new edition of the DRM provides rationales for most of the design requirements to help the design team understand reasons behind the requirements. Specific items discussed in this course will be laboratory planning guidance, doors, finishes, casework, cleaning, access, biosafety cabinet placement requirements, decontamination, use of appropriate sealants, anterooms, storage, certification for high-containment facilities, air change rates, pressurization, filtration, exhaust, redundancy, mechanical controls, testing requirements for BSL-3, water, drainage, compressed gases, vacuum, lab plumbing fixtures, and special equipment. The course will also discuss common challenges in the design, construction, and operation of the biomedical and animal research facilities. Exercises will be conducted to ensure that the participants get a clear idea of the design criteria.

Objectives:

  • Explain the key biomedical and animal research lab planning concepts
  • Describe the importance of selecting appropriate sealants for various applications
  • Paraphrase the impact of air flow on safe operation of chemical fume hoods and biosafety cabinets
  • Identify equipment or systems planned to be provided with emergency power in case of power failure

Suggested Background: Fundamental knowledge of research facility design
Target Audience: All Safety Professionals, Architects, Engineers
Audience Level: Intermediate

8am-12pm: 22. Working Safely with Arthropods in the Laboratory
Partha Krishnan, PhD, Yale University, New Haven, CT; Sukanya Narasimhan, PhD, Yale School of Medicine, New Haven, CT; Brian Weiss, PhD, Yale School of Public Health, New Haven, CT
Research with live arthropods in a laboratory setting presents unique challenges in terms of biosafety issues, facility design, and safety practices. This course will focus on the biology of arthropods; risk assessment tools, engineering controls, personal protective equipment (PPE), good work practices while handling arthropods, the creation of SOPs for high-risk tasks, review of Arthropod Containment Levels (ACL) and facility design; emergency response procedures, including exposures and loss or release of arthropods from containment, primarily focusing on ACL biosafety levels 1 and 2. Ticks and mosquitoes will be the main arthropod classes that will be the focus of this course. Attendees will learn of the risks posed by working with arthropods, especially when infected with a known pathogen, adopting effective biosafety controls to mitigate or eliminate these risks and handling exposures competently. This course also caters to lab design architects and professionals who may be in need of expertise in factors to be taken into consideration before building or renovating laboratory space for arthropod work.

Objectives:

  • Design adequate risk assessment of research using arthropods primarily at ACL levels 1 and 2
  • Describe the possible routes of arthropod exposure by understanding the biology of the organism
  • Apply best practices and employ effective protocols while working with arthropods with example SOPs
  • Identify the most effective engineering controls to contain arthropods and to prevent inadvertent exposures and effective ways to handle exposures, near misses and accidents involving arthropods

Suggested Background: Fundamentals of Biosafety, Micro/Molecular Biology 101
Target Audience: All Safety Professionals, Laboratory Architects and Workers, Insectary Design Consultants
Audience Level: Basic

8am-12pm: 23. Concepts of Virology
Patrick Condreay, PhD, Biosafety Consultant Services, Carrboro, NC
This course will briefly review gene expression in eukaryotes and 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 antiviral intervention will also be explored. Participants should have a familiarity with molecular biology. The course is targeted to the biosafety professional who does not actively conduct laboratory research, but would like to gain a basic knowledge of virology.

Objectives:

  • Define the nature of viruses and clarify how the 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: Experienced Biosafety Professionals, Laboratory Workers
Audience Level: Intermediate/Advanced

1pm-5pm: 24. Advanced Laboratory Design Principles and Practices
Jeffrey Owens, MPH, CBSP, CSP, SM(NRCM), HDR Architecture, Inc., Atlanta, GA; Mark Fitzgerald, HDR Architecture, Inc., Los Angeles, CA; Natasha Griffith, MS, University of California—Los Angeles, Los Angeles, CA; Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM
Advanced Laboratory Design Principles and Practices will provide participants with an in-depth examination of key principles and practices for designing safe and efficient laboratories. It is intended for architects, designers, and biosafety professionals desiring a more comprehensive analysis of the laboratory design process. Participants are expected to have some experience with laboratory facility design and/or have previously attended the Laboratory Facility Programming and Design Best Practices ABSA pre-conference course. Participants will engage in guided discussions and analyze laboratory plans with respect to the design principles and practices under consideration.

Objectives:

  • Illustrate methods of design and analysis that promote good laboratory design
  • Identify examples of good design solutions for laboratory room and laboratory building layouts
  • Summarize how good design practices work to enhance both biosafety and biosecurity
  • Evaluate the effectiveness of laboratory designs from multiple perspectives

Suggested Background: Laboratory Facility Programming and Design Best Practices
Target Audience: Experienced Biosafety Professionals, Laboratory Architects and Engineers
Audience Level: Intermediate

1pm-5pm: 25. Responsible Research: Introduction to Dual-Use Biosecurity
Lela Bakanidze[icon icon=”0273.png”][/icon], RBP, Georgian Biosafety Association, Tbilisi, Georgia; Tatyana Novossiolova, University of Bradford, Bradford, West Yorkshire, United Kingdom
This train-the-trainer course will be useful for anyone specializing/working in the biological sciences. It is designed to raise awareness and foster understanding of the broader social, ethical, and legal implications of modern biotechnology, and thus enhance participant skills and competency to recognize and address potential dual use and biosecurity issues in their work. The course is based on a Team-Based Learning (TBL) training methodology. TBL is a special form of collaborative active learning that uses a specific sequence of individual work, group work, and immediate feedback to create a motivational framework, whereby the focus is shifted from conveying concepts by the instructor to the application of concepts by the learner teams. The specifically selected active learning methodology allows participants to develop appreciation and engage with the broader biosecurity and dual use issues arising in life science research. The training format has built-in asset, since it is easy to replicate, which in turn would allow participants, to become trainers themselves and promote awareness and responsible conduct of science at their workplace.

Objectives:

  • Compare and contrast the concepts of dual-use research and dual-use research of concern
  • Recall the concept of beyond the laboratory door biosecurity
  • Explain the social, ethical, and legal responsibilities incumbent upon life scientists
  • Develop a dual-use biosecurity awareness-raising program to be applied in your local institution
  • Apply active learning methodology in training

Suggested Background: None
Target Audience: All Safety Professionals, Life Science Researchers
Audience Level: Intermediate

1pm-5pm: 26. Virus-based Gene Transfer Vectors
Patrick Condreay, PhD, Biosafety Consultant Services, Carrboro, NC
This intermediate course will examine the molecules, processes, and techniques involved in recombinant gene expression. Participants 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. This 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: Fundamentals of Biosafety, Micro/Molecular Biology 101
Target Audience: Laboratory Workers, All Safety Professionals, All Biosafety Professionals
Audience Level: Intermediate/Advanced

1pm-5pm: 27. Large-scale Biosafety
Brian Petuch, MA, RBP, CBSP, Merck, West Point, PA
This course will review the biosafety involved for working at large-scale, which the NIH Guidelines for Research Involving Recombinant DNA Molecules defines as >10L. This course will also review Appendix K from the NIH Guidelines from good large-scale practice to BSL-3 large-scale with a focus on primary and secondary containment. Basic bioprocessing steps, such as fermentation/cell culture and purification technologies will be reviewed, examples of classic and newer single use technologies will be provided, and the perils and pitfalls of the various technologies will be discussed. A review of risk assessment techniques used for large-scale bioprocesses will also be discussed.

Objectives:

  • Recognize large-scale bioprocessing technologies, the inherent risks, and how to perform and document risk assessments
  • Restate the advantages and disadvantages of single use biotechnology equipment
  • Develop a plan for issues of waste disposal and emergency response
  • Recall the components of the NIH rDNA Guidelines Appendix K and how implement them for large-scale bioprocessing projects

Suggested Background: Fundamentals of Biosafety, Risk Assessment
Target Audience: All Biosafety Professionals
Audience Level: Basic/Intermediate

3-5:30pm

ABSA International Panel

Please join us for the ABSA International Panel and learn about US global biosafety and biosecurity initiatives from panelists representing the Biosecurity Engagement Program (BEP), the Global Health biosecurity Agenda (GHSA), The Twinning Program and more. Panelists will share what they are doing internationally through case studies, success stories, and lessons learned.

Panelists
Samantha Arnett, Biosecurity Engagement Program
Ambassador Bonnie Jenkins, Global Health Biosecurity Agenda
Eric Cook, Geoffrey Phillips, and Bassel Mamdouh[icon icon=”0273.png”][/icon], Twinning Program

Moderator
Maureen O’Leary, Dartmouth College



6:30-8pm

Opening Reception

The Opening Reception will be held on Sunday, October 11 from 6:30 – 8:00 pm in the Exhibit Hall.

12openingreception