Sherry Bohn, PhD, CBSP, University of Maryland—College Park, College Park, MD
Ashley Grant, PhD, U.S. Government Accountability Office, Washington, DC
Lori Miller, PE, U.S. Department of Agriculture, Riverdale, MD
Susan Weekly, MS, RBP, Department of Defense, Falls Church, VA
David M. White, DVM, PhD, U.S. Department of Agriculture, Ames, IA

Careful selection, validation, and verification of inactivation processes in the laboratory and disinfection in the field is critical to work with high-consequence pathogens. Recently, a series of high profile laboratory incidents has highlighted the need for the inclusion of biosafety and quality assurance elements into laboratory procedures addressing microbial inactivation. Beyond the need for regulatory compliance, the ability to work with inactivated materials at a lower containment level protects the researcher by reducing exposure to high-containment labs, reduces logistical and ergonomics issues associated with high- and maximum-containment work, and expands the ability of researchers to use diagnostic and investigative equipment and technologies not readily available at BSL-3 or BSL-4. Case studies, table top exercises and reviewing decontamination, disinfection, inactivation, and sterilization techniques will be used to provide an interactive, introductory course that will provide a foundation for the selection of inactivation procedures for use in the laboratory and disinfection in the field. Topics covered will include: policies, guidelines and regulations; regulatory and programmatic gaps; disinfection and inactivation of agriculturally-important agents; and, methodologies and validation. Benefits and points of collaboration with biosafety in the implementation of a program that performs and documents inactivation and disinfection procedures to ensure safe use of an agent preparation or building are stressed.

Objectives:

• Identify risk assessment and risk mitigation procedures to use in the development of an inactivation process or disinfection program
• Describe the pros and cons of common disinfection, decontamination, and/or inactivation methods
• Discuss best practices in the development of disinfection, decontamination, and/or inactivation procedures and programs

Target Audience: All persons working in the Veterinary and Agriculture fields including: biosafety officers, researchers, facility managers, quality assurance, veterinarians.

Audience Level: Basic

Joseph Kozlovac, MS, RBP, CBSP, U.S. Department of Agriculture, Beltsville, MD
Caird Rexroad, PhD, U.S. Department of Agriculture, Beltsville, MD
Eileen Thacker, DVM, PhD, U.S. Department of Agriculture, Athens, GA
Nick Chaplinski, MS, RBP, U.S. Department of Agriculture, Athens, GA

Agriculture research laboratories must conduct work on important pathogens to develop technologies that reduce economic losses due to disease. Experiments including pathogens must be contained and prevented from introduction to the community, including spread to local agriculture production sites and habitats of native species. Topics covered will focus on assessing risk for agricultural disease agents and developing multi-layered containment procedures for implementation to protect agriculture, public health and the worker and a discussion about the need to continually monitor the adequacy of controls using a robust diagnostic testing and surveillance. Specific emphasis will be placed on aquatic species, poultry, cattle, and small ruminants.

Objectives:

• Describe the importance of terminology as it relates to the “Biowords” (Biosafety, Biosecurity, Bioexclusion, etc.)
• Restate the difference in worker protection, public health risks vs agricultural risks and the need for a risk assessment process prior to start of work with agents which impact agriculture only
• Explain the importance of instituting an animal health monitoring program
• Identify and develop a basic understanding of operational and infrastructure challenges related to veterinary research activities related to endemic and transboundary animal diseases of agricultural significance

Target Audience: Biosafety or Biorisk Professionals, Veterinarians and Veterinary Technicians, Farm and Animal Facility Managers and Supervisors, Research Scientists and Research Technicians

Audience Level: Basic

Kathryn Harris, PhD, RBP, National Institutes of Health, Rockville, MD
Freeda Isaac, DVM, U.S. Department of Agriculture, Beltsville, MD
Samuel Edwin, PhD, Centers for Disease Control and Prevention, Atlanta, GA
Mary Winkler, CSP, Smithsonian Institute, Washington, DC
Susan Harper, DVM, U.S. Department of Agriculture, Beltsville, MD
Sacha Gutierrez, MD, U.S. Food and Drug Administration, Silver Spring, MD

The regulatory and policy landscape is constantly evolving, and this course provides a broad overview of the various legal requirements that pertain to research institutions. Participants will discover how federal, state, and local environmental, health, and safety requirements apply to the laboratory environment, and learn how to improve overall regulatory compliance, reduce liability exposure, and most importantly how to encourage others at their institution to adhere to these principles. Special emphasis will be given to unique applications and challenges that pertain to agricultural research programs.

Objectives:

• Discuss the regulatory and policy framework that governs research activities involving hazards
• Recall how the regulatory standards apply in an agricultural research environment
• Define common compliance challenges and ways to improve accountability at your institution

Target Audience: Researchers, Principal Investigators; Laboratory Managers, Supervisors, Laboratory Workers; Environmental, Health, and Safety Professionals; Institutional Biosafety Committee Members; New Biosafety Professionals; Science and Technology Faculty

Audience Level: Basic/Intermediate

Vibeke Halkjaer-Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM
Mark Fitzgerald, SOTER Bioconsulting, Inc., Los Angeles, CA
Natasha Griffith, PhD, University of California—Los Angeles, Los Angeles, CA

This course will begin with a brief review of the key principles underlying the design features of containment laboratories. Participants will be introduced to and have a discussion on the differences in prescriptive and performance based requirements. A discussion will be held on the common biocontainment challenges; participants should come prepared to share their experiences and challenges. In addition to examples provided by the instructors, participants will be able to learn from the experiences of everyone in the room and will help identify possible solutions to challenges shared by other participants. The course will include lecture, pictures of many examples of biocontainment challenges from around the world, and small group activities analyzing case studies and developing alternate solutions. The goal of this course is to give students confidence in using critical thinking skills to tackle problems in biocontainment facilities in lower resource settings.

Objectives:

• Explain the difference between prescriptive and performance based requirements
• Recognize key biocontainment challenges for institutions in lower resource countries
• Identify alternate solutions to meeting ventilation and waste disposal needs

Target Audience: International biosafety professionals

Audience Level: Basic

Robert Ellis, PhD, CBSP, Colorado State University, Fort Collins, CO
Julie Johnson, PhD, CBSP, Kansas State University, Manhattan, KS

Many times in our research and biosafety careers, we are challenged to provide the optimal large animal ABSL-2 containment. This course will discuss the mechanisms for determining and achieving the appropriate containment criteria from the practical biosafety and biosecurity standpoints. We will discuss risk assessment and management, animal handling, housing, and decontamination considerations.

Objectives:

• Describe large animal ABSL-2 criteria
• Analyze risks of large animal ABSL-2 work to personnel and the environment
• Compare differences between application of ABSL-2 criteria for small lab animals and large animals (livestock, exotic species, wild animals, feral animals, etc.)
• Apply knowledge and risk assessment to develop biosafety/biosecurity protocols for specific large animal ABSL-2 circumstances (species, containment, PPE, decontamination, etc.)

Target Audience: Biosafety Professionals, Veterinarians, Veterinary Technicians, Farm and Animal Facility Managers and Supervisors, Research Scientists, and Research Technicians

Audience Level: Intermediate

6. Facility Operational Biosafety
Mark Fitzgerald, SOTER Bioconsulting, Inc., Los Angeles, CA
Natasha Griffith, MS, University of California—Los Angeles, Los Angeles, CA
Vibeke Halkjaer‐Knudsen, PhD, Sandia National Laboratories, Albuquerque, NM
John Henneman, MS, RBP, Pennsylvania State University, University Park, PA

This course offers a basic understanding of key principles underlying the design and operation of large animal facilities, the systems required to support a typical animal facility, how these influence facility design and how specialized systems enhance biosafety. The course will focus specifically on those facilities that do not fall under the Select Agent regulation. Participants will be introduced briefly to laboratory design best practices as they relate to; building zoning, operational efficiency, and biosecurity factors, supporting good lab protocols and flexibility. They will learn how architectural, structural, HVAC (heating, ventilating and air conditioning), Plumbing and Electrical systems are influenced by laboratory designs. Through guided discussions and interactive exercises participants will learn about the type of information required to design the systems, how services are distributed through a typical laboratory building and the type of redundant features required to keep facilities running. The course will be highly interactive with facilitated group discussions by the instructors.

Objectives:

• Restate the principles of good laboratory design and the methods for developing, analyzing and improving laboratory designs
• Summarize how building systems support laboratory functions
• List the biological containment implications of system distribution concepts
• Describe the intent of providing redundancy on engineering systems for laboratories

Target Audience: Biosafety professionals who want to be able to interact in a seamless manner with a design team, from drafting user requirements for the new facility, engaging as a facility representative through the design and building process to final commissioning.

Audience Level: Basic, Intermediate, Advanced

Susan Harper, DVM, U.S. Department of Agriculture, Beltsville, MD
Steve Kappes, PhD, U.S. Department of Agriculture, Beltsville, MD
F. Claire Hankenson, DVM, Michigan State University, East Lansing, MI
Carl Grunfeld, MD, U.S. Department of Veterans Affairs, San Francisco, CA
Barbara Owen, MPH, RBP, CBSP, Merck & Co., Inc., Kenilworth, NJ

This course will enlighten scientists, managers, safety professionals, and administrators to their critical role in the development and implementation of effective organization-wide safety programs. The discussion centers on the most critical issues influencing the effectiveness of local oversight systems, including building support for safety programs, leading transformation of institutional culture, enhancing communication and consistency between multiple oversight entities, managing an organization that is in crisis mode, and international initiatives that may influence future research safety goals and objectives. Explore strategies to lead innovation and implement changes that focus on quality improvement. Special emphasis will be given to unique applications and challenges that pertain to agricultural research programs.

Objectives:

• Discuss successful initiatives designed to raise support and cultivate a positive and progressive safety culture
• Identify oversight committees that have responsibility for research worker and/or environmental safety
• Describe strategies to manage crisis situations associated with research safety
• Identify methods to prepare institutions to understand and support major international research safety initiatives

Target Audience: Researchers/Principal Investigators; Laboratory Managers and Supervisors; Environmental, Health, and Safety Professionals; Institutional Biosafety Committee Members; Biosafety Professionals; Risk and Operations Managers; Science and Technology Faculty

Audience Level: Intermediate/Advanced