BIOSAFETY MANAGEMENT

PLANNING FOR THE FUTURE BY LEARNING FROM THE PAST

14TH CDC INTERNATIONAL SYMPOSIUM ON BIOSAFETY

January 30 - February 3, 2016Crowne Plaza Ravinia, Atlanta, GA

eagleson.org/CDC#BIOSAFETY2016

WORKSHOPS

WORKSHOP #1: SATURDAY, JANUARY 30, 8:00 AM - 5:00 PM • $325Becoming Audit-Ready: Developing a Tool for Program EvaluationJoseph Kozlovac, MS, RBP, CBSP, SM(NRCM), United States Department of Agriculture - Agricultural Research Service; Rich Rebar, RBP, CBSP, GlaxoSmithKline; Kalpana Rengarajan, PhD, MPH, RBP, Emory University; Beatrice Mouille, FAOThis eight-hour course will introduce individuals to the anatomy of a regulatory inspection, discuss the merits of having an assessment process to assess and strengthen biorisk management programs. The course will introduce tools and processes that have been used in the biopharmaceutical industry, academia and international organizations to improve and strengthen biorisk management programs at individual institutions to regional laboratory networks. Class exercises and Case studies will be used to illustrate the importance of having the right tool in your tool box.

WORKSHOP #2: SATURDAY, JANUARY 30, 8:00 AM - 12:00 PM • $225Decontamination Strategies from the Laboratory to LiberiaJeffrey Sheppard; Linda Pezzanite; Sabrina Debose, MS, Centers for Disease Control and PreventionStrategies implemented for years in the laboratory under controlled conditions were used to control the transmission of Ebola virus in field, clinical and laboratory environments during the recent epidemic. This training focuses on decontamination methods, budgetary limitations and allowances as well as governmental standards that must be considered. Types of decontamination agents, the advantages and disadvantages of each decontaminant, and the recommended personal protective equipment will be identified by CDC instructors with experience in developing decontamination procedures.

WORKSHOP #3: SATURDAY, JANUARY 30, 1:00 PM - 5:00 PM • $225Principles and Practices of Working in an ABSL3 FacilityBelinda Rivera, MLAS, LVT, RLATG, CMAR, University of Texas Medical Branch – GavlestonThere has been an increase in the number of ABSL3 facilities being built around the US and internationally. Institutions are responsible

to inform staff of all the hazards in the facility, provide proper training specific to the agent(s) and animal species being handled, and maintain proper documentation of training to fulfill institutional and regulatory agencies. This lecture will provide basic principles and practices of working safely with rodents in an ABSL3 facility based on BMBL standards. Topics that will be discussed include: differences in biosafety levels, primary and secondary barriers including practices, engineering controls and PPE, aerosol producing procedures, waste management, spill and biological exposure response, transportation, and general laboratory practices.

WORKSHOP #4: SATURDAY, JANUARY 30, 1:00 PM - 5:00 PM • $225Hardhats, Headaches, and Hallelujah: Learning From Past Design & Construction ProjectsMark Fitzgerald, HDR; Natasha K. Griffith, MS, University of California - Los Angeles; Jeffrey Owens, MPH, CBSP, HDR; Vibeke Halkjaer-Knudsen, PhD, Sandia National LaboratoriesThe design and construction process can be complicated and even intimidating. Often, those not in the Architecture, Engineering & Construction industries are asked to participate in a design & construction project once in their career and can be included on an owner’s team with little preparation. In addition, this process is often a significant capital investment by an institution, making the importance of getting the process right all the more critical. This course will focus on practical application of lessons learned from past design and construction projects including: Project Delivery Methods, A/E & Contractor Selection Process, Decision Making, Quality Management Tools, Material and Equipment Selection, Construction Administration and Supervision, and Change/Move Management. The course will focus particular attention on the construction, acceptance and occupancy phases of projects. These phases are often confusing and difficult to plan for, however with some anticipation of requisite time commitments, schedules, and sequencing, it is possible to reduce stress, manage costs and avoid potential negative impacts on a project. The course will also provide construction documentation examples and explain how these elements can benefit an institution long after the design and construction team has walked away from the project.

SATURDAY, JANUARY 30, 2016 SUNDAY, JANUARY 31, 2016

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WORKSHOP #1 Becoming Audit-Ready: Developing a Tool for Program EvaluationALL DAY WORKSHOP

WORKSHOP #2 Decontamination Strategies from the Laboratory to Liberia

WORKSHOP #5 Basic Risk Assessment: An Intorductory Course on Theory, Application and Tools

WORKSHOP #6 Necessary Management Skills for Biosafety Professionals

WORKSHOP #7 Communication in Building Operations: Lessons Learned and Benefits of Having a Building Owners Group (BOG)

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WORKSHOP #3 Principles and Practices of Working in an ABSL3 Facility

WORKSHOP #8 A Model for Planning and Development of a Mock ABSL3 Laboratory Training Program

WORKSHOP #9 Tools to Enhance Laboratory BiosafetyWORKSHOP #4 Learning From Past Design & Construction Projects

WORKSHOP #10 Establishing Effective BSL3 Facility Performance Criteria

WORKSHOP #5: SUNDAY, JANUARY 31, 8:00 AM - 12:00 PM • $225Basic Risk Assessment: An Introductory Course on Theory, Application and ToolsSusan Caskey, MS, Sandia National Laboratories; Michelle McKinney, MS CBSP, Centers for Disease Control and PreventionRisk assessment is the basis for the safeguards developed by the CDC, and the microbiological and biomedical community to protect the health of laboratory workers and the public from the risks associated with the use of hazardous biological agents in laboratories. Biological risk assessment is a subjective process requiring consideration of many hazardous characteristics of agents and procedures, with judgments based often on incomplete information. There is no standard approach for conducting a biological risk assessment, but some structure can be helpful in guiding the process. This course describes a five-step approach from the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition, that gives structure to the risk assessment process and also demonstrates several risk assessment tools available to students to facilitate a rigorous and consistent application of risk assessment methodologies. The featured tool for this course, BioRAM, was developed by Sandia National Laboratories’ International Biological Threat Reduction Department and designed to provide visualization of the relative risks, and help to identify risk mitigation measures which can aid program management in allocating recourses to mitigate facility biorisks or to assess current biorisk program management effectiveness.

WORKSHOP #6: SUNDAY, JANUARY 31, 8:00 AM - 12:00 PM • $225Necessary Management Skills for Biosafety ProfessionalsRobert Emery, DrPH, CBSP, CHP, CIH, CSP, CHMM, CPP, ARM, University of Texas Health Science Center at HoustonA recurrent challenge for biosafety professionals is the ability to garner the resources necessary for program support. The basis for this difficulty is that, on a good day in the world of biosafety “nothing happens” so upper management may not fully appreciate or comprehend all of the effort that went 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 workshop will focus on some key management techniques that can be used within biosafety programs to help improve stakeholder understanding of the program and its associated goodwill value, which in turn can result in the provision of necessary programmatic resources. Numerous real world examples of successful applications of the techniques discussed will be displayed for review and discussion. Ample time will be provided throughout the session for discussion.

WORKSHOP #7: SUNDAY, JANUARY 31, 8:00 AM - 12:00 PM • $225Communication in Building Operations: Lessons Learned and Benefits of Having a Building Owners Group (BOG)John Henneman, MS, RBP, The Pennsylvania State UniversityForming a Building Owners Group (BOG) in the early stages of a Biocontainment construction project is beneficial for safe biocontainment operations management. A BOG will allow all those involved in ownership (management, scientists, and maintenance), to have regular meetings throughout the project for updates of project status. Meeting monthly after the building is in operation to address any operations issues becomes a habit, as all the participants are familiar with the project, have a better understanding of the entire project, and are less likely to overlook important details of operations. This course will help one decide if a BOG will be a useful tool for your facility operations.

WORKSHOP #8: SUNDAY, JANUARY 31, 1:00 PM - 5:00 PM • $225A Model for Planning and Development of a Mock ABSL3 Laboratory Training ProgramNathaniel Powell, Jr., DVM, DACLAM; George Lathrop, DVM, DACLAM; Capt. Brianna Skinner, DVM, MPH; Gregory Langham, DVM, MPH; Yvonne Reed, MPH; Eddie Jackson, LATG; James White, MPH, Centers for Disease Control and Prevention and Residents in the CDC Laboratory Animal Medicine Residency ProgramThere continues to be a need to train investigators, veterinarians, animal technicians, and support staff on how to work safely with animals in ABSL3 laboratories. This training is not always available to meet existing expectations because of a lack of readily available expertise, inadequate funding to support travel to conferences/workshops, or potential failure to recognize the need for specialized training. This workshop will focus on processes and procedures necessary to develop a mock ABSL3 training laboratory within an existing animal care and use program and/or a stand-alone laboratory. Some of the issues we will discuss include: strategies for engaging senior level leadership and requesting support, clearly defining goals and objectives for the mock laboratory training program, securing necessary resources for funding and staffing, incorporating specific training requirements, selection of animals to enter the suite, and identifying equipment, facilities, and organizational needs. This interactive course will include hands-on opportunities to handle selected animal equipment commonly used in ABSL3 laboratories, and donning and doffing of personal protective equipment used in biocontainment laboratories and in field operations.

WORKSHOP #9: SUNDAY, JANUARY 31, 1:00 PM - 5:00 PM • $225Tools to Enhance Laboratory BiosafetyMichael Pentella, PhD, MS, D(ABMM), Massachusetts State Public Health Laboratory; Andrew Cannons, PhD, HCLD/CC(ABB), Florida Bureau of Public Health Laboratories; Maureen Sullivan, MPH, Minnesota Public Health Laboratory DivisionThe risk of a laboratory acquired infection is a reality for diagnostic, public health, research, and teaching facilities because of the potential for exposure to infectious agents. There are several tools to mitigate the risk including risk assessments, safety practices, trainings, competencies, and audits. The goal of this session is to provide the tools to build and enhance biosafety and biosecurity practices. The workshop describes and review the components of the biosafety and biosecurity program, and provides templates and examples for use in the laboratories.

WORKSHOP #10: SUNDAY, JANUARY 31, 1:00 PM - 5:00 PM • $225Establishing Effective BSL3 Facility Performance CriteriaDan Frasier, PE, CCP, Cornerstone Commissioning; John Henneman, MS, RBP, The Pennsylvania State UniversitySome laboratory facilities have operated for years without a clear set of pass/fail criteria for normal and failure conditions. This shouldn’t be happening in biocontainment facilities. This course will provide a list of important criteria to be considered and a methodology for determining the best range of values or parameters for establishing effective functional and operational criteria.

Meet Our Sponsors and Exhibitors at the Opening Reception Sunday Evening

5:00PM - 6:30PM

SYMPOSIUM AGENDASUNDAY, JANUARY 31, 2016

5:00 Opening Reception (5:00 PM - 6:30 PM)Meet the Sponsors and Exhibitors

MONDAY, FEBRUARY 1, 2016

8:00 WelcomeCristina Bressler, MBA, Centers for Disease Control and Prevention; Mary Ann Sondrini, EdM, Eagleson Institute

SESSION 1: RISK GOVERNANCEModerator: Paul Meechan, PhD, MPH, RBP, CBSP, Centers for Disease Control and Prevention

8:15 Risk and Decision Analysis for Biosafety ManagementSusan Caskey, Sandia National Laboratories

8:45 Building ConnectionsPaula DesRoches, ANP-BC, COHN-S, Emory Healthcare and Emory University; Dee Pettit, PhD, North Carolina Department of Health & Human Services

9:45 Break

10:15 Using ROI Analysis to Inform QI & Decision MakingKarl Ensign, MPP, Association of State and Territorial Health Officials

10:45 ROI Animal FacilitiesSharon Dietz, DVM, Centers for Disease Control and Prevention

11:15 World Development Report, Pandemic RiskOlga Jonas, World Bank

11:45 ABSA International UpdateMelissa Morland, MS, RBP, CBSP, University of Maryland Baltimore

12:00 Lunch

1:15 Activity: Designing Risk Assessment TemplatesPaul Meechan, PhD, MPH, RBP, CBSP, Centers for Disease Control and Prevention

2:15 USDA ARS: Building a Culture of SafetySteven Kappes, PhD, USDA-ARS

3:00 Break

3:30 Setting Risk Tolerance Limits: A Panel DiscussionRob Weyant, PhD, RBP, Centers for Disease Control and Prevention; Dee Zimmerman, University of Texas Medical Branch; Kazunobu Kojima, MD, PhD, World Health Organization; Barbara Owens, MPH, RBP, CBSP, CHMM; Merck & Company; Dee Pettit, PhD, North Carolina Department of Health and Human Services; John Balog, RBP, Food and Drug Administration

SPECIAL PRESENTATION

4:30 Standing on the Shoulders of Giants: Evolution of the Architecture and Engineering Industry’s Influence on Biosafety Mark Fitzgerald, HDR

5:00 Conclusion

TUESDAY, FEBRUARY 2, 2016

8:00 Welcome

SESSION 2: RISK COMMUNICATION Moderator: Nathaniel Powell, Jr., DVM, DACLAM, Centers for Disease Control and Prevention

8:15 Risk Communication and Biosafety: Making First Impressions You Want to LastBarbara Reynolds, PhD, Centers for Disease Control and Prevention

9:15 Skills for Communicating within an OrganizationAnn Turner, PhD, FASAE, CAE, AALAS

9:45 Questions and Answers

10:00 Break

SESSION 3: EMERGING REGULATIONS AND GUIDELINESModerator: Joseph Kozlovac, MS, RBP, CBSP, USDA - ARS

10:30 Revisions: Where are these regulations and guidelines going? How have they changed?• WHO Laboratory Biosafety Manual: Kazunobu Kojima, MD,

PhD, World Health Organization;• OIE Terrestrial Guide: Keith Hamilton, Kansas State Univer-

sity;• Biosafety in Microbiological and Biomedical Laboratories

(BMBL) 6th Edition: David Holmes, PhD, Centers for Dis-ease Control and Prevention;

• Proposed Regulatory Changes to the Federal Select Agent Program Regulations: 7 CFR Part 331; 9 CFR Part 121, and 42 CFR Part 73: Charles Divan, PhD, USDA-APHIS;

• Ag Biocontainment Guidance: Eilyn Fabregas, MS, RBP, USDA-APHIS;

• Select Agents: Rob Weyant, PhD, RBP, Centers for Disease Control and Prevention

12:15 Lunch

1:30 Public Health Agency of Canada’s Experience: Lessons Learned on Harmonizing Animal and Human Regulations

SESSION 4: HEALTHCARE FOR FIELD WORKERS AND INTERNATIONAL VISITORS Moderator: Kalpana Rengarajan, PhD, MPH, RBP, Emory University

2:15 Medical Assessments: Physical and Mental

3:00 Break

3:30 Post-Deployment Support: Lessons Learned from Ebola ResponseRichard Klomp, MOB, MS, LPC, BCPC, Centers for Disease Control and Prevention

4:00 Biological Risk Management Implementation: Experiences with Ebola in West Africa and ElsewhereGavin MacGregor Skinner, BVSc, MSc, MPH, MRCVS, Penn State College of Medicine

4:30 Questions and Answers

4:45 Conclusion

6:00 Banquet (6:00 PM - 9:00 PM)

WEDNESDAY, FEBRUARY 3, 2016

8:00 Welcome

SESSION 5: BIOSAFETY IN THE FUTURE: WORKFORCE, TRAINING, COMPETENCIES Moderator: Dee Pettit, PhD, North Carolina Department of Health and Human Services

8:15 Competencies: The Building Blocks of the Safety CultureMichael Pentella, PhD, D(ABMM), Massachusetts State Public Health Laboratory

8:45 Training and Professional Development: How to Evaluate TrainingTom Chapel, Centers for Disease Control and Prevention

9:30 Break

10:00 Panel Discussion: Ideas on How People Can Enter the Biosafety Field When No Educational or Career Path ExistsRobert Ellis, PhD, CBSP, DACVM(Hon.), Colorado State University; Bonnie Rubin, CLS, MBA, MHA, University of Iowa Hygienic Laboratory

11:00 Use of ISO 35001 (CWA 15793) as a Tool for MetricsPatty Olinger, RBP, Emory University

HOT TOPICS

11:30 Hot Topics

12:30 Conclusion

More Information Online At

eagleson.org/CDC

EXHIBITORS

Exciting opportunities to connect with your colleagues are being planned now.

Stay tuned for details.

For late-breaking conference information,join the conversation

#BIOSAFETY2016

MEET OUR SPONSORS AND EXHIBITORS AT THE OPENING RECEPTION ON

SUNDAY, JANUARY 31 FROM 5:00 - 6:30 PM

SILVER SPONSORS

Bakerbakerco.com

Booth #12

Elizabeth R. Griffin Research Foundation

ergriffinresearch.org

NuAirenuaire.comBooth #15

BRONZE SPONSORS

Cornerstone Commissioning, Inc

cornerstonecx.comBooth #28

Germfree Laboratories, Inc

germfree.comBooth #34

EXHIBITORS

Allentown, Incallentowninc.com

Booth #30

Arcoplastarcoplast.com

Booth #39

Art’s Way Scientific, Incbuildingsforscience.com

Booth #40

bioBUBBLE, Incbiobubble.com

Booth #23

Biosafety & Biosecurity Training Coursebbtcfortcollins.com

Booth #24

Carter 2 Systems, Inccarter2systems.com

Booth #19

ClorDiSys Solutions, Incclordisys.com

Booth #20

DRS Laboratories, Incdrslaboratories.com

Booth #21

ENV Services, Incenvservices.com

Booth #10

Life Science Products, Inclspinc.comBooth #16

Lord Aeck Sargentlordaecksargent.com

Booth #22

Quip Laboratories, Incquiplabs.com

Booth #31

Steris Corporationsteris.comBooth#13

Tecniplasttecniplastusa.com

Booth #3

WSP / Parsons Brinckerhoffwspgroup.com/usa

Booth #29

To Exhibit or Sponsor, please download an exhibitor packet at: eagleson.org/CDC

Presented in Partnership by the American Biological Safety Association and the

Eagleson Institute

REGISTRATION INFORMATION

HOTEL INFORMATIONThe Crowne Plaza Ravinia is located in the heart of Atlanta’s Perimeter Center, across the street from the Perimeter Mall. It is surrounded by ten acres of lush Japanese gardens containing walking trails.

Amenities include: high-speed internet access in all rooms, an indoor pool and health club, and three restaurants. In addition, the hotel provides complimentary shuttle service to the MARTA train station. The MARTA provides continuous transportation to and from the airport, as well as a variety of other Atlanta locations.

A block of rooms has been reserved at the special rate of $138.

To make reservations, call +1 (770) 395-7700 or visit www.eagleson.org/CDC for a link to the hotel’s room registration website. Please indicate that you will be attending the CDC Biosafety Symposium. Reservations must be received by January 15, 2016.

SYMPOSIUM FEES: Fees include Opening Reception, Symposium Banquet, attendance at Symposium sessions and lunch on Monday and Tuesday

FEES By December 18, 2015 After December 18, 2015SYMPOSIUM $725 $7954 HOUR PRESYMPOSIUM WORKSHOP $225 $225FULL DAY PRESYMPOSIUM WORKSHOP $325 $325BANQUET GUEST $75 $75

REGISTRATION INFORMATION: To register for this symposium online, please go to www.eagleson.org/CDC or call +1 (207) 490-1076 to register by phone or request a registration form.

CANCELLATION POLICY:Individuals who cancel more than 15 business days prior to the class date will receive a full refund. For cancellations made 6 to 15 business days before the start of the program, a 50% refund will be given. For cancellations made 5 business days or less prior to the class date, no refunds will be given. Notification of cancellation must be received in writing. Substitutes for a registered attendee may be made at any time.

www.eagleson.org/CDC

January 30 - February 3, 2016Crowne Plaza Ravinia, Atlanta, GA

eagleson.org/CDC#BIOSAFETY2016

EAGLESON INSTITUTEPO Box 954 • Sanford ME 04073

207-490-1076 • eagleson.org

NON PROFIT ORGUS POSTAGE

PAIDPORTLAND, MEPERMIT NO. 284

14th CDC International Symposium on Biosafety

Biosafety ManagementPlanning for the Future by Learning from the Past

Presented in Partnership by the American Biological Safety Association and the Eagleson Institute