Biosafety and Export Control Programs Overlap – Operations Focused!

 Registration is closed for this event
During the training, didactic sessions will be used to facilitate question and answer opportunities covering the overlap of the IBC and Export areas. In addition to a detail-oriented slide deck (Power Point presentation), attendees will briefly review and discuss the primary laws governing IBC and Export Control oversight. Dr. W. Johnson will provide a brief overview of the export control federal expectations and talk about some of the most common questions received regarding biologics. The training will also use scenarios that will challenge attendees to consider, deliberate, and develop action plans for a variety of situations with the goal of identifying the general points that may be included in an institution’s MOU. During the session, attendees will collectively discuss the topic by, for example, posing questions to the speakers and other attendees, offering their own effective ideas, and ultimately identify compliant processes for managing and overseeing a Biosafety Program.

Meeting Objectives

Biosafety Administrators Association (BSAA) faculty and Dr. Westley Johnson (US Department of Commerce, Chemical and Biological Controls Division) will work with meeting attendees to develop a Memorandum of Understanding (MOU) template that can be implemented at each institution. The goal of the MOU will be to provide practical criteria that can be implemented through Biosafety and Export Control Compliance units to ensure they are working in unison to protect the interest of the research scientists and ultimately the institution.  

The development of the MOU will be based on didactic and scenario sessions, which will drive the specific points defined in the MOU template.

Questions to consider:

  1. Regarding biologics that are covered by the Export Control Laws; are they only Select Agents? No, the Export Control Laws cover many biologics, including biological toxins, that are not classified as Select Agents.

 

  1. Are your faculty members shipping animals internationally that require Export Control Licensing? Probably, if the animal’s genetic composition requires IBC oversight (NIH Guidelines) and the export laws classify them as a controlled commodity, or if the animals are carrying a controlled commodity such as a biological agent or a segment of DNA.

 

  1. Do you have faculty working with strains of Clostridium, Mycoplasma, Salmonella, or Shigella? Many of these require an Export Control license; has your IBC informed your Export Control Unit. In addition, a lot of viruses that are not Select Agents are export controlled.

 

  1. Do you have scientists studying plant pathogens? Many plant pathogens are export controlled (e.g., strains of Pseudomonas).

 

  1. Do members of your Biosafety and Export Control Compliance Units have a formalized process for communication? Should they?

 

  1. What methods do you use to identified biological hazards that are also regulated under the Export Control Laws?

 

Participants are encouraged to submit (wggreer@umich.edu) questions regarding controlled biologics (export and biosafety) PRIOR TO the event. During each session, attendees will be encouraged to discuss their own institutions practices and ideas.

Brief List of Discussion Points (Subject to change)

Opening Remarks

  1. Understanding how to use the resources and where to find relevant information.
  1. Specific examples of a collaborative process.
  1. Intellectual Property and Material Transfer agreements; what do they tell the IBC Administrator and the Export Control Officer
  1. Material Security Processes – any information to be gained?
  1. Executive Officers – what are they aware of, what do they expect, practical discussions
  1. Risk Tolerance – what is your institution comfortable with – Export Control; fines and a such; IBC – loss of grant money and future opportunities OR potentially both
  1. Scenario Discussions…

 

Program Facilitators and Standing Faculty

Bill Greer, Assistant Vice President for Research, University of Michigan

Bill graduated from The Pennsylvania State University in 1985 with a degree in Microbiology.  He currently oversees the animal care and use, biosafety, lab safety, controlled substances and autonomous systems research compliance programs.  His previous roles included the Associate Director for Research Compliance, IACUC Vice-Chair, and Biosafety Committee Chair at The Pennsylvania State University, and the production manager and safety director at Intervet, State College, PA (Formally Tri Bio Laboratories). Bill has overseen animal care and biosafety programs for over 30 years. 

In 2005, he organized and held the very first research administrators Best Practice Meeting, which establish a venue for research oversight professionals to informally meet and discuss programmatic concerns.  He continues to facilitate at least five annual Best Practice meetings covering both biosafety and animal care and use programs.  In 2010, he chaired the founding committee for the non-profit education based IACUC Administrators Association (IAA), and continues to serve as the organization’s president and chair of the board of directors.  Since 2007, Bill has served as ad hoc consultant to AAALAC Council where he performs institutional program reviews, assessments, and status determinations.  He served as a member of the Council of Certified Professional IACUC Administrators (CCPIA).  Bill continues to serve as an educator for the IBC and IACUC Administrative communities and has lectures at multiple venues including PRIM&R, AALAS, BTAA, and C3, as well as facilitates IBC and IACUC Best Practice Meetings.

Jonah Lee: As the Acting Senior Associate Director for the Animal Care & Use Office (ACUO), Dr. Lee brings experience and a proven track record in the biomedical sciences and academic research administration to provide thoughtful leadership, program oversight, and process optimization with specific attention to researcher/user-experience coordination across the Animal Care & Use Program.

In collaboration with other U-M research administrative departments and academic department leadership, Dr. Lee is charged with the strategic development of research engagement infrastructure and resource support.

Dr. Lee has an extensive background in the biomedical life sciences and applied translational sciences, where his research focus involves stem cell biology and regenerative medicine in aging skeletal muscle.  Along with his postdoctoral research experience at the Center for Muscle Biology at the University of Kentucky, and his work at U-M, his animal research experience includes considerable diversity in both small and large animal models across multi-disciplinary and inter-departmental research projects.  His applied human research studies are centered around muscle adaptation and applied exercise metabolism. 

Andrew Maksymowych, Ph.D., Associate Director, Biosafety Programs

Andrew has been at the University of Pennsylvania since 2006.  He is Penn’s Associate Director for Biological Safety Programs, Penn’s Institutional Biosafety Officer, IBC Administrator, and the Institutional Contact for Dual Use Research.  He sits on the Vice Provost’s for Research, Human Research Advisory Committee, the Human Stem Cell Research Advisory Committee, and the Cadaver and Body Parts Oversight Committee.  Andrew obtained his B.S. and M.S. degrees from Villanova University, and his Ph.D. in Biochemistry from Bryn Mawr College.  He has more than 20 years of teaching and 35 years of research experience.  A major portion of which included oversight of research safety and compliance programs.  Prior to his journey at Penn, he held a faculty appointment at Thomas Jefferson University where his research focused on the analysis of structure-function relationships in proteins, including protein toxins that poison the human nervous system.  Most recently, the mechanism of action of botulinum neurotoxins.  Andrew attended his first Best Practice Meeting in 2015 and has since been continually involved with Biosafety Administrator’s Association.

Raymond F. Scheetz, MS, RBP is currently the Institutional Biosafety Officer and a Compliance Manager at The Penn State University College of Medicine in Hershey, Pa, located in the Research Quality Assurance office a division of the College of Medicine Office of Research Affairs.  He is responsible for the oversight of all Biosafety compliance aspects within the College of Medicine, providing ancillary reviews of IACUC and IRB protocols, biosafety training and required annual lab surveys, administration liaison for research lab activities and emergencies, and operation of the equipment and asset management plan. He is a member of the College of Medicine Institutional Biosafety Committee, Research Mission team and COVID 19 Ramp up Research task force.  Ray also serves as a Biosafety consultant for CBS (Clinical Biosafety Services)/Shield Consulting.  Formally the Lab Manager in the Department of Microbiology and Immunology at the Penn State College of Medicine for 25 years.  Responsibilities included the Management of the BL3 facility located within the Department.

Guest Faculty Members – Others to be announced

Quinton Johnson currently serves as the Chief Compliance and Export Control Officer for University of North Carolina at Chapel Hill. Upon graduation from Wake Forest University School of Law, Quinton began his career in research administration at VCU and served as the director of VCU’s export and trade sanctions compliance program. Quinton is a member of the Association of University Export Compliance Officers and has presented at several conferences across the country including SRA International. He is experienced in identifying gaps in regulatory compliance in the university setting, creating compliance efficiencies through process improvement, cost-benefit analysis, and systems testing, and improved communication. Before his time at VCU, Quinton taught Business Law at Forsyth Technical Community College, researched policy at George Washington University, and spent time at the law firm Tolin and Elam PLLC.

Wesley Johnson, Bureau of Industry and Security, the U.S. Department of Commerce

Dr. Wesley Johnson is a microbiologist with the U.S. Department of Commerce.  He holds a BS and PhD in marine science and has an extensive background in microbial ecology, molecular microbiology, functional genomics, and metagenomics.  He has served for seven years as a licensing officer and technical subject matter expert for the Chemical and Biological Controls Division of BIS, which implements the Export Administration Regulations for export of dual-use biological and chemical commodities and technologies.  Dr. Johnson also serves as the biological technical expert for the Department of Commerce for the Australia Group multilateral export control regime, with a primary focus on synthetic biology and emerging biotechnologies.

William E. Bucha, Jr., Esq., EAR/ITAR (ECoP®), Export Compliance Manager, University of North Carolina at Chapel Hill.

William is currently the Export Compliance Manager in the UNC-Chapel Hill Office of Institutional Integrity and Risk Management (IIRM). In this capacity, William works with the University Chief Compliance Officer on the strategic development, modification, and management of the University’s Export Compliance Program. This work is done primarily through the creation, implementation, and management of consistently effective export control review procedures for all pertinent University activities. William serves as a non-voting member on UNC-Chapel Hill’s Institutional Biosafety Committee (IBC) and routinely provides guidance to University faculty, staff, and students on the procedural intersection between biosafety and export controlled biologics. Having previously worked at multiple R1 institutions, William continues to enjoy assisting University faculty, staff, and students in achieving the institutional research potential while maintaining export compliance obligations. William is a licensed attorney of the New York State Bar and is also a certified EAR/ITAR Export Compliance Professional (ECoP®).

 

Programs Support

The Biosafety Administrator Association (BSAA) meetings and related activities are supported through BSAA memberships and event attendance fees.  Membership fees through ongoing involvement from the community allow the BSAA to keep activities fees at a minimum.  We ask that you please become a new member or maintain your membership status (memberships are renewed annually).  If you are a current member of the BSAA, you are free to attend BSAA meetings at significantly reduced rates.  Individuals that are non-members or those with expired memberships will be asked to provide $300 in support for each meeting they attend.

 

The meeting times are Eastern Time Zone

When
October 5th, 2022 11:30 AM through  4:30 PM
Location
Electronic Meeting
Event Fee(s)
Nonmember's Attendance Fee $300.00
Member's Attendance Fee $200.00