Program Summary, Discussion Points and Brief Agenda

Research institutions must operate programs that protect the health of personnel working with hazardous biological agents and animals. While regulations and guidance documents may title these programs differently, Medical Surveillance under biosafety and Occupational Health and Safety under animal care, their foundations and expectations are functionally the same. Understanding one equips you to manage the other, with only minimal differences.

Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (April 2024), institutions must implement Medical Surveillance Programs when conducting:

• Large-scale rDNA production, or
• Work involving Risk Group 3 or higher organisms.

In addition, the Guidelines recommend Medical Surveillance for work involving Risk Group 2 agents, which is further reinforced by the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th Edition. The BMBL clearly states that a comprehensive Occupational Health Program is a fundamental component of any biosafety program, and that risk-based medical evaluations should be conducted for personnel exposed to biological agents. Specific BMBL expectations include:

• Pre-placement medical evaluations
• Periodic health assessments based on risk
• Access to immunizations (e.g., tetanus, hepatitis B, rabies)
• Evaluation following occupational exposure
• Confidentiality of health information
• Integration with biosafety training and PPE use

In parallel, institutions with animal care and use programs are required by the Guide for the Care and Use of Laboratory Animals and Occupational Health and Safety in the Care and Use of Research Animals to operate a robust Occupational Health and Safety Program (OHSP). These programs address both physical and biological risks and must include health evaluations for personnel with animal contact.

Importantly, OHSPs are always evaluated during AAALAC International site visits. A clear understanding of these expectations is critical to prepare for and maintain accreditation.

This session will unify both perspectives biosafety and animal care to help administrators streamline efforts, build effective programs, and reduce regulatory risk.

Agenda Highlights

• Medical Surveillance (NIH Guidelines) vs. Occupational Health (Animal Research Guidance)
• Specific expectations under BMBL 6th Edition for Risk Group 2 and above
• Required and recommended components of a compliant health program
• OHSP expectations during AAALAC accreditation site visits
• Integration of biosafety and animal care frameworks
• Common institutional challenges and practical solutions
• Open Q&A with case examples

Programs Support

Maintaining an BSAA membership provides valuable benefits, including access to exclusive discounts on programs, resources, and services that enhance professional development and organizational efficiency. BSAA activities are supported through memberships, and event fees.

We encourage you to join or renew your membership annually. As a member, you can attend webinars for free and receive discounted attendance fees at both online and in person meetings.

Memberships are important!

Support the vital work of the association while unlocking exclusive benefits designed to enhance your professional growth. By becoming a member, you ensure our ability to continue providing top-tier professional development opportunities—not just for IBC administrators, but for anyone involved in their organization’s Institutional Biosafey Program.

As a member, you’ll enjoy free access to regular webinars throughout the year, discounted rates for online and in-person virtual meetings, and a host of resources to support your career and program management goals.

Don’t miss out please secure or renew your membership today.  

Join us in shaping the future of animal care and use program compliance while reaping the rewards of BSAA membership!

Presenter(s) Biographies:

Standing BSAA Faculty and Facilitators

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 oversees research compliance programs for animal care and use, biosafety, lab safety, controlled substances, and autonomous systems. Over his 30+ year career, Bill has held roles including Associate Director for Research Compliance, IACUC Vice-Chair, and Biosafety Committee Chair at Penn State, as well as production manager and safety director at Intervet (formerly Tri Bio Laboratories).

In 2005, Bill organized the first Research Administrators Best Practice Meeting, creating a platform for research oversight professionals to discuss programmatic concerns. He continues to facilitate at least five annual Best Practice Meetings focused on biosafety and animal care and use programs. In 2010, he chaired the founding committee of the IACUC Administrators Association (IAA), a nonprofit organization dedicated to education and serves as its president and board chair.

Since 2007, Bill has been an ad hoc consultant to the AAALAC Council, conducting institutional program reviews and assessments. He also served on the Council of Certified Professional IACUC Administrators (CCPIA). As an educator, Bill regularly lectures at conferences including PRIM&R, AALAS, BTAA, and C3, and facilitates IBC and IACUC Best Practice Meetings, continuing to support the IBC and IACUC administrative communities.

Jonah Lee, BS, MS, PhD, Senior Associate Director, University of Michigan

Dr. Lee brings experience and a proven track record in the biomedical sciences and academic research administration to provide thought 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 life sciences, where his research focus involves stem cell biology and regenerative medicine in aging skeletal muscle. Along with his postdoctoral research 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-departmental, federally funded research projects. 

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

Ray 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.