Occupational Health and Safety Programs, an In-depth Discussion of Regulatory Requirements and Common Practices

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During the training, didactic sessions will be used to facilitate question and answer opportunities on the components of an institution’s OHSP. In addition to a detail-oriented slide deck (Power Point presentation), attendees will review and discuss the primary components of OHSPs. The meeting will also provide individuals the opportunity to identify, share and discuss best/common practices that are used regarding OHSPs. 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 community best practices. 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

The objective of the OHSP meeting is to perform an in-depth analysis of the regulatory requirements institutions must observe for developing, implementing, and managing an OHSP. During the meeting, attendees will define and discuss common practices used across the research compliance community. The primary focus of the meeting is to analyze the OHSP elements associated with Biohazards used in a laboratory, and the use of all hazards (e.g., biological, chemical, and physical) in conjunction with animal models. The influencing regulations, for example, include: 1) The NIH Guidelines, The Guide for Care and Use of Laboratory Animals, The BMBL, Occupational Health and Safety in the Care and Use of Animals, Codes of Federal Regulations (42 and 29 CFRs), HIPPA Laws, the Americans with Disabilities Act, and Pregnancy Discrimination Act of 1978.

The program is intended to support the training needs of both IBC and IACUC Administrators, or anyone (e.g., IBC and IACUC chairs, compliance monitors and directors, and compliance committee members) else having a role in related research compliance programs. Questions to be answered:

  1. What governance documents were established that ensure the proper facilitation of the institutions OHSP?
  1. What units within an institution should have a role in the operations and management of its OHSP?
  1. What personal medical practices should be in place to support the health and wellbeing of every individual having direct or incidental exposure to hazards used with the Life Sciences?
  1. How are relevant research related hazards identified, risk assessed, classified, and managed?
  1. What methods are used to control identified hazards?
  1. What processes have been established to identify and manage laboratory exposures?

Participants are encouraged to submit (wggreer@umich.edu) questions regarding OHSPs 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. Program Governance, what do each of the regulations require, and how do the regulations overlap.
  1.  How should/do various units (e.g., IACUC and IBC Administrators, EHS, Animal Care, Medical Offices and HR) duties overlap?
  1. How do institutions satisfy the requirements regarding “personal” medical evaluations and subsequent surveillance plans?
  1. How are hazards identified, assessed, and categorized? What animals should be in containment housing vs. ABSL 2 (etc.)?
  1. What methods are used to mitigate personal exposures?
  1. What do OHSP type training programs look like and what do they cover?
  1. What processes are in place to control and manage exposures?

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.

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.

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.

Guest Faculty Members – To be announced

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 meetings times are Eastern Time Zone.

When
September 21st, 2022 11:30 AM through  4:30 PM
Location
Webinar
Event Fee(s)
Nonmember's Attendance Fee $300.00
Member's Attendance Fee $200.00