Topic Summary

Animal experiments that involve the use of recombinant or synthetic nucleic acid molecules are governed through the NIH Guidelines, and in some cases the FDA and Export Control regulations. 

During this webinar, we plan to discuss:

1. The production of transgenic animals;
2. When the use of transgenic animals is exempt under the NIH Guidelines;
3. Ways to minimize regulatory burden associated with transgenic animal use;
4. The FDA/Export Control expectations;
5. Experiments involving animals; and
6. USDA proposed changes to the oversight of genetically modified animals.

We will consider the regulatory requirements, use scenarios, and question/answer sessions to explore and understand the specifics of the topic. 

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 producing and overseeing the use of transgenic animals.      

Meeting Facilitators and Presenters

Bill Greer, BS:  received his Bachelor’s in Microbiology from Penn State University in 1985.  He currently serves as the Assistant Vice President for Research at the University of Michigan.  His previous roles included Associate Director for Research Compliance at the Pennsylvania State University, and research technician, production manager and Safety Officer at Intervet, State College, PA (Formally Tri Bio Laboratories).  In 2005, he organized and held the first IACUC Administrators’ Best Practices Meeting, which establish a venue for administrators meet informally and discuss programmatic concerns.  He continues to facilitate at least three annual Best Practice meetings.  In 2007, he initiated the process of establishing the IACUC Administrators Association (IAA), which is a professional organization of IACUC Administrators.  In 2010, he chaired the founding committee for the non-profit education based IAA organization.  He now serves as the president and chair of the IAA board of directors.  Since 2007, Bill has served as ad hoc specialist to AAALAC Council where he participates in institutional program reviews, assessments, and status determinations.  He served as a member of the Council of Certified Professional IACUC Administrators (CCPIA).  He continues to facilitate training activities at multiple venues including PRIM&R, AALAS, BTAA, C3, and both IACUC and IBC Administrators Best Practice Meetings.

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.

Meeting Times are in Eastern Standard Time