Regulatory Framework for Nucleic Acid Synthesis Screening (Implementation by April of 2025)
Brief Agenda and Discussion Points
Join the Biosafety Administrators Association (BSAA) for an exclusive webinar exploring the newly released “updated” Framework for Nucleic Acid Synthesis Screening, developed under President Biden’s Executive Order on AI. This forward-looking framework, equivalent to Dual Use Research of Concern (DURC) standards but broader in scope, aims to prevent the misuse of synthetic nucleic acid production while supporting groundbreaking advancements in synthetic biology.
The framework introduces robust expectations to ensure that information and technology critical to nucleic acid synthesis are not exploited for harmful purposes. It addresses risks associated with unregulated pathogens, novel genetic sequences, and Sequences of Concern (SOCs), establishing requirements for federally funded researchers and encouraging industry-wide adoption of secure practices.
Learn about the framework's key elements, its implications for researchers, industry, and funders, and how it aligns with national goals for safe and responsible AI development.
Key topics include:
- Implementation Grace Period: A grace period until April 2025 has been established for federally funded researchers and institutions to fully implement the framework.
- Exempted Sequences: Providers may remain compliant when exempted sequences, categorized as SOCs (sequences of concern), pose no known pathogenic or toxicity risk, without verifying customer legitimacy for these sequences.
- Self-Attestation Requirements: Providers and manufacturers must ensure self-attestations are signed by authorized representatives, include updated contact information, and commit to notifying customers of any changes to framework adherence. Annual updates are required by January 1st or sooner if point-of-contact details change.
- Customer Identity Assessment: Providers and manufacturers must assess customer identity for all orders while verifying customer legitimacy specifically for orders containing SOCs.
This regulatory framework exceeds traditional DURC standards by addressing modern challenges, such as the accessibility of benchtop synthesis equipment and the versatility of RNA and DNA conversion techniques.
Don’t miss this opportunity to engage with colleagues and understand how these policies shape the future of synthetic biology.
Register Now to Secure Your Spot!
Stay ahead of these changes and ensure your institution is ready. Submit related questions in advance to wggreer@umich.edu and join us to prepare for this important regulatory update!
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Guest Speaker: Ryan McAllister, Rutgers University Biosafety Program Manager
Dr. Ryan McAllister (Ph.D.) is the biosafety program manager, lead university biosafety officer, and alternate responsible official at Rutgers University. In this position, he oversees a staff of 7 professionals across 3 campuses. Before his time at Rutgers, Dr. McAllister served as Stanford University’s assistant biosafety officer and completed a Biosafety fellowship within the University of Louisville’s environmental health and safety office. Dr. McAllister’s career began in academia at Northern Michigan University where he received a Bachelor of Science in Biochemistry, followed by a Master of Science and Doctor of Philosophy from the University of Louisville. Dr. McAllister holds two credentials, the Registered Biosafety Professional credential through the American Biological Safety Association and the Biorisk Management credential through the International Federation of Biosafety Associations. In addition, Dr. McAllister also is involved in consulting related to biosafety, biosecurity, human gene therapy, and artificial intelligence through various organizations.
Standing BSAA 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 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.
The Meeting Time is EASTERN TIME ZONE
When: February 19, 2025, from 3:00 PM to 4:30 PM
Webinar - This session will be held remotely.
BSAA Nonmembers Registration Fee | $75.00 |
BSAA Member's Attendance Fee | $0.00 |