Julius Reitemeier
Dr. Julius Reitemeier is a Scientist in Exponent’s Chemical Regulation and Food Safety practice in Washington, DC. He specializes in (1) FIFRA regulatory submissions and stewardship for antimicrobial products, (2) root-cause analysis of chemical impurities in consumer product formulations, and (3) large-data solutions, leveraging AI/ML to accelerate regulatory and technical workflows. He has authored numerous publications in bioanalytical chemistry and chemical engineering journals and has developed novel analytical approaches and data processing models to characterize impurities in complex drug formulations. Dr. Reitemeier earned his Ph.D. in Analytical Chemistry from the University of Notre Dame and completed his B.S. and M.S. in Organic Chemistry at the University of Heidelberg, Germany.
Tuesday Dec 8
Scientific Affairs Committee and Task Force Meeting
Scientific and regulatory professionals are navigating two rapidly evolving areas: the use of generative AI in regulatory workflows and new hazard classes for persistent and mobile substances. This session will explore both topics, providing practical guidance on responsible AI use and an update on the science and regulatory direction for persistent, mobile substances, using trifluoroacetic acid (TFA) as a case study.
AI Governance in Regulatory Workflows: Generative AI is increasingly being incorporated into regulatory work, from label changes to agency responses, raising new questions about how AI-generated outputs may be evaluated by regulators or opposing counsel. This interactive presentation will focus on three capabilities that can help make AI use defensible: governance, human-in-the-loop workflow design, and auditability. Drawing on frameworks from the EPA, FDA, and the Institute of Internal Auditors, this session will include live polling on the risks associated with AI-assisted decisions and a practical workflow design exercise.
Highly Mobile Substances: In 2023 the EU added two hazard classes – persistent, mobile and toxic (PMT) and very persistent, very mobile (vPvM) – for substances that move with water and are only partially removed by conventional treatment. Using TFA as a case study, this session will examine the evolving science and regulatory landscape, including the hazard-versus-risk debate, the path from EU classification to drinking water standards and restrictions, diverging U.S. federal and state PFAS definitions, and key considerations for ingredient portfolios and suppliers.
Speakers:
Adel Malek, Regulatory Consultant and Applied AI Workflow Architect, Yordas Group by 3E
Julius Reitemeier, Senior Scientist, Exponent