John Hott
Dr. Hott is a Product Stewardship and Regulatory Affairs executive with more than 30 years of experience leading stewardship, compliance, quality, and EHS organizations across chemicals, agrochemicals, personal care, food ingredients, drug excipients, food contact materials and animal nutrition products. He has worked with regulatory agencies around the globe, including the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and comparable international agencies, and has led or managed product stewardship teams at Evolved By Nature, Eastman Chemical, Syngenta, Arch Chemicals/Lonza and Ashland. Dr. Hott currently advises the Board of Shield Nutraceuticals, founded Compliance and Regulatory Strategies LLC, and consults for the Yordas Group, which was recently acquired by 3E.
John has been a regular speaker at GlobalChem and the Product Stewardship Society Conference (PSX). He previously chaired The Conference Board’s Product Stewardship and Regulatory Affairs Council, the Household and Commercial Products Association’s International Affairs Council and is a past President of the Product Stewardship Society. Dr. Hott serves on the Member Advisory Council of Change Chemistry (formerly GC3), the Green Chemistry and Commerce Council founded at the University of Massachusetts Lowell. Dr. Hott received his Ph.D. in Chemistry from the Georgia Institute of Technology, where he collaborated with Columbia and Emory Universities, and his undergraduate degree from Mercer University.
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:
John Hott, Client Solution Principal Consultant, Yordas Group
Adel Malek, Regulatory Consultant and Applied AI Workflow Architect, Yordas Group by 3E
Julius Reitemeier, Senior Scientist, Exponent