Dr. Sharon Koh-Fallet is the Branch Chief for the Regulatory Review Branch in the Division of Food Contact Substances (DFCS) in the Office of Food Additive Safety (OFAS) in the U.S. FDA. Dr. Koh-Fallet has worked on a variety of review work within DFCS ranging from premarket industry submissions to post-market safety review projects. Dr. Koh-Fallet received her Bachelor of Science degree as a dual major in Chemistry and Physics from James Madison University in 2002. She received her doctorate in Chemistry from Northwestern University in 2007. Following the completion of her doctorate degree, Dr. Koh-Fallet worked at Milliken & Company for 6.5 years as a Research Chemist. Dr. Koh-Fallet then worked at the Naval Research Laboratory as a postdoctoral fellow, followed by a position as a staff scientist at Strategic Analysis, Inc., where she served as scientific and technical support to various government program managers. Dr. Koh-Fallet joined the FDA in January of 2017. Since 2019, Dr. Koh-Fallet has served as a team lead and was promoted to Branch Chief in July 2022, in the regulatory review branch, where she continues to assist in managing premarket industry submissions, and other projects for both herself and the branch.
Danny Rubenstein provides strategic counseling to industry regarding regulatory compliance requirements for food packaging materials and food ingredients across the globe.
With a technical background in Industrial Engineering, Danny recognizes the importance of providing clients with timely and actionable advice regarding critical regulatory decisions that drive product innovation, marketing, and promotion. Danny leverages this experience to assist companies in proactively establishing compliance for products under the laws and regulations administered by the US Food and Drug Administration (FDA). He also is familiar with food contact material regimes in the European Union (EU) and jurisdictions throughout Asia and South America.
Food Engineer, MSc and PhD in Food Science from the Faculty of Food Engineering/UNICAMP.
Scientific Researcher at Cetea/Ital, Brazil and specialized in the assessment of package/product
interaction and national and international packaging legislation. Member of the Workgroup of
FCM of ANVISA and official member of the MERCOSUR Subcommittee on Food Packaging, SubWorkgroup III, Technical Standards. Professor at the Master’s Program of Food Science &
Technology from Ital.
Kimberly Sheehy is a regulatory affairs leader with more than a decade of experience in global food-contact material compliance across the packaging value chain. With a Master's degree in Biochemistry from Northern Illinois University, she has built her career at the intersection of science, risk assessment, and regulatory strategy, helping organizations navigate complex and evolving regulatory requirements.
As Global Regulatory Manager at Tekni-Plex, Kim leads regulatory compliance initiatives for sealing, lidding, and tubing products used in consumer and food-contact applications worldwide. Having worked in consulting as well as at both the brand owner and converter levels of the supply chain, she brings a unique, end-to-end perspective on regulatory challenges and opportunities. Her expertise spans global food-contact regulations, with a focus on risk assessment, chemicals of concern, regulatory intelligence, and practical compliance solutions.
A recognized industry thought leader, Kim is a frequent speaker at food-contact and packaging conferences and serves on the Executive Board of the Food Safety Alliance for Packaging (FSAP), a technical committee of the Institute of Packaging Professionals (IoPP). In recognition of her contributions to the packaging industry, she was named one of PMMI's 2024 Women in Packaging & Processing.
• Scientific Evaluator in the Food Packaging Materials and Incidental Additives Section of the Bureau of Chemical Safety at Health Canada since 2006.
• Our work includes conducting evaluation of the chemical safety of food packaging materials and Incidental Additives.
• Received a Bachelor in Science Honours Chemistry Co-operative Education Program at the University of Ottawa, Canada.
