Qingdong (Karin) Ke, Ph.D., is a board-certified toxicologist (D.A.B.T.) and a European Registered Toxicologist (ERT) specializing in toxicology, risk assessment, product safety, and regulatory affairs. She collaborates with food lawyers and supports multinational companies on the regulatory compliance and safety of food and food ingredients, with a unique emphasis on alternative proteins (plant- and cell-based/cultivated, precision fermentation). Karin performs gap analysis of the data and prepares regulatory dossiers for submission to agencies in the United States (U.S.), Europe, Asia, and other regions.
Karin has extensive experience in providing regulatory strategies, conducting safety evaluations, performing risk assessments, and providing litigation support involving a broad range of products, such as food and animal foods and veterinary ingredients, dietary supplements, medical devices, drugs, cosmetics, household products, pesticides, and industrial chemicals, as well as impurities and other constituents in these products.
Karin provides support to clients to ensure that products comply with the regulatory and scientific requirements of the U.S. Food and Drug Administration (FDA), Environmental Protection Agency (EPA), California Proposition 65, the European Food Safety Authority (EFSA), the Singapore Food Agency (SFA), the Australia New Zealand Food Standards Code (FSANZ), the European Union (EU) Cosmetics Directive and Regulation, the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), and other global regulations. She is experienced in FDA submissions of Generally Recognized As Safe (GRAS) Notifications, Food Additive Petitions (FAPs), Color Additive Petitions (CAPs), New Dietary Ingredient Notifications (NDINs), and Novel Food Applications to SFA and FSANZ, among others.
Prior to joining Keller and Heckman, Karin was a toxicologist and product safety specialist in the consumer products industry, where she performed hazard and risk assessments for human health, reviewed safety of raw materials and formulations, developed and managed models for risk assessment, and ensured product safety and regulatory compliance.
Karin was the President of the Food Safety Specialty Section (FSSS) and served as the Secretary of the American Association of Chinese in Toxicology (AACT) of the Society of Toxicology (SOT). She has authored and co-authored numerous scientific articles for peer-reviewed journals and book chapters, some of which were selected as the journal cover story. She is a frequently invited manuscript reviewer for scientific journals, such as Food and Chemical Toxicology, Toxicology and Applied Pharmacology, and Carcinogenesis.
- Society of Toxicology (SOT)
- SOT, Food Safety Specialty Section
- SOT, Regulatory and Safety Evaluation