Biomed/Biotech SIG: How Are Candidate Ingredients Reviewed at FDA  

To be presented by

Director, Division of Human Food Safety

Office of New Animal Drug and Evaluation 

Center for Veterinary Medicine, US FDA

6:00 – 6:20 PM – Networking; Pizza/drink 

6:20 – 8:30 PM – Program 

8:30 – 8:45 PM – Door-prizes drawing; Networking

Open to Public - $5 for non-ASQ members to cover pizza/drink cost; 

Free to ASQ Members, students, local interns, postdocs, FDA Commissioner’s Fellows, and current job-seekers 

Location: Kelly’s Deli Conference Center, 7519 Standish Place, Rockville, MD 20855

Registration Deadline: Please register by Thursday noon, January 26, 2012.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; gchang2008@yahoo.com or 240-793-8425 (cell).

Dr. Ekelman will discuss the various ways in which chemicals that are, or may be, human carcinogens are reviewed - and sometimes approved - as food additives, animal feed ingredients, and new animal drugs at the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) of US FDA.  She will provide examples and describe some of the current unresolved policy issues associated with such substances.  

Dr. Karen Ekelman has a PhD in developmental biology from the Ohio State University, where she studied mechanisms of human chemical carcinogenesis with Dr. George Milo.  After graduation, Karen conducted research in this area for several more years at the Argonne National Research Laboratory and at the University of Chicago School of Medicine.  After moving to Maryland, Karen earned a MPM (Masters of Public Management) degree at the University of Maryland – College Park and spent several years as an IEEE Science Fellow at the USEPA and as a Fellow at the National Academy of Engineering, National Academy of Sciences, working and writing in the areas of environmental and human health risk assessment policy and practice.  

In 1987, Karen joined FDA’s Center for Food Safety and Applied Nutrition (CFSAN) as a toxicologist in the Office of Food Additive Review (OFAR).  During her 14 years with CFSAN, she was recognized as an expert in the review of carcinogenic food additives, break-down products, and constituents, and served as Executive Secretary of CFSAN’s Cancer Assessment Committee.  In 2001 Karen joined Center for Veterinary Medicine (CVM) as Leader of the Feed Safety Team in the Division of Animal Feeds/Office of Surveillance and Compliance (OSC), and in 2008 she became Director of the Division of Human Food Safety in CVM’s Office of New Animal Drug Evaluation (ONADE).