Microbiological Research at OARSA/CFSAN/FDA -Preparing for Emergencies

Dr. Marleen M. Wekell, Ph.D., Director, Office of Applied Research and Safety Assessment (OARSA), Center for Food Safety and Applied Nutrition (CFSAN), FDA, Laurel, Maryland

Much of the research at OARSA is geared towards preparing for microbiological emergencies. These emergencies can include examination of the genomics of microorganisms responsible for food borne illness, or analysis of samples for materials intentionally added to foods or the environment such as anthrax spores. Preparation for emergencies requires setting up an infrastructure and developing procedures that can be deployed when needed. This involves a certain amount of skill (and luck!) in correctly forecasting which emergencies are likely to arise. It takes resources and commitment to achieve a state of functional readiness which also fits into the ongoing research program at FDA. Emergency readiness is built on several key components which include: 1. good leadership; 2. personnel on board with appropriate skill sets; 3. ties to counterparts 3. facilities; 4.equipment; 5. on-going training program; 6. QC/QA measures. When emergencies do arise, personnel need to be flexible and if it requires work 24/7, care must be taken to avoid employee burn out. Data reporting and adequate sample storage need to be anticipated as well. CFSAN has developed the Microbiology Emergency Response Team (MERT) to ensure that scientists are properly trained to meet emergencies. In addition, OARSA is a part of the Food Emergency Response Network (FERN) set up after 9/11 to coordinate the state and federal laboratories in the U.S. responsible for analyzing foods, and the CDC Laboratory Response Network (LRN) responsible for emergency preparedness and response to biological and chemical terrorism.

Dr. Marleen Wekell, Ph.D. is the Director of the Office of Applied Research and Safety Assessment (OARSA) with the Center for Food Safety and Applied Nutrition (CFSAN) with FDA. The research facility is located in Laurel, Maryland. She provides leadership to the research program at OARSA which includes Divisions of Toxicology, Molecular Biology and Virulence Assessment of Pathogenic Organisms. Prior to joining CFSAN, Dr. Wekell was the Director of the Office of Research at the FDA’s Center for Veterinary Medicine (CVM) in Laurel, Maryland. From 2000-2003, she was the Director of the FDA’s New York Laboratory (North East Regional Laboratory) in New York City for the Office of Regulatory Affairs (ORA). She spent 18 years as the Director of the FDA Seafood Products Research Center in the Seattle, Washington area. Prior to joining FDA in 1982, Dr. Wekell was on the graduate and undergraduate faculty of the Department of Nutrition at the University of Washington in Seattle.

Dr. Wekell has been on the editorial board of several journals, is a member of many national and international committees and has published numerous articles in scientific journals on marine toxins, pathogenic microorganisms, and seafood quality and safety. She received her M.S. and Ph.D. at the University of Washington and B.Sc. in chemistry at Seattle University. She is a native of the state of Washington and proud of it. Go Huskies!