FSMA Update Webinar: What the New Proposed Rules for Preventive Controls for Food and Produce Safety Mean to the Industry

Presenters
 


Joseph A. Levitt
Partner
Hogan Lovells US LLP
Washington, DC



Joseph Levitt is a 25-year veteran of the U.S. Food and Drug Administration (FDA). He focuses on the development and implementation of legislative and regulatory policy regarding the manufacture and marketing of food, drugs and medical devices and how to work effectively with the FDA and related agencies. Joe also brings in-depth knowledge to a wide range of matters, including food and drug safety, biotechnology, labeling, advertising, and bioterrorism.

For six years, from February 1998 through December 2003, Joe served as Director of the FDA's Center for Food Safety and Applied Nutrition (CFSAN), where he led successful efforts to modernize food safety regulation and enhance the security of the U.S. food supply. He also initiated a revitalization of FDA's nutrition program. During his FDA tenure, Joe also helped streamline the new drug review process and launch the agency's food labeling initiative. Additionally, he served as Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health. He began his FDA career in the Office of Chief Counsel.

Since joining Hogan & Hartson in January 2004, Joe counsels numerous food, drug and device companies and trade associations regarding compliance with federal laws and regulations. Joe has been directly engaged in all phases of the Food Safety Modernization Act, from development through implementation.


Elizabeth B. Fawell
Associate
Hogan Lovells US LLP
Washington, DC

 


Elizabeth Fawell practices in the area of food and agriculture law with specific focus on the regulation of foods, dietary supplements and consumer products, as well as advertising and promotion issues. She represents clients regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, Consumer Product Safety Commission and other health and safety regulatory agencies at both the federal and state levels.

Prior to joining Hogan & Hartson, Elizabeth was a legislative assistant with the Office of Congresswoman Anne M. Northup. Previously, she was an English teacher with Foshan Yi Zhong Xue.

 

 Jenny Scott
 Senior Advisor
 Office of Food Safety

 FDA Center for Food Safety and Applied Nutrition
 Washington, DC

 



Jenny Scott is Senior Advisor to the Director of the Office of Food Safety at the Food and Drug Administration’s Center for Food Safety and Applied Nutrition. In that position she develops and implements policies, regulations and guidelines related to food safety and provides technical expertise in a variety of food safety areas. Prior to joining FDA in August 2009, Ms. Scott was Vice President of Science Policy, Food Protection, at the Grocery Manufacturers Association in Washington, D.C., where she held various positions over a 29-year tenure. She received a B.A. degree in biology from Wellesley College, an M.S. in bacteriology from the University of Wisconsin, and an M.S. in food science from the University of Maryland. She has published widely in the area of microbial food safety.  She has been active in professional associations such as the American Society for Microbiology, the Institute of Food Technologists, and the International Association for Food Protection, of which she was President in 2000-2001. She is a fellow of both IAFP and IFT.  Ms. Scott served three terms on the US National Advisory Committee on Microbiological Criteria for Foods and currently serves as the U.S. Delegate to the Codex Committee on Food Hygiene. She currently leads both the Workgroup for the Preventive Controls Rule for Human Food and the Workgroup for Preventive Controls Guidance for Human Food.


 Don Kraemer
 Senior Advisor
 FDA Center for Food Safety and Applied Nutrition
 Washington, DC

Don Kraemer is a Senior Advisor for the Center for Food Safety and Applied Nutrition where he oversees the Preventive Controls Team and is responsible for the development of preventive controls rules and guidance.  Former roles include Acting Deputy Director, Center for Food Safety and Applied Nutrition (2010-2011) and Deputy Director, Office of Food Safety in College Park, Maryland (2007-2008).  He was responsible for administration of seafood policy and research divisions as the Acting Director, Office of Seafood from 2005-2007Prior to this role, Don was responsible for the development of policy and government and industry training in FDA's Seafood Hazard Analysis Critical Control point (HACCP) Program as the Associate Director, Office of Seafood.  Don has a B.S. in Plant and Soil Science from the University of Maine.