FSMA Final Rules Webinar Series

FACULTY

 


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 served as Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for six years, from February 1998 through December 2003.  Joe counsels numerous food companies and trade associations in food safety, labeling and compliance matters and how to work effectively with the FDA, as well as on regulatory aspects of Federal, state and private litigation.  He is particularly accomplished in helping companies who face significant compliance challenges with the FDA.  He is a recognized expert in the FDA Food Safety Modernization Act (FSMA), including all phases of its development and implementation.

Joe’s deep knowledge of the FDA is reflected in the many roles he held at the agency.  While serving as FDA/CFSAN Director, Joe was involved in virtually all aspects of food regulation.  In particular, 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. Earlier in his FDA tenure, Joe functioned as the executive assistant to the commissioner, director of executive operations, chief of staff and acting deputy commissioner in the Office of the Commissioner, where he 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 where he led efforts to implement safe medical device and mammography quality standards programs. He began his FDA career in the Office of Chief Counsel as a litigating attorney.

In the private sector, Joe has served on the Boards of Directors for the:  Food and Drug Law Institute (FDLI); Food Allergy & Anaphylaxis Network (FAAN) (recently rebranded as Food Allergy Research & Education, Inc. (FARE) (Board Chair, 2007); and FDA Alumni Association (Board Chair, 2012-14).

Joe has received numerous honors and awards in both the public and private sectors.


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

 

Elizabeth Fawell practices in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, as well as restaurants and foodservice operators, and their trade associations. Her clients are regulated by the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and other health and safety regulatory agencies at both the federal and state levels.

Elizabeth counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, distribution, and marketing. She analyzes legislation introduced in Congress and state legislatures, as well regulations proposed by FDA and USDA. Elizabeth provides assistance to trade associations and food companies with preparing comments and developing strategies in response to legislative proposals, agency rulemakings, guidance documents, and other public policy issues. Her practice increasingly involves counseling companies and trade associations regarding implementation of the FDA Food Safety Modernization Act (FSMA), having been directly involved in the development of this landmark legislation on behalf of food industry clients. She also advises clients on the development of label claims, website and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. Elizabeth assists clients in advertising disputes and with responses to Federal Trade Commission, congressional, and state Attorney General investigations.

Elizabeth’s practice also includes advising food and consumer product companies subject to the jurisdiction of the Consumer Product Safety Commission (CSPC). She counsels clients on compliance with CPSC safety standards, as well as testing and certification requirements. In addition, Elizabeth assists companies in complying with CPSC reporting requirements.

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.


 

Maile Hermida
Senior Associate
Hogan Lovells US LLP
Washington, DC

 

Maile Gradison Hermida practices with Hogan Lovells in the area of food and agriculture law. She represents food companies, including manufacturers, distributors, retailers, and their trade associations. Her clients are regulated by the Food and Drug Administration, Department of Agriculture, Federal Trade Commission, and other health and safety regulatory agencies at both the federal and state levels.

Maile advises clients on the development of label claims, website and promotional campaigns for products, as well as the various requirements applicable to the labeling of foods. She also provides assistance to trade associations and food companies with fashioning comments and developing strategies in response to agency rulemaking and other public policy issues. Her practice is increasingly focused on counseling companies and trade associations as to the implementation of the FDA Food Safety Modernization Act. Maile also assists clients with responses to Federal Trade Commission, Congressional, and state Attorney General investigations and counsels clients on the development, interpretation, and enforcement of laws and regulations governing food production, processing, and distribution.

Prior to joining Hogan & Hartson, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.

 

 
  Shannon Cooksey
  Vice President, Science Program Management
  Grocery Manufacturers Association
  Washington, DC



 

Shannon (Shana) Cooksey is the Vice President of Science Policy and Program Management at the Grocery Manufacturers Association (GMA) in Washington, D.C.  GMA represents the world’s leading food, beverage, and consumer products companies.  Shana is a globally recognized project manager, matching cutting edge science to food policy issues, and delivering expert scientific and technical assistance to the food and consumer product goods industry.  At GMA, Mrs. Cooksey oversees all scientific program management activities, including managing all aspects of implementation of the Food Safety Modernization Act (FSMA) and all Ingredient Safety programs.  In addition, she also provides leadership and execution of Program Management capabilities across the broad GMA organization and management of several important operational functions within the Science and Regulatory Affairs (SRA) department including budget oversight, strategic planning process, and logistical oversight of all scientific conferences, workshops and webinars. Prior to her role as Vice President, she supervised all laboratory operations at GMA and co-managed over 20 scientists and professional technical staff in the disciplines of chemistry, biochemistry, microbiology, processing technologies, packaging and product forensics.  

Mrs. Cooksey holds Master of Science degree in Bio-Inorganic Chemistry from the University of New Mexico and a Bachelor of Arts in Chemistry and Biology from the University of Northern Colorado.  She is a certified Project Management Professional (PMP), holds top certification in Microsoft Project, and is a professional Lean Six Sigma leader (green belt).

Jenny Scott,
Senior Advisor, Office of Food Safety,
FDA, CFSAN

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. Ms. Scott has published widely in the areas of microbial food safety and has been active in professional associations such as the American Society for Microbiology, the Institute of Food Technologists, and the Inter-national Association for Food Protection, of which she was President in 2000–2001. She is a fellow of both IAFP and IFT.

Ms. Scott served 3 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.


Daniel G. McChesney, M.S., Ph.D.,
Director, Office of Surveillance and Compliance, CVM
Food and Drug Administration


Dr. Daniel G. McChesney is the Director of the Office of Surveillance and Compliance in FDA’s Center for Veterinary Medicine. He has served in this position since October 2003. Prior to becoming the Director, he served as the Deputy Director for the Office of Surveillance and Compliance (1999-2003) and as the Acting Director of the Division of Compliance. His Office is responsible for developing and implementing surveillance and compliance policy concerning FDA regulatory responsibility with respect to animal drugs, feeds, food additives, veterinary medical devices, and other veterinary medical products. He joined FDA's Center for Veterinary Medicine (CVM) as a microbiologist in 1990 and served as the Center’s expert on microbial contaminants of animal feed, and application of HACCP programs to the feed industry.

He received a B.S. in Biology from Mercer University in Macon, Georgia and his M.S. and Ph.D. in Cell and Molecular Biology from the Medical College of Georgia, Augusta, Georgia. Upon completing his degree, he entered the U.S. Army and was stationed at the Walter Reed Army Institute of Research (1978-1987) where he served as a research microbiologist. After completing his active military service, he was a senior investigator at the Armed Forces Radiobiology Research Institute responsible for determining the mechanism involved in increasing survival after radiation injury.

Charlotte Christin
Senior Advisor for Food and Veterinary Medicine,
Office of Food and Veterinary Medicine

Food and Drug Administration
Washington, DC

Ms. Christin is a Senior Policy Advisor in the Office of the Commissioner, Office of Policy, where she focuses on food issues.  Ms. Christin led the team that developed the proposed rule on Accreditation of Third-Party Auditors and is continuing to work on policy and operational issues associated with that new program.  Before coming to the Office of the Commissioner, she served as the Director of Executive Operations in FDA’s Office of Regulatory Affairs and Senior Regulatory Counsel in FDA’s Office of Counterterrorism and Emerging Threats.  She is licensed to practice law in California and Virginia.

Brian Pendleton
Senior Policy Advisor
Office of the Commissioner, Office of Policy

Food and Drug Administration
Washington, DC

Brian Pendleton is a Senior Policy Advisor in the Office of Policy in FDA’s Office of the Commissioner.  Mr. Pendleton received a B.A. and M.A. in political science from Kent State University and a J.D. from the University of Michigan.  He is a member of the District of Columbia Bar.  Before joining FDA, Mr. Pendleton was an associate at Hyman, Phelps & McNamara, P.C., in Washington, D.C., from 1991-1996.  Mr. Pendleton began his FDA career in November 1996 as a regulatory counsel on the Regulatory Policy Staff in the Center for Drug Evaluation and Research (CDER).  In CDER, Mr. Pendleton worked on numerous drug regulatory matters, including citizen petition responses, guidance documents, and regulations on NDA and ANDA review and approval procedures, current good manufacturing practices, and foreign clinical studies.  In 2009, Mr. Pendleton joined the Office of Policy, where he works primarily on multi-Center rulemakings and guidances.  He currently leads the working groups developing FDA’s regulations on foreign supplier verification programs for food importers and good importing practices for drug importers.