MSU Food Law Current Issues Seminar
Day 1 Theme: The Food Safety Modernization Act (FSMA): Prevention is the Guiding Principle
Tuesday, July 12, 2016 - The Henry Center For Executive Development
President Lou Anna K. Simon, Michigan State University
Lou Anna K. Simon, the 20th president of Michigan State University, leads the university’s work to advance the common good in Michigan and around the world. She began her career at MSU after earning her doctorate there in 1974. Prior to her appointment as president in 2005, President Simon held a variety of administrative roles, including assistant provost for general academic administration, associate provost, and provost and vice president for academic affairs.
As president, President Simon has engaged MSU in a strategic and transformative journey to adapt the principles of the land-grant tradition to 21st-century challenges. She has expanded MSU’s reach in the state and around the world by focusing the university’s strengths on solutions that enhance and protect quality of life: clean and affordable energy, access to education, safe and plentiful food, and health care.
P. Vincent Hegarty, Founding Director/Professor Emeritus. MSU Institute for Food Laws and Regulations
P. Vincent Hegarty is the Founding Director of the International Food Law Program and Founding Director, Institute for Food Laws and Regulations at Michigan State University (MSU); Adjunct Professor, College of Law and Professor Emeritus, Department of Food Science and Human Nutrition at MSU. He has degrees in Biochemistry, Human Nutrition and Economics. He received his PhD degree from the University of London, England. He is a Fellow, International Academy of Food Science and Technology. He had Visiting Professorships at universities in Africa, Asia, Canada, Caribbean, Europe and the Middle East. He has written four books. His consultancies include: WHO, FAO, NIH, FAS/USDA, USAID, Pew Charitable Trust, etc.
David Acheson, M.D., President and CEO, The Acheson Group LLC
Dr. David Acheson is the President and CEO of the Acheson Group; he graduated from the University of London Medical School in 1980, and following training in internal medicine and infectious diseases in the United Kingdom, moved to the New England Medical Center and Tufts University in Boston in 1987. As an Associate Professor at Tufts University, he undertook basic molecular pathogenesis research on foodborne pathogens, especially Shiga toxin-producing E. coli.
In September 2002, Dr. Acheson became the Chief Medical Officer at the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition. Following several other positions at FDA he was appointed as Associate Commissioner for Foods, which gave him an agency-wide leadership role for all food and feed issues, including health promotion and nutrition.
Dr. Acheson was a partner at Leavitt Partners and managed Leavitt Partners Global Food Safety Solutions from 2009 to 2013. In 2013 Dr. Acheson founded The Acheson Group, a consulting firm which provides strategic advice as well as recall and crisis management support to food companies and ancillary technology companies on a global basis on all matters relating to food safety and food defense.
Preventive Controls and Produce Safety Regulations: Understanding the Nuances of the New Requirements
Leslie Bourquin, PhD, Professor of Food Science and Human Nutrition, Michigan State University
Dr. Leslie D. Bourquin is a Professor of Food Science and Human Nutrition and Extension Food Safety Specialist at Michigan State University (MSU). Dr. Bourquin also holds appointments in the MSU Asian Studies Center, the Center for Advanced Studies in International Development, and the Center for Integrative Toxicology.
Dr. Bourquin’s work focuses on food safety education and market development for the global food industry. He provides consultation, education and outreach on food safety practices, good agricultural practices and food safety management systems such as HACCP (Hazard Analysis and Critical Control Points) for food producers and processors, foodservice workers, consumers, government agencies and the media. He collaborates extensively with the private sector, academia, governments and international organizations (e.g. WTO, APEC, World Bank, SSAFE) in implementing food safety capacity development projects globally, and particularly in emerging economies.
Stuart Pape, JD, Shareholder, Polsinelli
Stuart Pape helps clients understand and face challenges presented by regulations imposed by the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide.
Regularly appearing before the FDA, USDA, the Consumer Product Safety Commission, the U.S. Customs and Border Protection, numerous other federal and state regulatory bodies, and the Congress of the United States, Mr. Pape serves clients across the U.S. and around the world in many capacities. Previously, he served in various positions in the Office of the Chief of Counsel at the FDA, including as associate chief counsel for food. He also served as executive assistant to FDA Commissioner Donald Kennedy. Mr. Pape is a 1970 graduate of the University of Virginia and a 1973 graduate of its School of Law.
Moderator: Steve Kluting, Esq., Regional Director, Food & Agribusiness Practice; Arthur J. Gallagher & Co
Using his experience as a "food lawyer" (he practiced at a large Michigan law firm for 13+ years and was chair of their Food Industry practice), a certified HACCP manager, and an executive at a food wholesaler, Steve Kluting, Esq., now advises Gallagher’s food industry clients, helping them to better identify and manage their industry-specific risk (in particular, contamination exposures), to make better business decisions, and to navigate through industry-related crises, especially food safety incidents and product recalls. In addition, he assists clients in the evaluation, negotiation, marketing and placement of Product Contamination/Product Recall insurance coverage. Arthur J Gallagher is a global risk consultancy and insurance brokerage, with more than 20,000 colleagues world-wide.
Charles Breen, Senior Consultant, EAS Consulting Group
Charles M. Breen is a Senior Consultant for EAS Consulting Group, LLC (www.easconsultinggroup.com). As an expert regulatory consultant for food companies on FDA food safety regulation, he brings with him the benefit of a distinguished 41 year career at the FDA in food safety, imports, and program management, including 14 years as Director of FDA’s Seattle District. Since retiring in 2013, he advises firms in the US and internationally on what to expect from FDA, and what FDA expects from firms to document compliance with current regulations and the soon to be required rules for the Food Safety and Modernization Act (FSMA).
Ken Odza, JD, Corporate Counsel, Food Safety, Kellogg Company
Ken Odza joined Kellogg Company in August, 2011. Mr. Odza’s was formerly a partner in the Seattle office of the law firm Stoel Rives LLP. Mr. Odza’s work has been focused historically on food and environmental law. In private practice, Mr. Odza advised clients on reducing risk from the sale of food products by employing perspectives gained as both a seasoned products liability litigator and as an experienced food regulatory lawyer. Mr. Odza’s specialty areas include food safety regulatory compliance, food liability litigation, insurance coverage and environmental law. Mr. Odza holds a JD from Cornell Law School and a BS from the University of Rochester.
Robert Prevendar, MPH, Managing Director, Global Supply Chain Food Safety, NSF International
Robert Prevendar has 25 years of public health and food safety experience, including work in regulatory agencies, training, auditing, consulting, operations, and program management. Throughout his career he has gained true global experience by living and working in Asia and Europe.
Mr. Prevendar joined NSF in 2002 and helped lead the expansion of NSF’s Food Division. He currently serves as Global Managing Director of Supply Chain Food Safety at NSF International, the leading certifier to Global Food Safety Initiative (GFSI)-benchmarked standards. NSF has had a public health mission for 70 years and provides food safety solutions throughout the entire supply chain. Mr. Prevendar works closely with major manufacturers, retailers, and food service companies to help improve their food safety systems.
Daniel Dwyer JD, Partner, Kleinfeld, Kaplan and Becker, LLP
Dan Dwyer is a partner with Kleinfeld, Kaplan and Becker, LLP, Washington, DC. His practice focuses primarily on representing food, dietary supplement, pharmaceutical, cosmetic, medical device, and consumer products companies on a variety of matters involving regulatory and advertising law. Mr. Dwyer has substantial expertise in food and drug safety issues, clinical trials, labeling and advertising claim substantiation, sales and marketing practices, good manufacturing practices, FDA inspections, recalls, corporate compliance programs and related matters. He regularly advises clients on developing strategies for product development, strengthening compliance programs, and dealing with legal challenges.
All on the Same Page: How States Are Working with the FDA to Achieve National Uniformity
Jamie Clover Adams was appointed by Governor Rick Snyder in July 2012. Prior to becoming Director, Ms. Clover Adams worked in various governmental leadership roles for nearly 25 years, including the Michigan Senate as well as Director of the Kansas Department of Agriculture from 1999-2003. Ms. Clover Adams earned her bachelor’s degree from the University of Michigan and has a Master’s Degree in Public Policy from Georgetown University. She is a farm girl from the small town of Saranac in Ionia County and is a strong advocate for the state’s food and agriculture industry.
Tim Slawinski has 16 years of experience as a food safety professional in the food industry. He joined the Michigan Department of Agriculture and Rural Development in the Food and Dairy Division in 2012 to help identify how government and industry can work together to address food safety issues. Mr. Slawinski is on the National Association of State Departments of Agriculture (NASDA) FSMA Technical Working Group and Produce Safety Implementation Team. He has played a large role in developing Michigan’s feedback to the FSMA proposed rules and implementation plan. Mr. Slawinski has a degree in Microbiology from Michigan State University. Prior to joining MDARD, he worked for several companies in the industry including Cargill and Kellogg’s.
Day 2 Theme: Globalized Food Chains: The Regulation of Novel Technologies and Managing Risks and Legal Liabilities
Wednesday, July 13, 2016 - College of Law
Art Czabaniuk, Supervisor of Consumer Safety Officers/District Director, Detroit District Office, Office of Regulatory Affairs, U.S. Food and Drug Administration
Mr. Czabaniuk has over 35 years of experience in public and private scientific organizations and holds a BS Degree in in Environmental Health. Mr. Czabaniuk is currently serving as the FDA Detroit District Director. The FDA Detroit District has eight locations in Michigan and Indiana and employs over 100 FDA personnel. The Detroit District regulates nearly 8000 firms in this two state area. These regulated firms include Bioresearch, Medical Devices, Foods, Pharmaceuticals, Biologics, and regulated Veterinary activities. Mr. Czabaniuk previously served as the Deputy District Director for a period of 3 years. Prior to joining the FDA in 2002, Mr. Czabaniuk was an independent consultant in the contract pharmaceutical testing industry. Over a six year period, his primary responsibilities were contract laboratory management, and review of NDA/ANDA analytical method validation data. Mr. Czabaniuk began his career in the environmental testing industry and held numerous scientific and managerial positions over an 18 year period. These positions include: Project Manager for Nuclear/Chemical hazardous waste clean-up investigations; Project Manager for industrial wastewater, ground and surface water contamination studies: and Project Manager for source and ambient air pollution studies. During this period, Mr. Czabaniuk also held numerous management positions including; Laboratory Manager, Branch Manager, Laboratory Director, VP General Manager for a Division of 3 multi state environmental testing laboratories, and also served as the corporate QA Director for national network of 8 environmental/ radiochemical laboratories.
Francesco Planchenstainer, JD, PhD, Senior Regulatory & Food Law Specialist at Mead Johnson Nutrition
Francesco Planchenstainer, JD, PhD, is a Senior Regulatory and Food Law Specialist at Mead Johnson Nutrition (Evansville, IN), a global company specializing in the field of pediatric nutrition. Dr. Planchenstainer completed his legal education from University of Trent (Italy). He went on to obtain his PhD in Food Law from Agrisystem, the Doctoral Program focused on the Agro-Food system at the Catholic University of Milan (Italy). Following his graduate studies he broadened his expertise in Food Law and Regulation by joining Cherchi & Co., PA (2011) and the European Commission (DG SANTE) as a Bluebook Intern (2012). In 2014, he successfully defended a dissertation on the legal framework for the management of food crises and emergencies in the EU and the US. Recently, he has been involved with the organization of several executive trainings including ‘Food Law and RASFF Training’ (Cremona, Italy - 2012) and ‘Innovation and Regulation: new trends and opportunities’ (Piacenza, Italy - 2013). Presently, he serves as a scientific adviser to the Italian Food Bank Federation in addition to his role at Mead Johnson Nutrition.
Robert Hollingworth, Institute for Environmental Toxicology, Emeritus Professor of Entomology, Michigan State University
Dr. Hollingworth has been active in research, teaching and outreach on topics of food and agricultural toxicology for almost 50 years. His research has focused primarily on pesticides. Within this area he has worked on their biotransformation, toxicokinetics and mechanisms of toxicity with emphasis on differences between vertebrates and target invertebrates that can lead to selective toxicity, and on the physiological changes that allow insects to become resistant to pesticides. He has also published on pesticide regulation and, more recently, on the safety assessment and regulation of genetically modified crops. In total he has published approximately 135 reviewed articles in scientific publications, and has edited or co-edited 8 books.
He became Emeritus in 2007, but has continued several activities at MSU including acting as Director of the North Central Region IR-4 pesticide registration program (funded by USDA) that develops data for the registration of pesticides on minor and specialty crops by USEPA. This program involves collaborators in 12 NC States and the operation of a modern residue analytical laboratory at MSU. For several years he has acted as consultant on food safety issues on a Gates Foundation Grant to educate regulators for GMOs in Africa, and he teaches modules on risk assessment and regulation for both chemical and biotechnological risks in foods in several international summer courses as well as at invitational meetings in numerous countries. He has served on a variety of state, national and international government panels and commissions dealing with pesticide and food safety issues, most recently a National Academy of Sciences review of the California pesticide regulatory system, and has received awards from both the USDA and the American Chemical Society for his research in these areas.
Moderator, Cory Carter, MJ, Founder/CEO, Carter Regulatory Group
Cory Carter is the founder of Carter Regulatory Group, a regulatory consulting firm specializing in food, beverage, dietary supplement and cosmetic regulations in over 40 countries. He has served on many industry association committees and played a significant role in representing the tree nut and fresh produce industries. He has provided regulatory services for over 12 years and specializes in areas such as regulatory risk assessment, regulatory strategy, interacting with regulatory agencies, labeling, advertising, product development, international product registration, good manufacturing practices, and all other regulatory matters
Mr. Carter holds undergraduate degrees in zoology and Russian language and literature from Brigham Young University. He completed the graduate certificate program from the Michigan State University Institute of Food Law and Regulation, and holds a Masters of Jurisprudence in global food law from the Michigan State University College of Law.
The most important thing to know about Mr. Carter is that he is a proud husband and father of 5 children.
Hannah Chanoine, Counsel, O’Melveny & Myers; Lecturer-in-Law, Columbia University School of Law
Hannah Chanoine practices in the consumer class action defense group at O’Melveny & Myers LLP in New York. She has represented leading manufacturers of Greek yogurt, kombucha, pet food, baking products, probiotic baby food, and juice beverages against plaintiffs raising nationwide false advertising class action claims. Ms. Chanoine also counsels manufacturer clients on strategies for mitigating litigation risk during product and label development. After clerking for the Hon. Sonia Sotomayor on the Second Circuit Court of Appeals, Ms. Chanoine served as a trial attorney in the Department of Justice, Civil Division (Federal Programs Branch) through the Attorney General's Honor's Program. Ms. Chanoine spent six years in the Supreme Court & Appellate practice of another national law firm. Currently, Ms. Chanoine teaches US Food Law & Policy at Columbia Law School as a member of the adjunct faculty.
Jennifer McEntire, VP, Science Operations, Grocery Manufacturers Ass’n
Dr. Jennifer McEntire uses her background in food microbiology and safety, and experience as a food industry consultant, to help GMA members understand and address scientific and technical issues. At GMA Dr. McEntire oversees the microbiology, chemistry, processing, packaging, and product forensic teams. She also oversees GMA’s FSMA implementation assistance and training. She holds a PhD in Food Science from Rutgers University and a BS with Distinction from the University of Delaware. She has always worked in the Washington DC area, including at the Institute of Food Technologists and The Acheson Group.
John Spink, PhD, Assistant Professor and Director of the Food Fraud Initiative, Michigan State University
Dr. Spink has been focused on product fraud since Michigan State University’s Food Safety Program and the School of Packaging began research on the topic in 2006. This work expanded to the behavioral sciences and criminology and led to the establishment of the Anti-Counterfeiting and Product Protection Initiative in 2008. In 2009 the work shifted to the School of Criminal Justice where the Initiative evolved into a Program.
Prior to returning to MSU in 2006, Dr. Spink spent more than 15 years in Corporate America. He draws from his experience in general management, operations, sales, product management, and headquarters staff to bring a unique awareness of the needs of industry. His long-time affiliation with MSU brings an awareness of the needs of academia and of MSU.
Shawn Stevens, JD, Food Industry Counsel LLC
Shawn Stevens is a global food safety lawyer and founding member of Food Industry Counsel LLC, the only law firm in the nation that represents the food industry exclusively. For more than a decade, Mr. Stevens has worked throughout the country and abroad with food industry clients (including the world’s largest food processors, international restaurant chains, and food distributors and grocers) helping them protect their brand by proactively reducing their food safety risk, complying with complex FDA and USDA food safety regulations, managing recall response efforts, and defending high-profile foodborne illness claims.
In addition to his legal practice, Mr. Stevens also serves as the only food safety mediator in the world, helping parties who have food safety disputes resolve their claims. Mr. Stevens also speaks regularly to national and international audiences on a wide variety of emerging scientific, regulatory and legal food safety trends, and authors dedicated food safety columns for Meatingplace, the National Provisioner, and Food Safety Tech. Mr. Stevens is also a regular contributor to Food Quality Magazine. Additional information about Mr. Stevens’ food safety and food quality legal practice can be found at www.foodindustrycounsel.com.
Day 3 Theme: Current Issues in Labeling and Advertising
Thursday, July 14, 2016 - The Henry Center For Executive Development
Adam Ekonomon, Director and Assistant General Counsel, Marketing and Regulatory The J. M. Smucker Company
Adam Ekonomon is the Vice President and Deputy General Counsel at The J. M. Smucker Company where he is primarily responsible for legal compliance of all Marketing and Regulatory related matters. Mr. Ekonomon’s practice focuses on advertising, marketing and promotion law, including advertising compliance, advising on product claims and substantiation, drafting and negotiating agency, license and talent agreements, and promotion structure and compliance. Mr. Ekonomon also advises in the areas of food labeling, food safety and regulatory compliance. He is also responsible for managing Smucker’s trademarks worldwide. Mr. Ekonomon earned his BS in Finance at Youngstown State University, his JD from the University of Akron School of Law, and his Masters from the University of Akron Graduate School of Business. In 2015, he received his LLM in Global Food Law from Michigan State University College of Law.
Mary Engle, JD, Associate Director for Advertising Practices at Federal Trade Commission
Mary K. Engle directs the Federal Trade Commission’s Division of Advertising Practices. The Division is responsible for regulating national advertising matters, including claims about food, over-the-counter drugs, dietary supplements, alcohol, tobacco, and Internet services. Ms. Engle joined the FTC as a staff attorney in 1990, has held a number of management positions in the FTC’s Bureau of Consumer Protection, and has served as an advisor to a Commissioner. Before joining the FTC, Ms. Engle practiced law with a firm in Washington, D.C. She received an A.B. from Harvard University and a JD from the University of Virginia School of Law.
Kimberly Wingfield, Director, Science Policy, Labeling and Standards, Grocery Manufacturers Ass’n
Kimberly Wingfield is Director, Science Policy, Labeling and Standards, with the Grocery Manufacturers Association. She is the association’s liaison between the food industry and the federal government agencies on food labeling and standards issues. She interacts extensively with GMA members to provide guidance on food labeling inquiries on FDA and USDA regulated products. Ms. Wingfield joined GMA in November of 2012. Prior to GMA, Ms. Wingfield held various positions in regulatory affairs and compliance in the food industry amounting to over ten years of experience.
Ms. Wingfield received her BS in Chemical Engineering from North Carolina A&T State University and MBA from Emory University.
Steve Steinborn, Attorney and Partner, Hogan Lovells, US, LLP
Steven Steinborn practices food and drug law with a focus on food labeling, advertising, and food safety. He works closely with food processors, restaurants, food service operators, and supermarkets with respect to compliance with nutrition and related labeling regulations. He routinely assists clients in enforcement proceedings before the U.S. Food and Drug Administration and the U.S. Department of Agriculture (USDA). Mr. Steinborn provides assistance to the firm’s trade association and company clients in fashioning comments and developing strategies in dealing with key rulemaking and other public policy issues. In recent years, his practice is increasingly focused on counseling companies that seek to promote the health benefits of traditional foods.