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July 16-19, 2012

Michigan State University
East Lansing, Michigan

David ACHESON is a Partner at Leavitt Partners and oversees the company’s Food and Import Safety Practice. Dr. Acheson was the Chief Medical Officer at the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN), beginning in September 2002. In January 2004, he was named Director, CFSAN, Office of Food Defense Communications and Emergency Response. In January 2005, the mission of the office was expanded and renamed the Office of Food Safety, Defense and Outreach. In January 2007 it was further expanded to become the Office of Food Defense, Communication and Emergency Response. In May 2007, Dr. Acheson was appointed as the Assistant Commissioner for Food Protection to provide advice and counsel to the FDA Commissioner on strategic and substantive food safety and food defense matters. In January 2008, he was named Associate Commissioner of Foods, which provided him an agency-wide leadership role for all food and feed issues, including health promotion and nutrition.  Dr. Acheson has published extensively and is internationally recognized both for his public health expertise in food safety and his research in infectious diseases. Additionally, Dr. Acheson is a fellow of both the Royal College of Physicians (London) and the Infectious Disease Society of America.  Dr. Acheson graduated from the University of London Medical School in 1980 and practiced internal medicine and infectious diseases in the United Kingdom until 1987 when he moved to the New England Medical Center and Tufts University in Boston. As an Associate Professor at Tufts University, he undertook basic molecular pathogenesis research on foodborne pathogens, especially Shiga toxin-producing E. coli. 

Glenn T. BASS is the Detroit District Director of the U.S. Food and Drug Administration.  He began working with The Food and Drug Administration in 2001.  He served various positions in The Office of Compliance at The Center for Food Safety and Applied Nutrition (CFSAN) in College Park, Maryland.  He served as Branch Director, Field Programs Branch, Division Director, Division of Field Programs and Guidance, Deputy Director, Office of Compliance.   On August 16, 2011, Glenn was appointed the FDA, Detroit District Director.   He is responsible for all FDA regulated products both domestic and imported.  Detroit District has two of the busiest land border stations in the United States at the Ambassador Bridge and Port Huron, MI. Detroit has five resident posts located in Grand Rapids, MI, Kalamazoo, MI, Indianapolis, IN, Evansville, IN and South Bend, IN.  In addition, the District also has a State Of The Art, Award Winning Laboratory.  The district inspectional obligation covers the State of Michigan and the State of Indiana.  He received his B.A. in Biology from the College of Charleston, Charleston, South Carolina; Masters in Administration from Central Michigan University, Mt. Pleasant, Michigan; and B.S. in Nursing from the University of Maryland, Baltimore Maryland.

Leslie D. BOURQUIN is a Professor of Nutrition and Extension Food Safety Specialist in the Department of Food Science and Human Nutrition at Michigan State University. Dr. Bourquin’s extension efforts focus 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, FAO, and WFP) in implementing food safety capacity development projects globally, and particularly in emerging economies.  Dr. Bourquin’s applied research program currently focuses on the impact of improved standards compliance by the food industry on 1) indicators of improved safety of food products and 2) enhanced market access by food producers and processors.  Dr. Bourquin also conducts basic research on the impact of dietary factors on cancer risk in humans.  Currently, this research focuses on the potential of dietary flavonoids and carbohydrate sources to influence colon cancer initiation, promotion and progression in transgenic mouse models of human colon cancer, and mechanisms (such as epithelial cell cytokinetics and inflammatory pathways) whereby these effects are elicited.  In 2007–08, Dr. Bourquin was a Fulbright Research Scholar at Polytech’Lille (Ecole Polytechnique Universitaire de Lille), part of the University of Sciences and Technology of Lille in France.

Ricardo CARVAJAL is a Lawyer and Director in the law firm of Hyman, Phelps & McNamara, P.C., in Washington, D.C. He provides FDA regulatory counseling to manufacturers and marketers of foods, drugs, devices, and cosmetics. He has substantial experience with regulatory issues pertaining to foods, including dietary supplements. He has worked on GMP and HACCP compliance issues, and on a wide array of labeling compliance issues, including those that arise from the use of health, nutrient content, structure/function, and disease claims. He also has experience with drug, medical device, and cosmetics issues. He has worked on due diligence review teams for major acquisitions and initial public offerings, helped manufacturers to determine the regulatory status of products, and provided advice on labeling, advertising, and promotion issues. He has particular expertise in the regulation of products derived through biotechnology and nanotechnology. From 2002 to 2007, he served as Associate Chief Counsel in FDA’s Office of Chief Counsel, where his work was recognized with several individual and team awards. He is an active member of the Food and Drug Law Institute and the Institute of Food Technologists. He holds a J.D. from Northwestern University School of Law and an M.S. in Biology from the University of Michigan. He is admitted to practice in Illinois, and his application for admission to the District of Columbia bar is pending. Mr. Carvajal is a native of New Orleans, Louisiana.

Roger CLEMENS is the Chief Scientific Officer of Horn and part-time faculty within the University of Southern California (USC) Regulatory Science program where he also enjoys an adjunct appointment as Professor of Pharmacology and Pharmaceutical Sciences within the USC School of Pharmacy. He served as Scientific Advisor for Nestlé USA for more than 21 years. Dr. Clemens has published more than 50 original manuscripts in nutrition and food science, participated in more than 300 invited domestic and international lectures, and served as an expert panel member for the food industry, scientific organizations, trade associations and regulatory agencies in the United States, Canada and Europe. Dr. Clemens is President (2011-2012) of the Institute of Food Technologists (IFT) and member of the Board of Directors. He served on numerous IFT expert panels, including Functional Foods, and Making Decisions about the Risks of Chemicals in Foods with Limited Scientific Information. He cofounded, established and contributes to a Food, Medicine and Health column published monthly in Food Technology. As a spokesperson for IFT, Dr. Clemens has been cited and interviewed by more than 500 domestic and international health journalists, and has appeared on numerous televised (e.g., Good Morning America, CNN, CBS 48 Hours) discussions on contemporary health, nutrition and food safety issues. Dr. Clemens was a member of the USDA 2010 Dietary Guidelines Advisory Committee, and is a second-term member of the US Pharmacopeia Food Ingredient Expert Committee. He was a member of the Commission on Dietetic Registration for the American Dietetic Association. Dr. Clemens received an AB in Bacteriology, a MPH in Nutrition, and a DrPH. in Public Health Nutrition and Biological Chemistry from the University of California, Los Angeles.

Nicole COUTRELIS is a Lawyer at the Paris Bar since 1985, and is a Partner of Coutrelis & Associes with Offices in Paris and in Brussels, specializing in EU law, mainly in antitrust, agriculture, food and drug regulations, free movement of goods, and customs. Before starting her private practice, she was at the French "Office National Interprofessionnel des Céréales" (Cereals Authority) where she was in charge of the European Affairs (1972-1978). She was then nominated as "Attaché Agricole” at the French Permanent Representation to the EC in Brussels from 1978 to 1982 and joined afterwards the Legal Service of the European Commission where she was in charge of antitrust matters, particularly as applied in the food and agricultural sectors, from 1982 to1985. Currently President of the European Food Law Association, she is also a Member of the International Bar Association. Nicole Coutrelis is the author of many articles related to food and drug law as well as, more generally, the European law.

Neal FORTIN is the Director of the Institute for Food Laws & Regulations (IFLR) at Michigan State University (MSU), Professor in the MSU College of Agriculture and Natural Resources, and an Adjunct Professor of Law at the MSU College of Law. He is the author of the book, Food Regulation: Law, Science, Policy, and Practice (http://www.FoodRegulation.US) and numerous articles. Neal Fortin has extensive experience with food labeling requirements both as an attorney representing food businesses and working for the Michigan Department of Agriculture. He has trained over 1,800 people on labeling law.  Neal Fortin is past President of the North Central Association of Food & Drug Officials (NCAFDO) and past President of the Great Lakes Conference on Food Protection. He has also served as a Commissioner for the Michigan Local Public Health Accreditation Program, the Advisory Council of the Michigan Community Health Leadership Institute, and the NSF Council of Public Health Consultants.

P. Vincent HEGARTY is the Founding Director and Professor Emeritus of the Institute for Food Laws & Regulations (IFLR) at Michigan State University (MSU). He holds B.Sc and M.Sc degrees in Biochemistry and a BA degree in Economics from the National University of Ireland; a Ph.D. in Human Nutrition, University of London. He held academic and administrative positions at the University of Minnesota, University of Houston, and Michigan State University. Recently he was Dean of the College of Food and Agriculture, United Arab Emirates University. He held Adjunct Professor appointments at the University of Guelph and the University of Texas. He has taken sabbatical leaves to universities in Jamaica, Zimbabwe, and Ireland and at Zayed University (UAE). He is a Fellow of the International Academy of Food Science and Technology. His consultancies include: Abu Dhabi Food Control Authority (ADFCA), WHO/FAO, USAID, USDA, National Institute of Health (USA) and many food companies. Presently he is Team Leader in a USAID-funded project assisting in the establishment of a National Authority of Food Safety in Egypt. He founded the Institute for Food Laws & Regulations at Michigan State University. Its distance education program has students from over 80 countries; in 2003 it won the American Distance Education Consortium’s Excellence Award for Distance Education. Professor Hegarty has published two university-level textbooks and has over 100 papers in international journals such as Nature, New England Journal of Medicine, Journal of the American Medical Association, British Journal of Nutrition, American Journal of Clinical Nutrition, and Journal of Food Science.

James HOADLEY is a Senior Consultant with EAS Consultant Group. Dr. Hoadley’s 20-year FDA career, which began in 1987, includes work as a Research Scientist in the Center for Food Safety and Applied Nutrition (CFSAN), Division of Nutrition, and as a Toxicologist in performing food additive and GRAS petition safety reviews in the Office of Premarket Approval.  With the passage of the Nutrition Labeling and Education Act (NLEA) he participated in the development of NLEA-implementing nutrition labeling and health claim regulations. Over the past ten years, Dr. Hoadley’s position had been as a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) with primary responsibilities in food label claim regulations.  In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims.  During this period Dr. Hoadley was involved in some of the most precedent-setting health claim regulatory problems as CFSAN adapted to the FDA Modernization Act provision for authorization of food label claims based on authoritative statements, the 1999 Pearson v. Shalala federal court decision that led to qualified health claims, and Pearson-related lawsuits. Dr. Hoadley has been directly involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by CFSAN over the last decade. Dr. Hoadley has received the CFSAN Distinguished Career Service Award. Dr. Hoadley earned his Ph.D. in Toxicology at the University of Cincinnati College of Medicine, and did postdoctoral research in Nutrition at the University of Florida. His Bachelor of Science degree is from Ohio State University with a Major in Agricultural Education.

Steve KLUTING is an Attorney and Partner at Varnum, LLP. He received his B.A. in Economics and Political Science from the University of Michigan, and his J.D. from Indiana University School of Law.  Steve’s practice is focused on the business and regulatory (FDA) issues – some day-to-day operational, others "bet the farm" – affecting companies in the food, beverage and dietary supplement industry.  In particular, he provides counseling on: labeling compliance; reporting and registration requirements; international transactions, including customs issues; crisis prevention (preparing policies, programs, and strategies for regulatory compliance); crisis management (including misbranding lawsuits, PACA claims, government enforcement actions, recalls, etc.); and the "business of food", including documenting and negotiating commercial relationships, structuring a supply or distribution system, and minimizing liability exposure.  Steve is committed to understanding the legal and business needs of his food business clients. Knowing that food safety is a huge priority for his clients, Steve, through training and testing, is a Certified HACCP Manager, trained in SQF and internal auditing; this perspective allows him to better serve his food business clients in dealing with developing their food safety and food defense programs, working through recall situations, mitigating against product liability risks, complying with regulatory and customer demands, and being competitive in the industry.

Janine LEWIS is Principal Nutritionist at Food Standards Australia New Zealand. She leads a team responsible for risk management of nutrition-related changes to food regulation, after recently changing from leading the nutrition risk assessment team for 10 years. Janine is a highly experienced food regulator whose career in national and international regulation spans 20 years.  Her major projects have included mandatory and voluntary fortification with vitamins and minerals; foods for special dietary use such as infant formula and medical foods; nutrition labeling and health claims; and nutrient composition databases. Since 1998, Janine has led the Australian delegation to the Codex Committee on Nutrition and Foods for Special Dietary Uses, which produces international food standards and guidelines. Janine contributed to Guidelines on Food Fortification with Micronutrients (WHO and FAO, 2006).  She also worked with the World Health Organization, Geneva, for 11 months during 2006-8 assisting WHO and FAO to develop a new approach for the provision of scientific nutritional advice to Member States and Codex Alimentarius.

Ken ODZA is Corporate Counsel, Food Safety, for Kellogg Company.  Ken joined Kellogg Company in August, 2011.  He was formerly a partner in the Seattle office of the law firm Stoel Rives LLP. Ken’s work has been focused historically on food and environmental law. In private practice, Ken 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.  Attorney Odza holds a J.D. from Cornell Law School and a B.S. from the University of Rochester.  Ken’s specialty areas include food safety regulatory compliance, food liability litigation, insurance coverage and environmental law.

F. Edward SCARBROUGH is the Principal of Scarbrough Consultants, LLC, consulting on food regulatory policy, food safety, and international harmonization.  He has recently conducted a number of Codex and food labeling training courses. He is the former U.S. Manager for Codex and Codex Contact Point for the United States.  He has been the Head of Delegation to over 15 Codex sessions (Commission, Executive Committee, and Codex Committees on General Principles, Food Labelling, and Nutrition and Foods for Special Dietary Uses) and has attended over 40 other Codex committee, executive committee, and commission sessions.  Prior to that he was the Director of the Office of Food Labeling, U.S. Food and Drug Administration.  In this capacity, he headed up the team that developed regulations that require nutrition labeling on all packaged foods in the US.  He holds a Ph.D. in Chemistry from Harvard University.

Jenny SCOTT is a Senior Advisor to the Director of the Office of Food Safety at the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN). 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 (GMA) 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 areas 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.

John SPINK is the Director of the Packaging for Food and Product Protection Initiative at Michigan State University (MSU), Assistant Professor with MSU Criminal Justice, and a faculty member at the MSU Food Safety & Toxicology Center. Dr. Spink developed and teaches the graduate classes “Packaging for Food Safety” and “Food Protection & Defense – Packaging Module”, and the “Future of Sustainability” module for Criminal Justice 491 Environmental Enforcement. In addition, John is very involved in sustainable packaging initiatives and is a frequent guest lecturer on the topic at the MSU School of Packaging. Other work includes assisting corporations to both define “sustainable sustainability” and to successfully evolve their business and research plans to meet initiatives by Wal-Mart and others.  John is President of York Partners LLC, a management, sales & marketing, and packaging consulting company that specializes in innovation and execution in the business-to-business marketplace.  Current packaging consulting work ranges from review of policy to retail audits, to package review and development for Fortune 250 corporations. Current management and marketing consulting focuses on managing the retail market strategy of product development through sales execution for start-up and micro-cap corporations.

Steven B. STEINBORN is an Attorney and Partner in Hogan Lovells. He 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 FDA and USDA. Steven 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. Steven also advises food companies on a range of issues pertaining to the development of advertising, including the adequacy of substantiation and the express and implied terms conveyed by an advertisement. Steven has significant experience representing clients in enforcement matters before the U.S. Federal Trade Commission and has assisted in defending and initiating challenges against competitors. In addition, he advises food and other companies concerning games of chance and other promotional contests and awards to ensure compliance with an array of state laws. Steven’s practice also includes an emphasis on safety issues in connection with consumer products subject to the jurisdiction of the U.S. Consumer Product Safety Commission (CPSC). He routinely advises a variety of consumer products companies on compliance with the CPSC labeling and reporting requirements, and related product liability considerations. He has experience working with companies from diverse industries, ranging from gas grill manufacturers to toy companies, in enforcement proceedings before the CPSC. He also counsels companies with respect to a variety of different rulemaking and standard-setting activities at the CPSC, and similar activities undertaken by private organizations. Steven is an experienced writer and frequent speaker on topics relating to food labeling and advertising. He also serves as an instructor for the Basic Food Law course sponsored by the Food Drug and Law Institute. Steven is a co-author of A Guide to Federal Food Labeling Requirements, a report commissioned by the U.S. Department of Health and Human Services and the USDA.  He received his J.D. from the University of Michigan Law School in 1987 and his BA with honors from Michigan State University in 1984.

Mary Anne VERLEGER is the Course Manager for the Institute for Food Laws and Regulations at Michigan State University.

Cathy WEIR serves as the Global Rgulatory Associate Director for Mead Johnson Nutrition (MJN).  MJN is the leader in infant and pediatric nutrition with over 100 years of ensuring safe products. Cathy is responsible for directing global regulatory strategy and guidance to MJN’s regulatory team in more than 70 markets around the world including the European Community, Asia and Latin America.  Cathy holds a Ph.D. from Michigan State University, and is currently an adjunct faculty member in the Department of Food Science and Human Nutrition.  Dr. Weir’s past research activities included consultation work with international agencies (FAO, WHO, WTO, USAID) to build capacity and technical capability with authorities establishing or updating their food safety systems.  Today, she continues to design and deliver training programs aimed at those who work in the regulatory arena including government, academia and industry representatives. 

Gerald WOJTALA is the Executive Director of the International Food Protection Training Institute (IFPTI). Formerly he was the Deputy Director of the Food & Dairy Division at the Michigan Department of Agriculture. He is a past President of the Association of Food and Drug Officials (AFDO). Jerry holds a degree in microbiology from Eastern Michigan University and graduate work in food science at Wayne State University. Prior to government service, he worked as a microbiologist with Difco Laboratories in Detroit. Jerry received the FDA Commissioner’s Special Citation for his role in investigating an outbreak of Hepatitis A among school children from the consumption of strawberries and also for managing the response to the Power Blackout of 2003 that occurred in the N.E. United States. He has enjoyed working with Michigan’s apple industry in efforts to implement safe cider production practices and with the Michigan food processing industry on process water discharge issues.

Charles F. WOODHOUSE is an Attorney and Partner, in the law firm of Woodhouse Shanahan PA.  Charles is admitted to the Bars of Pennsylvania, Florida, and the District of Columbia and to the US Court of International Trade in New York City and the US Court of Appeals for the Federal Circuit in Washington, DC. Charles earned his BA at Dartmouth, MBA at Wharton, JD at Rutgers, and his MS Food Safety at Michigan State University. He serves as Guest Instructor in Neal Fortin’s US Food Law and Regulation course at MSU. His business career includes being a founding shareholder of Marine Harvest International (salmon, shrimp, and other fin-fish aquaculture) and service as its president during its years as a publicly traded company on the American Stock Exchange. Since 1999, Charles has devoted his full time to his law practice which specializes in the seafood and produce industries. His Food Law Blog (http://www.food-label-compliance.com/) receives over 25,000 visits each month from Regulatory Food Science professionals. His law firm’s website is: http://www.seafood-and-produce-law.com/ and he can be contacted at e-mail address:  .(JavaScript must be enabled to view this email address)