Understanding FDA's Reportable Food Registry Webinar (Recorded)

Featured Speakers:

• Kathy Gombas, Senior Advisor, Office of Food Safety
  Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
• Joseph Lyzcek, Policy Analyst, Office of Food Defense, Communication and Emergency Response, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
• Moderated by Robert A. Hahn, Principal at Olsson Frank Weeda Terman Bode Matz P.C.

Recently the Food and Drug Administration (FDA) implemented the long-awaited Reportable Food Registry (RFR), an electronic portal Industry must use to alert the FDA when they find their products might sicken or kill people or animals. Facilities that manufacture, process or hold food for consumption in the U.S. must notify FDA of an article of food or animal feed that may cause serious adverse health consequences or death to humans or animals through the Reportable Food Registry no later than 24 hours after determining that an article of food is a reportable food.

The reporting requirement applies to all foods and animal feed regulated by the FDA, except infant formula and dietary supplements, which are covered by other regulatory requirements. Some examples of reasons a food may be reportable include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

FDA issued a guidance document on the RFR in September. But questions remain:

• If a food has microbial contamination but will undergo further processing that includes a "kill step," is it a "reportable food?" For example, flour for use in baking bread, raw nuts for roasting. Does FDA really want reports for these foods?
• If a food tests positive for an indicator organism, such as Listeria species, is it a "reportable food?"
• If a company rejects a "reportable food" at its loading dock, must it submit a report to FDA? If the supplier takes the shipment back and destroys it, must the supplier report? According to FDA’s draft guidance, both companies must report it to FDA, because the food was physically released by the supplier to its customer.

This webinar, which featured FDA's Kathy Gombas and Joseph Lyzcek, addressed questions such as these and updated participants on FDA’s current thinking regarding the RFR. In addition, webinar moderator Robert Hahn provided insight on the legal obligation of reporting an adverse event through the RFR.

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About Kathy Gombas

Kathy Gombas is a senior advisor in the FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Office of Food Safety. Kathy is co-lead for FDA’s Reportable Food Registry. Previously, Ms. Gombas was a corporate director for supplier quality at Dean Foods Company based in Dallas, TX. Her prior experience includes working for CFSAN as the deputy director for the division of HACCP programs and at Kraft Foods in Corporate Worldwide Quality and Food Safety conducting food safety audits worldwide. Ms. Gombas graduated from Northern Arizona University with a B.S. in Microbiology.

About Robert A. Hahn

Robert A. Hahn is a Principal at Olsson Frank Weeda Terman Bode Matz PC. He advises companies and trade associations on compliance with Food and Drug Administration law and regulations, with a primary focus on foods. The core of his practice consists of advising food and dietary supplement companies - including manufacturers, processors, distributors, and retailers - on labeling and advertising, formulation, import/export, Bioterrorism Act and food defense, inspection, recall, and enforcement matters. Mr. Hahn also practices health care law, with a focus on the Medicare program. He joined the firm in 1998 after serving for several years as Director of Legal Affairs at the consumer group Public Voice for Food and Health Policy (now merged with the Consumer Federation of America). Prior to that, he worked in Guangzhou, China with the U.S. law firm Lewis, D'Amato, Brisbois, Bisgaard, Buxbaum & Choi (now Lewis Brisbois Bisgaard & Smith LLP). He is proficient in Mandarin Chinese. Mr. Hahn graduated magna cum laude, Phi Beta Kappa from Brown University in 1980. He earned his J.D. from Columbia University Law School in 1984 and a master's degree in public health from the Harvard School of Public Health in 1994. Mr. Hahn was admitted to the New York State Bar in 1985 and the District of Columbia Bar in 2001. He is currently a member of the New York and District of Columbia Bars.