8 California Food Producer EDITION 1, 2018 Food recalls have always been serious business. They require a lot of time, a lot of manpower and a lot of money. Even worse, they have grown in num- ber in recent years. Between 2010 and 2014, the United States averaged 85 recalls per year. In 2015 that number rocketed to 150. In 2016, we saw 122 and in 2017, 131. Prior to January 2011, recalls were always voluntary. President Barack Obama amended the Federal Food, Drug, and Cosmetic Act by signing into law the Food and Drug Administration Food Safety Modernization Act of 2011 (FSMA). FSMA authorizes the Food and Drug Admin- istration to require recalls in certain circumstances. While California has not given the Department of Public Health – Food and Drug Branch (CDPH-FDB) the same power to force a mandatory recall, FSMA and the increase in the number of food recalls in recent years prompt a hard look at the requirements, consequences and best practices surrounding food recalls. What can be recalled and who does the recalling? Most of you are probably aware that food has a broad definition. It includes everything from chewing gum to dietary supplements. Any of this food with a “reasonable probability” of being “adulterated” or “misbranded” is subject to recall, and those responsible for actually enacting or participating in a recall are “responsible parties.” As you can imagine, the definition of responsible parties is similarly all encompassing - essentially anyone with a facility where food is “manufactured, processed, packed, or held.” This creates a whole chain of responsible parties including manufacturers, distributors, wholesalers, retailers, retail distributions centers and food service companies. Depending on how long responsible parties have been selling the food, a successful recall may require an immense amount of coordination and communication between all these responsible parties. While starting a recall is voluntary in most cases, once a recall begins all responsible parties have similar obligations. What are my obligations during a recall? Whether or not a recall is mandatory or voluntary, under both federal and California law a responsible party is obligated to take several actions once a recall begins: 1. Identify, isolate and stop selling the recalled food. 2. If you are the recalling party, contact your FDA District Recall Coordinator and then prepare a press release and Recall Notice to be reviewed by CDPH-FDB. 3. Notify customers. Customers include all individual food purchasers and any potential responsible parties. 4. Prepare a “Distribution List” of all customers to be sent to CDPH-FDB and your FDA District Recall Coordinator. The FDA can use its mandatory recall authority when certain criteria are met. First the FDA must believe there is a "reasonable probability" food is adulterated or misbranded. Food Recalls