California League of Food Producers 9 5. Complete any applicable FDA safety reports. 6. Actively monitor responses from customers. Every responsible party must track all communications from notified customers to ensure acknowledgement of and compliance with the recall. 7. Reconcile returned products with production and distribution lists. 8. Obtain disposition instructions from your supplier or CDPH-FDB. 9. Do not stop your recall efforts until the FDA and CDPH-FDB formally terminate the recall. Your FDA District Recall Coordinator can be found at http://www.fda.gov/Safety/Recall/IndustryGuidance/ ucm129334.htm. You said the FDA can force a recall. When does that happen? 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 misbrand- ed. Second, the FDA must believe there is a “reasonable probability” that “use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.” If the FDA deems these two criteria met, it will contact the responsible party in writing. At this point, the responsible party will still have the opportunity to voluntarily cease distribution and recall the food. If the responsible party refuses or does not voluntarily recall the food within the time and manner set by the FDA, the FDA may (a) order the responsible party to cease distributing the article of food, (b) order the responsible party to notify other responsible parties, and (c) give the responsible party an opportunity for an informal hearing. After all these steps, then the FDA may order a mandatory recall. That seems like a lot of hoops for the FDA to jump through. Why not just wait for a mandatory recall? First, it is precisely all these steps and all the time the FDA takes to stop distribution of potentially harmful food that makes a mandatory recall more of a publicity nightmare than a voluntary one. A mandatory recall also opens responsible parties up to fees and civil penalties that it would otherwise not have to pay. Any responsible party who does not comply with a mandatory recall can be assessed fees covering the time the FDA spent conducting food recall activities, such as technical assistance, follow-up effectiveness checks and public notifications. In California, public notifications are typically a public service. A manda- tory recall also requires responsible parties conduct the recall in a certain manner and within a specified time. NICHOLAUS E. JOHNSON Downey Brand, LLP A Legal Compliance Overview from a California Perspective by NICHOLAUS E. JOHNSON – Downey Brand, LLP