Actions of Regulatory Agency Issue Consumer Events that may Advisory/Press Release trigger (Typically for situations Regulatory warranting Class 1 Initiate Regulatory Traceback Contact Firm Recalls) Recall Required Traceback (1) Specific food/feed item associated with foodborne illnesses or found to be adulterated by laboratory testing or routine inspection and… (1A) Food item Inform firm and Inform firm of the need to Recall required; Collect necessary still in commerce share epi evidence notify public through firm to contact the distribution documents. or available for (include epi consumer advisory appropriate Determine if additional consumption agency). (coordinate with regulatory agencies lots or ingredients may Firm shall submit epidemiologic agency) and make be contaminated. an RFR. notifications up and down their distribution. (1B) Food item Inform firm and No Consumer Advisory Recall may be Collect necessary NOT in share epi evidence required unless additional required on other distribution documents. commerce or (include epi lots/ingredients identified. products if Determine if additional available for agency). Consider including summary regulatory lots or ingredients may consumption of outbreak/investigation in traceback identifies be contaminated. annual summary (coordinate other potentially with epidemiologic agency). contaminated lots or ingredients. (2) Report of contamination to Reportable Food Registry (RFR) Firm should already Consumer Advisory may be Recall required if Collect necessary be aware; request necessary if product is in food item still in distribution documents. additional commerce or available for commerce or Determine if additional information if consumption AND firm available for lots or ingredients may necessary. hasn’t issued press release consumption; firm be contaminated. to contact FDA Contact epidemiologic District Office agency to determine if any associated illnesses have been reported.
Events that may trigger Regulatory Traceback Actions of Regulatory Agency Contact Firm Issue Consumer Advisory/Press Release (Typically for situations warranting Class 1 Recalls) Recall Required Initiate Regulatory Traceback (1) Specific food/feed item associated with foodborne illnesses or found to be adulterated by laboratory testing or routine inspection and… (1A) Food item still in commerce or available for consumption Inform firm and share epi evidence (include epi agency). Firm shall submit an RFR. Inform firm of the need to notify public through consumer advisory (coordinate with epidemiologic agency) Recall required; firm to contact the appropriate regulatory agencies and make notifications up and down their distribution. Collect necessary distribution documents. Determine if additional lots or ingredients may be contaminated. (1B) Food item NOT in commerce or available for consumption Inform firm and share epi evidence (include epi agency). No Consumer Advisory required unless additional lots/ingredients identified. Consider including summary of outbreak/investigation in annual summary (coordinate with epidemiologic agency). Recall may be required on other products if regulatory traceback identifies other potentially contaminated lots or ingredients. Collect necessary distribution documents. Determine if additional lots or ingredients may be contaminated. (2) Report of contamination to Reportable Food Registry (RFR) Firm should already be aware; request additional information if necessary. Consumer Advisory may be necessary if product is in commerce or available for consumption AND firm hasn’t issued press release Recall required if food item still in commerce or available for consumption; firm to contact FDA District Office Collect necessary distribution documents. Determine if additional lots or ingredients may be contaminated. Contact epidemiologic agency to determine if any associated illnesses have been reported.