Currently, providing information in response to the new data elements is voluntary. However, responses to these elements will become mandatory later in 2012, FDA said. The additional elements are:
• The reason the food has been determined to be reportable (agent);
• A description of the root cause of the reportable food (if applicable);
• A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected;
• Whether or not the submitter believes all of the reportable food has been removed from commerce;
• A brief description of the corrective actions taken to avoid repeating the reportable event;
• The commodity type of the reportable food;
• The dates that the product was manufactured;
• Whether or not the reportable food underwent treatment to reduce microorganisms;
• A brief description of the microbial reduction treatment;
• Whether or not a bacterial isolate is available for FDA collection;
• For reportable foods intended for animal consumption, the animal species that the reportable food was intended to be consumed by;
• For reportable foods intended for animal consumption, the life stage of the animal that the reportable food was intended to be consumed by;
• Whether the responsible party has notified all of its immediate previous sources (suppliers) of the reportable food (if applicable); and
• Whether the responsible party has notified all of its immediate subsequent recipients (customers) for the reportable food (if applicable).
