FSMA Draft Guidance for Notifying Customers of Hazards That Need to be Controlled

FDA issued a draft guidance that applies to food containing a hazard that must be controlled by a customer that is a further processor (not a consumer). This applies to the FSMA rules for Human Food, Animal Feed, Produce, and FSVP. The guidance titled "Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry " (Link) details how to make a disclosure in documents accompanying food that certain hazards have not been controlled by that entity.  

For example, if Company A is selling pepper to Company B, and that pepper had not been treated to eliminate Salmonella (which Company A has identified as a potential hazard), Company A would need to disclose on paperwork / documentation that "the pepper was not processed to adequately reduce the presence of microbial pathogens". 

So what are the documents of the trade? It has to be something the manager in charge of food safety is likely to read: "documents accompanying the food, in accordance with the practice of the trade." See 21 CFR 117.136(a)(2)(i), (a)(3)(i), and (a)(4)(i). This allows for the disclosure statement to be provided using a wide variety of types of documents that accompany the food, such as labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read."   " It is permissible, for the purposes of the requirements of the part 117 disclosure statement, to use labeling that includes a disclosure statement such as "not processed to control microbial pathogens" and then directs the recipient to a website for additional information about those microbial pathogens."

How does it need to state the hazards?  "For biological hazards, we will consider a manufacturing/processing facility that describes the "identified hazard" using a general term (e.g., "microbial pathogens," "microorganisms of public health significance") rather than a specific biological hazard (e.g., Salmonella or Listeria" 

For a chemical or physical hazard, the statement must be more specific.  "For chemical and physical hazards, a manufacturing/processing facility that chooses to not control chemical and physical hazards and to rely on its customers to do so, would be subject to the requirements of the part 117 disclosure statement. We expect such a facility to describe the identified chemical or physical hazard using a specific term (e.g., "mycotoxins," "aflatoxin," "stones") that adequately communicates the key safety information regarding the chemical or physical hazard that needs to be controlled."

Again, this is only needed when the supplier identifies a hazard and is relying on their customer (non-consumer) to control that hazard.