Draft Guidance Addresses Suppliers’ Disclosure of Uncontrolled Hazards in Foods 

October 30, 2016

By Ricardo Carvajal

FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled.  A disclosure requirement is included in four of the FSMA rules, namely the preventive controls rule for human food, the preventive controls rule for animal food, the produce safety rule, and the foreign supplier verification program (FSVP) rule.   Because of rolling compliance dates for the rules, the disclosure requirement is not yet in effect for many suppliers.

With respect to the specificity of the disclosure required under the human and animal food preventive controls rules and the FSVP rule, FDA would consider acceptable a general disclosure for biological hazards (e.g., “microbial pathogens” as opposed to “Salmonella”), but not for chemical or physical hazards.  Those hazards would need to be disclosed in more specific terms (e.g., “mycotoxins” for that type of chemical hazard, and “stones” for that type of physical hazard).  As to the method of disclosure, the rules require that the disclosure be made in documents that accompany the food, “in accordance with the practice of the trade.”  According to the draft guidance, FDA would consider acceptable providing the disclosure in documents such as “labels, labeling, bill of lading, shipment-specific certificates of analysis, and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.”  Methods of disclosure that are unlikely to pass muster include references to websites, as well as documents such as “contractual agreements, letters of guarantee, specifications, or terms and conditions” because those types of documents usually aren’t shipment-specific, and might not be seen by a customer’s food safety manager.

FDA’s recommendations with respect to the disclosure required under the produce safety rule parallel the recommendations summarized above, but are silent with respect to disclosure of chemical and physical hazards because that rule does not require their control.

Comments on the draft guidance are due by May 1, 2017.