FDA has released draft guidance for industry regarding suppliers’ disclosure of uncontrolled hazards in foods as required by four rules implementing the Food Safety Modernization Act (FSMA).

• As previously covered on this blog, over the past several months, FDA has issued guidance documents to support the implementation of various FSMA requirements, see e.g., here and here.

• On October 28, 2016, FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled.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—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.  The draft guidance reflects FDA’s current thinking on how to describe the hazard under each of the four rules, and which documents the Agency considers to be “documents of the trade” for the purpose of the statements accompanying the food.  Key takeaways from the guidance include:

  • Under the human and animal food preventive controls rules and the FSVP rule, FDA would consider a general disclosure for biological hazards (e.g., “microbial pathogens” as opposed to “Salmonella”) to be adequate, but not for chemical or physical hazards.  FDA expects chemical or physical hazards to be disclosed in more specific terms (e.g., “mycotoxins”, “aflatoxin”, “stones”).

  • With respect to the appropriate method of disclosure, FDA expects the disclosures to be made via 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”.

  • The disclosure requirements under the produce safety rule align with those applicable to human and animal food preventive controls rule and the FSVP rule except that the draft guidance does not specifically address chemical and physical hazards as these are not required to be controlled under the produce safety rule.

• Comments submitted to FDA by May 1, 2017 will be considered in preparing the final version of the guidance.