October 31, 2016

FDA Releases Draft Guidance on Customer Disclosure Statements for Uncontrolled Hazards in Human and Animal Foods

The U.S. Food and Drug Administration (FDA) released draft guidance on October 28, 2016, offering insight into customer disclosure statements required for certain food and feed products that have not, under the Food Safety Modernization Act (FSMA), controlled for identified hazards. The draft guidance outlines how entities should describe these hazards in customer disclosures, as well as the types of documents in which such statements should be included. Notably, the draft guidance does not discuss requirements related to FSMA written customer assurances. 

FSMA requires food and feed manufactures/processors, importers of food and feed products, and fresh produce growers to identify certain hazards (i.e., physical, chemical and biological hazards) that require preventive controls and to develop and implement the appropriate preventive controls. Under rule provisions outlined below, food manufactures, importers and produce growers/handlers are not required to implement preventive controls provided they notify downstream customers that the foods are “not processed to control for [the identified hazard].” The applicable regulations are found within:

  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (Human Food)
  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Animal Food)
  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP)
  • Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption (Produce Safety) (note: the produce exemption applies only to microbiological hazards)

How Hazards Should Be Described in Disclosure Statements

The draft guidance discusses how hazards — specifically biological, physical and chemical hazards — should be described in customer disclosure statements. Generally, FDA feels that disclosure statements will mostly be required for biological hazards, since most physical hazards (e.g., rocks or other foreign material) and chemical hazards (e.g., mycotoxins) will “likely be controlled by the first manufacturing/processing facility in the supply/distribution chain.” If not, FDA expects entities will use specific terms to identify the uncontrolled hazards (such as “aflatoxins” or “stones”) that downstream customers need to address.

For biological hazards, FDA proposes that customer disclosure statements identify biological hazards using general terms such as “microbial pathogens,” or “microorganisms of public health significance,” instead of identifying specific biological hazards such as Salmonella, E. coli or Listeria monocytognes. FDA regards a statement such as “the [food or feed] has not been processed to control for [microbial pathogens or microorganisms] of public health significance” to be an adequate disclosure that the product will have to undergo some sort of kill step or sanitizing step to control for the identified hazard.

FDA emphasizes that any establishment — regardless of whether it is subject to CGMP or preventive controls requirements — receiving foods accompanied by disclosure statements for microbial pathogens must control for such hazards before the food reaches consumers. Therefore, receiving facilities such as restaurants and grocery stores, which are not generally subject to FSMA requirements, are reminded that they are “responsible for taking appropriate steps to ensure biological hazards” are controlled. A similar reminder for chemical and physical hazards is notably missing.    

What Kind of Documents Should Disclosure Statements Be Included In?

FDA’s regulations require customer disclosure statements to be made in “documents accompanying the food, in accordance with the practice of the trade.” The Guidance clarifies that “documents of trade” means labels, labeling, bills 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.” FDA does not regard references to website-hosted disclosures as sufficient. Similarly, FDA does not recommend including customer disclosures in documents that are not shipment-specific or ordinarily available to food safety managers, such as supply agreements, general terms and conditions sheets, specifications documents or letters of guarantee. The general intent is that customer disclosure statements should be placed in documents accompanying product shipment so that food safety personnel will have immediate notice of uncontrolled hazards for incoming food or feed shipments.

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