Product tracing is an essential element of the Food Safety Modernization Act.  Documenting your production on up through the chain of suppliers and down through distributors and other producers to retailers facilitates tracking and sourcing in the event of contamination or an outbreak. In case you’re curious, it’s at Section 204.

An equally important component of that chain of tracing is passing necessary information between the tiers of your chain to ensure delivery of any necessary information like uncontrolled hazards such as microorganisms or identify that a food is not processed.

To help with this issue, the FDA has released a draft guidance entitled:

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

There are four rules impacted by the guidance:

Each of these rules mandates that a disclosure statement, in documents accompanying food, come with the produce whenever the manufacturer/processor has not controlled hazards or is relying on another down the chain of distribution to take care of the hazard. One method for disclosing that is offered under the guidance is use of a particular statement “not processed to control [identify hazard]” – which should be disclosed in the documents accompanying the product.  By way of example, under the produce safety regulation, an example given is that the disclosure would state “not processed to adequately reduce the presence of microorganisms of public health significance.  

Because the disclosure “must be made in documents accompanying the food in accordance with the practice of the trade” – a wide variety of types of documents are cited under the guidance as potentially acceptable:  “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.”

What the guidance states is not acceptable: “it is not sufficient to reference a website in a document of the trade without including the disclosure statement”  additionally, the guidance recommends against “ documents such as contractual agreements, letters of guarantee, specifications, or terms and conditions be used to communicate the information required … Such documents generally are not specific to a particular shipment, and some of these documents may not be available to the customer’s food safety manager.”

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

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