FSMA Supply Chain Disclosure Rules

A little noticed provision of the new Food Safety Modernization Act (FSMA) gives food companies some degree of relief from having to implement costly preventive food safety controls — as long as they disclose to their supply partners that their product may contain potentially dangerous food hazards that will have to be dealt with.

The provision went into effect earlier this year under Section 21 CFR 117.136 of the FSMA regulations. It allows a manufacturing or processing facility to sell product containing a known hazard to the next business in its distribution network as long as both companies, the sender and receiver, have written assurances from each other that the product will be handled to remove the hazard before it reaches the retail market.

(Note that the word “customer” is not synonymous with “consumer,” as in an end-use household. A customer in FSMA parlance is a supply chain partner that purchases a food product, processes it, and then moves it on through the distribution system).

A good example of how these provisions will work are items such as coffee or cocoa beans that would likely not be eaten without further processing. The first entity in the distribution that handles the beans would not be required to have a hazard control plan in place as long as it was selling the beans to a customer (say, a bean processor) that does have a preventive control plan to remove any potential health hazard.

In essence, the disclosure provisions incorporated in FSMA establishe interwoven and binding food safety checks and balances among various players in the food supply chain. The procedures apply to food products, food ingredients, and produce as well as to foreign suppliers importing food products or ingredients into the United States.

The critical component in this procedure is proper notification between suppliers and customers, according to the Food and Drug Administration. In its rule making, the FDA emphasized that a businesses adquately disclose known or potential food safety hazards in products.  Written documentation must accompany all food shipments. Additionally, the customer obtaining product with a hazard declaration must provide the supplier with written assurances that it has an established preventive control process to remove the hazard. These assurances — from supplier to customer and from customer to supplier — must be disclosed annually.

Bread productionBottom line: if you are a manufacturer or processor working with business partners who have given you written assurances that they have a preventive control plan in place, you can sell product to those partners as long as you have written assurances that the potential hazard will be eliminated before the food reaches the end-use consumer.

FDA requires the disclosure must be made in “documents accompanying the food in accordance with the practice of the trade.”  This allows for 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 shipments that the customer’s food safety manager is likely to see and read. However, contractual agreements, letters of guarantee, specifications or terms and conditions of use are not considered adequate since these documents are not applicable to particular shipments.

Importantly, the FDA is soliciting additional public comments on these customer notification provisions. After it goes through the comments, it will issue a “guidance” document intended to help businesses better understand their disclosure requirements.






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