If your business will be affected by the Food & Drug Administration’s proposed Food Traceability Rule, there is no time like the present to lay the groundwork for the increased record-keeping.

The proposal’s goal is for food growers and suppliers to keep specific information (what it is calling key data elements, or KDEs for short) on hand to assist the FDA during an outbreak, recall, or other threat to public health.

To be clear, the FDA doesn’t care about how or where you’re keeping the records. Go ahead and keep the ‘ole notebook with the data in it if you want. However, the rule will require that suppliers hang on to the data for two years, and when the FDA asks for it, you must supply the information in a searchable spreadsheet within 24 hours.

Here are some ways to prepare.

1. EDUCATE YOURSELF

Education is key. Understand the food categories listed in What is the Food and Drug Administration’s Proposed Food Traceability Rule? and ask questions if you’re unsure if your products will be affected by the rule. It will take time to get your questions answered and to figure out your next steps.

The FDA has provided extensive information on its website about every aspect of the proposal.

2. GET AUTOMATED

Next, ask the questions about how to automate your process. Let this rule be the jumpstart to push your operation ahead digitally, if you’re not quite there yet. Start to keep track of the data now, so when it comes time to comply, you are ahead of the game. 

“For many small suppliers, the rule provides a timely opportunity to automate information gathering to support the requirements,” says Siobhan O’Bara, Senior Vice President at GS1 US. (Source: Preparing for Traceability Regulations and Supply Chain Digitization.)

3. INVEST IN EDI

Take your automation to the next level with EDI.  A fully integrated electronic data interchange (EDI) system in place makes the data exchange with your trading partners completely automatic — which means it will be much simpler to comply with the FDA’s new rule.

Yes, this costs money, but it’s an investment that will pay off. Not only will you feel secure in your company’s adherence to the new rules, but you will gain other benefits. Automation means the removal of human error, quicker inventory movement, and fewer chargebacks from grocers. You’ll save money on all of those fronts and being able to nip a catastrophic outbreak in the bud is priceless!

(For more about how EDI can help in the grocery industry, see my article, From Farm to the Cloud to Table.)

If you’re interested in a full-service EDI solution, get in touch with us by calling 844-265-3777 or emailing info@boldvan.com.

4. UNDERSTAND THE FIVE CRITICAL TRACKING EVENTS

There are five “critical tracking events” (CTEs) the FDA is seeking to track.

• Growing — This is pretty self-explanatory. For products such as fruits and vegetables, growing is generally the first step in the supply chain.
• Receiving — This event occurs when food is received by a customer (other than a consumer) at a defined location after being transported from another defined location. In addition to the general KDEs for receiving, “first receivers” would need to establish and maintain additional KDEs. The FDA defines a first receiver as “…the first person (other than a farm) who purchases and takes physical possession of a listed food. Only foods that are originated (i.e., grown, raised, caught, or, in the case of a non-produce commodity such as eggs, harvested) can have a first receiver … We are proposing this category in part because on-farm activities can involve movement of a food between different entities (e.g., growers, harvesters, coolers) without sale of the food, and the relevant business relationships can be complex.”
• Creating — This is the manufacturing or processing of an FTL food product using only ingredient(s) that are not on the Food Traceability List. The FDA says this does not include originating or transforming a food.
• Transformation — This CDE involves changing a food item on the FTL, its package, and/or its label (regarding the traceability lot code or traceability product identifier), such as by combining ingredients or processing a food (e.g., by cutting, cooking, commingling, repacking, or repackaging).
• Shipping — a CDE when a food item is arranged for transport (e.g., by truck or ship) from a defined location to another location at a different farm, a first receiver, or a subsequent receiver.