The Food Safety Modernization Act (FSMA) shifts the focus of federal regulators, especially the FDA, from reacting to food contamination to preventing it. The first major upgrade to America’s food protection system since the 1930s, FSMA gives the FDA sweeping new powers to regulate how food is grown, imported and stored.
Prompted by the escalation of food-borne illnesses and costly food recalls in recent years, FSMA’s mandate to protect the public will certainly impact food warehouses and food logistics providers.
The initial guidance that President Obama signed into law in 2011 is essentially a blueprint. FSMA requires the FDA to undertake more than a dozen rulemakings and issue over ten guidance documents, as well as an array of reports, plans, notices, and other information. Public comment on revised provisions are still under review, but the comment period closed on December 15, 2014.
Publication of revised guidelines is therefore imminent, and most businesses will be required to be in compliance within one year after publication of the final rule. Now is the time to get ready for the new rules.
FSMA specifically emphasizes the role that warehouse and logistics providers play to keep food safe. All FDA registered facilities, which includes warehouses and distribution centers, will be required to implement preventive controls.
Though the specifics of these controls are not yet spelled out in their entirety, there is no doubt that warehouses and others in the food supply chain will be mandated to provide traceability and recall of goods from raw ingredients to final product. This is essential for compliance with lot traceability requirements to support efficient recalls.
When a recall occurs – and they will – all partners in the food supply chain will need to demonstrate complete visibility and detailed tracking capabilities at the lot level. Is your warehouse management system (WMS) up to the task?
Inability to prove basic FSMA compliance for recall purposes is likely to hurt your business, as retailers and manufacturers will seek warehouses that can provide traceability to support recalls as part of their own FSMA compliance efforts. Beyond that, there could be further repercussions such as FDA fines and sanctions.
Depending on the severity of a violation, penalties could range up to pulling your FDA registration, which would put you out of business. Other FDA enforcement actions could include warning letters and mandatory recalls. Worse than the sanction itself could be the resulting brand and reputational damage to your operation.
If you are currently unable to track and trace any item by lot number, you will need to bring these traceability capabilities online within the next year or so. You will probably need to prove compliance to retailers, manufacturers, and other supply chain partners well before you need to demonstrate it to the FDA.
To learn how a family-owned food manufacturer achieved seamless inventory accuracy to meet the needs of large retailers in only five weeks, while achieving significant cost savings, download our Arthur Schuman case study.
To start a conversation with WMS experts on how to bring lot-level traceability online quickly and cost-effectively, contact Accellos.