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In September 2015, the CDC announced an investigation into an outbreak of Salmonella infections linked to imported cucumbers from Mexico. Since then, the infection has spread to 39 states affecting 888 people. To its credit, Andrew and Williamson Fresh Produce has issued two voluntary recalls as a result of the investigation, but this is a great case of why the FDA has passed section 301 of the Food Safety Modernization Act (FSMA) regulation, the Foreign Supplier Verification Program (FSVP).
According to the FDA, 15 percent of the U.S. food supply, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables, is imported. Therefore, establishing a preventative process to keep Americans protected from foreign foodborne illnesses, like the Salmonella outbreak caused by cucumbers from Mexico, is critical.
The FSVP, an important part of FSMA, is the FDA’s solution to address this issue. FSVP requires that importers perform varying levels of risk-based activities to verify that food imported into the U.S. has been handled in a manner that meets applicable U.S. safety standards. The goal is to proactively catch imports that could potentially be contaminated before they enter the U.S.
Under FSVP, importers will be faced with enormous responsibility, which will be challenging for companies who do not have experience managing suppliers to the necessary detail required by law. Importers will now be responsible for ensuring that the foreign suppliers they are working with meet the same safe food handling and production standards required for food handling and manufacturing within the U.S. This includes:
- Determining known or reasonably foreseeable hazards with each food;
- Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance;
- Approving suppliers and determining appropriate supplier verification activities; and
- Conducting corrective actions.
The following is a recommended to-do list for companies needing to comply with FSVP.
- Establish a global catalog of all the suppliers, supplier sites, importers, and importer sites you receive ingredients from: Food and beverage companies will need to know where the food or ingredients they are importing are actually produced. This will be a challenge for organizations that simply capture the broker or the parent company of the imported product, as that will not give the level of visibility required when it comes time to do a risk assessment or audit of the actual manufacturing or handling site.
- Organize all of the food safety documents and certifications required from suppliers and importers: One of the easiest way to ensure compliance is to make sure all supplier and importer certifications, as well as the key documents sent with each shipment (certificate of analysis, lab results, safe handling) are easily accessible during an FDA audit. Leveraging a supplier document control solution as part of a quality management system can greatly help here.
- Perform regular supplier and importer risk assessments.
- Schedule auditing of supplier sites and importer sites: Based on the results of the risk assessment, determine if an audit of the importer manufacturing or handling site is required. Be sure to keep record of the audits performed and the status of any corrective actions that were sent to the supplier as result of the audit. This will significantly ease the burden of responding to an FDA audit, as well as reduce the risk of shipments being delayed in customs.
- Remain in continuous communication with suppliers and importers to stay up to date on incident follow-up, corrective action, supplier document requests, and specification changes: Ideally, this would be accomplished through a supplier quality management portal, reducing the risk of lost communication often found when interaction with the supplier is typically done via phone and email.
- Implement a system that provides alerts and notifications when a supplier or importer is out of specification or behind on action requests: This system should also ensure that audit programs and any follow-ups are being executed in a timely manner, and if they are not, that all parties involved are notified.
- Leverage data for supplier and importer analysis: Utilize reporting and analytics to monitor supplier performance and to determine if the safety programs put in place are effective.