Understanding US FDA Foreign Supplier Verification Program (FSVP)

Table of Contents: 

• US Foreign Supplier Verification Program (FSVP)
• Improving US Foreign Supplier Verification Program Compliance
• CrimsonLogic Solutions for United States Foreign Supplier Verification Program
   

The U.S. Food and Drug Administration (FDA) issued a final rule requiring U.S. importers to have Foreign Supplier Verification Programs (FSVP). The FSVP determines whether FDA-regulated foods imported into the U.S. meet safety standards for production. The FSVP focuses on preventing contamination of food products instead of reacting to problems after they occur. These include preventive controls for facilities that manufacture, process, pack and hold human and animal food.

The rules apply to domestic food producers and foreign food producers who export to the U.S. All FDA-regulated products are covered, with some exceptions: juice, fish, seafood, small quantities of food for research purposes and personal consumption, some alcoholic beverages, and some meat, poultry and egg products covered under different FDA rules.

The rule impacts importers the most. Importers must develop, maintain, and follow an FSVP for each food product imported, unless an exemption applies. A qualified person must develop the FSVP and perform FSVP activities, conduct hazard analysis (biological, chemical, physical), and evaluate risks associated with the food and foreign supplier, including food safety practices and procedures, food safety performance history, compliance, supplier verification and annual audits.

The FSVP importer is considered the U.S. owner or consignee of the imported food. If there is no U.S. consignee at time of entry, the FSVP importer is the U.S. representative of the foreign owner.

Improving US Foreign Supplier Verification Program (FSVP) Compliance

While there are systems in place to prevent the contamination of food across the supply chain at home, it can be difficult to monitor the supply chain of foreign food importers. The FDA has deployed the FSVP to improve importer accountability and processes for tracking red flags, identifying suppliers, and ensuring that food processing meets the FDA’s safety and preventive standards.

For importers and businesses, the FSVP will mean the introduction of processes to keep up with customs filing, reporting requests and new regulations. The FSVP importer is considered the U.S. owner or consignee of the imported food. If there is no U.S. consignee at time of entry, the FSVP importer is the U.S. representative of the foreign owner.

Technology plays a critical role in streamlining FSVP processes, keeping the flow of trade efficient, strengthening the food supply chain, and easing the burden on importers. Technology can make it easier for food importers, customs brokers, and businesses to comply with the FDA’s new food safety standards by:

Improving supply chain visibility. The right technology provides a comprehensive picture of the supply chain, helping food importers identify and trace supplier networks and easily find D&B D-U-N-S numbers. For example, software that tracks the movement of goods across borders and stores product details and HS codes greatly improves visibility.

Monitoring supplier networks. The FSVP emphasizes periodic verification of food suppliers and manufacturers. Suppliers must undergo regular audits in order for the FDA to conduct hazard analysis effectively. Complex supply chain networks, large number of SKUs per product and constantly evolving ecosystems (fluctuating costs and demand) can make supplier identification difficult. FSVP software can streamline the management of supplier networks and keep costs low.

Automating FDA entries. FDA depends on information in entry filings to control food imports. If a food product is subject to FSVP, self-filers or customs brokers must include the importer’s name, address, email address and D-U-N-S number. If any of these data elements are unknown, the shipment is highly at risk for scrutiny. FSVP solutions can automate the population of importer data to streamline entries and security filings.

Streamlining entry and PGA data filing. FSVP software greatly improves the speed of electronic data transmission and the accuracy of submitted information, leading to faster processing and clearance of food shipments. Filers receive and respond to real-time messages, including rejections, expirations, exams, requests for additional documentation and more.

Streamlining D-U-N-S lookup. Under the FSVP, importers must submit a D&B D-U-N-S Number for each line entry food product imported into the U.S. The FDA chose D-U-N-S numbers to identify importers by a common reference system. Businesses working with a large network of importers use software to find D-U-N-S numbers quickly for network members and populate the numbers into the required forms.

CrimsonLogic Solutions for United States Foreign Supplier Verification Program

Under the rules, American food importers are responsible for understanding requirements and ensuring compliance. On a practical level, this means maintaining appropriate processes and using the right technology. As early as possible, trade participants are encouraged to prepare for FSVP implementation to avoid problems, penalties, and delayed food shipments.

CrimsonLogic provides FSVP Agent Service if there is no U.S owner or consignee at time of entry. Additionally, if there is a U.S owner or consignee at time of entry, CrimsonLogic can provide FSVP Training and Consultations to importers who are looking to perform risk-based foreign supplier verification activities.

Technology streamlines the transmission of required electronic information from self-filing importers and customs brokers to U.S. Customs and Border Protection (CBP), Canada Border Services Agency (CBSA), FDA, other regulatory agencies. Importers that are unable to develop their own software can partner with a trusted technology provider to better prepare for FSVP.

The right technology provider can help importers and trade participants develop a holistic strategy for customs compliance and processing while reducing costs. CrimsonLogic is a leader in global trade facilitation, providing advanced comprehensive solutions to help businesses optimize compliance and keep up to date with changing regulations.

CrimsonLogic FDA Prior Notice solution streamlines the preparation and submission of Prior Notices through a user-friendly interface. CrimsonLogic FDA PN allows users to view and track FDA responses directly and upload shipment data easily through integration. Meanwhile, CrimsonLogic ACE ABI helps importers, customs brokers and qualified participants file required import data with customs.